Development of Therapeutics and Vaccines
EMA published new safety updates for COVID-19 vaccines (12/05)
The European Medicines Agency (EMA) monitors the safety of COVID-19 vaccines authorised in the European Union (EU) extremely carefully. This enables the detection of any rare side effects that may emerge once many millions of people are vaccinated.
More than 870 million doses of vaccines have been given to people in the EU and European Economic Area (EEA), as of late April 2022.
The authorised COVID-19 vaccines are safe and effective. They were evaluated in tens of thousands of participants in clinical trials and have met EMA’s scientific standards for safety, efficacy and quality.
The safety of COVID-19 vaccines is continuously monitored and evaluated.
Monthly safety updates give an overview of the PRAC’s regular safety evaluation.
The vast majority of known side effects of COVID-19 vaccines are mild and short-lived.
Serious safety problems are extremely rare.
ICMRA published a report on the global regulatory response to the Omicron variant (21/01)
International regulators have published a report highlighting their discussions on the effectiveness of current vaccines against the COVID-19 Omicron variant, regulatory requirements for a variant vaccine and considerations on clinical study design. The workshop on the global response to the COVID-19 Omicron variant was organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) and took place on 12 January 2022.
Reviewing data on the impact of Omicron, the participants concluded that current vaccines offer less protection against infection and mild disease caused by this variant. However, vaccination continues to offer considerable protection from hospitalisation and severe COVID-19 with Omicron, especially after a booster dose. It is becoming increasingly clear that a booster dose is needed to extend vaccine protection.
EMA published an update on the use of mRNA vaccines during pregnancy (18/01)
Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue to spread in EU/EEA countries. EMA’s COVID-19 task force (ETF) highlights the growing evidence indicating that mRNA COVID-19 vaccines do not cause pregnancy complications for expectant mothers and their babies.
The task force undertook a detailed review of several studies involving around 65,000 pregnancies at different stages. The review did not find any sign of an increased risk of pregnancy complications, miscarriages, preterm births or adverse effects in the unborn babies following mRNA COVID-19 vaccination. Despite some limitations in the data, the results appear consistent across studies looking at these outcomes.
EMA updated the risk management plan for COVID-19 Vaccine Janssen
The PRAC has recommended a change to the product information for Vaxzevria and COVID-19 Vaccine Janssen to include a warning to raise awareness among healthcare professionals and people receiving the vaccines of very rare cases of transverse myelitis (TM) reported following vaccination. TM has also been added as an adverse reaction of unknown frequency.
EMA published an update on the effectiveness of COVID-19 vaccines against the Omicron variant
Although Omicron appears to be more infectious than other variants, studies from South Africa, UK and some EU countries show a lower risk of being hospitalised after infection with Omicron.
Results from recently published studies show that vaccine effectiveness against symptomatic disease is lower for Omicron than for other variants and tends to wane over time.
However, these studies also show that vaccination continues to provide a high level of protection against severe disease and hospitalisation linked to the Omicron variant. The latest evidence also suggests that people who have had a booster dose are better protected than those who have only received their primary course.
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EMA started evaluating a conditional marketing authorisation application for Pfizer's COVID-19 treatment Paxlovid
EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine Paxlovid from Pfizer.
The application is for the treatment of mild-to-moderate COVID 19 in adult and adolescent patients (12 years of age and older weighing at least 40 kg) who are at high risk of progression to severe COVID 19.
EMA will assess the benefits and risks of Paxlovid under a reduced timeline and could issue an opinion within weeks, depending on whether the data submitted are sufficiently robust and whether further information is required to support the evaluation.
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Novavax’s COVID-19 vaccine Nuvaxovid now authorised across the EU (20/12/2021)
EMA has recommended granting a conditional marketing authorisation for Novavax’s COVID-19 vaccine Nuvaxovid (also known as NVX-CoV2373) to prevent COVID-19 in people from 18 years of age.
Nuvaxovid is the fifth vaccine recommended in the EU for preventing COVID-19. It is a protein-based vaccine and, together with the already authorised vaccines, will support vaccination campaigns in EU Member States during a crucial phase of the pandemic.
As of 20 December 2021, Nuvaxovid is authorized across the EU, following the granting of a conditional marketing authorisation by the European Commission.
EMA recommends authorisation of antibody medicine Xevudy (16/12/2021)
EMA’s human medicines committee (CHMP) has recommended authorising the monoclonal antibody Xevudy (sotrovimab) for the treatment of COVID-19. The applicant is GlaxoSmithKline Trading Services Limited, who developed the medicine together with Vir Biotechnology. Xevudy is the third monoclonal antibody recommended in the EU for treating COVID-19 and follows the approval of Regkirona and Ronapreve in November. Monoclonal antibodies are proteins designed to attach to a specific target, in this case the spike protein of SARS-CoV-2 (the virus that causes COVID-19), which the virus uses to enter human cells.
EMA and the ECDC provided recommendations on using different COVID-19 vaccines, both during initial vaccination courses and as boosters (07/12/2021)
The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) continue to urge all EU citizens to get fully vaccinated and to adhere to recent recommendations on booster vaccination.
In line with measures already taken by many Member States, an increasing number of clinical studies, supported by real world evidence, have now looked at the possibility of using two different COVID-19 vaccines, either for the first and second doses of a primary (initial) course, which is known as heterologous primary vaccination, or using a third dose of a different COVID-19 vaccine as a booster 3 to 6 months after a primary vaccination course (heterologous boosting).
Evidence from studies on heterologous vaccination suggests that the combination of viral vector vaccines and mRNA vaccines produces good levels of antibodies against the COVID-19 virus (SARS-CoV-2) and a higher T-cell response than using the same vaccine (homologous vaccination) whether in a primary or booster regimen.
EMA recommends approval for use of RoActemra in adults with severe COVID-19 (06/12/2021)
EMA’s human medicines committee (CHMP) has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of adults with COVID-19 who are receiving systemic treatment with corticosteroids and require supplemental oxygen or mechanical ventilation.In reaching its conclusion, the CHMP evaluated data from a main study involving 4,116 hospitalised adults with severe COVID-19 who required extra oxygen or mechanical ventilation and had high levels of C-reactive protein in the blood (indicating inflammation).
The study showed that treatment with RoActemra given by infusion in addition to standard treatment reduces the risk of death when compared with standard treatment alone.
EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001) (02/12/2021)
EMA’s human medicines committee (CHMP) has started a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva.
The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes COVID-19, and may help protect against the disease.
EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for a formal marketing authorisation application.
ICMRA and WHO map out flexibilities used by regulators to respond to the COVID-19 pandemic (03/12/2021)
The International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have reviewed some of the practices applied by regulatory authorities worldwide to respond to the challenges faced during the COVID-19 pandemic.
