Pfizer to Request Emergency Use Permit for COVID Booster Shots – But CDC, FDA Say Lack of Science • Child Health Defense

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Pfizer Office has partnered Thursday it will find out Emergency Use Permit (EUA) from the U.S. Food and Drug Administration (FDA) in August for the third dose of the COVID-19 vaccine. The vendor predicts fully vaccinated people will need a booster shot within six to 12 months from receiving their second dose of Pfizer vaccine.

But hours later, the U.S. Department of Health and Human Services (HHS) released a joint statement by the FDA and the Centers for Disease Control and Prevention (CDC) saying, “Americans who have been vaccinated no longer need a booster shot now.”

The statement is not clear talk about Pfizer, but is said to be “a science-based, meticulous process” led by the CDC, FDA and National Institutes of Health to determine when or if boosters are needed.

According to the HHS statement:

“The FDA, CDC and NIH have developed a science-based, meticulous process to consider when or when a booster is needed. This process considers laboratory data, clinical trial data and cohort data – which may include data from specific drug companies, but does not rely exclusively on the data. “

In a statement on CNN Friday, the World Health Organization said:

We don’t know if booster vaccines are needed to maintain protection against COVID-19 until more data is collected, ”he added,“ limited data [is] Use how long the protection will last from the current dose, and if an additional dose of the booster would be beneficial and for whom. “

Scientists “praised the statement” from HHS, The Washington Post reports, it is said that promoters are not to be expected and science is not clear when or when they should be.

“My opinion now… is that the current vaccination seems to be largely“ held, ”as E. John Wherry, an immunologist at the Perelman School of Medicine at the University of Pennsylvania. “But companies as suggested in their ongoing follow-up of their patients settled in the trial have shown about the level of reduced resistance. Not much of this data from companies is available to the public. I agree. that we need as much independent data and analysis as possible on this topic. ”

John P. Moore, professor of microbiology and immunology at Weill Cornell Medicine, said:

“No one is saying we will never need a booster, but to say we need it now and give the public the impression that vaccines have failed and something needs to be done as an urgency.… Not yet. The decisions to be made will be made by federal agencies. ”

The HHS statement followed recommendations held on June 23 by the CDC’s Advisory Committee on Immunization and Practices (ACIP). Members of the group working on ACIP COVID-19 say they recommend booster shots only if there is a demonstrated decrease in effectiveness-not just a disappearance of the antibody response.

Boosters may be recommended if there is a different avoidance of vaccines, according to slide Dr. showed. Sara Oliver, a medical epidemiologist with the CDC’s National Center for Immunization and Respiratory Diseases.

Sharon Frey, ACIP member and clinical director of the Center for Vaccine Development at Saint Louis University Medical School, said:

“I have to agree with the working group’s interpretation of the meaning that there is no data to support the recommendations to support the current proponents. There is no evidence against the current reduction in protection.”

The Pfizer CEO insists boosters are needed

Pfizer worked two different booster strategies it is expected to bring about more immediate pandemic need: a third 30 mg dose of current vaccines and an updated vaccine targeting the South African variety.

All U.S. pharmaceutical companies involved in making COVID vaccines are working to create and test booster shots to prepare for the possibility, The Washington Post reports.

Pfizer arguing that in order to stop the concentration of antibody in the blood, promoters need to ensure that the majority of the population does not carry the virus. It will make it easier to extinguish the epidemic, according to the company.

Pfizer SAYS the effectiveness of the vaccine was wasted, citing two lines of evidence outside of scientists who did not see the detail. Along with this is a Investigation of the Israeli government showed a decrease in the efficacy of Pfizer’s vaccine and the Delta different, and data from Pfizer’s ongoing follow-up of people who were vaccinated last summer.

“While protection against acute illness remained high over the entire six months, the observed decrease in efficacy against acute illness symptoms over time, and the continued improvement in variability, were significant. factors that motivate our belief that a booster dose may be necessary to maintain the highest level of protection, ” Pfizer said in a statement.

Pfizer said it will submit data to regulators within a few weeks showing the third dose of its vaccine in six months caused antibody levels to get five to 10 times higher than the original two. dose regimen. Moderna announced similar data in May.

Pfizer is driven by profit margins

Less than 24 hours later Pfizer announced plans to seek emergency authorization for the use of the third dose, the drug manufacturer’s stock. up 1.6%.

Pfizer CEO Albert Bourla has said in months a booster is likely to be needed within a year from the initial two -dose inoculation – followed by annual vaccination, even as public health officials and academic scientist It is said that it is not yet clear when a booster will be needed.

Shot shots for COVID are expected to serve as a key revenue driver in the coming years for Pfizer and its main rival in the US, Modern. Pfizer expects worldwide sales of COVID vaccine in May $ 26 billion in 2021.

The company is also frank that current price – $ 19.50 per dose in the US – temporary. In a earnings call in February, Frank A. D’Amelio, Pfizer’s executive president of global supply, investors are insured the company sees the vaccine market changing as the pandemic disappears, and is likely to charge more per dose than it gets with a pandemic supply deal.

D’Amelio SAYS the most common vaccine price is $ 150 or $ 175 per dose.

“Now, we’re going to go further around the pandemic price market, the environment we have now. Obviously we’re going to get more out of the price,” D’Amelio said. “As is clear, there is a significant opportunity for margins to improve once we break through the risky environment we are in.”

Pfizer said it would begin testing a booster shot specifically programmed to combat the Delta variety in August, also confirming the concerns of scientists who predicted in April that pharmaceutical companies like Pfizer , make a vaccine treadmill with a continuous booster shot aimed at different races.

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