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FDA advisory panel rejects widespread Pfizer booster shots

BREAKING: An influential federal advisory panel rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans. The 16-2 vote was a blow to the Biden administration’s effort to increase virus protections amid the contagious delta variant.

9/17/2021 10:50:00 PM

BREAKING: An influential federal advisory panel rejected a plan to offer Pfizer booster shots against COVID-19 to most Americans. The 16-2 vote was a blow to the Biden administration’s effort to increase virus protections amid the contagious delta variant.

WASHINGTON (AP) — An influential federal advisory panel overwhelmingly rejected a plan Friday to offer Pfizer booster shots against COVID-19 to most Americans, dealing a heavy blow to the Biden administration’s effort to shore up people’s protection amid the highly contagious delta variant.

In an extraordinary move, both FDA leaders and the panel indicated they were likely to take a second vote Friday afternoon on recommending the booster shots for older Americans and other high-risk groups.ADVERTISEMENTThat would help salvage part of the Biden administration’s campaign but would still be a huge step back from the sweeping plan proposed by the White House a month ago to offer booster shots of both the Pfizer and Moderna vaccines to nearly all Americans eight months after they get their second dose.

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During several hours of vigorous debate Friday, members of the panel questioned the value of offering boosters to nearly everyone.“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner of Tufts University. “And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses.”

Dr. Amanda Cohn of the Centers for Disease Control and Prevention said: “At this moment it is clear that the unvaccinated are driving transmission in the United States.”Panel members also complained that data provided by Israeli researchers about their booster campaign might not be suitable for predicting the U.S. experience. headtopics.com

Scientists inside and outside the government have been divided in recent days over the need for boosters and who should get them, and the World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough vaccine for their first.

While research suggests immunity levels in those who have been vaccinated wane over time and boosters can reverse that, the Pfizer vaccine is still highly protective against severe illness and death, even amid the spread of the highly contagious delta variant.

The FDA advisory panel was the first major hurdle that the Biden administration plan faced. The FDA itself has yet to make its own determination but typically follows the recommendations of its expert panel.In yet another step to the process, a CDC advisory committee that sets policy for U.S. vaccinations campaigns is set meet on Wednesday to debate who, exactly, should get boosters and how many months after their second dose should them receive the extra shot.

The CDC has said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.ADVERTISEMENTSeparate FDA and CDC decisions will be needed in order for people who received the Moderna or J&J shots to get boosters. headtopics.com

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The FDA panel’s overwhelming rejection came despite full-throated arguments about the need for boosters from both Pfizer and health officials from Israel, which began offering boosters to its citizens in July.Sharon Alroy-Preis of Israel’s Ministry of Health said the booster dose improves protection tenfold against infection in people 60 and older.

“It’s like a fresh vaccine,” bringing protection back to original levels and helping Israel “dampen severe cases in the fourth wave,” she said.And representatives for Pfizer argued that it is important to shore up immunity before protection against severe disease starts to erode. A company study of 44,000 people showed effectiveness against symptomatic COVID-19 was 96% two months after the second dose, but had dropped to 84% by around six months.

Both Pfizer and the Israeli representatives faced pushback from panelists. Several expressed skepticism about the relevance of Israel’s experience to the U.S. Also complicating the committee’s decision: No one yet knows the antibody level below which infection is likely and boosters are needed.

Another concern was whether third doses would exacerbate serious side effects.Dr. Cody Meissner of Tufts Medical Center said he is worried about extra doses for younger age groups given the risk of heart inflammation that has been seen in mostly younger men after a second dose. While the condition is very rare, he said, it is not clear if that risk would increase with another dose. headtopics.com

Pfizer pointed to Israeli data from nearly 3 million boosters to suggest side effect rates would be similar to that seen after second doses.Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, said he was more likely to support approving a third dose for adults over 60 or 65 but “I really have trouble” supporting it for anyone down to age 16.