In the context of COVID-19, regulatory authorities have adapted some of their regulatory frameworks and streamlined their procedures while ensuring a high level of quality, safety and efficacy of the medicinal products made available to patients around the world. The measures aimed at addressing the urgent need for medicines and vaccines to tackle COVID-19 but also at dealing with the constraints posed by the pandemic, e.g. travel restrictions or lockdowns.
EMA's PRAC provided an update on the risk of myocarditis and pericarditis with mRNA vaccines (03/12/2021)
EMA’s safety committee (PRAC) has assessed recent data on the known risk of myocarditis and pericarditis following vaccination with COVID-19 vaccines Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna). This review included two large European epidemiological studies. One study was conducted using data from the French national health system (Epi-phare) and the other one was based on Nordic registry data. Based on the reviewed data, the PRAC has determined that the risk for both of these conditions is overall “very rare”, meaning that up to one in 10,000 vaccinated people may be affected. Additionally, the data show that the increased risk of myocarditis after vaccination is highest in younger males.
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11 (25/11/2021)
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11. The vaccine, developed by BioNTech and Pfizer, is already approved for use in adults and children aged 12 and above.
In children from 5 to 11 years of age, the dose of Comirnaty will be lower than that used in people aged 12 and above (10 µg compared with 30 µg). As in the older age group, it is given as two injections in the muscles of the upper arm, three weeks apart.
The efficacy of Comirnaty was calculated in almost 2,000 children from 5 to 11 years of age who had no sign of previous infection. In this study, the vaccine was 90.7% effective at preventing symptomatic COVID-19 (although the true rate could be between 67.7% and 98.3%).
The CHMP therefore concluded that the benefits of Comirnaty in children aged 5 to 11 outweigh the risks, particularly in those with conditions that increase the risk of severe COVID-19.
EMA recommends approval for use of RoActemra in adults with severe COVID-19 (06/12/2021)
EMA’s human medicines committee (CHMP) has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of adults with COVID-19 who are receiving systemic treatment with corticosteroids and require supplemental oxygen or mechanical ventilation.
The medicine, marketed by Roche Registration GmbH, is already approved in the EU for treating the inflammatory conditions rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis and cytokine release syndrome (CRS).
EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid (17/11/2021)
EMA has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known as NVX-CoV2373). The assessment will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine.
Such a short timeframe is only possible because EMA has already reviewed a substantial portion of the data on the vaccine during a rolling review. During this phase, EMA’s human medicines committee (CHMP) assessed data from laboratory studies (non-clinical data), some information on the quality of the vaccine and the way it will be produced, and data on its safety, immunogenicity (how well it triggers a response against the virus) and efficacy against COVID-19 from clinical studies in adults.
EMA evaluating data on booster dose of COVID-19 Vaccine Janssen (22/11/2021)
EMA has started evaluating an application for the use of a booster dose of COVID-19 Vaccine Janssen to be given at least two months after the first dose to people aged 18 years and older.
EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data submitted by the company that markets the vaccine. These data include results from more than 14,000 adults who received a second dose of COVID-19 Vaccine Janssen or placebo (a dummy treatment) two months after the initial dose.
The CHMP will recommend whether updates to the product information are appropriate. The outcome of this evaluation is expected within weeks, unless supplementary information is needed, and will be communicated by EMA.
EMA recommends authorisation of two monoclonal antibody medicines (11/11/2021)
EMA’s human medicines committee (CHMP) has recommended authorising Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19. The Committee recommended authorising Ronapreve for treating COVID-19 in adults and adolescents who do not require supplemental oxygen and who are at increased risk of their disease becoming severe. The company that applied for authorisation of Ronapreve was Roche Registration GmbH.
Ronapreve and Regkirona are now authorised in the EU. This follows the granting of marketing authorisations for these products by the European Commission on 12 November 2021.
EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11 (10/11/2021)
EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to children aged 6 to 11.
Spikevax is a vaccine for preventing COVID-19, currently authorised for use in people aged 12 years and older. It contains a molecule called messenger RNA (mRNA) with instructions for producing a protein, known as the spike protein, which is naturally present in SARS-CoV-2, the virus that causes COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2.
The European Commission issued a decision renewing the conditional marketing authorisation for Vaxzevria (10/11/2021)
EMA and Heads of Medicines Agencies update on molnupiravir
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed on the need for additional guidance on COVID-19 treatments in light of rising rates of infection and deaths due to COVID-19 across the EU.
To this end, EMA is reviewing available data on the use of molnupiravir (also known as MK 4482 or Lagevrio) to support national authorities who may decide on the use of this medicine for COVID-19 treatment prior to its authorisation.
While the more comprehensive rolling review is ongoing ahead of a possible application for a marketing authorisation, EMA’s Committee for Medicinal Products for Human Use (CHMP) will provide EU-wide recommendations in the shortest possible timeframe to help national authorities decide on possible early use of the medicine, for example, in emergency use settings.
Molnupiravir is an oral antiviral medicine developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics.
EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
EMA has ended the rolling review of bamlanivimab and etesevimab, two antibodies for the treatment of COVID-19 developed by Eli Lilly Netherlands BV, after the company informed the Agency that it was withdrawing from the process.
The withdrawal was a decision by the company and the reasons can be found in the company’s letter of withdrawal . This means that EMA is no longer reviewing data on these antibodies and will not conclude this review. The company retains the right to request another rolling review or submit a marketing authorisation application in the future.
Comirnaty and Spikevax: EMA recommendations on extra doses and boosters (04/10/2021)
EMA’s human medicines committee (CHMP) has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) may be given to people with severely weakened immune systems, at least 28 days after their second dose.
The recommendation comes after studies showed that an extra dose of these vaccines increased the ability to produce antibodies against the virus that causes COVID-19 in organ transplant patients with weakened immune systems.
Although there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19, it is expected that the extra dose would increase protection at least in some patients. EMA will continue monitoring any data that emerges on its effectiveness.
The product information of both vaccines will be updated to include this recommendation.
EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19 (04/10/2021)
EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Regkirona (regdanvimab, also known as CT-P59) to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19. The applicant is Celltrion Healthcare Hungary Kft.
Regdanvimab is a monoclonal antibody with activity against SARS-CoV-2, the virus that causes COVID 19. Regdanvimab has been designed to attach to the spike protein of SARS-CoV-2. When it attaches to the spike protein, the ability of the virus to enter the body’s cells is reduced. This is expected to reduce the need for hospitalisation in patients with COVID-19.
EMA recommends second Oxford/AstraZeneca dose amid rare blood-clotting concerns (17/09/2021)
The European Medicines Agency still recommends giving a second shot of the Oxford/AstraZeneca vaccine after concluding a review of rare blood-clotting events.
At the European Commission’s request, the agency’s human medicines committee conducted a further analysis of rare blood clots linked to low levels of blood platelets, called thrombosis with thrombocytopenia syndrome or TTS.
