FDA Staff Declines To Take Stance On Pfizers Covid Vaccine Booster Shots, Citing Lack Of Verified Data

Jim Cramer says PayPal is a buy after pulling back from its high

CNBC Logo CNBC
  • Ann Mukherjee, Chairman and CEO of Pernod Ricard North America, joins Worldwide Exchange to discuss the company's full year 2021 earnings and the state of the spirits industry. Ann Mukherjee, Chairman and CEO of Pernod Ricard North America, joins Worldwide Exchange to discuss the company's full year 2021 earnings and the state of the spirits industry.>

    Pernod Ricard North America CEO on how bars are back to boosting company's sales

    CNBC Logo CNBC
  • Lawmakers are facing another debt ceiling countdown, and now Democrats are looking for ways to change the limit or eliminate it entirely. CNBC's Ylan Mui reports. Lawmakers are facing another debt ceiling countdown, and now Democrats are looking for ways to change the limit or eliminate it entirely. CNBC's Ylan Mui reports.>

    Dems look to shift debt limit responsibility, Biden trims spending bill

    CNBC Logo CNBC
  • OKCoin CEO Hong Fang discusses the launch of the first U.S. bitcoin futures ETF, and cautions that while the increasing number of financial instruments coming in will drive mainstream acceptance for this asset class, volatility will increase as well. OKCoin CEO Hong Fang discusses the launch of the first U.S. bitcoin futures ETF, and cautions that while the increasing number of financial instruments coming in will drive mainstream acceptance for this asset class, volatility will increase as well.>

    SEC's approval of bitcoin ETF takes away a lot of uncertainty in the market: OKCoin CEO

    CNBC Logo CNBC
  • World champion skier and Olympic gold medalist Lindsey Vonn is teaming up with Softbank-backed startup Wellness Coach to host an interactive fitness class to help people stay physically and mentally healthy while at home during the COVID-19 pandemic, all the while raising money for Meals on Wheels. World champion skier and Olympic gold medalist Lindsey Vonn is teaming up with Softbank-backed startup Wellness Coach to host an interactive fitness class to help people stay physically and mentally healthy while at home during the COVID-19 pandemic, all the while raising money for Meals on Wheels.>

    Staying fit during a pandemic: Exercising with Olympian Lindsey Vonn

    CNBC Logo CNBC
  • Paul Tudor Jones, founder and CIO at Tudor Investment Corporation and founder of the Robin Hood Foundation, joins 'Squawk Box' to explain why cryptocurrencies are a better hedge against inflation than gold right now. Paul Tudor Jones, founder and CIO at Tudor Investment Corporation and founder of the Robin Hood Foundation, joins 'Squawk Box' to explain why cryptocurrencies are a better hedge against inflation than gold right now.>

    Crypto is winning the race against gold right now: Paul Tudor Jones

    CNBC Logo CNBC
  • United Airlines CEO Scott Kirby sits down with CNBC's Phil LeBeau and 'Squawk Box' to discuss the company's latest quarterly earnings and the holiday travel season. United Airlines CEO Scott Kirby sits down with CNBC's Phil LeBeau and 'Squawk Box' to discuss the company's latest quarterly earnings and the holiday travel season.>

    United CEO: Higher fuel prices ultimately lead to higher ticket prices

    CNBC Logo CNBC
  • CNBC's Jim Cramer interviewed Domino's Pizza CEO Ritch Allison on Thursday's episode of CNBC's Jim Cramer interviewed Domino's Pizza CEO Ritch Allison on Thursday's episode of >

    Domino's CEO discusses the effects of U.S. immigration slowdown and benefits of company-owned shops

    CNBC Logo CNBC
  • The U.S. has options that it can use to put pressure on Iran, but it has not taken full advantage of them, says Behnam Ben Taleblu of the Foundation for Defense of Democracies. The U.S. has options that it can use to put pressure on Iran, but it has not taken full advantage of them, says Behnam Ben Taleblu of the Foundation for Defense of Democracies.>

    A 'Plan B' for Iran could involve more coercive diplomacy, analyst says

    CNBC Logo CNBC
  • Paul Tudor Jones, founder and CIO at Tudor Investment Corporation and founder of the Robin Hood Foundation, joins 'Squawk Box' to discuss inflation and the Federal Reserve. Paul Tudor Jones, founder and CIO at Tudor Investment Corporation and founder of the Robin Hood Foundation, joins 'Squawk Box' to discuss inflation and the Federal Reserve.>

