[ad_1]
WASHINGTON (AP) – Just a month ago, President Joe Biden and his health advisers announced big plans to soon deliver a coronavirus vaccine booster to all Americans. But after campaigning for the White House on a pledge to “follow the science,” Biden found himself unusually early with this lofty statement.
Some of the country’s top medical advisers rebuked the idea on Friday, essentially telling the White House: not so fast.
Key government advisory group overwhelmingly rejects Biden’s plan to give COVID-19 booster shots at all levels and instead recommended the supplemental dose of vaccine only for people 65 years of age or older or at high risk of serious illness.
Biden’s Aug. 18 announcement that the federal government was preparing to step up protection for nearly all Americans came with great fanfare. It aimed to calm the nerves of millions of Americans fearing a new, more transmissible strain of the coronavirus.
“The plan is for each adult to receive a booster shot eight months after receiving your second injection,” Biden said, noting that his administration would be ready to begin the program on September 20.
Biden added the qualification that the third doses would require approval from health officials from the Food and Drug Administration and the Centers for Disease Control and Prevention, but his public message glossed over the nuance.
“Just remember,” he said, “as a simple rule of thumb: eight months after your second injection, give yourself a booster shot. “
Biden’s plan sparked immediate outrage from global health groups who urged the United States and other wealthy countries to refrain from administering boosters until poorer countries can provide them. first doses to their most vulnerable citizens.
“Viewed from a global perspective, this is a waste of a scarce global resource, as a result of which people will die,” said Dr Peter Lurie, president of the Center for Science in the Public Interest. “I feel quite comfortable saying this,” he added, acknowledging that national political considerations weigh differently on presidents.
The Biden plan has also been criticized by medical professionals, who cited a lack of safety data on additional doses and raised doubts about the value of mass boosters, rather than those aimed at specific groups.
“This created tremendous pressure on the agency to accept what the White House wanted,” said Lurie, who called the FDA panel’s decision a “rebuke” of Biden’s efforts to bypass procedures. standard. “This is what we are trying to get past after the Trump era.”
“Tracking them has served the FDA very well when they did,” he added. He compared the rapid clearance of vaccines to the agency’s brief flirtation with unproven COVID-19 treatments such as the antimalarial drug hydroxychloroquine during the Trump administration. “When they get away from it, they’re in trouble.”
The non-binding recommendation of external experts who advise the FDA is not the last word. The FDA will review the group’s advice and make its own decision, likely in a few days. The CDC is expected to weigh in next week.
One of the FDA advisers, Dr Paul Offit of the Children’s Hospital of Philadelphia, told reporters after the meeting that although the Biden administration has scheduled recalls for the general population, “it is not that. It’s, ‘We’re going to test the water one foot at a time.’ ”
The committee “parked it all and did its job,” said Norman Baylor, former director of the FDA’s vaccine review office. “I’m going to be very frank here: I think this meeting was rushed. I would say it should have happened later, ”so the FDA had more data to make the decision.
White House allies have defended the administration’s aggressive preparation for the boosters, which included regular messages from medics about their need and the strengthening of the federal stockpile of doses.
They argue that the American people elect a president, not a scientist, to act in their best interests. They believe the alternative – waiting for recalls to be prepared until federal health officials give the green light – could have cost lives.
US Surgeon General Dr Vivek Murthy told reporters ahead of the panel vote that the administration aims to be transparent with the public about the promise of boosters that provide long-lasting protection and does not try to pressure regulators for them to act. He said the administration also wanted to be ready in case the recalls were approved.
“We have always said that this initial plan would be subject to independent assessment by the FDA and CDC,” Murthy said. “We will follow this assessment and their recommendations, we will ensure that our final plan reflects it.”
“What we were doing in August and continue to do there is really prioritizing transparency and preparation,” he added.
Administration officials noted that the experts’ recommendation on Friday would likely result in callbacks for those most likely to get them anyway if the general public were given the green light. Seniors were among the first group of Americans to be eligible for vaccination after being cleared last December, followed by those with pre-existing conditions that put them at a higher risk of serious illness. These populations represent tens of millions of Americans, officials said.
After Friday’s vote, the White House attempted to portray the advisory group’s action in a positive light.
“Today was an important step forward in providing better protection to Americans against COVID-19,” White House spokesman Kevin Munoz said. “We are ready to provide booster shots to eligible Americans once the process is complete at the end of next week.”
Dr Leana Wen, a former Baltimore health commissioner who regularly comments on the pandemic, said the decision on the recalls “is not just a matter of science. It is one of the values.
“Because when we are looking at issues like extra doses for Americans or people around the world, it’s not the right decision for a scientific regulatory committee,” she said. “It depends on the President of the United States. “
___
Associated Press editors Matthew Perrone and Lauran Neergaard contributed to this report.
[ad_2]
Source link