Covid-19 roundup: EMA official says 'clear' link between AstraZeneca shot and blood clots — report; Novavax allows placebo group to get vaccine
For the first time Tuesday, health officials acknowledged a link between the AstraZeneca/Oxford University Covid-19 vaccine and blood clots following a tense few weeks of countries across Europe suspending use of the shot.
A top vaccine expert at the EMA said in an interview with Italian newspaper Il Messaggero that there is a connection between the vaccines and thrombotic events, but the causes remain unknown. The individual appeared to disclose the information separately from an official EMA announcement but noted that the agency would do so later Tuesday and provide updated guidelines on the shot Wednesday, according to The Guardian.
“In my opinion we can now say it, it is clear that there is an association with the vaccine. However, we still do not know what causes this reaction,” EMA head of vaccines Marco Cavaleri told the paper.
Cavaleri notably did not provide any evidence to back up his claims. AstraZeneca did not immediately respond to an Endpoints News request for comment.
Reports of the blood clots first popped up in early March after a 49-year-old woman in Austria died from “severe coagulation disorders” after receiving the shot. Soon after, several EU member states began suspending use of the shot while studies into the blood clots began. The EMA is still looking into 14 deaths among individuals who had received the shot by March 22.
In a culmination of the suspensions, Germany, the de facto leader of the EU, halted vaccine administration for its under-60 population just last week.
AstraZeneca has maintained that the shots are safe, and received backing from the EMA and the World Health Organization, who both said the benefits of taking the shot outweigh the risks. During a press conference last week with the EMA safety committee, known as PRAC, the agency reported that though the blood clot cases are rare, they appear to be occurring more frequently in young and middle-aged women than other groups.
The total cases showed that about 1 in 100,000 individuals who received the AstraZeneca shot are seeing these rare and severe events in Europe, the EMA said. An announcement providing updates of the PRAC studies was expected this week.
Tuesday’s comments come as European countries continue to block exports of the shots from leaving their shores. The EU has blocked about 3.1 million vaccines headed for Australia so far, Reuters reported.
Novavax allows placebo group to receive vaccines
Novavax has updated its vaccine trial protocol to allow patients in the placebo arm to receive the shot, the company announced Monday.
The crossover allows for those in Novavax’s UK and US/Mexico Phase III studies to receive an additional round of injections while remaining blinded. Individuals who received the vaccine in the initial round will get the placebo, and vice versa.
In the company’s South Africa Phase IIb study, volunteers who received the placebo will also get the vaccine, while those who received the vaccine will get a booster shot. Participants from all three arms will continue to be followed for up to two years.
“The crossover arms ensure that all participants have access to an active vaccine candidate while allowing Novavax to continue to monitor the safety and efficacy of our vaccine over the long term,” CMO Filip Dubovsky said in a statement.
Last month, Novavax’s UK trial showed a final efficacy of 96% in the arm against mild, moderate and severe Covid-19 cases in the UK. But that number fell precipitously in the South Africa arm, where it registered only 50% efficacy.
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