Pfizer plans to seek authorization for booster shot, FDA & CDC say no booster needed

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Pfizer Biontech announced yesterday that it would seek emergency use authorization for a booster shot to be administered six months after their second dose, when antibodies wane. The company wrote in a statement that initial data from a study they’re conducting shows that a booster shot, given six months after the second one, is well tolerated, effective at preventing specific variants and shows “neutralization titers… 5 to 10 times higher than after two primary doses.” That’s amazing news and is promising for those of us who are vaccinated and are worried about the variants. Only the CDC and FDA, in what was surely a response to Pfizer’s release, have stated that boosters aren’t currently necessary. Here’s more on this from CNN:

Drugmaker Pfizer said Thursday it is seeing waning immunity from its coronavirus vaccine and says it is picking up its efforts to develop a booster dose that will protect people from variants.

Pfizer said it would soon publish data about a third dose of vaccine and submit it to the US Food and Drug Administration, European Medicines Agency and other regulators. The company specified it would seek FDA emergency use authorization for a booster dose in August.

But in an unusual move, two top federal agencies said Americans don’t need boosters yet and said it was not up to companies alone to decide when they might be needed.

Hours after Pfizer issued its statement, the FDA and Centers for Disease and Control issued a joint statement saying Americans do not need booster shots yet. “Americans who have been fully vaccinated do not need a booster shot at this time,” they said.

In a statement to CNN on Friday, the World Health Organization said, “We don’t know whether booster vaccines will be needed to maintain protection against COVID-19 until additional data is collected,” adding, “limited data available on how long the protection from current doses lasts and whether an additional booster dose would be beneficial and for whom.”

Pfizer and its partner BioNTech said evidence was building that people’s immunity starts to wane after they have been vaccinated. The Pfizer vaccine requires two doses to provide full immunity.

“As seen in real world data released from the Israel Ministry of Health, vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high,” Pfizer said in a statement emailed to CNN.

“Additionally, during this period the Delta variant is becoming the dominant variant in Israel as well as many other countries. These findings are consistent with an ongoing analysis from the Companies’ Phase 3 study,” it added.

“While protection against severe disease remained high across the full six months, a decline in efficacy against symptomatic disease over time and the continued emergence of variants are expected. Based on the totality of the data they have to date, Pfizer and BioNTech believe that a third dose may be beneficial within 6 to 12 months following the second dose to maintain highest levels of protection.” It gave no further details.

[From CNN]

I’m truly sick of the clowns at the CDC and am following the advice and guidelines of the WHO. If the CDC and FDA wanted to issue a statement it could have been a more measured one, similar to the one from the WHO, saying that they’re still evaluating whether boosters are needed. Instead they dismissed Pfizer’s statement with this terse one. They seem to be catering to the lowest common denominator in the US and are focusing on cajoling people into getting vaccinated instead of following the science. If the efficacy of the shots wanes at six months people should be getting booster shots. We don’t know the long term effects of coronavirus and even mild case have resulted in long haul symptoms.

There are people who are not going to be convinced to get vaccinated no matter what and a lot of them are getting sick and dying. Unfortunately those covid deniers are also enabling the virus to mutate in a way that makes the shots less effective. If Pfizer says we should get another shot at six months I hope the FDA makes it possible for us to get one.

Below and on the front page is a photo of Sandra Lindsay, “a Queens nurse who was the first American to receive the Pfizer vaccine in December.” She was the grand marshal at NYC’s tickertape parade on Wednesday for COVID-19 workers.

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