Johnson & Johnson Covid vaccine benefits outweigh risk of side effects: EMA

The European Medicines Agency on April 15 said that the benefits of the Johnson and Johnson vaccine in preventing the COVID-19 outweigh the risks of side effects. The agency further said that they are reviewing the safety of vaccines for the European Union. They also revealed that they are assessing the very rare cases of unusual blood clots with low platelets.

While its review is ongoing, EMA remains of the view that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects, EMA said in a press release.

PRAC reviewing cases of unusual blood clots

More than 6.8 million doses of the Johnson and Johnson vaccine have been administered and six cases have been reported with blood clots. EMA’s safety committee Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the cases of unusual blood clots that occurred in the United States after the administration of the Johnson and Johnson COVID-19 vaccine. EMA in a press release said that they are working closely with the US Food and Drug Administration and Centres for Disease Control.
 

EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots that occurred in the United States following the use of Janssen’s COVID-19 vaccine, it said.

EMA is investigating all the cases reported and will decide whether regulatory action is required or not. EMA is evaluating the cases rapidly and it hopes to issue a recommendation next week. The vaccine was authorised in the European Union on 11 March 2021 but the widespread use of the vaccine within the European Union has not started. Meanwhile, Johnson and Johnson has announced their decision to proactively delay the rollout of the vaccine in the European Union while investigations continue.

We have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe and pause vaccinations in all Janssen COVID-19 vaccine clinical trials while we update guidance for investigators and participants,  j&j said in a statement.

Meanwhile, the US Food and Drug Administration and the Centres for Disease Control are determining the “potential significance” of the six cases reported of blood clots following the administration of the J&J vaccine. In a joint statement, the US FDA and CDC have already said that they “are recommending a pause in the use of this vaccine out of an abundance of caution”. US FDA took to their Twitter account to say that they are suggesting a pause in using the vaccine.

(Image Credit: The Associated Press)