Johnson & Johnson asks not to use vaccine until EMA decision next week

Johnson & Johnson asks not to use vaccine until EMA decision next week
Credit: Belga

Pharmaceutical company Johnson & Johnson is recommending countries that have already received deliveries of the coronavirus vaccine to not use the doses until the European Medicines Agency (EMA) has made a decision on its safety.

Next week, the EMA will be making a decision on the vaccine, of which Johnson & Johnson decided to proactively delay deliveries to Europe following six cases of blood clots and low platelet counts in the United States, it stated in a press release.

“Johnson & Johnson is in contact with national authorities and is recommending to store the doses already received vaccines until the PRAC (EMA’s safety committee) issues an expedited recommendation,” the statement read.

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The PRAC is currently reviewing the very rare cases of unusual blood clots that occurred in the US following the use of Johnson & Johnson’s coronavirus vaccine and will decide whether regulatory action is necessary.

In the US, where more than 6.8 million doses of the vaccine have been administered, the Food and Drug Administration (FDA) and the Centres for Disease Control and Prevention (CDC) recommended on Tuesday that the use of the vaccine should be paused while the cases are being reviewed.

The type of blood clot reported, cerebral venous sinus thrombosis (CVST), occurred in most cases in combination with low levels of blood platelets (thrombocytopenia), similarly to the AstraZeneca vaccine.

France announced on Wednesday that it will limit the administering of the Johnson & Johnson vaccine, which received approval from the EMA on 11 March, to people over the age of 55, as is already the case for AstraZeneca.

"We have received the first delivery of vaccines, that is 200,000 doses which arrived at the beginning of the week on our territory and which are currently being sent to town doctors and pharmacies," said government spokesman Gabriel Attal.

It "will be distributed and administered under the same conditions as those currently in place for the AstraZeneca vaccine, i.e. for people aged over 55," Attal added.

Meanwhile, Denmark has said it will put the use of the Johnson & Johnson vaccine, of which the country has ordered 8.2 million doses, on hold. Widespread use of the vaccine has not yet started across the EU.

The EMA said that “while the review is ongoing, it remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects,” and that it has provided member states with the “information they need to make decisions on the use of vaccines in their national vaccination campaigns.”

Lauren Walker

The Brussels Times

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