E.U. Regulator Says Benefits Of Johnson & Johnson Vaccine Outweigh Risks

The European Medicines Agency (EMA) said that the benefits of the Johnson & Johnson COVID-19 vaccine outweigh the possible risk of blood clots. “(The) EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen.” (Janssen is J&J’s Belgian unit name.)

“Healthcare professionals and people who will receive the vaccine should be aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within three weeks of vaccination.”

The one-dose J&J vaccine, which has been administered to over seven million people in the U.S. as of April 7, was linked to only eight reports of unusual blood clots (one of which was fatal), according to the EMA’s report.

Earlier this month, the U.S. Food and Drug Administration advised states to halt the J&J vaccine rollout “out of an abundance of caution.” Last week, the FDA allowed J&J vaccinations to resume.

Similarly, the vaccine rollout was suspended in Europe in order to give regulators a chance to examine the health risks.

However, in light of the recent EMA review, which concluded that the benefits of the vaccine outweigh any potential risks, the pharmaceutical firm has confirmed that it will continue sending supply to European countries.

It still remains unclear how different countries will respond to this hopeful news. France has decided to only administer the vaccine to those over the age of 55.

The EMA has reiterated that it is important to bear in mind the risk of severe COVID-19 infection when discussing risks of the vaccine. “COVID-19 is associated with a risk of hospitalisation and death,” the statement read. “The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of COVID-19 Vaccine Janssen in preventing COVID-19 outweigh the risks of side effects.”

The J&J vaccine is not the only COVID vaccine that has been linked to blood clots.

In March, over a dozen European countries stopped administering the AstraZeneca shot after receiving 18 reports of fatal blood clot incidents.

The EMA also commented on the risks associated with the AstraZeneca vaccine. “There was a possible link to very rare cases of unusual blood clots with low blood platelets,” qualifying these instances as “very rare side effects.”

Much like France’s recent decision regarding the J&J vaccine rollout, some countries decided to, going forward, only administer the AstraZeneca vaccine to people over the age of 60. (Denmark suspended use of this vaccine entirely.)

According to the the European Centre for Disease Prevention and Control, over 103 million vaccine doses have been administered in the E.U. so far.

Article by Elizabeth Letsou