The FDA advisory panel on Friday dealt a massive blow to the Biden Regime, Mainstream Media, and Big Tech and Corporate overlords hammering them with a 16-2 vote of NO to boosters for those under the age of 65.
The FDA cited a lack of safety data on extra doses and also raised doubts about the value of mass boosters, rather that ones targeted for specific groups.
The FDA did vote 18-0 to endorse boosters for those individuals over the age of 65 or those at rise of serious disease. The panel are that health workers and those who run a high rise of being expose to the virus on the job should get boosters also.
The move all but destroyed the White Houses tyrannical push for boosters for all Americans. The news also coming out that India has beaten Covid in their largest state with Ivermectin didn’t help matters either for the Biden Regime.
“Today was an important step forward in providing better protection to Americans from COVID-19,” said White House spokesman Kevin Munoz. “We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week.”
The CDC has said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.
During several hours of vigorous debate Friday, members of the panel questioned the value of offering boosters to almost everybody 16 and over.
“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.”
“While I would probably support a three-dose recommendation for those over 60 or 65, I really have trouble supporting this as written for anyone of greater than or equal to 16,” said Paul Offit of the Children’s Hospital of Philadelphia.
Dr. Amanda Cohn of the CDC said, “At this moment it is clear that the unvaccinated are driving transmission in the United States.”
In a statement, Kathrin U. Jansen, Pfizer head of vaccine research and development, said the company continues to believe that boosters will be a “critical tool in the ongoing effort to control the spread of this virus.”
Of course she did, they want that money y’all! Apparently the FDA is following the science, can’t say the same for the CDC and Biden Regime now can we.
Others focused on the clear lack of data on the booster’s safety in young people, especially 16- and 17-year-olds.
“We have no data on the safety for this population at all,” Chatterjee said.
The following is from Politico:
Tensions over the booster debate were palpable in opening statements delivered by two senior FDA officials, one of whom signed onto an essay published in The Lancet this week arguing that boosters are not immediately needed for most adults.
Earlier in the day, Marks urged the committee to focus on the science behind the booster application “and not on operational issues related to a booster campaign or on issues related to global vaccine equity” — adding that any forays into those topics would be interrupted.
“We know that there may be differing opinions as to the interpretation of the data regarding the potential need for additional doses, and we strongly encourage all the different viewpoints to be … discussed regarding the data, which is complex and evolving. It also requires near real-time analyses,” he said.
Marion Gruber, the retiring director of FDA’s Office of Vaccines Research and Review, said she looked forward to a “robust and transparent and evidence-based discussion.” The scientists who wrote the Lancet essay, including Gruber, argued the existing science doesn’t support boosting the general population just yet, especially when much of the world has yet to receive their initial shots.
“All of my actions and decisions over my 32-year FDA career have been grounded in science and with you in mind and in the best interest of your health and safety, and I will continue to hold fast to these principles moving forward,” she said.
Scientists from FDA and other institutions this week suggested that the Israeli data contained several limitations that could make it difficult to underpin a regulatory decision in the U.S.
“I honestly don’t think there is enough good quality data at this point to make an informed decision,” said Brittany Kmush, an epidemiologist at Syracuse University, of the Israeli study, noting the 12-day follow-up period and the variability of the authors’ estimates.
Walid Gellad, director for the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, pointed to the lack of direct safety data on additional doses given to 16- and 17-year-olds.
“The question for me is not do the boosters have some effect. The question is how much of an effect they have,” he said. “I’m not sure the Israeli data is giving us enough certainty about that.”