Pfizer Fails to Convince FDA of Immediate Need for COVID Booster Shots • Protecting Children’s Health

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After a meeting with Pfizer executives on Monday, U.S. regulators said they were not yet ready to recommend the COVID vaccine booster shot.

“Nothing has really changed,” Anthony Fauci Dr., director of the National Institute of Allergy and Infectious Diseases, told CNN’s Chris Cuomo after the meeting.

Pfizer executives met privately with senior U.S. scientists and regulators Monday night through pursue their case for quick clearance COVID booster vaccines amid push from federal health agencies last week no overdose is necessary.

Officials said after the meeting that a lot of data – and possibly many more months – would be needed before administrators could determine whether booster shots were necessary.

During the 1-hour period online virtual meeting, Pfizer’s chief scientific officer informed the federal government’s top physicians, including: Fauci; Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC); Francis Collins, director of National Institutes of Health; U.S. Surgeon General Dr. Vivek Murthy; Janet Woodcock, acting commissioner of the U.S. Food and Drug Administration (FDA); Assistant Secretary for Health Dr. Rachel Levine; David Kessler, chief science officer of the COVID response team in the Biden administration.

the meetings mostly seen as a good practice after Pfizer’s advertisement last week it will find Emergency Use Permit for its booster shot that brings out the uncommon pushing back from the FDA and CDC.

Both agencies responded to Pfizer’s news in a joint statement, released last week by the U.S. Department of Health and Human Services (HHS), in which they say vaccinated Americans no longer need boosters today and lack science.

“The CDC and the FDA say that based on the data we know now, we no longer need an expansion,” Fauci said. told CNN Monday. “That doesn’t mean that won’t change. We may need, as a matter of fact, a few hours to give presenters anywhere on the board or to certain select groups, such as seniors or those with underlying conditions, ”Fauci said.

Officials say any recommendations regarding booster shots are likely to be scaled, even within age groups. For example, if a booster shot is recommended, they may first go to nursing home residents who received their vaccines in late 2020 or early 2021, while seniors who received their first shot in the spring. there may be a longer wait, The New York Times reports.

Then there is the issue of how different the booster should be: a third dose of the original vaccine, or a shot adapted to Delta different.

“It was an interesting meeting,” Fauci said. “They share their data. There’s nothing like a decision. It’s just a piece of a much larger puzzle, and it’s a piece of data, so there’s no question of a convincing case. in one way or another. ”

Pfizer the meeting was called “Fruitful”:

“We had a fruitful meeting with U.S. public health officials about elements of our research program and preliminary booster data in our ongoing trials. Both Pfizer and the U.S. government have agility to continue to be the first virus that causes COVID-19, and we also agree that scientific data will dictate the next steps in the cumbersome management process that we have always followed. ”

Pfizer reported that it publishes “highly accurate data in a peer -reviewed journal and continues to work with regulatory authorities to ensure that our vaccine continues to offer the highest level of protection possible.”

According to The New York Times, HHS, which convened the meeting, issued its own statement reiterating the administration’s stance. “At this time, fully vaccinated Americans don’t need a booster shot,” according to the agency.

An HHS spokeswoman told CNN that the CDC and FDA take laboratory data, clinical trial data, cohort data – which could include data from specific strengthening companies, but don’t “just rely on that data.”

The administration is ready for booster doses if science shows they are necessary, in addition to the spokesperson, and will continue to review any new data if they are available.

Prior to Monday’s meeting, Drs. Scott Gottlieb, former FDA commissioner and now board member at Pfizer, told CBS News Updated efficacy figures from the Israeli Ministry of Health led Pfizer to seek Emergency Use Authorization for a booster dose of the COVID vaccine.

The Israeli health ministry said in a statement last week that it saw an improvement in Pfizer’s vaccine coverage from more than 90% to almost 64% as the variety spread in the Delta.

As a result, Israel began administration of a third dose of Pfizer’s COVID vaccine at admonished heart transplant patients – however link to the vaccine of inflammation of the heart.

WHO says Pfizer should focus on improving vaccine access, not boosters

World Health Organization (WHO) officials insist that there is not enough evidence to demonstrate the need for a third dose of COVID vaccines. They said Pfizer should instead focus on improving vaccine access around the world, The Guardian reports.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus says the grotesque vaccine differences are driven by “greed.”

“We’re making smart choices now not to protect those in need,” Ghebreyesus said, adding that people who have not yet received a dose should be given priority. He called on Pfizer and Moderna to “go all out to give COVAX, the Africa Vaccine Acqu acquisition Task Team and low- and low -income countries. ”

Soumya Swaminathan, WHO’s lead scientist, said: “At this point… there is no scientific evidence to suggest that promoters are really necessary.”

Swaminathan said the WHO would make recommendations about booster shots “based on science and data, not on individual companies declaring that vaccines should be given as a boosting dose.”

Dr. Michael Ryan, WHO’s chief of emergencies, suggested that if rich countries decide to give booster shots rather than give them to the developing world, “we will look at the anger and I think we will go back to shame. “

Pfizer stands to make billions from boosters

Pfizer seeks to benefit financially when a booster dose is needed, according to The Motley Fool who wrote: “The more doses of COVID vaccine are needed, the higher sales of companies and the better the likelihood of vaccine stocks operating.”

Agreed to Finance at YAHOO, Pfizer is now experiencing an increase in support from most financial managers in the world. Among these funds, Diamond Hill Capital held the most valuable stake in Pfizer – worth $ 407.3 million at the end of the fourth quarter.

In second place is the New York -based hedge fund Two Sigma Advisors, which amassed $ 387.2 million worth of barriers. Citadel Investment Group and AQR Capital Management – a management firm dedicated to delivering results for its clients – has become one of the company’s largest hedge fund owners.

In terms of portfolio weight assigned to each position Beneficial Capital allocated the most weight to Pfizer.

Specific cash managers include Marshall Wace LLP, which invested $ 56.1 million in the company at the end of the quarter, and Steven Boyd’s Armistice Capital, which made $ 43.5 million in stock investments during the quarter.

Other funds with new positions at Pfizer are Charles Clough’s Clough Capital Partners, Michael Rockefeller and KarláKroeker’s Woodline Partners, and Phill Gross and Adage Capital Management by Phill Gross and Robert Atchinson.

As in Defender reports July 9, 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 in May anticipated global sales of the COVID vaccine to be reached $ 26 billion in 2021.

The company is also frank that current price – $ 19.50 per dose in the US – temporary. In an earnings call in February, Frank A. D’Amelio, Pfizer’s executive vice 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.

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.

The company said they would begin testing a booster shot specifically programmed to combat the Delta variety in August, which also confirmed the concerns of scientists who predicted in April that pharmaceutical companies like Pfizer , make a vaccine treadmill with a continuous booster shot aimed at coming out different – music to the ears of investors.

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