The EMA confirmed that countries should continue giving people a second dose of the viral-vector vaccine four to 12 weeks after the first. It added that there is “no evidence” that delaying the second shot decreases the TTS risk.
When countries do use a different vaccine for a second dose, the EMA said that it could not give a “definitive recommendation” on which vaccine should be used. The agency also was unable to identify risk factors that make TTS more likely due to limited data.
Moderna, Novavax working on combination COVID-19 and flu vaccines (09/09/2021)
Moderna and Novavax are each moving ahead withcombination COVID-19 and flu vaccines, the companies said this week.
Moderna’s combination shot is intended to be a booster for both COVID-19 and flu vaccines, while Novavax’s shot would serve as a vaccine for both the flu and COVID-19. The company said Wednesday it had enrolled the first participants in a Phase I/II study of the vaccine.
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty (06/09/2021)
EMA has started evaluating an application for the use of a booster dose of Comirnaty to be given 6 months after the second dose in people aged 16 years and older. Booster doses are given to vaccinated people (i.e. people who have completed their primary vaccination) to restore protection after it has waned.
Separately, EMA is also assessing data from the literature on the use of an additional, third dose of an mRNA vaccine (Comirnaty or SpikeVax) in severely immunocompromised people (i.e., with weakened immune systems). People with severely weakened immune systems who do not achieve an adequate level of protection from their standard primary vaccination may need an ‘additional’ dose as part of their primary vaccination. Read more>>>
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines (02/09/2021)
Based on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued yesterday by the European Centre for Disease Prevention and Control (ECDC). The report also notes that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination.
The European Medicines Agency (EMA) is currently assessing data on additional doses and will consider whether updates to the product information are appropriate. EMA will also be assessing data on booster doses. Read more>>>
WHO’s Solidarity clinical trial enters a new phase with three new candidate drugs (11/08/2021)
The World Health Organization (WHO) has announced the next phase in its Solidarity trial: Solidarity PLUS will enroll hospitalized patients to test three new drugs in hospitalized COVID-19 patients.
These therapies - artesunate, imatinib and infliximab – were selected by an independent expert panel for their potential in reducing the risk of death in hospitalized COVID-19 patients. They are already used for other indications: artesunate is used for severe malaria, imatinib for certain cancers, and infliximab for diseases of the immune system such as Crohn’s Disease and rheumatoid arthritis. Read more>>>
COVID-19 Vaccine Janssen: Guillain-Barré syndrome listed as a very rare side effect (22/07/2021)
Guillain-Barré syndrome (GBS) will be listed as a very rare side effect of COVID-19 Vaccine Janssen and a warning will be included in the product information to raise awareness among healthcare professionals and people taking the vaccine.
GBS is a rare neurological disorder in which the body’s immune system damages nerve cells which can result in pain, numbness and muscle weakness, progressing to paralysis in the most severe cases. Most people fully recover from the disorder.
Although cases of GBS after vaccination with COVID-19 Vaccine Janssen have been reported very rarely, healthcare professionals should be alert to signs and symptoms of GBS, in view of the seriousness of this condition, to allow for early diagnosis, supportive care and treatment.
EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure ( 19/07/2021)
EMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment of COVID-19 in adult patients with pneumonia who are at risk of developing severe respiratory failure (inability of the lungs to work properly).
Kineret is an immunosuppressant (a medicine that reduces the activity of the immune system) currently authorised for the treatment of a number of inflammatory conditions. Its active substance, anakinra, blocks the activity of interleukin 1, a chemical messenger involved in immune processes that lead to inflammation. It is thought that this could also help reduce the inflammation and tissue damage associated with COVID-19. Read more>>>
COVID-19 Therapeutics Strategy: Commission identifies five promising candidate therapeutics (29/06/2021)
Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial (14/06/2021)
Novavax, Inc. announced that NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, demonstrated 100% protection against moderate and severe disease, 90.4% efficacy overall, and met the primary endpoint in its PREVENT-19 pivotal Phase 3 trial. The study enrolled 29,960 participants across 119 sites in the U.S. and Mexico to evaluate efficacy, safety and immunogenicity, with an emphasis on recruiting a representative population of communities and demographic groups most impacted by the disease.
The company intends to file for regulatory authorizations in the third quarter, upon completion of the final phases of process qualification and assay validation needed to meet chemistry, manufacturing and controls (CMC) requirements.
Vaxzevria: EMA advises against use in people with history of capillary leak syndrome (11/06/2021)
EMA’s safety committee (PRAC) has concluded that people who have previously had capillary leak syndrome must not be vaccinated with Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). The Committee also concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk.
Capillary leak syndrome is a very rare, serious condition that causes fluid leakage from small blood vessels (capillaries), resulting in swelling mainly in the arms and legs, low blood pressure, thickening of the blood and low blood levels of albumin (an important blood protein).
EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome (07/06/2021)
EMA’s COVID-19 taskforce (COVID-ETF) is advising healthcare professionals in the EU to consider recommendations by learned societies when assessing people with signs and symptoms of thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria and COVID-19 Vaccine Janssen.
For the management of suspected TTS, especially if no local guideline is available, the taskforce recommends that healthcare professionals consider the ISTH interim guidance on vaccine-induced immune thrombotic thrombocytopenia (VITT), which is based on ongoing international collaboration of healthcare professionals.
The conclusions reached are based on EMA’s safety signal evaluations, which led to updates of the product information for both Vaxzevria and COVID-19 Vaccine Janssen. Healthcare professionals have been informed through direct healthcare professional communications (DHPCs) of the signs and symptoms of TTS with either vaccine, so that people affected can be diagnosed and treated as soon as possible using the available guidelines.
EU regulators develop recommendations to forecast demand of medicines (03/06/2021)
The EU Executive Steering Group on Shortages of Medicines Caused by Major Events has adopted a 
reflection paper which contains recommendations to support forecasting of demand for human medicinal products across the European Union (EU) and also at the national level in exceptional situations like the COVID-19 pandemic, whenever such activity is undertaken.
The methodology is based on pragmatic predictions of demand for certain medicines and encourages the use of the best available information, with an aim to reach the right balance between existing uncertainties with regards to the actual future demand, and the imperative public health need to prepare for a potential major increase in demand.
The reflection paper - developed by an ad hoc working group of experts from EMA, national competent authorities and the European Commission - summarises best practices that can help develop accurate forecasting.
First COVID-19 vaccine approved for children aged 12 to 15 in EU (28/05/2021)
EMA’s human medicines committee has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15. The vaccine is already approved for use in adults and adolescents aged 16 and above.
