2021 Sep 17, 1:19pm
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After the chairman of the FDA advisory committee said the question being evaluated might be modified amid growing concern about the balance between safety and efficacy of the Pfizer jabs, the committee has disappointed Big Pharma and the Biden Administration by voting against approving booster shots for the Pfizer-BioNTech jab.The final tally was Yes: 2, No: 16, Abstain: 0As CNBC’s Meg Tirrell reports, with advisors now considering a modified question, this might not be the final vote of the day.VRBPAC voting now on 16+ recommendation for Pfizer booster (but this likely won’t be end of meeting/or even necessarily final vote as some may want to change the age) pic.twitter.com/W86s2pbsvN— Meg Tirrell (@megtirrell) September 17, 2021Stocks of vaccine-makers are tumbling on the news.The results hit just as Dr. Fauci was set to start an interview with the CNBC, where he was left twisting in the wind, insisting that he was totally unsurprised by the FDA’s decision not to rubber-stamp the Biden Administration’s non-science-based plan.Update (1255ET): As The FDA Panel hears from various health officials during the public comment section on the pros and cons of a booster shot, some very uncomfortable facts are coming out about vaccine efficacy and vaccine side effects – facts that anywhere else would immediately be deplatformed and banned from discourse.The @US_FDA scientific advisors are reviewing @pfizer proposal to give 3rd doses of #COVID19 #vaccines . Right now the public comment period is happening — so far, most speakers are attacking the company &/or the safety or need for more vaccine.— Laurie Garrett (@Laurie_Garrett) September 17, 2021Perhaps this is why two top FDA officials just resigned. ...“If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate,” the scientists said.
— T (@SevenSeasGoonie) September 17, 2021Pfizer shares are sliding but Moderna and BioNtech stock prices are plunging as Evercore ISI analyst Umer Raffat predicts that the panel of advisers won’t recommend booster shots (with the vote due later today)…Raffat in a midday note Friday says voting members on the advisory committee “are already leaning against boosters” and the “FDA does not sound convinced by balance of evidence to date”The CDC advisory group now says it will take up the need for booster shots at a meeting now scheduled for Sept 22nd and Sept 23rd. That makes it all but certain no booster rollout will happen Monday as the President gave as a date to possibly get boosters.The big day has finally arrived.On Friday, a group of key FDA advisors – the Advisory Committee on Immunization Practices – is meeting to debate and vote on Pfizer’s request for approval of a third COVID booster shot of its “Comirnaty” vaccine for all Americans age 16 and older. The two big questions they must answer are: is there enough evidence to suggest that booster shots are safe and should be made available to everyone, or should they be limited to a smaller group of older and immunocompromised Americans?On the agenda are presentations from Pfizer, FDA staff, CDC staff, Israeli researchers, and others. At the end of the virtual meeting, which began at 0830ET Eastern, members will be asked to vote yes or no. That vote isn’t expected until later in the afternoon after a long day of debate.Interested parties can watch the debate streaming live via YouTube...Despite the drug companies’ best efforts, the FDA has seemingly remained unconvinced about the necessity of booster jabs. ...One exasperated scientist lamented that the scientific process was being “short circuited” by politics, a reference to President Biden’s push to start doling out booster jabs in the face of the delta driven wave that surged over the summer and – in the US, at least – appears to have finally peaked (with deaths hopefully soon to follow). ...Meanwhile, on Monday, an international group of scientists led by Dr. Philip Krause, deputy chief of the FDA’s vaccine regulation office, and his boss, Dr. Marion Gruber – both of whom are leaving the FDA, apparently in protest, published an essay in The Lancet that questioned the need for widespread booster shots right now. Gruber, who has decided to remain at the agency until later this fall, is listed as a participant in Friday’s meeting, ...“My guess is we are going to end up with a recommendation for booster doses for a certain subpopulation, such as adults older than 65,” said Bill Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. ...For what it’s worth, when confronted about natural vs. vaccine-induced immunity, Dr. Fauci said “I really don’t know what to tell you.”But most importantly: the White House says ‘GET YOUR BOOSTER JABS NOW!’ with President Biden pushing ahead with a plan to start doling out the jabs on Monday...The bigger question: will ‘Uncle Joe’ and myriad state and local officials require Americans to get booster jabs like they’re requiring even those with natural immunity to get vaccinated, potentially exposing these patients to rare side effects while it’s unclear whether they’re making a meaningful difference in immunity.The panel is meeting between 1425 and 1625. It’s likely the decision won’t arrive until after the market close. We will update readers with the result once it’s finally released.Read the agenda below:Agenda on Scribd
FDA panel votes against approving vaccine boostersel gato malo 25 min ago 11the panel of experts assessing boosters for the FDA just voted 16-2 AGAINST recommending booster shots for pfizer. (early reports of 16-3 were incorrect)given some of the craziness we’ve seen this year (like aduhelm) where the FDA overrode a unanimous panel and approved anyhow, this is not a 100% reason to believe they will not do it (or try to modify it, perhaps for age groups) but given the politicization of this issue and the klieg light glare of attention, they i suspect they have to play it pretty straight.retiring staffers grueber and krasuse stood very tall here despite being repeatedly told to shut up. this just drives home why they are leaving.but many others stood up too.they foregrounded severe safety issues in the public comments.
but maybe, just maybe, the FDA is remembering what its job is and maybe the endless public scrutiny and opprobrium heaped on them for doing such haphazard, slapdash, and politicized work is forcing them back onto the straight and narrow.(and if so, we owe marion grueber and philip krause (retiring director and deputy director respectively of the FDA office of vaccines research and review) a serious debt of grattitude.)and just maybe we’re going to demand science first and policy second again.because one thing is manifestly clear: if the FDA approves boosters for 16 and up after that panel, they will blow whatever remains of their credibility to smithereens and lose any remaining tatters of their claim to be “on the side of science” and not of politics.
As Covid cases, hospitalizations, and now deaths soar in Israel even though over 90 percent of older adults are fully vaccinated, the country is aggressively pushing a third shot.Hundreds of thousands of older Israelis have already received it.And other countries are preparing to follow.Now the inevitable is happening. The third shot is beginning to fail. ...The desperate move for a third shot is the latest and maybe most desperate manifestation of the panic around the vaccine failure that health authorities still will not openly admit is happening.And it is profoundly anti-science.These mRNA vaccines are not Pepto-Bismol. They have profound biological effects. They are encapsulated in fat particles whose long-term effects are unknown. They spread throughout the body (despite the early promise they would not). They hijack cellular machinery in exactly the same way an actual virus does.They are no joke. ...
Biden Could Dismiss FDA Committee’s Pfizer Decision: At Great Cost However