The U.S. Centers for Disease Control and Prevention is expected to follow suit with what is known as a permissive recommendation, which means shots will not be formally recommended, but may be given to those who want them, a source told CNN. the condition of anonymity since they had not been allowed to discuss the details with reporters.
Details of the plans were first reported by the New York Times.
The decision to make the fourth tranches available now will bypass independent scientific advisory teams for both the FDA and the CDC, who will normally meet and publicly review available science and then make recommendations to the agencies.
Dr Eric Topol, a cardiologist and director of the Scripps Translational Research Institute in California, said the decision is expected next week ahead of the April 6 meeting of the Vaccine and Related Biological Products Advisory Committee (VRBPAC), a group of independent experts advise the FDA on its vaccine decisions. Amplifiers are on the agenda for discussion at this meeting, which will focus on future design for enhancers and vaccines for specific variants.
Topol, who was briefed on the FDA plans, said he understood the change would apply to both the Pfizer / BioNTech vaccines and the Moderna vaccines.
Topol also said he was in favor of giving the Americans the option of a fourth tranche.
“There are stable data from Israel for the age of 60+ (the only group reported to date) for enhanced protection (against serious illness) for up to 3 months compared to 3 doses. It makes sense to extend and provide as an option, since “The third dose has a strong benefit at the age of 50+”, Topol wrote in an email to CNN.
Topol noted that the FDA move legitimizes what many Americans do anyway. Anyone who wants a fourth dose can go to a pharmacy and get one just by saying it is needed because it is immunosuppressed.
Others felt that there was not enough science available to support the decision.
Dr Eric Rubin, editor-in-chief of The FDA VRBPAC The New England Journal of Medicine, said he had not yet seen enough data on the fourth installment to decide if it was needed for someone other than those already recommended. adults who have severe immunodeficiency.
“The only data I saw was for participants who were monitored for just a few weeks. The most important information will be how well a fourth dose protects extremely vulnerable people from serious illness and death and I do not know when it will be available,” he said. Rubin said in an email to CNN that Rubin could have accessed the data but had not yet seen it.
Dr. Paul Offit, director of the vaccine training center at Philadelphia Children’s Hospital and a member of the FDA VRBPAC, also said he felt the administration was acting ahead of science.
“Where is the evidence that someone over 50 is benefiting from a fourth dose? Because the evidence to date seems to support the possibility for people over 65, although I have not seen it, we have not seen all the data,” Offit said. on CNN. talking about the members of the VRBPAC committee. “But where is the evidence for a 50- to 64-year-old man? Where is the evidence? Because it does not exist, then there should be no such recommendation,” he said.