    Paul Tudor Jones: Inflation is the number one issue facing investors

    CNBC Logo CNBC
  • Caitlin Long, chairman and CEO of Avanti Bank, joins The Exchange to discuss the new Bitcoin futures ETF that started trading today. The ProShares ETF is the first of it's kind, but others are expected to follow. Caitlin Long, chairman and CEO of Avanti Bank, joins The Exchange to discuss the new Bitcoin futures ETF that started trading today. The ProShares ETF is the first of it's kind, but others are expected to follow.>

    Bitcoin futures ETF starts trading today

    CNBC Logo CNBC
  • Last month, an internal survey done by a group of first year analysts at Goldman Sachs found that most junior bankers are suffering from burnout and demanding hours. Goldman Sachs CEO David Solomon joined Last month, an internal survey done by a group of first year analysts at Goldman Sachs found that most junior bankers are suffering from burnout and demanding hours. Goldman Sachs CEO David Solomon joined >

    Goldman CEO David Solomon addresses work-life balance concerns

    CNBC Logo CNBC
  • Marco Alverà, CEO of Snam, and Christian Bruch, CEO of Siemens Energy, discuss the role hydrogen can play in powering the energy transition, whether that transition is coming fast enough and what investment is still needed. Marco Alverà, CEO of Snam, and Christian Bruch, CEO of Siemens Energy, discuss the role hydrogen can play in powering the energy transition, whether that transition is coming fast enough and what investment is still needed.>

    Energy CEOs on the future of hydrogen use and investment

    CNBC Logo CNBC
  • Keith Tan of the Singapore Tourism Board says Singapore and Indonesia are exploring options to reopen travel between the two countries in a more significant way. He says it's crucial for both governments to restore and rebuild connectivity. Keith Tan of the Singapore Tourism Board says Singapore and Indonesia are exploring options to reopen travel between the two countries in a more significant way. He says it's crucial for both governments to restore and rebuild connectivity.>

    Reopening travel between Singapore, Indonesia is important: Singapore Tourism Board

    CNBC Logo CNBC
  • $6.7 trillion. That is how much Americans spent using their debit or credit cards in 2019. More than 60% of those purchases were made using cards from Visa, a company that has long dominated the payment card industry. As payment cards become more essential in people's daily lives, Visa has quickly become one of the most valuable companies in America. So how exactly does Visa make money and why does it dominate the payment card industry? $6.7 trillion. That is how much Americans spent using their debit or credit cards in 2019. More than 60% of those purchases were made using cards from Visa, a company that has long dominated the payment card industry. As payment cards become more essential in people's daily lives, Visa has quickly become one of the most valuable companies in America. So how exactly does Visa make money and why does it dominate the payment card industry?>

    Why Visa is the most popular card in the U.S.

    CNBC Logo CNBC
  • Diana Olick joins The Exchange with news about refinancing and the housing market. Diana Olick joins The Exchange with news about refinancing and the housing market.>

    Mortgage rates rise, refinance demand drops

    CNBC Logo CNBC
  • > > > > >
    • Jim Cramer says PayPal is a buy after pulling back from its high Jim Cramer says PayPal is a buy after pulling back from its high> Jim Cramer says PayPal is a buy after pulling back from its high CNBC Logo CNBC
    • Ann Mukherjee, Chairman and CEO of Pernod Ricard North America, joins Worldwide Exchange to discuss the company's full year 2021 earnings and the state of the spirits industry. Ann Mukherjee, Chairman and CEO of Pernod Ricard North America, joins Worldwide Exchange to discuss the company's full year 2021 earnings and the state of the spirits industry.> Pernod Ricard North America CEO on how bars are back to boosting company's sales Ann Mukherjee, Chairman and CEO of Pernod Ricard North America, joins Worldwide Exchange to discuss the company's full year 2021 earnings and the state of the spirits industry. CNBC Logo CNBC
    • Lawmakers are facing another debt ceiling countdown, and now Democrats are looking for ways to change the limit or eliminate it entirely. CNBC's Ylan Mui reports. Lawmakers are facing another debt ceiling countdown, and now Democrats are looking for ways to change the limit or eliminate it entirely. CNBC's Ylan Mui reports.> Dems look to shift debt limit responsibility, Biden trims spending bill Lawmakers are facing another debt ceiling countdown, and now Democrats are looking for ways to change the limit or eliminate it entirely. CNBC's Ylan Mui reports. CNBC Logo CNBC
    UP NEXT UP NEXT

    The staff of the Food and Drug Administration on Wednesday declined to take a stance on whether to back booster shots of Pfizer's Covid-19 vaccine, saying U.S. regulators haven't verified all the available data.

