The US Medicines Agency announced on Thursday that it is limiting Johnson & Johnson's Covid vaccine to only adults who refuse to be vaccinated with Pfizer or Moderna due to "
personal concerns
", as well as those who cannot receive an injection. of these last two vaccines for medical reasons or of limited access.
The FDA said it made this decision because of the risk of serious thrombosis (blood clot formation) associated with the “
J&J
” vaccine.
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For this same reason, the country's main public health agency, the CDC, had already recommended in December that Americans get vaccinated against Covid-19 with Pfizer and Moderna, rather than with Johnson & Johnson.
These three vaccines are the only ones authorized in the country.
The restriction is now part of the emergency use authorization of the vaccine from “
J&J
”.
Cases of thrombosis
The FDA has identified 60 confirmed cases of thrombosis in the United States, including nine deaths.
Just under 19 million doses of Johnson & Johnson's vaccine have been administered in the country, or about 3% of total doses injected.
The frequency of these thromboses is thus 3.23 per million doses administered, detailed the American agency.
Still, "
we recognize that Janssen's Covid vaccine still has a role to play in the response to the current pandemic
," FDA official Peter Marks said in a statement.
The agency detailed three examples of people who can still receive the Johnson & Johnson vaccine: individuals at risk of severe allergic reactions (anaphylactic shock) to a messenger RNA vaccine injection, such as Pfizer and Moderna.
People with limited access to vaccines from Pfizer and Moderna due to availability issues.
And finally, individuals “
having personal concerns about receiving an mRNA vaccine
”, and who would otherwise remain unvaccinated.
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Messenger RNA technology, which had never been widely used before Covid-19 vaccines, has been the target of many conspiracy theories, despite being shown to be very safe.
A rare risk of myocarditis (inflammation of the heart muscle) has been detected after injections of Pfizer or Moderna, particularly in young male adolescents, but the vast majority of cases are not serious, with short hospitalization times.
The FDA said it will continue to closely monitor data on all vaccines.
“
Our action reflects the robustness of our surveillance system, and our commitment to ensuring that we follow science and data in our decisions
,” said Peter Marks.
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