Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

Milestones :: Perspectives :: Research

 

Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment

 

EMA
News: COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets (updated)
PRAC, Last updated: 19/03/2021
EMA’s safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people vaccinated with 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).

These are rare cases – around 20 million people in the UK and EEA had received the vaccine as of March 16 and EMA had reviewed only 7 cases of blood clots in multiple blood vessels (disseminated intravascular coagulation, DIC) and 18 cases of CVST. A causal link with the vaccine is not proven, but is possible and deserves further analysis.

The PRAC involved experts in blood disorders in its review, and worked closely with other health authorities including the UK’s MHRA which has experience with administration of this vaccine to around 11 million people. Overall the number of thromboembolic events reported after vaccination, both in studies before licensing and in reports after rollout of vaccination campaigns (469 reports, 191 of them from the EEA), was lower than that expected in the general population. This allows the PRAC to confirm that there is no increase in overall risk of blood clots. However, in younger patients there remain some concerns, related in particular to these rare cases.

The Committee’s experts looked in extreme detail at records of DIC and CVST reported from Member States, 9 of which resulted in death. Most of these occurred in people under 55 and the majority were women. Because these events are rare, and COVID-19 itself often causes blood clotting disorders in patients, it is difficult to estimate a background rate for these events in people who have not had the vaccine. However, based on pre-COVID figures it was calculated that less than 1 reported case of DIC might have been expected by 16 March among people under 50 within 14 days of receiving the vaccine, whereas 5 cases had been reported. Similarly, on average 1.35 cases of CVST might have been expected among this age group whereas by the same cut-off date there had been 12. A similar imbalance was not visible in the older population given the vaccine.

The Committee was of the opinion that the vaccine’s proven efficacy in preventing hospitalisation and death from COVID-19 outweighs the extremely small likelihood of developing DIC or CVST. However, in the light of its findings, patients should be aware of the remote possibility of such syndromes, and if symptoms suggestive of clotting problems occur patients should seek immediate medical attention and inform healthcare professionals of their recent vaccination. Steps are already being taken to update the product information for the vaccine to include more information on these risks.

The PRAC will undertake additional review of these risks, including looking at the risks with other types of COVID-19 vaccines (although no signal has been identified from monitoring so far). Close safety monitoring of reports of blood clotting disorders will continue, and further studies are being instituted to provide more laboratory data as well as real-world evidence.  EMA will communicate further as appropriate…

 

European Commission
Statement following the European Medicines Agency review of the COVID-19 vaccine AstraZeneca
Statement 18 March 2021
… “Security and trust in vaccines is key for vaccinations. The priority of the Commission has always been the safety and the efficacy of any COVID-19 vaccine authorised for use in the EU. This is why we have ensured that all vaccines, before being administered, go through the rigorous and independent safety scrutiny of the European Medicines Agency. This has always been non-negotiable for us. The EU conditional marketing authorisation also requires a robust pharmacovigilance system to ensure that any possible medicine related problem, however rare it is, does not go undetected.
“ As the European Medicines Agency has clearly stated today, the benefits of the vaccine in combating COVID-19 continue to outweigh the risks of side effects. It is an effective and safe vaccine that greatly contributes to the efforts to address the impact of COVID-19 and the very serious health risks of an infection. Vaccination is one of our strongest means to put an end to the pandemic and we must all continue our efforts to ensure that the roll-out is proceeding as quickly as possible whilst ensuring that the rigorous safety monitoring continues as part of the EU pharmacovigilance process.”

Statement 16 March 2021
Commission Statement on BioNTech-Pfizer top-up for Quarter 2 deliveries

Statement 13 March 2021
Statement of the European Commission on the methodology used to determine the allocation of doses of vaccines under the Advance Purchase Agreements