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Dubai, United Arab Emirates (CNN) – U.S. Food and Drug Administration vaccine advisers on Friday rejected the agency’s recommendation to approve booster doses of the coronavirus for all people vaccinated six ago months or more.
The counselors recommended that the booster dose be authorized for emergency use for people 65 years of age or older, people at high risk of serious infection, as well as healthcare workers and others at risk of severe infection. infection at work, even if they are not particularly at risk Critically ill infection risk.
The five reasons given by members of the Vaccines and Related Biologics Advisory Committee for voting against access to the recall are as follows:
No need to hurry
“The stated purpose of this vaccine is to protect against serious disease,” Paul Offit, professor of pediatrics at the Philadelphia Hospital, told the audience, adding that the data showed that these vaccines did just that, and that is. exactly what we expect.
Although Pfizer has announced that its vaccine protects against the consequences of serious injury, hospitalization and the risk of death by 90%, it has indicated that the effectiveness of the two doses of the vaccine will not last long.
There is not enough evidence to justify booster shots for everyone
“The need to use this dose includes the elderly and those working on the front lines,” said Dr. Mark Sawyer, clinical professor of pediatrics at the University of California, San Diego, noting that he agreed. with his colleagues on the scarcity of security data. provided.
One of the Food and Drug Administration’s vaccine officials, Dr Marion Gruber, concluded in a study published in the scientific journal “The Lancet” that it is too early to give the vaccine booster soon. ” Pfizer “.
The need for more study … and accuracy in conclusions
Dr Michael Corella, an infectious disease specialist at the National Center for the Advancement of Translational Sciences, said he suspected Pfizer had gone too far in extrapolating data on the elderly to a younger population group.
He felt that it was not clear to him, after reviewing the data provided by “Pfizer”, that they applied to the whole population, noting that the “Pfizer” studies were based on volume. antibiotics in the body without giving importance to other aspects related to the immune response.
And experts in immune system science had indicated that long-term protection came from so-called “B” and “T” cells, while “Pfizer” presented a study on antibiotics only.
For his part, the deputy director of the Office of Vaccine Research and Review of the United States Food and Drug Administration, Dr Philip Krause, said part of the lack of a booster dose recommendation is due to Pfizer’s reliance on data that has not been reviewed by specialists or by the agency.
In the same context, Dr Hayley Ganz, professor of pediatrics at Stanford University Medical Center, explained that “there is a lack of data regarding the doses of vaccines that have been administered so far”.
Concerns about myocarditis and endocarditis
“We were asked to approve this three-dose vaccine for people 16 years of age or older, with no clear evidence that the third dose for a younger person, compared to an older person, is of value,” he said. Offit said, adding: “If it isn’t worth the risks may outweigh the benefits. And we know that a 16 to 29 year old has a higher risk of developing myocarditis.”
Dr Doran Fink of the FDA told the meeting that the agency was not sure either, stating: “We do not yet have enough data to know what the risks of myocarditis or pericarditis are after a dose. reminder. “
Studies have shown that young adults and older adolescents, especially men, have a higher risk of developing this rare heart infection after receiving mRNA vaccines, although the problem is resolved quickly with prompt treatment.
Fink said details of this risk may not appear until the booster doses are given on a larger scale, adding: “We have discussed the need for such investigations with vaccine manufacturers.”
Before we talk about the third dose … Did the Americans get the two doses of the vaccine first?
Dr Cody Meisner, professor of pediatrics at Tufts University School of Medicine, noted that he did not believe the boosters would significantly help control the outbreak.
On the other hand, Dr Melinda Wharton, director of the division of immunization services at the United States Centers for Disease Control and Prevention, said: “It is frustrating when in the United States we have enough vaccines. , but we have not been able to achieve the expected vaccination rate in the population, which would lead to much better control of the epidemic than we have. “
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