FDA asks Pfizer to approve a 2nd Covid booster in order to treat people 65 years and older

If approved by the FDA, the additional shot will be given to those who are at highest risk for serious illness.

FDA asks Pfizer to approve a 2nd Covid booster in order to treat people 65 years and older

Pfizer and BioNTech announced Tuesday they had asked U.S. regulators for authorization to use a second Covid-19 booster vaccine for people aged 65 and over.

The Food and Drug Administration would authorize the extra shot to be given to people at highest risk for serious illness and death due Covid.

Pfizer provided data from Israel showing that Covid infection rates were 2x lower in people who had received two booster shots of the vaccine. They also reported a 4x decrease in severe illnesses among those who had received one booster shot.

Pfizer stated that the second booster was administered within four months of the first booster.

Data from Israel was also included in the company's report on health care workers who were vaccinated or boosted with vaccines.

The data showed that participants' neutralizing antibody levels increased sevenfold to eightfold in just a few weeks following the booster dose.

FDA approved booster shots for anyone 12 years old or older, on an emergency basis.

Multiple studies show that protection from the initial booster dose starts to fade after several months, especially against the omicron version of the coronavirus.

Albert Bourla, CEO of Pfizer, said Friday that the company was nearing submitting data on a fourth dose to the FDA after scientists discovered that the vaccine's protection had waned after only three to four months.

The Centers for Disease Control and Prevention recommends that everyone aged 12 and over receive a booster five to six months after they have received their second shot of either Moderna or Pfizer vaccines, or two months after they have received the single-dose Johnson & Johnson vaccine.

According to the CDC, more than 66 percent have been granted a booster for their 65-year-old eligibility.

It's not clear if everyone who is eligible for the Pfizer booster will be granted one. The U.S. government currently has only enough doses to treat immunocompromised patients to offer a fourth shot. A senior administration official stated Tuesday.

Health experts have indicated that additional shots are likely to be required, but it is not yet clear when or how often.

Experts are still unsure if everyone will require an extra dose. However, it is sensible for the elderly to get their vaccines first, according to Dr. Anna Durbin at Johns Hopkins University.

She stated, "Because they know that their immune systems don’t work as well and that there is a higher risk of severe disease."


 

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