The trial showed that the immune response to Comirnaty in this group was comparable to the immune response in the 16 to 25 age group (as measured by the level of antibodies against SARS-CoV-2). The efficacy of Comirnaty was calculated in close to be 100% effective at preventing COVID-19 (although the true rate could be between 75% and 100%). Read more>>>
Insufficient data on use of inhaled corticosteroids to treat COVID-19 (27/05/2021)
EMA’s COVID-19 taskforce (COVID-ETF) is advising healthcare professionals that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19.
Although the taskforce found no safety risks from studies so far, it could not exclude the possibility of harm from the use of inhaled corticosteroids in patients with COVID-19 who have normal levels of oxygen. Read more>>>
EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19 (21/05/2021)
EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibody sotrovimab (also known as VIR-7831 and GSK4182136) to treat patients with COVID-19.
The Agency concluded that sotrovimab can be used to treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40 kg) who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19.
More flexible storage conditions for BioNTech/Pfizer’s COVID-19 vaccine (17/05/2021)
EMA’s human medicines committee (CHMP) has recommended a change to the approved storage conditions of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer, that will facilitate the handling of the vaccine in vaccination centres across the European Union (EU).
This change extends the approved storage period of the unopened thawed vial at 2-8°C (i.e. in a normal fridge after taking out of deep-freeze conditions) from five days to one month (31 days). The change was approved following assessment of additional stability study data submitted to EMA by the marketing authorisation holder. Increased flexibility in the storage and handling of the vaccine is expected to have a significant impact on planning and logistics of vaccine roll-out in EU Member States.
Additional measures to allow experts to focus on COVID-19 activities (11/05/2021)
EMA is implementing additional temporary measures to further streamline activities in the European medicines regulatory network to enable experts to deal with an increasing volume of COVID-19-related assessment procedures.
The new temporary measures include:
- All initial marketing authorisation applications (MAAs) for COVID-19 vaccines and therapeutics will continue to be given first priority.
- For initial MAAs for non-COVID-19 products, unless they are advanced therapy medicinal products (ATMPs) or other very complex medicines to be considered by the CHMP, the co-rapporteur will no longer provide a separate assessment report to the rapporteur in the first phase of the evaluation.
- For all applications, there will temporarily no longer be a separate, formally appointed peer reviewer, but the assessment will rely on the intrinsic peer review that is part of the CHMP’s role in the evaluation process. In the case of COVID-19 products, there are additional reviews by the COVID-19 EMA pandemic Task Force (COVID-ETF).
These measures will apply to initial MAAs starting in May 2021.Read more>>>
EMA starts rolling review of sotrovimab (VIR-7831) for COVID-19 (07/05/2021)
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on sotrovimab (also known as VIR-7831 and GSK4182136), a monoclonal antibody developed by GlaxoSmithKline and Vir Biotechnology, Inc. for the treatment of COVID-19.
A separate review of sotrovimab is already underway to provide EU-wide recommendations to support national authorities who may decide on the use of the medicine for COVID-19 prior to marketing authorisation.
Sotrovimab (also known as VIR-7831 and GSK4182136) is a monoclonal antibody with activity against COVID-19. A monoclonal antibody is a type of protein that attaches to a specific structure (called an antigen). Sotrovimab is designed to attach to the spike protein of SARS-CoV-2, the virus that causes COVID-19. When it attaches to the spike protein, the ability of the virus to enter the body’s cells is reduced. This is expected to reduce the need for hospitalisation in patients with COVID-19.
EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated (04/05/2021)
EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co., Ltd. The EU applicant for this medicine is Life'On S.r.l.
EMA will assess the compliance of COVID-19 Vaccine (Vero Cell) Inactivated with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.
COVID-19 Vaccine (Vero Cell) Inactivated is expected to prepare the body to defend itself against infection with SARS-CoV-2. The vaccine contains SARS-CoV-2 that has been inactivated (killed) and cannot cause the disease. COVID-19 Vaccine (Vero Cell) Inactivated also contains an ‘adjuvant’, a substance that helps strengthen the immune response to the vaccine.
EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15 (03/05/2021)
EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to include young people aged 12 to 15.
Comirnaty is a vaccine for preventing COVID-19. It is currently authorised for use in people aged 16 and older. It contains a molecule called messenger RNA (mRNA) with instructions for producing a protein, known as the spike protein, naturally present in SARS-CoV-2, the virus that causes COVID-19. The vaccine works by preparing the body to defend itself against SARS-CoV-2.
EMA will communicate on the outcome of its evaluation, which is expected in June unless supplementary information is needed.
EMA starts evaluating use of Olumiant in hospitalised COVID-19 patients requiring supplemental oxygen (29/04/2021)
EMA has started evaluating an application to extend the use of Olumiant (baricitinib) to include treatment of COVID-19 in hospitalised patients from 10 years of age who require supplemental oxygen.
Olumiant is an immunosuppressant (a medicine that reduces the activity of the immune system). It is currently authorised for use in adults with moderate to severe rheumatoid arthritis or atopic dermatitis (eczema). Its active substance, baricitinib, blocks the action of enzymes called Janus kinases that play an important role in immune processes that lead to inflammation. It is thought that this could also help reduce the inflammation and tissue damage associated with severe COVID-19 infection.
Olumiant was first authorised in the EU in February 2017. More information about the medicine is available.
EMA and ECDC join forces for enhanced post-marketing monitoring of COVID-19 vaccines in Europe (26/04/2021)
The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) today kicked off a new initiative aimed at strengthening post-marketing monitoring of the safety, effectiveness and impact of COVID-19 vaccines in the European Union (EU) and the European economic Area (EEA).
EMA and ECDC will jointly coordinate and oversee a number of observational studies which will be funded from the EU budget and conducted in several European countries. In line with their respective mandates and in collaboration with EU/EEA countries, EMA leads on monitoring the safety, and ECDC the effectiveness, of these vaccines. This work will be supported by a Joint Advisory Board (JAB) to the two Agencies that held its first meeting today.
COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets (20/04/2021)
At its meeting of 20 April 2021, EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC also concluded that these events should be listed as very rare side effects of the vaccine.
In reaching its conclusion, the Committee took into consideration all currently available evidence including eight reports from the United States of serious cases of unusual blood clots associated with low levels of blood platelets, one of which had a fatal outcome. As of 13 April 2021, over 7 million people had received Janssen’s vaccine in the United States. Read more>>>
COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues (14/04/2021)
As announced last week, EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots that occurred in the United States following the use of Janssen’s COVID-19 vaccine. The type of blood clot reported, cerebral venous sinus thrombosis (CVST), occurred in most cases in combination with low levels of blood platelets (thrombocytopenia).
The US FDA and CDC recommended yesterday that the use of the vaccine should be paused while they review six reported cases in the United States. More than 6.8 million doses of the vaccine have been administered.
Janssen has announced their decision to proactively delay the rollout of the vaccine in the EU while investigations continue. The vaccine was authorised in the EU on 11 March 2021 but widespread use of the vaccine within the EU has not yet started. The company is in contact with national authorities, recommending to store the doses already received until the PRAC issues an expedited recommendation.