    Loading...

    Load Error

    "There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions," they wrote in a 23-page document published on the agency's website. "Some of these studies, including data from the vaccination program in Israel, will be summarized during the September 17, 2021 VRBPAC meeting."

    The staff said some observational studies have suggested declining efficacy of the Pfizer vaccine over time against symptomatic infection or against the delta variant, while others have not.

    "Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States," they wrote.

    The data the FDA is looking at includes efficacy numbers out of Israel, where researchers there have released observational studies showing the effectiveness of the Pfizer vaccine against infection waned over time.

    In separate documents released Wednesday, Pfizer argued a third dose of the Covid vaccine six months after a second shot restores protection from infection to 95%.

    FDA staff appeared to take a skeptical tone on the data, as observational studies don't adhere to the same standards as formal clinical trials.

    "It should be recognized that while observational studies can enable understanding of real-world effectiveness, there are known and unknown biases that can affect their reliability," agency staff said. "Furthermore, US-based studies of post-authorization effectiveness of BNT162b2 may most accurately represent vaccine effectiveness in the US population."

    Dr. Scott Gottlieb on the approval and rollout of booster shots > CNBC See more videos "> See more videos > > > > > What to watch next
    • Jim Cramer says PayPal is a buy after pulling back from its high Jim Cramer says PayPal is a buy after pulling back from its high>

      Jim Cramer says PayPal is a buy after pulling back from its high

      CNBC Logo CNBC
    • Ann Mukherjee, Chairman and CEO of Pernod Ricard North America, joins Worldwide Exchange to discuss the company's full year 2021 earnings and the state of the spirits industry. Ann Mukherjee, Chairman and CEO of Pernod Ricard North America, joins Worldwide Exchange to discuss the company's full year 2021 earnings and the state of the spirits industry.>

      Pernod Ricard North America CEO on how bars are back to boosting company's sales

      CNBC Logo CNBC
    • Lawmakers are facing another debt ceiling countdown, and now Democrats are looking for ways to change the limit or eliminate it entirely. CNBC's Ylan Mui reports. Lawmakers are facing another debt ceiling countdown, and now Democrats are looking for ways to change the limit or eliminate it entirely. CNBC's Ylan Mui reports.>

      Dems look to shift debt limit responsibility, Biden trims spending bill

      CNBC Logo CNBC
    • OKCoin CEO Hong Fang discusses the launch of the first U.S. bitcoin futures ETF, and cautions that while the increasing number of financial instruments coming in will drive mainstream acceptance for this asset class, volatility will increase as well. OKCoin CEO Hong Fang discusses the launch of the first U.S. bitcoin futures ETF, and cautions that while the increasing number of financial instruments coming in will drive mainstream acceptance for this asset class, volatility will increase as well.>

      SEC's approval of bitcoin ETF takes away a lot of uncertainty in the market: OKCoin CEO

      CNBC Logo CNBC
    • World champion skier and Olympic gold medalist Lindsey Vonn is teaming up with Softbank-backed startup Wellness Coach to host an interactive fitness class to help people stay physically and mentally healthy while at home during the COVID-19 pandemic, all the while raising money for Meals on Wheels. World champion skier and Olympic gold medalist Lindsey Vonn is teaming up with Softbank-backed startup Wellness Coach to host an interactive fitness class to help people stay physically and mentally healthy while at home during the COVID-19 pandemic, all the while raising money for Meals on Wheels.>

      Staying fit during a pandemic: Exercising with Olympian Lindsey Vonn

      CNBC Logo CNBC
    • Paul Tudor Jones, founder and CIO at Tudor Investment Corporation and founder of the Robin Hood Foundation, joins 'Squawk Box' to explain why cryptocurrencies are a better hedge against inflation than gold right now. Paul Tudor Jones, founder and CIO at Tudor Investment Corporation and founder of the Robin Hood Foundation, joins 'Squawk Box' to explain why cryptocurrencies are a better hedge against inflation than gold right now.>

