The Pfizer/BioNTech Covid-19 vaccine booster plan is on schedule for the week of September 20. Booster doses of Moderna’s vaccine may take a few weeks longer.
The Biden Administration’s September 20 Booster Distribution May Be Limited To Just The Pfizer Covid-19 Vaccine Initially.
Biden’s administration is contemplating lowering the ambitious timetable of Covid-19 vaccine boosters proposed last month by top federal health officials. According to a person familiar with the matter, officials warned that more time might be needed to recommend boosters for all people before adequate evidence is available.
It was stated that Moderna’s application was inadequate and needed more factual evidence, according to sources. On Friday, the company sent a tweet announcing that it had provided the FDA with the information for booster doses. This is not the first time Pfizer/BioNTech has attempted to get clearance for a larger dose.
Additional information indicated that the next meeting of the FDA’s Vaccine and Related Biological Products Advisory Committee is set for September 17. Moderna started reporting booster data to the FDA on Wednesday.
The New York Times broke the story on the booster shot idea being scaled down. The FDA had asked the White House not to set a date for releasing Covid-19 booster injections, but they did. The FDA and the US Centers for Disease Control and Prevention had to approve the September 20 booster deployment, according to White House coronavirus response coordinator Jeff Zients. On Friday, White House spokesperson Chris Meagher agreed.
In a statement that we are seeking FDA clearance and a recommendation from the Advisory Committee on Immunization Practices. We will be ready to execute the strategy prepared by our nation’s best physicians once it is approved and recommended,
Despite the White House’s September 20 start date, FDA Acting Commissioner Dr. Janet Woodcock said Thursday the FDA lacks data on Covid-19 booster shots.
In a video interview, Dr. John Whytesaid that they need a strategy, and that plan includes vaccinating vast numbers of Americans with a booster dose. Woodcock said WebMD’s Woodcock added that they have to create a strategy before getting all the facts.
Woodcock said that the FDA would soon have all the data it needs on booster doses. Dr. Anthony Fauci said Thursday that the FDA would likely recommend three doses of Moderna or Pfizer coronavirus vaccine to protect against Covid-19 infection. According to two Israeli studies, the third injection, in a statement issued by Fauci at the White House Covid-19 response team briefing, he said he is not surprised that the adequate complete regimen for vaccination will likely be three doses.
He further said that waiting a few months between doses allows the immune system to mature and boost. Based on Fauci, It is easy to see why the Israeli boost’s effects were so spectacular. In the event of significant response, he believes they have good reason to expect that it will be persistent, and if it is durable, then a three dosage regimen will be the routine.
He also stated that Moderna and Pfizer rely heavily on statistics to support their FDA submissions. To advertise a booster dosage, Zients added, the FDA and the CDC’s Advisory Committee on Immunization Practices must approve it.