EMA is investigating all the cases reported and will decide whether regulatory action is necessary. The Agency is working closely with the US FDA and other international regulators.
What do we know about China’s covid-19 vaccines? (09/04/2021)
AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets (07/04/2021)
EMA confirms overall benefit-risk remains positive. EMA’s safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca).
In reaching its conclusion, the committee took into consideration all currently available evidence, including the advice from an ad hoc expert group. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.
People who have received the vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets. Read more>>>
AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues (31/03/2021)
EMA’s safety committee (PRAC) continues its ongoing review of very rare cases of unusual blood clots associated with low numbers of platelets, in people vaccinated with AstraZeneca’s COVID-19 vaccine (now called Vaxzevria).
At present the review has not identified any specific risk factors, such as age, gender or a previous medical history of clotting disorders, for these very rare events. A causal link with the vaccine is not proven, but is possible and further analysis is continuing.
EMA is still of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects. Read more>>>
EMA issues advice on use of regdanvimab for treating COVID-19 (26/03/2021)
EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibody regdanvimab (also known as CT-P59) to treat patients with COVID-19. The Agency concluded that regdanvimab can be used for the treatment of confirmed COVID-19 in adult patients who do not require supplemental oxygen therapy and who are at high risk of progressing to severe COVID-19.
The medicine is given by infusion (drip) into a vein and the proposed conditions of use are available. While the current evaluation has concluded, a rolling review of regdanvimab, which started on 24 February, is currently ongoing. Once finalised, the rolling review will be the basis for an EU marketing authorisation application for this medicine.
Regdanvimab is a monoclonal antibody with activity against SARS-CoV-2, the virus that causes COVID‑19. Read more>>>
EMA published an open letter in response to questions it had received about COVID-19 vaccines (23/03/2021)
EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials (22/03/2021)
EMA has reviewed the latest evidence on the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data do not support its use for COVID-19 outside well-designed clinical trials.
In the EU, ivermectin tablets are approved for treating some parasitic worm infestations while ivermectin skin preparations are approved for treating skin conditions such as rosacea. Ivermectin is also authorised for veterinary use for a wide range of animal species for internal and external parasites.
Ivermectin medicines are not authorised for use in COVID-19 in the EU, and EMA has not received any application for such use. Read more>>>
COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets (18/03/2021)
EMA’s safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people vaccinated with Vaxzevria (previously COVID-19 Vaccine AstraZeneca) at its extraordinary meeting of 18 March 2021. The Committee confirmed that:
- the benefits of the vaccine in combating the still widespread threat of COVID-19 (which itself results in clotting problems and may be fatal) continue to outweigh the risk of side effects;
- the vaccine is not associated with an increase in the overall risk of blood clots (thromboembolic events) in those who receive it;
- there is no evidence of a problem related to specific batches of the vaccine or to particular manufacturing sites;
- however, the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e. low levels of blood platelets (elements in the blood that help it to clot) with or without bleeding, including rare cases of clots in the vessels draining blood from the brain (CVST). Read more>>>
EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU (11/03/2021)
EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Janssen to prevent COVID-19 in people from 18 years of age.
After a thorough evaluation, EMA’s human medicines committee (CHMP) concluded by consensus that the data on the vaccine were robust and met the criteria for efficacy, safety and quality. COVID-19 Vaccine Janssen is the fourth vaccine recommended in the EU for preventing COVID-19. The vaccine has a 67% efficacy. Read more>>>
EMA starts rolling review of Eli Lilly antibodies bamlanivimab and etesemivab for COVID-19 (11/03/2021)
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the antibodies bamlanivimab and etesemivab which are being developed by Eli Lilly to be used in combination for the treatment of COVID-19. The review will also look at bamlanivimab used alone.
The decision to start the rolling review is based on preliminary results from two studies, one looking at the ability of the medicines to treat COVID-19 when combined, the other one when bamlanivimab is used alone. However, EMA has not yet evaluated the full dataset and it is too early to draw any conclusions regarding the benefit-risk balance of the medicines.
Bamlanivimab and etesemivab are two monoclonal antibodies with activity against COVID-19. A monoclonal antibody is a type of protein that has been designed to attach to a specific structure (called an antigen). Bamlanivimab and etesemivab have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. Read more>>>
EMA starts rolling review of the Sputnik V COVID-19 vaccine (04/03/2021)
EMA’s human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine1 developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. The EU applicant for this medicine is R-Pharm Germany GmbH. EMA will communicate further when the marketing authorisation application for the vaccine has been submitted.
Sputnik V is expected to work by preparing the body to defend itself against infection with the SARS-CoV-2 virus. This virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause COVID-19. Read more>>>
EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab) (26/02/2021)
EMA’s human medicines committee (CHMP) has completed its review on the use of the monoclonal antibodies casirivimab and imdevimab to treat patients with COVID-19. The Agency concluded that the combination also known as REGN-COV2 can be used for the treatment of confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19. Read more>>>
Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers (25/02/2021)
EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in order to address coronavirus (SARS-CoV-2) variants.
Currently, three vaccines are authorised for use in the EU: Comirnaty, COVID-19 Vaccine Moderna and COVID-19 Vaccine AstraZeneca. Viruses typically mutate and several variant strains of SARS-CoV-2 have already been identified worldwide. The three authorised vaccines provide protection against the variants that are currently prevalent across Europe. However, it appears that with continued mutations and new variants emerging, authorised vaccines may need to be adapted, in time to ensure continued protection.
EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19 (24/02/2021)
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known as CT-P59), which is being developed by Celltrion, for the treatment of COVID-19.
Regdanvimab is a monoclonal antibody with activity against COVID-19. A monoclonal antibody is a type of protein that has been designed to attach to a specific structure (called an antigen). Regdanvimab has been designed to attach to the spike protein of SARS-CoV-2, the virus that causes COVID-19. When it attaches to the spike protein, the ability of the virus to enter the body’s cells is reduced. This is expected to reduce the need for hospitalisation in patients with mild to moderate COVID-19. Read more>>>
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine by Janssen (16/02/2021)
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by Janssen-Cilag International N.V. The Committee could issue an opinion by the middle of March 2021, provided the company’s data on the vaccine’s efficacy, safety and quality are sufficiently comprehensive and robust.
This is the fourth CMA application for a COVID-19 vaccine since the start of the current pandemic. It comes after EMA’s evaluation of vaccines from BioNTech/Pfizer, Moderna and AstraZeneca.