While an extra shot likely will at least temporarily decrease cases with mild or no symptoms, “the question becomes what will be the impact of that on the arc of the pandemic, which may not be all that much,” Offit said.President Joe Biden’s top health advisers, including the heads of the FDA and CDC, first announced plans for widespread booster shots a month ago, targeting the week of Sept. 20 as an all-but-certain start date. It said boosters would be dispensed eight months after the second dose of the Pfizer and Moderna vaccines.

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But that was before FDA staff scientists had completed their own assessments of the data. Some experts questioned whether Biden was breaking his own pledge to “follow the science” on COVID-19 by getting out ahead of government scientists.Earlier this week, two top FDA vaccine reviewers joined a group of international scientists in publishing an editorial rejecting the need for boosters in healthy people. The scientists said continuing studies show the shots are working well despite the delta variant.

On Friday, U.S. Surgeon General Dr. Vivek Murthy said that in announcing its booster plan, the Biden administration was not trying to pressure regulators to act but was instead trying to be transparent with the public and be prepared in the event that extra shots won approval.

“We have always said that this initial plan would be contingent on the FDA and the CDC’s independent evaluation,” Murthy said.The Biden plan has also raised major ethical concerns about impoverished parts of the world still clamoring for vaccine. But the administration has argued that the plan is not an us-or-them choice, noting that the U.S. is supplying large quantities of vaccine to the rest of the globe.

The U.S. has already approved Pfizer and Moderna boosters for certain people with weakened immune systems, such as cancer patients and transplant recipients.Some Americans, healthy or not, have managed to get boosters, in some cases simply by showing up and asking for a shot. And some health systems already are offering extra doses to high-risk people.

___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. Read more: The Associated Press »

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Count me out!!! SCAMDEMIC STOP THE HORSE SHIT If anti-vaxers are immune, how are they an issue? Please explain, I'm just curious. Good maybe go listen to what was said their data sucks I can't ride the bus in memphis tennessee and they don't want to hire me and they no I don't have no help and they need to go to prison and I think they don't like me and I don't care

Just think you got 2 more boosters after that then that should be your last🤣🤣🤣🤣🤣do you need a Shepherd Oh but before lot’s of people start firing, let’s give it to the Seniors over 65 ! Then we can watch them die !!!! They also authorize cigarettes, corn syrup Fluoride in our drinking water, how many people do cigarettes kill? How much do they profit from that? Let’s stop giving these losers authority to authorize killing us

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Hey POTUS , what happened to follow the science? You know when you pick and choose whose science to believe it is not science you believe but your own agenda. IVERMECTIN Dick move US_FDA Slecht nieuws voor alle vaccinatie aanbidders. Following the science is a “blow” in the eyes of the right-wing talking points sharing AP.

No one asked why they made that decision? Journalism is dead This is a genuinely weird headline. What a terribly written headline. Shame on AP for politicizing this. Blow? Why? Blow to pharmas, definitely. Not to admin. CDC and the WHO have failed... millions of preventable deaths under their guidance. What a historic medical failure and travesty unfolding here right before my eyes!The only COVIDIOTS here are government CDC, WHO.

FDA Questions Need For Pfizer Covid-19 Booster Shot Ahead Of Vote FridayScientists at the FDA said Pfizer’s Covid-19 vaccine seems to last long enough that a booster shot may not add much protection

How is this a blow to Biden? Please do not use right wing extremist framing on everything. It makes your conservative boss obvious, instead of subtle Try being journalists! This two sentence summary is not informative as to the actual decision and puts a political view (blow to Biden) ahead of presenting the facts!

Makes me ill reading this. WE ALL SHOULD BE ALLOWED TO GET & SOON! 65 an older for now...and those with health problems but no will come to pass,eventually How was this a blow to Biden? Pathetic Is the boosters aren’t needed for the genpop then it’s actually not “a blow to the Biden admin’s efforts to contain the virus.”

