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Wednesday, December 8, 2021

The FDA may approve Moderna boosters for all adults this week.

Moderna has asked federal regulators to allow revaccination of its coronavirus vaccine for all adults, a request that the FDA may approve this week along with a similar request from Pfizer, according to people familiar with planning.

If the Centers for Disease Control and Prevention also signed that every adult who was fully vaccinated with Pfizer-BioNTech or Moderna vaccine at least six months ago would not only be eligible for the booster, but could also choose which vaccine. The agency’s committee of independent experts is set to meet on Friday to discuss booster shots.

It would also allow President Biden to fulfill his August promise to offer booster shots to every adult – nevertheless, almost two months later than the administration originally planned, and amid ongoing debate among experts over the need for additional shots for younger, healthier adults.

Currently, only people who have received two doses of Pfizer-BioNTech or Moderna vaccine and are 65 years of age or older, or adults who are considered to be at particular risk because of their health, work or living environment, are eligible for revaccination. Anyone who has received a single Johnson & Johnson shot can already receive a booster shot two months after the first shot. Eligible people can choose any of three brands of vaccine as a booster.

It is estimated that the existing acceptability categories, which are broad but complex, cover up to 70 percent of the adult population. More than 30 million Americans, or about 16 percent of those fully vaccinated, have already received additional vaccinations. But according to federal rules, tens of millions more are not eligible.

Even if federal regulators don’t act on Moderna’s request this week, the FDA and CDC are expected to give all fully vaccinated adults access to the Pfizer booster vaccine. At a White House briefing on Wednesday, Dr. Anthony S. Fauci, the government’s chief infectious disease expert, defended the administration’s approach to widespread access to boosters, saying vaccines should protect against symptomatic illness, not just hospitalization and death.

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“I don’t know of any other vaccine that we only worry about keeping people out of hospitals,” he said. “I think it’s important to prevent people from getting symptomatic illness,” noting that it can have long-term consequences – a condition dubbed long-term Covid.

“There is a really good reason for optimal protection for young people,” as well as for older and more vulnerable people, he said.

An increasing number of states and localities are offering vaccinations to all of their adults on their own, either with generous interpretations or simply ignoring federal regulations. As of Wednesday, network access has been expanded by a number of states, including Kansas, Kentucky, Maine and Vermont. On Monday, New York City health officials urged all adults in need of boosters to look for them.

Moderna announced Wednesday that it has asked the FDA to expand its booster approval to include all adults, as recently done by regulators in Canada and the European Union.

Moderna vaccine is considered more protective than Pfizer-BioNTech vaccine; its dose for the first two shots is 100 micrograms, while Pfizer’s dose is 30. Regulatory authorities have authorized a half dose of Moderna as a booster for the elderly and other vulnerable groups, in part to alleviate concerns about side effects; Moderna is looking for the same half dose booster dose for the wider adult population.

State and local health officials have criticized the existing federal qualifications for Moderna and Pfizer booster shots as too complex for the public to understand. In addition to people aged 65 and over, the participants include people with a variety of medical conditions, from heart disease to obesity and depression.

The CDC said it was also eligible for people “at increased risk of contracting and transmitting Covid-19 due to occupational or institutional conditions,” a category that includes, inter alia, healthcare workers, residents of homeless shelters and prisoners.

World Nation News Deskhttps://www.worldnationnews.com
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