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Pfizer Vaccine: FDA and CDC Say Booster Dose Not Needed Yet

2021-07-09T21:00:49.210Z


Pfizer said Thursday that it has seen a decrease in the immunity of its coronavirus vaccine and is seeking to develop a booster dose that will protect people from the variants. But the FDA and CDC said a third dose is not necessary yet. | Health | CNN


Pfizer: Why is the third dose important?

2:20

(CNN) -

Pfizer said Thursday that it saw a decline in the immunity of its coronavirus vaccine and is resuming its efforts to develop a booster dose that will protect people from the variants.

The drugmaker said it would seek emergency use authorization from the U.S. Food and Drug Administration (FDA) for a booster dose in August, after releasing more data on how well one works. third dose of vaccine.

Pfizer: Vaccine is not the only measure to contain covid-19 6:15

But in an unusual move, two of the top federal agencies said the Americans don't need reinforcements yet and said it wasn't just up to companies to decide when they might be needed.

Hours after Pfizer issued its statement, the FDA and the Centers for Disease Control and Prevention (CDC) issued a joint statement saying that Americans still do not need booster doses.

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"Americans who have been fully vaccinated do not need a booster dose at this time," they said.

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Pfizer and its partner BioNTech said the evidence that people's immunity begins to wane after they have been vaccinated was on the rise.

The Pfizer vaccine requires two doses to provide full immunity.

"As seen in the real-world data published by the Israeli Ministry of Health, the efficacy of the vaccine in preventing infections and symptomatic diseases has decreased six months after vaccination, although the efficacy in preventing serious diseases remains high." Pfizer said in an emailed statement to CNN.

"Furthermore, during this period, the delta variant is becoming the dominant variant in Israel, as well as in many other countries. These findings are consistent with an ongoing analysis of the Phase 3 study of the companies," he added.

"While protection against severe disease remained high for the full six months, a decrease in efficacy against symptomatic disease is expected over time and continued emergence of variants. Based on the totality of the data available to date , Pfizer and BioNTech believe that a third dose may be beneficial within 6 to 12 months after the second dose to maintain the highest levels of protection. "

They did not give any further details.

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US government officials have stressed that fully vaccinated people have a low risk of infection, even from the delta variant or B.1,617.2, which is more transmissible than previous variants of the virus.

Additionally, several studies have indicated that mRNA vaccines manufactured by Pfizer and Moderna confer long-term protection.

"The FDA, CDC, and NIH (the National Institutes of Health) participate in a rigorous science-based process to consider whether or when a boost might be needed. This process takes into account laboratory data, data from clinical trials and the data cohort, which may include data from specific drug companies, but are not based exclusively on that data, "they added.

It was a clear message for Pfizer, which has been hinting at the need for a booster shot for months.

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"We continue to review any new data as it becomes available and will keep the public informed. We are prepared for booster doses as long as science shows they are necessary," the CDC and FDA said in the statement.

"The United States is fortunate to have highly effective vaccines that are widely available for those over the age of 12. People who are fully vaccinated are protected from serious disease and death, including from variants currently circulating in the country, such as delta, "the statement continues.

"People who are not vaccinated are still at risk. Virtually all hospitalizations and deaths from COVID-19 are from people who are not vaccinated. We encourage Americans who have not yet been vaccinated to get vaccinated as soon as possible to protect themselves. themselves and their community. "

Israel's Health Ministry said in a statement earlier this week that it had seen the efficacy of Pfizer's vaccine drop from more than 90% to about 64% as the B.1,617.2 or delta variant spread.

Pfizer said the research showed that booster doses of its vaccine, developed with BioNTech, produced levels of neutralizing antibodies that are five to 10 times higher than those produced after two doses.

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"The companies hope to publish more definitive data soon, as well as in a peer-reviewed journal, and plan to submit the data to the FDA, EMA (European Medicines Agency) and other regulatory authorities in the coming weeks," Pfizer said in a statement. .

He added that he is developing a new formulation for a booster dose that can further protect people from new variants.

"While Pfizer and BioNTech believe that a third dose of BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently known variants, including delta, companies remain vigilant and are developing an updated version of the vaccine. from Pfizer-BioNTech against covid-19 that completely targets the delta variant spike protein, "the company said.

Current vaccines target only part of the spike protein, the part of the virus that it uses to adhere to cells.

"The first batch of mRNA for the assay has already been manufactured at BioNTech's facilities in Mainz, Germany. The companies anticipate that clinical studies will begin in August, subject to regulatory approvals."

Pfizervacuna against covid-19

Source: cnnespanol

All news articles on 2021-07-09

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