Anjali Sundararaman, a student nurse at San Francisco State University, gives Cuixia Xu a dose of Moderna-COVID during a vaccination clinic at the Southeast Health Center in the Bayview-Hunters Point neighborhood of San Francisco, Calif. On Monday, February 24 19 vaccine. 8, 2021.
Stephen Lam | San Francisco Chronicle | Hearst Newspapers via Getty Images
Millions of Americans will be one step closer to getting a Covid-19 booster shot this week when a key Food and Drug Administration advisory panel meets on Thursday and Friday to discuss additional doses of the drug Modern and Johnson & Johnson Vaccinations.
The FDA’s Advisory Committee on Vaccines and Related Biological Products meets less than a month after US regulators authorized Covid booster recordings from Pfizer and BioNTechs Vaccine for a wide variety of Americans, including the elderly, adults with pre-existing conditions, and those who work or live in high-risk environments such as health and food workers.
More than 7 million Americans in the US received a booster dose as of Saturday, according to the latest data from the CDC.
Members on independent committees of the FDA and the Centers for Disease Control and Prevention said at the time they were frustrated that Pfizer recipients only entitled to get the extra shots, leaving out millions of Americans who got Moderna or J & J’s shots.
The FDA advisory group is due to discuss data on the safety and effectiveness of a Moderna booster in adults on Thursday. On Friday, the committee is expected to discuss J&J booster vaccinations for adults. The FDA could make a final decision within days of the meetings and pass it on to the CDC and its Vaccine Advisory Committee to make their own decision.
The CDC’s next vaccine advisory meeting is scheduled for October 20 through October 21, where the boosters are expected to be discussed.
The FDA meeting is based on the average daily Covid cases in the US fell below 100,000 last week more than 56% of the population are fully immunized against the virus and the pandemic is showing signs of easing. Getting vaccinated, getting booster shots, and avoiding large gatherings are crucial ways to mitigate a possible surge in cases over the holidays, according to health experts.
The Biden administration hopes that empowering the U.S. population will continue to provide long-term and lasting protection from serious illness, hospitalization, and death as the fast-paced Delta variant spreads.
The exposure led to an increase in hospital admissions in the US, mainly among the unvaccinated. Still, some vaccinated Americans have suffered what are known as breakthrough infections, and just over 19,000 of them – less than 1% – were hospitalized or died of Covid on Sept. 20, according to the CDC.
“Even with Delta, the current vaccines hold up reasonably well in terms of hospitalization and major illness,” said Norman Baylor, former director of the FDA’s vaccines office. “It’s the infections that seem to be a problem.”
Last month, Moderna said a third syringe at half the dose used for the first two injections was safe and produced a stronger immune response than that seen after the second dose in its phase III clinical trial .
J&J said last month that a second dose of its single vaccine was safe and increased protection against symptomatic infections from about 70% to 94% when given two months after the first dose in the US.
The FDA could approve Moderna and J&J booster syringes under the same criteria as Pfizer, or maybe change course and increase the number of Americans eligible for additional syringes, Baylor said in a telephone interview.
“The question is: does everyone need a booster now?” said Baylor, now president of the Biologics Consulting Group.
Committee members need to discuss whether it is safe and effective for J&J recipients to receive a second dose, Baylor said. He added that he did not expect any difficulty in getting third-dose approval of Moderna’s vaccine because it uses mRNA technology that was also used to develop Pfizer’s vaccines.
“If I was in my old position with the FDA, I probably wouldn’t have put Moderna on the advisory board because it’s in the same class as Pfizer,” he said.
Government communication on Pfizer booster vaccinations is already confusing and “very harmful” to public perception, said Dr. Isaac Bogoch, an infectious disease specialist at the University of Toronto.
“From the outside it looks a bit free for everyone,” said Bogoch. “Yeah, yeah, there are some loose guidelines in the United States. But basically it looks like anyone could go to any pharmacy and get a booster shot and say you know what I smoke or I’m obese or.” I work in healthcare. “