UK and EU Reaffirm Safety of AstraZeneca’s COVID-19 Vaccine

The Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) recently reaffirmed the benefits of AstraZeneca’s COVID-19 vaccine.

The agencies stated that COVID-19 Vaccine AstraZeneca continues to outweigh the risks and that individuals should continue to get the vaccine when invited to do so. 

“Vaccine safety is paramount and we welcome the regulators’ decisions which affirm the overwhelming benefit of our vaccine in stopping the pandemic. We trust that, after the regulators’ careful decisions, vaccinations can once again resume across Europe,” Ann Taylor, chief medical officer at AstraZeneca said in the announcement. 

MHRA reviewed a small number of blood clots in more than 11 million people who received COVID-19 Vaccine AstraZeneca in the UK. 

The agency stated in a press release that despite concern in different countries, the available evidence does not show that blood clots in veins are caused by COVID-19 Vaccine AstraZeneca.

But MHRA will continue to closely monitor reports and understand potential association.

Additionally, a detailed review of five UK reports of a very rare type of blood clot in the cerebral veins occurring together with lowered platelets (thrombocytopenia) is ongoing, AstraZeneca said.

This side effect has only been reported in one million vaccinated people so far in the UK, but it could also occur naturally.

“Given the extremely rare rate of occurrence of these CSVT events among the 11 million people vaccinated, and as a link to the vaccine is unproven, the benefits of the vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, continue to outweigh the risks of potential side effects,” said June Raine, MD, chief executive officer at MHRA. 

“We will continue to robustly monitor all the data we have on this extremely rare possible side effect,” Raine continued.

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) also concluded there was no increase in the overall risk of blood clots due to COVID-19 Vaccine AstraZeneca. And there was no evidence of problems related to specific batches of the vaccine or to manufacturing sites. 

The agency stated that although a link between the vaccine and rare cases of serious blood clot events with thrombocytopenia is not proven, it is still possible and will be further analyzed. 

“While the investigation is ongoing, EMA currently remains 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,” the agency stated in the press release. 

AstraZeneca stated that it will work with health authorities to ensure the appropriate use of COVID-19 Vaccine AstraZeneca. Additionally, it will implement the recommendations of PRAC, such as the update of product information, while also continuing to understand the relevance of the events.

These initiatives will ensure the safe delivery of the vaccine during the pandemic. 

At the end of January, COVID-19 Vaccine AstraZeneca was granted conditional marketing authorization (CMA) in the European Union (EU) for active immunization in individuals 18 years of age and older.

The Committee for Medicinal Products for Human Use (CHMP) recommended two doses of the vaccine to be administered at a four to 12-week interval, as this dosing regimen was previously shown to be safe and effective in preventing symptomatic COVID-19.

One month later, AstraZeneca and IDT Biologika partnered to increase manufacturing and supply capacity for COVID-19 Vaccine AstraZeneca in the second quarter of this year.

The companies will also launch a joint investment to build large additional drug substance capacity for the future and invest to expand IDT Biologika’s production site in Germany to build five 2,000-litre bioreactors that will make millions of doses of the vaccine per month. 

The investment will help to support Europe’s urgent vaccination needs and allow for the manufacture of other vaccines sharing a similar manufacturing process.