Pfizer Fails to Convince FDA COVID Booster Shots Are Needed
Pfizer met with U.S. regulators Monday evening to press its case for quick authorization of COVID booster vaccines but health officials, who remained unconvinced, calling for more data.
After meeting with Pfizer executives Monday, U.S. regulators said they are still not ready to recommend COVID vaccine booster shots.
โNothing has really changed,โ Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNNโs Chris Cuomo after the meeting.
Pfizer executives met privately with U.S. senior scientists and regulators Monday evening to press their case for quick authorization of COVID booster vaccines amid pushback from federal health agencies who last week said the extra doses are not needed.
Officials said after the meeting that more data โ and possibly several more months โ would be needed before regulators could determine whether booster shots were necessary.
During the 1-hour online virtual meeting, Pfizerโs chief scientific officer briefed top doctors in the federal government, including: Fauci; Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention (CDC); Dr. Francis Collins, director of the National Institutes of Health; U.S. Surgeon General Dr. Vivek Murthy; Dr. Janet Woodcock, acting commissioner of the U.S. Food and Drug Administration (FDA); Assistant Secretary for Health Dr. Rachel Levine; and Dr. David Kessler, chief science officer of the Biden administrationโs COVID response team.
The meeting was largely seen as a courtesy after Pfizerโs announcement last week that it would seek Emergency Use Authorization for its booster shot led to unusual pushback from the FDA and CDC.
The two agencies responded to Pfizerโs news in a joint statement, issued last week by the U.S. Department of Health and Human Services (HHS), in which they said fully vaccinated Americans donโt need boosters right now and the science is lacking.
โThe CDC and the FDA said that based on the data that we know right now, we donโt need a boost,โ Fauci told CNN Monday. โThat doesnโt mean that that wonโt change. We might need, as a matter of fact, at some time to give boosters either across the board or to certain select groups, such as the elderly or those with underlying conditions,โ Fauci said.
Officials said any recommendations about booster shots are likely to be scaled, even within age groups. For example, if booster shots are recommended, they might go first to nursing home residents who received their vaccines in late 2020 or early 2021, while elderly people who received their first shots in the spring might have a longer wait, The New York Times reported.
Then there is the issue of what kind of booster will be needed: a third dose of the original vaccine, or a shot tailored to the Delta variant.
โIt was an interesting meeting,โ Fauci said. โThey shared their data. There wasnโt anything resembling a decision. This is just one piece of a much bigger puzzle, and itโs one part of the data, so there isnโt a question of a convincing case one way or the other.โ
Pfizer called the meeting โproductiveโ:
โWe had a productive meeting with U.S. public health officials on the elements of our research program and the preliminary booster data in our ongoing trials. Both Pfizer and the U.S. government share a sense of urgency in staying ahead of the virus that causes COVID-19, and we also agree that the scientific data will dictate next steps in the rigorous regulatory process that we always follow.โ
Pfizer said it would be publishing โmore definitive data in a peer-reviewed journal and continuing to work with regulatory authorities to ensure that our vaccine continues to offer the highest degree of protection possible.โ
According to The New York Times, HHS, which convened the meeting, issued its own statement reiterating the administrationโs stance. โAt this time, fully vaccinated Americans do not need a booster shot,โ the agency said.
An HHS spokesperson told CNN the CDC and FDA take laboratory data, clinical trial data, cohort data โ which can include data from specific pharmaceutical companies, but do โnot rely on those data exclusively.โ
The administration is prepared for booster doses if the science demonstrates they are needed, the spokesperson added, and will continue to review any new data as it becomes available.
Prior to Mondayโs meeting, Dr. Scott Gottlieb, former FDA commissioner and current board member at Pfizer, told CBS News updated efficacy numbers from the Israeli Ministry of Health led Pfizer to seek Emergency Use Authorization for a booster dose of its COVID vaccine.
Israelโs health ministry said in a statement last week it had seen the efficacy of Pfizerโs vaccine drop from more than 90 percent to about 64 percent as the Delta variant spread.
As a result, Israel started administering a third dose of Pfizerโs COVID vaccine to immunocompromised people and heart transplant patients โ despite the vaccineโs link to heart inflammation.
WHO says Pfizer should focus on improving access to vaccine, not boosters
World Health Organization (WHO) officials insisted there was not enough evidence to show the need for third doses of COVID vaccines. They said Pfizer should concentrate instead on improving vaccine access around the world, The Guardian reported.
The WHO Director-General Dr. Tedros Adhanom Ghebreyesus said grotesque vaccine disparities were driven by โgreed.โ
โWe are making conscious choices right now not to protect those in need,โ Ghebreyesus said, adding that people who have yet to receive a single dose should be prioritized. He called on Pfizer and Moderna to โgo all out to supply COVAX, the Africa Vaccine Acquisition Task Team and low- and middle-income countries.โ
Dr. Soumya Swaminathan, chief WHO scientist, said: โAt this point โฆ there is no scientific evidence to suggest that boosters are definitely needed.โ
Swaminathan said the WHO would make recommendations on booster shots โbased on the science and data, not on individual companies declaring that the vaccines should now be administered as a booster dose.โ
Dr. Michael Ryan, WHO emergencies chief, suggested if rich countries decide to administer booster shots rather than to donate them to the developing world, โwe will look back in anger and I think we will look back in shame.โ
Pfizer stands to make billions from boosters
Pfizer stands to benefit financially if booster doses are needed, according to The Motley Fool which wrote: โThe more COVID vaccine doses are required, the higher the companiesโ sales will be and the better its vaccine stocks will likely perform.โ
According to YAHOO Finance, Pfizer has recently experienced an increase in support from the worldโs most elite money managers. Among these funds, Diamond Hill Capital held the most valuable stake in Pfizer โ worth $407.3 million at the end of the fourth quarter.
