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WASHINGTON — Senior federal health officials have told the White House this month to scale back its plan to introduce coronavirus-boosting vaccines to the general public, saying regulators need more time to gather and review all necessary data, according to people familiar with the debate. .
Deputy Director of the Food and Drug Administration, Dr. Janet Woodcock and head of the Centers for Disease Control and Prevention, Dr. Rochelle P. Walensky warned the White House on Thursday that her agencies could determine that in the coming days. Whether boosters are recommended for recipients of the Pfizer-BioNTech vaccine alone—and probably just some to begin with.
The two health leaders had their discussion at a meeting with the White House pandemic coordinator, Jeffrey D. Zients. Several people who heard the session said it was unclear how Mr. Zients responded. However, he insisted for months that the White House would always follow the advice of government scientists wherever he went.
“We have always said we will follow the science, and this is all part of an ongoing process right now,” a White House spokesperson said on Friday about the meeting, adding that it awaits “full review and approval” from the administration. A recommendation from the CDC along with supporting shots by the FDA
“Once this approval and recommendation is made, we will be ready to implement the plan developed by our nation’s best doctors to stay ahead of this virus,” spokesman Chris Meagher said.
Less than three weeks ago, Mr. Biden said the government is dependent on FDA approval planned to start offering boosters Adults who have received their second shot of the Pfizer-BioNTech or Moderna vaccine at least eight months ago by the week of September 20. This includes many health workers and nursing home residents, as well as some people over the age of 65 who are usually first vaccinated. Management officials have said that recipients of the single-dose Johnson & Johnson vaccine will likely be offered an additional shot soon.
Mr. Biden used strategy as another tool the nation needed to fight at a high level. contagious Delta variant that increases infection ratesIt filled hospitals with Covid-19 patients, leading to an average of more than 1,500 deaths per day last week, according to the New York Times database. “The plan is to get a booster shot for each adult eight months after you’ve had your second shot,” he said on August 18, adding: “This will make you safer and longer. And it will help us end the pandemic faster.”
But the announcement of a late-September target date to kick off the support campaign has sounded alarm bells within the FDA — apparently playing a role in the decision of the two top vaccine regulators announced this week to leave the agency this fall.
Both Dr. Woodcock and Dr. Walensky helped draft the plan and approved it publicly. Some public health experts said that by doing this, they increase pressure on scientists weighing the evidence for boosters at their institutions to comply with the administration’s strategy.
Professor of medical ethics and health policy at the University of Pennsylvania, Dr. “Now these agencies are in a box,” said Steven Joffe. “We want doctors, scientists, and the public to trust the recommendations and decisions made, and to be able to demonstrate that the FDA and CDC are doing their due diligence.”
Specifically, Dr. Woodcock argued that it is risky to set a firm date for a support presentation before regulators have had a chance to comprehensively review the data, some of which has yet to be submitted by vaccine manufacturers, and decide whether vaccines are safe. and necessary, according to a few people familiar with the controversies.
And since the White House announced its reinforcement plan in mid-August, new hurdles have emerged, they said.
Reasons for the delay include regulators needing more time to decide on the appropriate dose for a possible third shot of Moderna. A federal official familiar with the process said the company’s application asking the FDA to authorize a booster shot contained insufficient data. Other expected data from Johnson & Johnson were not delivered.
Neither does the raw data that the FDA expects from Israel. Anyone 12 years and older. Israeli officials say their data shows that the efficacy of Pfizer’s vaccine wanes over time against severe illness and hospitalizations, but that a third vaccine significantly boosts protection. The FDA wants to see baseline data to make sure it supports the summaries provided by the Israeli government.
Narrowing the support plan can confuse the public and create the perception that federal vaccine policy is in some degree of disarray. But some public health experts will likely welcome it.
They vehemently argue that the administration lacks data to justify the wide spread of extra vaccines and should instead focus on vaccinating the roughly 25 percent of Americans who are eligible for the vaccine but remain unprotected. Some said senior Biden officials, including leaders of health agencies, wrongly cornered regulators by announcing a strategy before it could give it a full review.
