The Food and Drug Administration revealed today, Wednesday,FDAToday, Wednesday, it called a meeting of vaccine advisors on September 17 to discuss the booster doses of the Corona virus vaccine.
Network explained CNN The news, that these statements come 3 days before the target date on September 20 to start providing booster doses, which the White House announced last month..
Dr. Peter Marks, who heads the US Food and Drug Administration’s Vaccine Division, said: FDAIn a statement, the FDA recently announced a plan to prepare for additional doses of the coronavirus vaccine, or “boosters,” this fall, and a key part of that plan is the FDA’s completion of an independent evaluation and determination of the safety and efficacy of the additional doses of the vaccine.
She added, CNN Pfizer has advanced Pfizer / BioNTech To the Food and Drug Administration to approve the booster doses of its vaccine last month.
Marks, who leads the FDA’s Center for Biological Evaluation and Research, added (CBER) , the US agency evaluates the data provided by Pfizer-BioNTech In its application for a supplemental biological license for its COVID-19 vaccine and will discuss this with the FDA Advisory Committee to inform our decision-making process,” she said, “If data from other manufacturers raise unique questions that would benefit from the panel’s input, the FDA intends to consider additional public discussions..”
The website said, “The US Food and Drug Administration has approved it.”FDA” fully on the Pfizer vaccine last month, adding that moments before the US Food and Drug Administration issued the announcement, the vaccine manufacturer, Moderna, said Modern She submitted a request to provide booster potions.
“We are pleased to begin the application process for our 50 mcg booster candidate with FDAOur presentation is supported by data generated with a 50 μg dose of our corona vaccine that shows robust antibody responses against the delta variant,
He explained that this is half a dose of the Moderna vaccine, which provides 100 micrograms in each dose for the initial vaccinations.
The company used data from a Phase 2 study providing a booster to 344 interested participants 6 months after the second dose..
“Neutralizing antibody titer was significantly diminished prior to booster at approximately 6 months,” the company said.
After a third dose, a similar antibody neutralization level was achieved across age groups, particularly in the elderly (aged 65 years and over), the company said.“.
“The safety profile following dose 3 was similar to that previously observed for dose 2 of mRNA-1273 This data will be submitted to a peer-reviewed publication.”
Only half a dose of Moderna produced abundant antibodies against the variants of concern, including Delta, the company said. Beta (B.1.351) and gamma”P.1“Gamma.