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US moves closer to ending Moderna and J&J Covid recall fire this week

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Millions of Americans will be one step closer to receiving a Covid-19 booster this week when a key Food and Drug Administration advisory group meets on Thursday and Friday to discuss additional doses of the Moderna and Johnson & Johnson vaccines.

Meetings of the FDA’s Vaccines and Related Biologics Advisory Committee take place less than a month after U.S. regulators authorized Covid booster injections of the Pfizer and BioNTech vaccine to a wide range of Americans, including seniors, adults with underlying health conditions, and those who work or live in high-risk settings such as healthcare workers and grocery stores.

Anjali Sundararaman, a nursing student at San Francisco State University, administers a dose of Moderna COVID-19 vaccine to Cuixia Xu during an immunization clinic at the Southeast Health Center in the Bayview-Hunters neighborhood Point in San Francisco, Calif., Monday, February 2. 8, 2021.

Stephen Lam | Chronicle of San Francisco | Hearst Newspapers via Getty Images

More than 7 million Americans received a booster dose in the United States on Saturday according to the latest available data from the CDC.

Members of the independent committees of the FDA and the Centers for Disease Control and Prevention said at the time that they were frustrated that only Pfizer beneficiaries would be eligible to get the additional injections, leaving out the millions of Americans who have received Moderna or J&J injections.

The FDA advisory group is scheduled 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 injections for adults. The FDA could make a final decision within days of the meetings, handing it over to the CDC and its Vaccine Advisory Committee for them to make their own decision.

The CDC’s next vaccine consultative meeting is scheduled for October 20-21, where it is expected to discuss recalls.

The FDA meeting comes after the average daily number of Covid cases in the United States fell below 100,000 last week with more than 56% of the population fully immune to the virus and the pandemic showing signs of ‘mitigation. Getting vaccinated, receiving reminders and avoiding large gatherings are crucial ways to mitigate a possible increase in cases during the holidays, according to health experts.

The Biden administration hopes the strengthening U.S. population will also continue to provide long-term, lasting protection against serious illness, hospitalizations, and death as the delta variant spreads rapidly.

The strain has led to an increase in hospitalizations in the United States, primarily among the unvaccinated. Yet some vaccinated Americans have suffered from so-called breakthrough infections and just over 19,000 of them, less than 1%, have been hospitalized or died with Covid as of September 20, according to data compiled by the CDC.

“Even with delta, current vaccines are quite resistant to hospitalization and serious illness,” said Norman Baylor, former director of the FDA’s office of vaccines. “It’s the infections that seem to be a concern.”

Last month, Moderna said a third injection at half the dose used for the first two jabs was safe and produced a stronger immune response than seen after the second dose in its Phase Three clinical trial.

J&J said last month that a second dose of his single-injection vaccine was safe and boosted protection against symptomatic infections by about 70% to 94% when given two months after the first dose to patients. United States.

The FDA could allow Moderna and J&J booster shots on the same criteria as Pfizer or perhaps change course and expand the number of Americans eligible to receive additional injections, Baylor said in a telephone interview.

“The question is: does everyone need a booster right now? said Baylor, now president of Biologics Consulting Group.

Committee members will need to debate whether it is safe and effective for J&J recipients to get a second dose, Baylor said. He added that he did not expect any problems to authorize the third doses of Moderna’s vaccine, as it uses mRNA technology, which has also been used to develop Pfizer’s vaccines.

“If I was at the FDA in my old job, I probably wouldn’t have presented Moderna to the advisory board because it is in the same class as Pfizer,” he said.

The administration’s communication on Pfizer’s recalls was already confusing and “very damaging” in terms of public perception, said Dr. Isaac Bogoch, an infectious disease specialist at the University of Toronto.

“From the outside it looks a bit like a free-for-all,” Bogoch said. “Like, yes, there are vague guidelines in the United States. But it looks like anyone can walk into any pharmacy and get a reminder and say you know what I smoke or that I am obese or that I am a healthcare worker. “

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2/ https://www.cnbc.com/2021/10/11/us-moves-closer-to-clearing-moderna-and-jj-covid-booster-shots-this-week.html

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