COVID-19 Vaccine Janssen works by preparing the body to defend itself against COVID-19. It is made up of another virus (an adenovirus) that has been modified to contain the gene for making the SARS-CoV-2 spike protein. This is a protein on the surface of the SARS-CoV-2 virus which the virus needs to enter the body’s cells. Read more>>>
EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV) (12/02/2021)
EMA’s human medicines committee has started a rolling review of CVnCoV, a COVID‑19 vaccine being developed by CureVac AG. Like other vaccines, CVnCoV is expected to prepare the body to defend itself against infection with COVID-19.
The SARS-CoV-2 virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause COVID-19. CVnCoV contains a molecule called messenger RNA (mRNA) which has instructions for making the spike protein. The mRNA is contained in tiny particles of fats (lipids) that prevent it from being broken down too quickly. Read more>>>
Clarification on Sputnik V vaccine in the EU approval process (10/02/2021)
The European Medicines Agency has to date not received an application for a rolling review or a marketing authorisation for the vaccine developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia, the Sputnik V vaccine (Gam-COVID-Vac), despite reports stating the opposite.
EMA is in dialogue and collaborating with the company to define the next steps. The developers have expressed their interest that the vaccine be considered for a rolling review. This ad-hoc procedure can only be used during emergencies such as the current pandemic. EMA publishes a news announcement when it receives a valid application for marketing authorisation. This means that if EMA has not communicated, the status of a given COVID-19 medicine/vaccine remains unchanged. Read more>>>
EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373) (03/02/2021)
EMA’s human medicines committee has started a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.).
The company is currently conducting trials in people to assess its safety, immunogenicity (how well it triggers a response against the virus) and its effectiveness against COVID-19. EMA will evaluate data from these and other clinical trials as they become available.
Like other vaccines, NVX-CoV2373 is expected to prepare the body to defend itself against infection. The vaccine is a protein-based vaccine which contains tiny particles made from a laboratory-grown version of the spike (S) protein found on the surface of SARS-CoV-2 coronavirus. It also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.
Russian coronavirus vaccine achieves over 90 percent efficacy: Lancet (02/02/2021)
The Russian-developed Sputnik V vaccine is 91.6 percent effective in protecting against symptomatic COVID-19 — on par with the currently approved Western jabs, according to a peer-reviewed study published in The Lancet Tuesday.
The data is from a Phase 3 study, with almost 20,000 participants across a number of hospitals and clinics in Russia taking part in the two-dose scheme. Starting from 21 days after the first dose, there were 16 cases of symptomatic COVID-19 in the vaccine group versus 62 cases in the placebo group, researchers reported. There were no cases of "moderate or severe" coronavirus infections in the vaccinated group 21 days after the first dose.
The clinical trial also analyzed people over 60, finding the jab to be 91.8 percent effective, based on 2,144 participants. Read more>>>
EMA starts rolling review of REGN-COV2 antibody combination (casirivimab / imdevimab) (01/02/2021)
EMA’s human medicines committee has started a ‘rolling review’ of data on a medicine known as REGN-COV2 antibody combination (casirivimab / imdevimab), which is being co-developed by Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd (Roche) for the treatment and prevention of COVID-19. EMA has started evaluating the first batch of data on the medicine, which come from laboratory and animal studies (non-clinical data).
This medicine is made of casirivimab and imdevimab, two monoclonal antibodies. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen). Casirivimab and imdevimab have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When the active substances are attached to the spike protein, the virus is unable to enter the body’s cells. Read more>>>
EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU (29/01/2021)
EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. This is the third COVID-19 vaccine that EMA has recommended for authorisation.
EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission. This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.
COVID-19 Vaccine AstraZeneca is given as two injections into the arm, the second between 4 to 12 weeks after the first. Read more>>>
EMA published the European public assessment report for COVID-19 Vaccine Moderna (20/01/2021)
COVID-19 Vaccine Moderna is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 18 years and older.
COVID-19 Vaccine Moderna contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. COVID-19 Vaccine Moderna does not contain the virus itself and cannot cause COVID-19. Read more>>>
Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines (19/01/2021)
International regulators explain how COVID-19 vaccines undergo scientific evaluation to determine their safety, efficacy and quality. They also reiterate that regulators continue to rigorously monitor the safety of vaccines after approval for use. Read more>>>
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca (12/01/2021)
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human medicines. COVID-19 Vaccine AstraZeneca is expected to work by preparing the body to defend itself against infection with the coronavirus SARS-CoV-2. This virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause disease. Read more>>>
Extra dose from vials of Comirnaty COVID-19 vaccine (08/01/2021)
EMA’s human medicines committee has recommended updating the product information for Comirnaty to clarify that each vial contains 6 doses of the vaccine.
Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 16 years and older. It was authorised in the EU on 21 December 2020.
EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU (06/01/2021)
EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent Coronavirus disease (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorisation.
EMA’s human medicines committee has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission. This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns. Read more>>>
Update on rolling review of AstraZeneca’s COVID-19 vaccine (30/12/2020)
EMA’s assessment of the COVID-19 vaccine being developed by AstraZeneca and Oxford University has been progressing over the past weeks. The Agency is currently assessing data on the vaccine as part of a rolling review.
The latest clinical package was received on 21 December and is currently being assessed. CHMP has already assessed data from laboratory studies (non-clinical data) and is currently assessing data on the vaccine’s quality (on its ingredients and the way it is manufactured).
Further information from the ongoing clinical trials is also expected from January. Interim data from a large trial ongoing in the USA are expected in Q1 2021.
EMA will complete its assessment according to its usual standards for quality, safety and effectiveness. A marketing authorisation ensures that COVID-19 vaccines meet the same high EU standards as for all vaccines and medicines. Read more>>>
Comirnaty: European Public Assessment Report (23/12/2020)
Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 16 years and older.
Comirnaty contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. Comirnaty does not contain the virus itself and cannot cause COVID-19. Read full report>>>
EMA recommends first COVID-19 vaccine for authorisation in the EU (21/12/2020)
EMA has recommended granting a conditional marketing authorisation for the vaccine Comirnaty, developed by BioNTech and Pfizer, to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. EMA’s scientific opinion paves the way for the first marketing authorisation of a COVID-19 vaccine in the EU by the European Commission, with all the safeguards, controls and obligations this entails.
EMA’s human medicines committee (CHMP) has completed its rigorous evaluation of Comirnaty, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available to recommend a formal conditional marketing authorisation. This will provide a controlled and robust framework to underpin EU-wide vaccination campaigns and protect EU citizens. Read more>>>
Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU (11/12/2020)
EMA held this virtual meeting to explain the processes for the development, evaluation, approval and safety monitoring of COVID-19 vaccines in the EU, including EMA’s specific role, to all interested parties.
The meeting also gave the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns. This feedback will be considered by EMA and the European medicines regulatory network in the decision-making process. Video Recording>>>
EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S (01/12/2020)
EMA’s human medicines committee has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag International N.V.
