Medicines Regulatory Agency at United State (FDA) Friday (23) lifted the temporary suspension on the vaccine Against A. Covid-19 Developed by Janssen, The pharmaceutical arm Johnson & Johnson.
With the suspension suspended, states will be able to re-apply Johnson’s immunity at their vaccination centers. Peter Marks, director of research at the Food and Drug Administration, said: The application can start again on Saturday (24).
The Food and Drug Administration (FDA) is following up on a recommendation made earlier by an independent panel of experts from the Center for Disease Control and Prevention (Center for Disease Control) Who requested Vaccine poster update With a warning about the risk of the A rare type of blood clot.
Of the 15 scholars who make up the independent commission, 10 voted in favor Return requests, 4 they were against e 1 abstained.
“The potential benefits of the vaccine are enormous,” said Sarah Oliver, a scientist at the Center for Disease Control and Prevention during the panel presentation.
According to scientists, 15 patients presented clot formation out of the nearly 8 million doses distributed, and this gives an incidence rate of 0.0002%.
Application paused
On April 13, the two US federal agencies, the Food and Drug Administration (FDA) and the Center for Disease Control (CDC), He recommended that Johnson’s vaccine against Covid-19 be temporarily stopped In the country after 6 cases of rare strokes in vaccinated patients.
In all, 6.8 million doses of the vaccine have been administered in the United States. Thrombotic states account for only 0.0000882353% of the doses applied, or less than one stroke state for every million doses applied.
Only Johnson’s vaccine is given in a single dose. As authorized by the National Health Surveillance Agency (Anvisa) To be used in Brazil, but not yet applied in the country.
All six cases occurred in women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination.
Which vaccine is this? Janssen (Johnson & Johnson;)
The type of thrombus detected was a cerebral venous sinus thrombosis, which occurs with low platelet levels.
Cerebral venous sinus thrombosis occurs when a blood clot forms in the venous sinuses of the brain, preventing blood from draining out of the organ. As a result, blood cells can rupture, leak into brain tissue, and form bleeding.
Johnson’s vaccine was Anvisa approved it for emergency use in Brazil on March 31. The Ministry of Health purchased 38 million doses with the deliveries Planned for the second semester.
The vaccine is the only one that will only be applied with a single dose when it is available in the country. So far, the vaccines used in the country – CoronaVac and Oxford – have to be administered in two doses. The Pfizer app, which has already been approved by Anvisa but is not yet available, is also implemented this way.
The vaccine It is also approved for emergency use by the World Health Organization (Who is the).
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