The European Medicines Agency supports the use of the single-dose COVID-19 vaccine, saying its overall benefits outweigh the risks.
The European Union medicines regulator said on Tuesday it had found a “possible link” between Johnson & Johnson’s (J&J) COVID-19 vaccine and the development of rare blood clots in a small number of recipients, but concluded that the overall benefits of the vaccine outweighed any risks. associated with its use.
The European Medicines Agency (EMA) said its safety committee had decided that a warning about unusual blood clots with low blood platelets should be added to vaccine labels, just as the regulator also demanded from the Rival vaccine maker AstraZeneca, whose own vaccine was found by the agency last month to also have a “possible link” to rare blood clots.
The EMA found that all cases of coagulation occurred in adults under the age of 60, mostly women, within three weeks of being vaccinated with J & J’s single-shot vaccine. The agency said these rare blood disorders should be considered “very rare side effects of the vaccine.”
He said all available evidence, including eight reported cases in adults who had received the vaccine in the United States, including one death, had been part of his assessment.
The watchdog also said most of the clots in the recipients occurred in the brain and abdomen, as was the case with the AstraZeneca injection, which is also being investigated for problems. similar rare coagulation.
Rare cases of blood clots in the United States
The EMA update came after J&J last week halted its European rollout of its single-dose injection in response to a US Food and Drug Administration (FDA) recommendation that officials were suspending its use while rare cases of blood clots were being examined.
The cases have been reported in more than seven million doses administered in the United States as of April 13, the EMA said.
J&J had advised European governments to stockpile their doses until the EMA issues guidelines on their use, and the US-based pharmaceutical giant is said to be ready to resume deployment of its vaccine after the review of the agency.
The company said it would aim to deliver 55 million doses to the European Union, as planned, by the end of June. It is one of four COVID-19 vaccines authorized for use in the block.
But widespread use of the vaccine among its 27 member states has not yet started, with the recent delay posing a further setback to already faltering vaccination efforts in the Union, in particular, and to global efforts to tackle the pandemic of coronavirus.
Irregular vaccine deployment in the EU has been plagued by problems including poor coordination between national and regional authorities, supply shortages, concerns over the AstraZeneca firing and a damaging contract dispute with the company Anglo-Swedish.
‘The suspicion rises’
With the AstraZeneca vaccine, scientists from Norway and Germany have suggested that some people experience an abnormal immune system response, forming antibodies that attack their own platelets.
It’s not yet clear if there could be a similar mechanic with the J&J shot.
But the J&J and AstraZeneca vaccines, along with a Russian-made COVID-19 vaccine and a Chinese vaccine, are made with the same technology.
They train the immune system to recognize the spike protein that covers the coronavirus. They do this by using a cold virus called adenovirus to carry the spike gene around the body.
“There is growing suspicion that these rare cases could be triggered by the adenovirus component of AstraZeneca and J&J vaccines,” Eleanor Riley, professor of immunology and infectious diseases at the University of Edinburgh, told the agency. Associated Press release.
Riley said that while more data is needed, “the fact remains that for the vast majority of adults in Europe and the United States, the risks associated with contracting COVID-19 far outweigh any risk of being vaccinated. “.