The Hague, The Netherlands:
The EU drug watchdog said Friday that a review of AstraZeneca’s Covid-19 vaccine found its benefits increase with age and continue to outweigh the risks to adults despite links to blood clots.
The European Medicines Agency (EMA) presented its findings after the European Commission asked it to look into concerns that have prompted several countries to restrict its use to older people.
“It has shown that the benefits of vaccination increase with increasing age and infection rates,” the Amsterdam-based EMA said in a statement.
“The benefits of Vaxzevria outweigh its risks in adults of all ages; however, very rare cases of low platelet blood clots have occurred after vaccination,” he added, using the vaccine brand.
The rare clots have occurred in about one in 100,000 people who have received the vaccine, he said.
“Vaxzevria is effective in preventing hospitalizations, intensive care unit (ICU) admissions and deaths due to COVID-19. The most common side effects are usually mild or moderate and improve within a few days.”
Despite reports that cases of blood clots were more prevalent among women, EMA said “the available data across the EU was not sufficient to provide further context on the benefits and risks in relation to sex”.
– Hit trust
Public confidence in the AstraZeneca jab has taken a hit since the EMA declared on April 7 that a very rare, but often fatal, form of blood clot affecting the brain should be listed as a side effect.
The clots are also listed as a side effect of the J&J vaccine, which uses the same adenovirus vector technology as AstraZeneca, the EMA said earlier this week.
Brussels asked the EMA earlier this month to carry out further investigations, and the watchdog said its announcement on Friday was to “provide an analytics update” on AstraZeneca.
EMA said it also shared the latest opinion issued by its Committee for Medicinal Products for Human Use “aimed at supporting national decision-making on how best to use the vaccine in their territories”.
The regulator said Tuesday there were 287 cases of rare clots worldwide linked to AstraZeneca, 25 to Pfizer-BioNTech vaccine, eight to Johnson & Johnson and five to Moderna.
The EU is now increasingly relying on the BioNTech / Pfizer vaccine, which uses rival mRNA technology, for its launch.
The European Commission is also seeking to initiate legal action against AstraZeneca for insufficient delivery of Covid-19 vaccine doses in the EU, which has hindered its early introduction.