      Crypto is winning the race against gold right now: Paul Tudor Jones

      CNBC Logo CNBC
    • United Airlines CEO Scott Kirby sits down with CNBC's Phil LeBeau and 'Squawk Box' to discuss the company's latest quarterly earnings and the holiday travel season. United Airlines CEO Scott Kirby sits down with CNBC's Phil LeBeau and 'Squawk Box' to discuss the company's latest quarterly earnings and the holiday travel season.>

      United CEO: Higher fuel prices ultimately lead to higher ticket prices

      CNBC Logo CNBC
    • CNBC's Jim Cramer interviewed Domino's Pizza CEO Ritch Allison on Thursday's episode of CNBC's Jim Cramer interviewed Domino's Pizza CEO Ritch Allison on Thursday's episode of >

      Domino's CEO discusses the effects of U.S. immigration slowdown and benefits of company-owned shops

      CNBC Logo CNBC
    • The U.S. has options that it can use to put pressure on Iran, but it has not taken full advantage of them, says Behnam Ben Taleblu of the Foundation for Defense of Democracies. The U.S. has options that it can use to put pressure on Iran, but it has not taken full advantage of them, says Behnam Ben Taleblu of the Foundation for Defense of Democracies.>

      A 'Plan B' for Iran could involve more coercive diplomacy, analyst says

      CNBC Logo CNBC
    • Paul Tudor Jones, founder and CIO at Tudor Investment Corporation and founder of the Robin Hood Foundation, joins 'Squawk Box' to discuss inflation and the Federal Reserve. Paul Tudor Jones, founder and CIO at Tudor Investment Corporation and founder of the Robin Hood Foundation, joins 'Squawk Box' to discuss inflation and the Federal Reserve.>

      Paul Tudor Jones: Inflation is the number one issue facing investors

      CNBC Logo CNBC
    • Caitlin Long, chairman and CEO of Avanti Bank, joins The Exchange to discuss the new Bitcoin futures ETF that started trading today. The ProShares ETF is the first of it's kind, but others are expected to follow. Caitlin Long, chairman and CEO of Avanti Bank, joins The Exchange to discuss the new Bitcoin futures ETF that started trading today. The ProShares ETF is the first of it's kind, but others are expected to follow.>

      Bitcoin futures ETF starts trading today

      CNBC Logo CNBC
    • Last month, an internal survey done by a group of first year analysts at Goldman Sachs found that most junior bankers are suffering from burnout and demanding hours. Goldman Sachs CEO David Solomon joined Last month, an internal survey done by a group of first year analysts at Goldman Sachs found that most junior bankers are suffering from burnout and demanding hours. Goldman Sachs CEO David Solomon joined >

      Goldman CEO David Solomon addresses work-life balance concerns

      CNBC Logo CNBC
    • Marco Alverà, CEO of Snam, and Christian Bruch, CEO of Siemens Energy, discuss the role hydrogen can play in powering the energy transition, whether that transition is coming fast enough and what investment is still needed. Marco Alverà, CEO of Snam, and Christian Bruch, CEO of Siemens Energy, discuss the role hydrogen can play in powering the energy transition, whether that transition is coming fast enough and what investment is still needed.>

      Energy CEOs on the future of hydrogen use and investment

      CNBC Logo CNBC
    • Keith Tan of the Singapore Tourism Board says Singapore and Indonesia are exploring options to reopen travel between the two countries in a more significant way. He says it's crucial for both governments to restore and rebuild connectivity. Keith Tan of the Singapore Tourism Board says Singapore and Indonesia are exploring options to reopen travel between the two countries in a more significant way. He says it's crucial for both governments to restore and rebuild connectivity.>

      Reopening travel between Singapore, Indonesia is important: Singapore Tourism Board

      CNBC Logo CNBC
    • $6.7 trillion. That is how much Americans spent using their debit or credit cards in 2019. More than 60% of those purchases were made using cards from Visa, a company that has long dominated the payment card industry. As payment cards become more essential in people's daily lives, Visa has quickly become one of the most valuable companies in America. So how exactly does Visa make money and why does it dominate the payment card industry? $6.7 trillion. That is how much Americans spent using their debit or credit cards in 2019. More than 60% of those purchases were made using cards from Visa, a company that has long dominated the payment card industry. As payment cards become more essential in people's daily lives, Visa has quickly become one of the most valuable companies in America. So how exactly does Visa make money and why does it dominate the payment card industry?>

      Why Visa is the most popular card in the U.S.