The company is currently conducting trials in people to assess safety and immunogenicity (how well the vaccine triggers a response against the virus), and effectiveness. EMA will evaluate data from these and other clinical trials as they become available. The rolling review will continue until enough evidence is available for a formal marketing authorisation application. Full details>>>
EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine (01/12/2020)
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 mRNA vaccine by Moderna Biotech Spain, S.L. The assessment of the vaccine known as Moderna Covid-19 vaccine (also referred to as mRNA1273) will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine. Full details>>>
EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2 by BioNTech and Pfizer (01/12/2020)
EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.
Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review. During this phase, EMA assessed data on the vaccine’s quality (such as information about its ingredients and the way it is produced) as well as results from laboratory studies. EMA also looked at results on the vaccine’s effectiveness and initial safety data emerging from a large-scale clinical trial as they became available. Read more>>>
Global regulators urge continuation of COVID-19 vaccine trials for longer-term safety and efficacy follow-up (27/11/2020)
EMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities (ICMRA) that urges all stakeholders, including vaccines researchers and investigators, academia, regulators and the pharmaceutical industry, to continue COVID-19 vaccine trials beyond the time when the pre-defined cases of COVID-19 disease for final analysis in a trial have been reached. This can provide important additional and more precise information on longer-term safety and efficacy of a vaccine against COVID-19.
Update on remdesivir - EMA will evaluate new data from Solidarity trial (20/11/2020)
The World Health Organization (WHO) has updated its guidelines advising against the use of remdesivir in hospitalised patients with COVID-19, regardless of disease severity based on a recent meta-analysis.
EMA has requested the full Solidarity data from WHO and the marketing authorisation holder. Once the data are available, EMA will assess the evidence, together with other relevant data, to see if any changes are needed to the marketing authorisation of Veklury (remdesivir) in the EU. Read more>>>
EMA considerations on COVID-19 vaccine approval (19/11/2020)
The European Medicines Agency laid out today the kind of data it needs to approve a coronavirus vaccine. The agency recommends having at least one large-scale Phase 3 clinical trial. The study’s main goal should be to assess whether the vaccine protects people from contracting the virus, but the trials should also estimate the protection against symptomatic and severe cases of COVID-19 — not just whether participants test positive or negative for the virus. Moreover, it called on vaccine developers to provide at least six weeks of safety data.
EMA also announced it’ll hold a public consultation on the safety of vaccines on December 11 to inform citizens about the process for approving coronavirus vaccines. Those who want to speak during the consultation can fill out a form before November 27. Read full considerations>>>
EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain (16/11/2020)
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.).
The CHMP’s decision to start the rolling review of mRNA-1273 is based on preliminary results from non-clinical studies and early clinical studies in adults which suggest that the vaccine triggers the production of antibodies and T cells (cells of the immune system, the body’s natural defences) that target the virus. Read more>>>
EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines (13/11/2020)
EMA and the national competent authorities (NCAs) in EU Member States have prepared a safety monitoring plan for COVID-19 vaccines. The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed.
The safety of COVID-19 vaccines will be monitored according to the guidance set out by EMA and NCAs in the good pharmacovigilance practices (GVP), that applies to all medicines. In view of the extraordinary circumstances, though, EU authorities have planned several activities that will apply specifically to COVID-19 vaccines. Read more>>>
BioNTech and Pfizer raise hopes with breakthrough Covid-19 vaccine (09/11/2020)
A coronavirus vaccine developed by Pfizer is more than 90 percent effective, according to the first look at data from a late-stage U.S. trial involving nearly 44,000 participants.
An analysis of 94 trial participants who contracted COVID-19 showed that the vaccine was 94 percent effective, the company and its partner BioNTech said in a press release Monday.
The pair added that they expect to apply to the FDA for an emergency-use authorization before the end of the month, after they have collected sufficient data on the vaccine’s safety. The better-than-expected result is the first Phase III data from any of the four candidates now in the final stage of testing in the U.S.
Extra transparency measures for COVID-19 vaccines and therapeutics (30/10/2020)
The European Medicines Agency (EMA) has implemented two further extra transparency measures for COVID-19 medicines, by publishing both the clinical data in support of the authorisation of Veklury (remdesivir) and information on the COVID-19 treatments and vaccines that have received scientific advice or informal guidance from EMA’s pandemic Task Force (COVID-ETF).
These are the latest measures in EMA’s drive to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19.
EMA starts first rolling review of a COVID-19 vaccine in the EU (01/10/2020)
EMA’s human medicines committee has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by the company AstraZeneca in collaboration with the University of Oxford.
The start of the rolling review means that the committee has started evaluating the first batch of data on the vaccine, which come from laboratory studies (non-clinical data). This does not mean that a conclusion can be reached yet on the vaccine’s safety and effectiveness, as much of the evidence is still to be submitted to the committee.
EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation (19/09/2020)
EMA’s human medicines committee (CHMP) has completed its review of results from the RECOVERY study arm that involved the use of the corticosteroid medicine dexamethasone in the treatment of patients with COVID-19 admitted to hospital, and has concluded that dexamethasone can be considered a treatment option for patients who require oxygen therapy (from supplemental oxygen to mechanical ventilation).
Based on the review of available data, EMA is endorsing the use of dexamethasone in adults and adolescents (from 12 years of age and weighing at least 40 kg) who require supplemental oxygen therapy. Dexamethasone can be taken by mouth or given as an injection or infusion (drip) into a vein. In all cases, the recommended dose in adults and adolescents is 6 milligrams once a day for up to 10 days.
Remdesivir wins conditional EU approval for COVID-19 (03/07/2020)
The European Commission today granted conditional approval for Gilead’s remdesivir to treat COVID-19, as a key MEP warned the EU is prepared to take aggressive measures to access the therapy. Early studies suggest it could help speed recovery time for seriously ill patients without causing unacceptable side effects. However, the drugmaker must submit final reports from clinical trials to the European Medicines Agency by December.
The Commission touted the speed of the decision, delivered less than a month after Gilead submitted a formal application.