Understand the Vaccine and Mask Instructions in the US
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- vaccination rules. On August 23, the Food and Drug Administration Pfizer-BioNTech’s coronavirus vaccine granted full approval It paves the way for people aged 16 and over to increase their tenure in both the public and private sectors. became private companies increasingly mandatory vaccines for employees. Such powers legally allowed and upheld in court appeals.
- Mask rules. Centers for Disease Control and Prevention in July suggested The fact that all Americans, regardless of vaccination status, wear masks in public in areas with outbreaks was a reversal of the guidance it presented in May. See where the CDC guidance applies, and where states created their own mask policies. The battle over masks has become contentious in some states. local leaders defying state bans.
- Colleges and universities. More than 400 colleges and universities require their students to be vaccinated against Covid-19. Nearly all in states that voted for President Biden.
- Schools. Both of them California and New York City imposes vaccination requirements for education personnel. A survey published in August found that many American parents with school-age children are against compulsory vaccinations for students, but More support for mask missions for unvaccinated students, teachers and staff.
- Hospitals and medical centers. Many hospitals and major healthcare systems require their employees to be vaccinated against Covid-19. He speaks of increased caseloads fueled by the delta variant and stubbornly low vaccination rates in their communities, even within the workforce.
- New York City. Proof of vaccination is required for workers and customers. indoor dining, gyms, performances and other indoor situations, but the app doesn’t start until September 13. Teachers and other education workers The city’s large school system will need at least one dose of the vaccine by September 27, with no weekly testing option. City hospital staff they should also be vaccinated or undergo weekly tests. Similar rules apply to New York State employees.
- at the federal level. The Pentagon has announced that it will try to make coronavirus vaccines mandatory for the country. 1.3 million active-duty soldiers No later than mid-September. President Biden announced all civilian federal employees would have to get vaccinated against coronavirus or subject to regular testing, social distancing, mask requirements and restrictions on most trips.
Regulators are just beginning to review critical data to help them determine whether and how supplements should be given. Pfizer completed its enhancer filing with the FDA last week, and Moderna said on friday that he has just completed his work.
Two vaccine regulators who announced they will be leaving the agency this fall – Dr. Marion Gruber and her assistant Dr. Philip Krause – they told people there wasn’t nearly enough data to justify the extra offers. shots for the general population starting in just weeks. Dr. Gruber in October, Dr. Krause will depart in November.
There may be more friction ahead. On September 17, the FDA’s external advisory committee is scheduled to publicly review Pfizer’s data supporting a booster shot. Although Pfizer has requested the FDA to approve supplemental doses for people 16 years of age and older, the agency may decide to restrict who receives support. The CDC and its external advisory panel would also have to weigh in.
One of the key members of the FDA’s advisory board is Dr. Paul A. Offit argues that boosters are premature. “There is no longer a compelling reason to take a third dose,” he said in an interview Thursday.
He said management expects the FDA and CDC to rubber-stamp the booster timeline. Dr. Gruber and Dr. “Bypassing and marginalizing these agencies has driven the veterans you need in this pandemic to leave the FDA,” he said, referring to Krause’s departures.
Various studies have shown that the efficacy of Pfizer-BioNTech and Moderna vaccines diminishes over time against infection, but suggests that the vaccines continue to provide strong protection against severe illness and hospitalizations.
However, general surgeon Dr. Vivek Murthy said in an interview on Thursday that several studies have suggested a decline in protection against serious diseases over time. “Our feeling was that if we wait a few more months, we’ll see the protection against hospitalizations and deaths deteriorate,” he said.
a Interview published on Thursday At WebMD.com, Dr. Woodcock echoed this view, saying that the breakthrough infection trend had led medics to believe that at some point, “we would see hospitalizations and more serious illness” among fully vaccinated people. When that happens, he said, “we want to be ready” with the empowering plan.
Some Americans are already taking booster shots before FDA approval: more than a million Since mid-August, fully vaccinated persons have received an additional dose. The agency authorized vaccinations for some people with weakened immune systems on August 12; It is not known how many people who took an overdose were in this group.
kitty bennett contributed to research.
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