In second place was New York-based hedge fund Two Sigma Advisors, which amassed $387.2 million worth of shares. Citadel Investment Group and AQR Capital Management โ an investment management firm dedicated to delivering results for its clients โ became one of the largest hedge fund holders of the company.
In terms of the portfolio weights assigned to each position, Healthcare Value Capital allocated the biggest weight to Pfizer.
Specific money managers include Marshall Wace LLP, which invested $56.1 million in the company at the end of the quarter, and Steven Boydโs Armistice Capital, which made a $43.5 million investment in the stock during the quarter.
Other funds with brand new Pfizer positions are Charles Cloughโs Clough Capital Partners, Michael Rockefeller and KarlรกKroekerโs Woodline Partners, and Phill Gross and Robert Atchinsonโs Adage Capital Management.
As The Defender reported July 9, Pfizer CEO Albert Bourla has said for months a booster would likely be needed within a year of the initial two-dose inoculation โ followed by annual vaccinations, even as public health officials and academic scientists said it wasnโt clear yet when a booster would be needed.
Booster shots for COVID are expected to serve as a key revenue driver in the years to come for Pfizer and its primary rival in the U.S., Moderna. Pfizer in May projected global sales of its COVID vaccine to reach $26 billion in 2021.
The company has also been frank that its current pricing โ $19.50 per dose in the U.S. โ is temporary. On an earnings call in February, Frank A. DโAmelio, Pfizerโs executive vice president of global supply, assured investors the company sees the vaccine market evolving as the pandemic wanes, and will likely be able to charge more per dose than it was getting under pandemic supply deals.
DโAmelio said a more typical price for a vaccination was $150 or $175 per dose.
Pfizer has been working on two different booster strategies it anticipates could carry sales beyond the immediate pandemic need: a third 30 mg dose of its current vaccines and an updated vaccine that targets the South African variant.
The company said it would begin testing a booster shot specifically programmed to combat the Delta variant in August, reaffirming concerns by scientists who predicted in April that pharmaceutical companies like Pfizer, would create a vaccine treadmill with continuous booster shots targeted at emerging variants โ which is music to the ears of investors.
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karlito
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Funny they want more data from a company that is known for: โโฆ persistently engaging in illegal and corrupt marketing practices, bribing physicians and suppressing adverse trial resultsโฆโ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2875889/
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Tom
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Itโs beyond funny.
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barry paul robinson
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Data can easily be interpreted as Money.
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Lit
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Pfizer is a very criminal company, nothing they say should be taken for truth.
https://www.dmlawfirm.com/crimes-of-covid-vaccine-maker-pfizer-well-documented/
Pfizer received the biggest fine in U.S. history as part of a $2.3 Billion plea deal with federal prosecutors for mis-promoting medicines (Bextra, Celebrex) and paying kickbacks to compliant doctors. Pfizer pleaded guilty to mis-branding the painkiller Bextra by promoting the drug for uses for which it was not approved.
In the 1990s, Pfizer was involved in defective heart valves that lead to the deaths of more than 100 people. Pfizer had deliberately misled regulators about the hazards. The company agreed to pay $10.75 Million to settle justice department charges for misleading regulators.
Pfizer paid more than $60 Million to settle a lawsuit over Rezulin, a diabetes medication that caused patients to die from acute liver failure.
In the UK, Pfizer has been fined nearly โฌ90 Million for overcharging the NHS, the National Health Service. Pfizxer charged the taxpayer an additional โฌ48 Million per year for what should have cost โฌ2 million per year.
Pfizer agreed to pay $430 Million in 2004 to settle criminal charges that it had bribed doctors to prescribe its epilepsy drug Neurontin for indications for which it was not approved.
In 2011, a jury found Pfizer committed racketeering fraud in its marketing of the drug Neurontin. Pfizer agreed to pay $142.1 Million to settle the charges.
Pfizer disclosed that it had paid nearly nearly 4,500 doctors and other medical professionals some $20 Million for speaking on Pfizerโs behalf.
In 2012, the U.S. Securities and Exchange Commission announced that it had reached a $45 Million settlement with Pfizer to resolve charges that its subsidiaries had bribed overseas doctors and other healthcare professionals to increase foreign sales.
Pfizer was sued in a U.S. federal court for using Nigerian children as human guinea pigs, without the childrensโ parentsโ consent. Pfizer paid $75 Million to settle in Nigerian court for using an experimental antibiotic, Trovan, on the children. The company paid an additional undisclosed amount in the U.S. to settle charges here. Pfizer had violated international law, including the Nuremberg Convention established after WWII, due to Nazi experiments on unwilling prisoners.
Amid widespread criticism of gouging poor countries for drugs, Pfizer pledged to give $50 million for an AIDS drug to South Africa. Later, however, Pfizer failed to honor that promise.
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