      CNBC Logo CNBC
    • Diana Olick joins The Exchange with news about refinancing and the housing market. Diana Olick joins The Exchange with news about refinancing and the housing market.>

      Mortgage rates rise, refinance demand drops

      CNBC Logo CNBC
    > > > > >
    • Jim Cramer says PayPal is a buy after pulling back from its high Jim Cramer says PayPal is a buy after pulling back from its high> Jim Cramer says PayPal is a buy after pulling back from its high CNBC Logo CNBC
    • Ann Mukherjee, Chairman and CEO of Pernod Ricard North America, joins Worldwide Exchange to discuss the company's full year 2021 earnings and the state of the spirits industry. Ann Mukherjee, Chairman and CEO of Pernod Ricard North America, joins Worldwide Exchange to discuss the company's full year 2021 earnings and the state of the spirits industry.> Pernod Ricard North America CEO on how bars are back to boosting company's sales Ann Mukherjee, Chairman and CEO of Pernod Ricard North America, joins Worldwide Exchange to discuss the company's full year 2021 earnings and the state of the spirits industry. CNBC Logo CNBC
    • Lawmakers are facing another debt ceiling countdown, and now Democrats are looking for ways to change the limit or eliminate it entirely. CNBC's Ylan Mui reports. Lawmakers are facing another debt ceiling countdown, and now Democrats are looking for ways to change the limit or eliminate it entirely. CNBC's Ylan Mui reports.> Dems look to shift debt limit responsibility, Biden trims spending bill Lawmakers are facing another debt ceiling countdown, and now Democrats are looking for ways to change the limit or eliminate it entirely. CNBC's Ylan Mui reports. CNBC Logo CNBC
    UP NEXT UP NEXT

    The staff report is meant to brief the FDA's Vaccines and Related Biological Products Advisory Committee, which meets Friday to review Pfizer's request to approve Covid booster doses for the general public. The documents published offer a glimpse of the agency's view on third shots.

    The Biden administration has said it wants to begin offering booster shots to the general public as early as next week, pending authorization from the FDA. The move is part of President Joe Biden's broader plan to confront a higher number of Covid cases fueled by the fast-spreading delta variant.

    Scientists and other health experts have repeatedly criticized the plan, saying data the federal health officials cited wasn't compelling and characterizing the administration's push for boosters as premature.

    There is currently not a consensus in the biomedical community on boosters for the general public, said Dan Barouch, an immunologist at Harvard Medical School.

    "There are senior experts who fall on different sides of the debate," he said. "Right now, it'll be interesting to see where the debate goes, but obviously it is known that the Biden administration has suggested that boosters are needed."

    The Biden administration has cited three studies, released by the Centers for Disease Control and Prevention, that showed the vaccines' protection against Covid diminished over several months. The administration's plan, outlined by senior health officials, calls for people to get a third dose eight months after they got their second shot of either the Pfizer or Moderna vaccine. Biden has said scientists were reviewing whether to move the third shot up by three months.

    When the administration announced the plan in August, senior health officials said they worried protection against severe disease, hospitalization and death "could" diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout.

    A group of scientists, including two senior FDA officials and the World Health Organization, published a paper Monday in the journal The Lancet that argued booster shots are not needed at this time for the general public. While Covid vaccine effectiveness against mild disease may wane over time, protection against severe disease appears to persist, the scientists said.

    On Tuesday, WHO officials called again for wealthy nations to stop distributing Covid vaccine booster doses in hopes of making more shots available for poorer countries with lagging immunization rates.

    "There are countries with less than 2% vaccination coverage, most of them in Africa, who are not even getting their first and second dose," Director-General Tedros Adhanom Ghebreyesus said at a press briefing. "And starting with boosters, especially giving it to healthy populations, is really not right."

    Source : https://www.msn.com/en-us/finance/markets/fda-staff-declines-to-take-stance-on-pfizers-covid-vaccine-booster-shots-citing-lack-of-verified-data/ar-AAOtnge

    10722
    Filed Under: MSN
    FDA staff declines to take stance on Pfizers Covid vaccine booster shots, citing lack of verified data

    Source:MSN

    FDA staff declines to take stance on Pfizers Covid vaccine booster shots, citing lack of verified data

    FDA Declines To Take Stance On Pfizers COVID-19 Booster Shots, Citing Lack Of Verified Data

    Source:Benzinga.com

    FDA Declines To Take Stance On Pfizers COVID-19 Booster Shots, Citing Lack Of Verified Data