Stop politicizing public health. Be part of the solution, not part of the problem, . Also, ASlavitt had a great thread on this issue today. Maybe you should interview him. There is a difference between public health policy that has a broad view, and simply vaccine function. 1) unidentified panel of outside experts who advise the FDA 2) all articles repeat w/o identifying panel 2) U.S. Surgeon General Dr. Vivek Murthy: 'We have always said that this initial plan would be contingent on the FDA and the CDC's independent evaluation,' = biased report

'blow to the Biden administration’s effort' This isn't a game, . Stop trying to make it into one.

FDA advisers vote to oppose Pfizer/BioNTech COVID-19 vaccine boosterA panel of outside advisers to the U.S. Food and Drug Administration on Friday voted against approval of a booster dose of the Pfizer Inc /BioNTech SE COVID-19 vaccine for people aged 16 and older. Wrong headline here. They voted against it for people as young as 16. They have not yet voted on it for adults 60 and older and those with compromised immunity.

what is wrong with you? Biden just wants to save lives The vote is not against anyone It’s a vote for a specific policy Boosters will be widespread. The only debate is the schedule. Thanks AP for making it sound like it's hysteria and politicizing it. 'a blow to the Biden administration' Jesus Fucking Christ, do better.

Why is it a blow to Biden unlike TFG he has NOT told the scientists what to do think or say. Your headline is the usual malpractice I think the FDA made a big mistake. We should just take Pfizers word for it. It's not as though they have multiple judgements against them for making false claims, kick backs, and off label use.

“Trust the science” = “Trust the scientists” = “Trust the politicians” I see the Biden administration is no better in having one clear voice on COVID. Maybe they ought to tell Faucci to stay off the airwaves for 2 weeks since his thoughts seems to change hourly It’ll be interesting to see if the Biden administration “follows the science.”

This is ridiculous AP!! The FDA is not a blow to an administration, they are the science! Remember follow the science? What happened to that Bless your heart that's the great thing about a President who trusts science....this isn't a win/lose deal. Enough. You've sunk back down to 2016 levels. Knock it off.

What to expect as FDA advisory panel debates Pfizer COVID booster shotsThe FDA's independent advisory committee is convening to review data submitted by Pfizer and discuss whether a booster dose is safe enough for widespread use and whether it's necessary and effective at improving protection levels against COVID-19. Great, we haven't even finished the first wave of hesitancy. They should of let our own DRs handle this booster when they Mandate it. I trust my Doc. Get it?

For those that are worried about not getting a third jab, don't worry, there will be a new, better vax soon...just wait and see 🤫 don't tell old man Biden as he doesn't know yet. .FDA is now responsible if more people die from Covid19 as a result. The blame is no longer on antivaxxers! DubbleH33lix Just like that the vaccinated became the unvaccinated 😂🤣😅😂🤣

The United States 2021 Covid deaths will pass the 2020 totals before the year ends….and that is with the vaccine. Are we still counting the 2021 deaths as under Trump’s watch ? If so when does Biden start to get blood on his hands? Asking for a friend. Branch Covidians are outraged 🤣 SGT_Buttercup It's not a blow to the Biden admin. That's hyperbolic. The Biden admin follows the recommendations of the scientists. Not the other way around. As it should be. Otherwise you'd have a president telling the scientists to look into injecting bleach, sun, or using bunk medicine.

You guys need to be more careful in how you phrase your headlines. Reading thru these comments is like going back to the dark ages. To ppl that don't understand anything about testing, review, immunity, airborne viruses- you are providing only sensationalism. Be better. Could they not have assigned someone who speaks English clearly to host the meeting?

Remember in the 90:s when the attitude towards all the gang violence in LA shifted from trying to fix the problem, to being so sick of their ignorance that it was easier to Sit back & let them continue killing each other until they snuffed each other & the problem, out entirely?