EMA receives application for conditional authorisation of first COVID-19 treatment in the EU (08/06/2020)
EMA has now received an application for conditional marketing authorisation (CMA) of the antiviral medicine remdesivir for the treatment of COVID-19 and has formally started its evaluation. The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted and whether further information is required to support the evaluation. Read More>>>
COVID-19: reminder of the risks of chloroquine and hydroxychloroquine (29/05/2020)
EMA is reminding healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine, given the serious side effects that can result from treatment with these medicines. Both chloroquine and hydroxychloroquine, which are authorised for malaria and certain autoimmune diseases, have been used to treat patients with COVID-19 but their beneficial effects in this patient population are not established. Read More>>>
EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation (15/05/2020)
EMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the medicine remdesivir so that more patients with severe COVID‑19 can be treated. The updated recommendations are based on preliminary results from the NIAID-ACTT study, which suggest a beneficial effect of remdesivir in the treatment of hospitalised patients with severe COVID-19. EMA is currently evaluating these data. Read more>>>
How EMA fast-tracks development support and approval of medicines and vaccines (04/05/2020)
As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible. The rapid procedures described in the the inventory can accelerate every step of a medicine’s regulatory pathway and the Agency is fully mobilised to deliver these fast-track assessments in the shortest possible timeframes while ensuring robust scientific opinions are reached. Read more>>>
EMA starts rolling review of remdesivir for COVID-19 (30/04/2020)
EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19). A rolling review is one of the regulatory tools available to the Agency to speed up the assessment of a promising investigational medicine during a public health emergency, such as the ongoing pandemic. Read Full Article>>>
Guidance on how to manage clinical trials during the COVID-19 pandemic (28/04/2020)
This version contains key changes based also on the feedback from different stakeholders’ groups (patients’ organisations, academia and industry) before and during the drafting process. Read full guidance here>>>
The EMA warns against using unproven cell-based therapies (28/04/2020)
EMA’s Committee for Advanced Therapies (CAT) is advising patients and the general public against using unregulated cell-based therapies which may not be safe or effective. The CAT’s advice is in response to individuals, companies and hospitals promoting unproven cell-based therapies as cures for a broad range of conditions including cancer, cardiovascular diseases, autism, cerebral palsy, muscular dystrophy and vision loss. These treatments can pose serious risks to patients for little or no benefit. Read more here>>> and read more about advanced therapy medicinal products here.
Reporting suspected side effects of medicines in patients with COVID-19 (24/04/2020)
EMA and the national competent authorities are reminding patients with confirmed or suspected coronavirus disease (COVID-19) to report suspected side effects that they experience with any of the medicines they are taking. Patients are reminded that there are currently no medicines authorised to treat COVID-19. Patients and healthcare professionals should report suspected side effects directly to their national authority via the contact details available here>>>
COVID-19: reminder of risk of serious side effects with chloroquine and hydroxychloroquine (23/04/2020)
Chloroquine and hydroxychloroquine are currently authorised for treating malaria and certain autoimmune diseases. In addition to side effects affecting the heart, they are known to potentially cause liver and kidney problems, nerve cell damage that can lead to seizures (fits) and low blood sugar (hypoglycaemia). These medicines are being used in the context of the ongoing pandemic for treating patients with COVID-19 and investigated in clinical trials. However, clinical data are still very limited and inconclusive, and the beneficial effects of these medicines in COVID-19 have not been demonstrated. Read more here>>>
Guidance on regulatory requirements in the context of the COVID-19 pandemic (10/04/2020)
The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.
Reducing COVID-19 transmission from potentially asymptomatic or pre-symptomatic people through the use of face masks (08/04/2020)
ECDC provides its opinion on the suitability of face masks and other face covers in the community by individuals who are not ill in order to reduce potential pre-symptomatic or asymptomatic transmission of COVID-19 from the mask wearer to others. Read their report>>>
EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines (09/04/2020)
As part of its health threat plan activated to fight COVID-19, the EMA has finalised and published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF), which draws on the expertise of the European medicines regulatory network and ensures a fast and coordinated response to the COVID-19 pandemic. Read their full mandate>>>
EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic (06/04/2020)
The continued availability of medicines, in particular those used for patients with COVID-19, is ofcritical concern for EMA and its partners in the European medicines regulatory network in light of the medical emergency presented by the pandemic. This discusses the role of EMA in actively supporting prevention and management actions during this crisis. Read full article>>>
EMA recommendations on compassionate use of remdesivir for COVID-19 (03/04/2020)
During an extraordinary virtual meeting held on 2 April 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral medicine remdesivir should be used for treating coronavirus disease (COVID-19) in compassionate use programmes in the European Union. Read full article>>>
COVID-19: chloroquine and hydroxychloroquine only to be used in clinical trials or emergency use programmes (01/04/2020)
The EMA advised patients and healthcare professionals to only use chloroquine and hydroxychloroquine medicines for their authorised indications or as part of clinical trials or national emergency use programmes for the treatment of COVID-19. This is to ensure patient safety and the best use of available supplies. Read full article>>>
Update on treatments and vaccines against COVID-19 under development (31/03/2020)
EMA’s COVID-19 response team has been in contact with developers of around 40 therapeutic medicines, allowing better understanding of potential treatments. EMA’s response team will continue to interact with developers of potential therapeutics or vaccines against COVID-19. The aim is to provide advice on regulatory requirements so that any promising medicinal product can be made available as rapidly as possible to patients, initially in the clinical trial setting and then, once authorised, on the market. Read Full Article>>>
Preserving Clinical Trial Integrity During the Coronavirus Pandemic (25/03/2020)
Clinical trials typically require years to design, fund, conduct, and complete but are essential for improving health and preventing and managing disease. The real effects of the coronavirus pandemic on randomized trials are as yet unknown but will hopefully be short-lived as they could be damaging to the long-term benefits of these trials to millions of people who will continue to live with devastating medical diseases after the crisis ends. This article discusses that creativity and persistence are required to preserve clinical trial integrity, especially during these unprecedented and uncertain times. Read Full Article>>>
Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic (27/03/2020)
The impact of the COVID-19 pandemic on European health systems and more broadly on society, will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials. As a result, The European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage clinical trials in the context of the coronavirus disease (COVID-19) pandemic. Read Full Article>>>
EMA’s Statement: Beware of falsified medicines from unregistered websites (24/03/2020)
EMA is urging the general public not to buy medicines from unauthorised websites and other vendors aiming to exploit fears and concerns during the ongoing pandemic of coronavirus disease (COVID-19). Read their Full Statement>>>
MHRA Advice for Management of Clinical trials in relation to Coronavirus (12/03/2020)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials. As a result, they have taken the time to offer advice for patients and organisations during this difficult time. Read MHRA’s Advice>>>
COVID-19 infection: the perspectives on immune responses (23/03/2020)
SARS-CoV-2 infection can be roughly divided into three (3) stages: stage I, an asymptomatic incubation period with/without detectable virus; stage II, non-severe symptomatic period with the presence of virus; stage III, severe respiratory symptomatic stage with high viral load. This article proposes some approaches to the treatment of COVID-19 patients, believing that a two-phase division is very important. Read Full Article>>>
ESPEN Expert Statements and Practical Guidance for Nutritional Management of Individuals with SARS_CoV-2 (24/03/2020)
In the current document, the European Society for Clinical Nutrition and Metabolism (ESPEN) aims to provide concise guidance for nutritional management of COVID-19 patients by proposing 10 practical recommendations. The practical guidance is aimed at those in an ICU setting or in the presence of older age and polymorbidity, which are independently associated with malnutrition and its negative impact on patient survival. Read Full Article>>>