Archive image of a Janssen vaccine against covid. PATRICK T. FALLON (AFP)
All vaccines are safe enough, but some are safer than others.
That is the opinion of the US Food and Drug Administration (FDA).
The agency announced this Thursday in a statement that it has decided to further restrict the use of the Janssen covid vaccine, from the Johnson & Johnson group, due to the risk of suffering thrombosis after its administration.
The FDA now limits the use of the Janssen vaccine to those over 18 years of age who do not have access to Pfizer or Moderna vaccines or for whom the latter are not clinically appropriate.
The message from the FDA is that it is better to get the Janssen vaccine than nothing, but better one of the other vaccines than the Janssen vaccine.
“After conducting an updated review, evaluation, and investigation of reported cases, the FDA has determined that the risk of thrombosis with thrombocytopenia syndrome (TTS), a rare and life-threatening blood clot syndrome in combination with low levels of blood platelets whose Symptoms appear approximately one or two weeks after the administration of the Janssen vaccine against covid justifies the limitation of the authorization for the use of the vaccine, ”says the agency's statement.
60 confirmed cases
Even so, the agency points out that the known and potential benefits of getting vaccinated with the Johnson & Johnson needlestick, when there is no other alternative, outweigh the risks.
US authorities have identified 60 confirmed cases of thrombosis with thrombocytopenia syndrome, including nine fatal cases.
That gives a notification rate of 3.23 per million doses of vaccine administered, a rate that has not been falling with the administration of more vaccines.
The US regulator emphasizes that the factors that put an individual at risk of suffering this type of thrombosis after administration of the vaccine are unknown.
And by limiting its use, it has considered that those who suffer from this type of disease can get worse quickly, despite rapid diagnosis and treatment, that the disease can have long-term and debilitating health consequences and that this thrombosis has a high rate of mortality.
Given these risks and the availability of authorized and approved alternative vaccines against covid without this problem, the FDA has decided to restrict the use of the Janssen vaccine as much as possible.
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