Pfizer says third COVID shot gives antibodies in threefold, likely can handle Delta variantThe FDA on Wednesday posted much of the evidence from Pfizer on booster shots to be considered by its advisory panel on Friday. If I trust anyone with my life…it’s Pfizer and the FDA. 🙄

This will fuel the antivaxxer delerium even further. They twist facts to appear in support of their position. Their logic has zero to do with science or medicine, & is instead focused entirely on their resentment of being told what to do. Like a small child protesting bed time. Ok. So.... I got my shot in early January. I don't get a Booster. But I DID get a Flu Shot with a Fine CVS person telling me it would Cover Four Possible 'Variants'. You guys guys better have a helluva vaccine ready for our Annual!

Funny how Biden was the one saying booster shots were not needed. Just a couple of weeks was the one saying they were . He wants more people vaccinated before boosters this is just bad journalism TheLastRefuge2 Biden is only for big pharma it has nothing to do with the safety of Americans or he wouldn’t let non vaccinated people come into the country

Okay, so how effective are vaccines in Smarties form? If I ate a COVAX Smartie in June and then another in July, would I need a booster pack of Smarties to eat periodically or no? So many people in here not trusting the scientists and asking questions!!! 😡😡😡😡 they know what’s best for you!! I thought the opposite happened? I'm confused

Because the FDA knows it’s a scam & Fauci is in bed with big pharma. Nice move, FDA. damn it.

US govt advisers vote no to Pfizer Covid boosters for ages 16 and upLeading US medical experts advising the government voted against recommending booster doses of Pfizer's COVID-19 vaccine for everyone aged 16 and up, citing concerns about potential side-effects in younger age groups. The tweet does not match the article.

Blessed be! My Texas Governor gets the booster but I don’t. Makes me furious. POTUS iwantthebooster And they said they’d “follow the science” I got my second shot exactly 8 months ago today. This doesn't work for me. Don't expect me to pursue any activities that result in paying taxes and boosting economic recovery.

Hopefully teachers will be among the “front line” “high risk” groups! That's what it looks like when the powers at be realize they almost let their underlings ruin the whole con. Too late anyway sweetie, you're KNOWN ABOUT. Any word on the Moderna & J&J vaccines? A blow? Come on, AP. They'll probably advise a stepped approach, with most vulnerable like over 60's and people at higher risk, first. Hardly a blow, more an unfortunate reluctance that might not keep pace with variants. Instead, how about Biden's effort partially supported.

Finally! 3rd shot is a killer Why is there no mention that they were approved for 65 and older Media narrative has to create winners and losers because just reporting the facts would be too responsible. The Gates $10 Billion initiative that is being pushed out by his cohorts must be halted. This is not about limiting a virus, it’s a well planned strategy to fulfill an agenda. Let dark things be brought to Light.

This is bulshit It’s a blow to American people who believe in vaccines are effective. Who is FDA anyway…let people get protected. Why wait until all get bad then do something Wondering if anyone's even looked into this? This. Really. STINKS. Now we'll never be free from this pandemic set off by the CCP and worsened in the USA by Trump. SMH.

But keep jabbing sheeple... 😂🤣😂🤣 🤣🤣🤣🤣🤣🤣🤣🤣liberal meltdown in the comments 🥴🥴🥴

Great, I was concerned. If I had to take the booster I’d but I did not like that. Come on...was it really a blow to the administration. It's the same exact situation it has always been People who want it will get it...people who don't want it won't get it. Very few people are basing there beliefs on the FDA at this point.

Lmfao so is the FDA good or bad, watch people call it bad again. Don't flip narratives because you want something Boost your antibodies to last year's strain. Go ahead people. Get those infection enhancing antibodies through the roof for this winters new strain! Don't listen to the FDA, follow dear leader Biden!

The data now does not support the benefit of a third shot over the standard 2-dose for all. It does not mean we will not need one ever. Science will guide us when it is of most benefit. Risk-Benefit calculations. Just like when you buy something: the most bang for your buck. The entire panel are all going to Jail