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    FDA backs Pfizer COVID-19 boosters for seniors, high-risk – Atlanta, Georgia

    Atlanta, Georgia 2021-09-23 08:56:20 –

    File – This September 14, 2021 file photo shows a syringe with the Pfizer COVID-19 vaccine at the Reading Area Community College clinic in Reading, Pennsylvania. Vaccinations took place on Wednesday, September 22nd, deciding who will receive the COVID-19 booster shot and when. (AP Photo / Matt Rourke)

    The United States took a step closer to Wednesday and decided to offer Pfizer’s COVID-19 vaccine boost to seniors and others at high risk for the virus as the Food and Drug Administration approved the targeted use of additional shots.

    The FDA has approved booster immunization for young adults over the age of 65 with underlying health and Americans at high risk for COVID-19. The ruling is a significant reduction in the Biden administration’s drastic plans, with a third dose to nearly all American adults to enhance protection amid the prevalence of highly contagious delta variants. Thing.

    However, more regulatory hurdles await before the booster dispensing begins.

    Centers for Disease Control and Prevention advisors met on Wednesday for a two-day meeting to make their own more specific recommendations on who would get additional shots and when. And on the first day of the discussion, some experts were very confused by the questions surrounding Booster’s rationale and suggested that the decision be postponed for a month in the hope of more evidence.

    Uncertainty further reminded us that the science surrounding boosters is more complex than the president and his top aides suggested by the Biden administration. Deployed their plans at the White House last month.

    The FDA’s decision on Wednesday was expected after FDA’s own advisory board overwhelmingly rejected the Biden plan last week. Instead, the panel recommended boosters only to those who were most vulnerable to severe cases of COVID-19.

    Dr. Janet Woodcock, FDA’s deputy commissioner, said in a statement that FDA approval would allow healthcare workers, teachers, grocery workers, and homeless shelters and prison boosters.

    “As we learn more about the safety and efficacy of the COVID-19 vaccine, including the use of booster doses, we will continue to evaluate rapidly changing science and inform the general public,” Woodcock said. Stated.

    Under FDA approval, vaccinated Americans are eligible for a third vaccination six months after receiving a second Pfizer vaccination. This is different from Biden’s proposal announced in August, which requested a booster eight months later.

    “Today’s FDA decision is a major step forward in our efforts to provide Americans with additional protection from COVID-19,” White House spokesman Jen Psaki tweeted Wednesday night. “We have been preparing to administer booster shots to eligible Americans for several weeks and are ready to do so according to the CDC’s final recommendations later this week.”

    The timing of the FDA’s decision was extremely unusual, given that authorities would take normal action before the CDC convened its own experts.

    CDC panelists heard a series of presentations on Wednesday outlining the state of the science section on boosters. On the one hand, the COVID-19 vaccine continues to provide strong protection against severe illness, hospitalization, and death. On the other hand, as immunity weakens, there are signs of milder infections among vaccinated people.

    Ultimately, the Commission must decide who is considered to be at high enough risk for additional doses. Data provided by Pfizer and the Israeli government suggest a strong case of boosters for people over the age of 65, but evidence that extra shots bring many benefits to young people with underlying health conditions. Is almost nonexistent.

    Some CDC advisors have agreed that boosters are also important for maintaining the work of healthcare professionals.

    Dr. Helen Kape Talbot of Vanderbilt University said: “They just keep coming.”

    The CDC has already stated that it is considering boosters for the elderly, nursing home residents, and front-line healthcare professionals, rather than all adults.

    The World Health Organization and other global health advocates oppose rich countries giving a third dose when poor countries do not have enough vaccine for the first dose. And many independent scientists say the vaccine continues to work well against the worst effects of COVID-19, and its ability to control the overall trajectory of the epidemic is uncertain.

    US regulators will later decide on boost immunization for those who have been vaccinated with Moderna or Johnson & Johnson. They pointed out that Pfizer injections would not be recommended for people who were initially vaccinated with different brands.

    The full rollout of boosters proposed by the White House should have started this week. Some wondered if President Joe Biden was ahead of science by announcing his plans before government regulators came to a conclusion.

    Despite recent resistance, some top US health officials said they expect boosters to eventually gain broad approval in the coming weeks or months. “This is not the end of the story,” Dr. Anthony Fauci said over the weekend.

    Other officials said the FDA’s decision targeted tens of millions of Americans, with older people and other high-risk groups first boosting, even if additional shots were allowed for the entire population. Said I would have acquired it. Elderly people belonged to the first group of Americans eligible for vaccination last December.

    The United States has already approved a third dose of the Pfizer and Modana vaccines for certain people with weakened immunity, such as cancer patients and transplant recipients. Other Americans could get boosters by simply asking, whether healthy or not.

    The United States has averaged about 760,000 vaccinations per day, starting at a high of 3.4 million per day in mid-April. Approximately 180 million Americans are fully vaccinated, accounting for 64% of qualified individuals.

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    FDA backs Pfizer COVID-19 boosters for seniors, high-risk Source link FDA backs Pfizer COVID-19 boosters for seniors, high-risk

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