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FDA Supports Pfizer COVID-19 Booster for Elderly and High-Risk People

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 Biden administration suggested when the president and his top aides announced 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.

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
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The Israeli government has proposed a strong case of boosters for people over the age of 65, but there is little evidence that additional shots will bring many benefits to young people with underlying health conditions.

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.

U.S. regulators will decide at a later date about boosters for those who receive Moderna
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Or Johnson & Johnson
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vaccination. They pointed out that the injection 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.

FDA Supports Pfizer COVID-19 Booster for Elderly and High-Risk People

Source link FDA Supports Pfizer COVID-19 Booster for Elderly and High-Risk People

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