FDA backs Pfizer COVID-19 boosters for high-risk seniors – World News – .

FDA backs Pfizer COVID-19 boosters for high-risk seniors – World News – .

The United States moved closer on Wednesday to offering booster doses of Pfizer’s COVID-19 vaccine to the elderly and others at high risk of the virus as the Food and Drug Administration approved the targeted use of the injections additional.

The FDA has cleared booster doses for Americans 65 and older, younger people with underlying health conditions, and those in jobs that put them at high risk for COVID-19. The move represents a significantly scaled-down version of the Biden administration’s sweeping plan to administer third doses to nearly all American adults to bolster their protection amid the spread of the highly contagious delta variant.

However, other regulatory hurdles await us before booster distribution can begin.

Advisors from the Centers for Disease Control and Prevention opened a two-day meeting on Wednesday to make their own more specific recommendations on who should get the additional injections and when. And on their first day of talks, some experts were so perplexed by questions surrounding the rationale for the recalls that they suggested postponing a decision for a month in the hope of more evidence.

The uncertainties have been another reminder that the science surrounding boosters is more complicated than the Biden administration suggested when the president and his top aides presented their plan to the White House last month.

The FDA’s decision on Wednesday was expected after the agency’s own group of advisers last week rejected the Biden plan by an overwhelming majority. Instead, the panel recommended boosters only for those most vulnerable to severe cases of COVID-19.

The timing of the FDA decision was highly unusual given that the agency typically takes action before the CDC summons its own experts.

CDC panelists heard a series of presentations on Wednesday describing the thorny state of science on boosters. On the one hand, COVID-19 vaccines continue to offer strong protection against serious illness, hospitalization and death. On the other hand, there are signs of weaker infections among those vaccinated as immunity wanes.

Ultimately, the committee must decide who is considered to be at high enough risk for an additional dose. Data provided by Pfizer and the Israeli government suggests a strong case for recalls in people 65 years and older, but there is less evidence that additional injections offer much benefit to younger people with problems. underlying health.

Several CDC advisers have agreed that boosters are also important in keeping healthcare workers on the job.

“We don’t have enough healthcare workers to take care of the unvaccinated people,” said Dr. Helen Talbot of Vanderbilt University. “They keep coming. “

The CDC has previously said it is considering boosters for seniors, nursing home residents and frontline healthcare workers, rather than all adults.

The World Health Organization and other global health advocates oppose rich countries handing out a third round of vaccines when poor countries do not have enough vaccines for their first doses. And many independent scientists say vaccines continue to work well against the worst effects of COVID-19, and their ability to slow the overall trajectory of the epidemic is uncertain.

US regulators will later decide on recalls for people who have received Moderna or Johnson & Johnson vaccines. If Pfizer recalls are allowed this week, US regulators have said the injections would not be recommended for people who initially received another brand of vaccine.

The widespread deployment of boosters offered by the White House was to have started this week. Some have questioned whether President Joe Biden got ahead of the science by announcing his plans before government regulators reached any conclusions.

Despite resistance in recent days, some senior U.S. health officials have said they expect the boosters to eventually gain wider approval in the weeks or months to come. Dr Anthony Fauci said over the weekend that “this is not the end of the story”.

Other administration officials noted that the FDA decision covers tens of millions of Americans and that the elderly and other high-risk groups would have been the first to receive boosters even if additional injections had been required. authorized for the entire population. Seniors were among the first group of Americans eligible for vaccination last December.

The United States has already authorized third doses of Pfizer and Moderna vaccines for certain people with weakened immune systems, such as cancer patients and transplant recipients. Other Americans, healthy and unhealthy, have been successful in getting reminders, in some cases simply by asking.

The United States dispenses about 760,000 vaccines per day on average, up from a peak of 3.4 million per day in mid-April. About 180 million Americans are fully immunized, or 64% of those eligible.


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