Based on EMA, J & J Shot could be launched throughout the EU
A box of Janssen COVID-19 vaccine doses from Johnson & Johnson is pictured in Grubbs Pharmacy on Capitol Hill on Monday April 12, 2021.
Tom Williams | CQ Appeal, Inc. | Getty Images
LONDON – The European Medicines Agency said Tuesday the Johnson & Johnson Covid-19 vaccine had possible links to rare blood clots but reiterated that its benefits still outweighed the risks.
“The EMA’s Safety Committee (PRAC) concluded that a warning of unusual blood clots with low platelets should be added to the product information for the Janssen COVID-19 vaccine,” the agency said in a press release.
“Health professionals and those receiving the vaccine should be aware of the possibility of very rare cases of blood clots combined with low platelet levels within three weeks of vaccination.”
The EMA examined all available evidence, including eight reports from the United States of serious cases of unusual blood clots, one of which had a fatal outcome. As of April 7, more than 7 million people in the United States had received the vaccine.
The US Food and Drug Administration advised states earlier this month to suspend the use of J & J’s shot “out of caution”. As a result, the pharmaceutical company decided to delay the launch of its vaccine in Europe while regulators assessed all risks. On Tuesday, the company confirmed that it would resume deliveries to the block after being reviewed by the EMA.
The EMA said last week that when they reviewed the latest details, it was still believing that the vaccine’s benefits outweighed the risks.
The J&J shot, which only requires one, was initially lit in green on March 11 in the European Union. It remains to be seen how different countries will interpret the latest guidelines from the EMA. France has already indicated that it will only use the vaccine in people over 55 years of age.
“COVID-19 is associated with a risk of hospitalization and death. The reported combination of blood clots and low platelets is very rare, and the general benefits of the Janssen COVID-19 vaccine in preventing COVID-19 outweigh the risk of side effects. “said the EMA on Tuesday under the name of the Belgian unit of J & J.
This isn’t the first problem with blood clots and a Covid-19 vaccine.
More than a dozen European countries stopped using the AstraZeneca shot in March after some people who received the shot reported unusual incidents of blood clots, 18 of which were fatal.
The EMA reviewed the cases and also said the vaccine was safe and should be used in the fight against the coronavirus.
However, a few days later, the EMA also said there was a “possible association with very rare cases of unusual blood clots with low platelets” and should therefore be listed as a “very rare side effect” for the AstraZeneca vaccine.
Some countries have adjusted the introduction of this vaccine and decided to only give it to people over the age of 60, and Denmark took it a step further by stopping its use entirely.
According to the European Center for Disease Prevention and Control, more than 103 million doses have been administered in the EU to date.
Correction: The U.S. Food and Drug Administration advised states earlier this month to suspend the use of J & J’s shot. An earlier version incorrectly characterized the move.
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