The Oxford-AstraZeneca Covid-19 vaccine is “safe and effective,” the European Medicines Agency (EMA) concluded after an extensive review prompted when more than a dozen European countries stopped using the shot after reports it was linked to dangerous blood clotting—the agency ruled out a broad link to blood clotting but said it was unable to definitively rule out an association with extremely rare clotting events.
Emer Cooke, the executive director of Europe’s medicines regulator, called the AstraZeneca shot “a safe and effective vaccine,” after a thorough investigation into reports of dangerous blood clots in vaccine recipients.
Cooke said the vaccine was not linked to an “overall risk” of blood clots but the investigation was not able to conclusively rule out a link between some extremely rare types of clotting.
The World Health Organization and the U.K.’s medicines regulator also backed the shot, joining Cooke in stressing the vaccine’s “benefits in protecting people against Covid-19 outweigh the possible risks.”
Officials said further investigations into the rare clotting would be undertaken and warning labels added to vaccine information as a precaution.
The EMA’s Dr. Sabine Straus said encountering such rare events is “not unexpected” when millions of people are being vaccinated.
Straus said only 25 cases of two types of rare clotting were reported in almost 20 million people being vaccinated.
AstraZeneca’s vaccine was once held up as a beacon of hope for most of the world, a more accessible, affordable and practical alternative to offerings from Pfizer and Moderna. However, and in spite of clinical trials showing it to be safe, well-tolerated and effective, it has been mired in seemingly endless controversy: Methodological issues in its Phase 3 trial created confusion over the study and the shot’s suggested dosing regimen; health workers eschewed the vaccine in favor of more effective doses from Pfizer and Moderna; and researchers failed to recruit enough seniors in clinical trials and left many regulators reticent to clear it for use in seniors, many of whom were then reluctant to roll up their sleeves when the shot was cleared. This snap suspension is not even the first of its kind in the months since it was cleared in late January, with several countries banning it older people after widespread reports of deaths in elderly recipients (which regulators said were unconnected to the shot). Overall, experts are concerned these decisions are eroding confidence in vaccines just as the world is fighting to keep up with a mutating virus which has already killed more than 2.6 million people.
Amid the continent-wide crisis over vaccine safety, Europe is also struggling with significant supply chain issues. Even though most of the bloc’s vaccine suppliers have repeatedly downgraded predictions on what they can deliver, AstraZeneca has drawn the most ire from lawmakers, who accused the company of reneging on contractual commitments in order to make more money selling the vaccine elsewhere. This criticism has continued even as many member states refuse the shot, with EU Commission chief Ursula von der Leyen blaming the company’s delivery failures for the region’s sluggish vaccination drive Wednesday.
What To Watch For
Despite its approval by major European regulators and the World Health Organization, the AstraZeneca shot is not authorized for use in the U.S.. The company hasn’t actually applied yet, likely waiting for results in its U.S.-based clinical trial. The New York Times reported the U.S. is sitting on tens of millions of doses ahead of this approval, doses other countries sorely need and have requested access to.
How Europe fell behind on vaccines (Politico)