CDC Expert Panel Meets to Determine Who Gets Booster Injections After FDA Decision
Scientific advisers from the Centers for Disease Control and Prevention take up a thorny challenge on Thursday: who qualifies for the new Pfizer-BioNTech coronavirus booster and why?
On Wednesday evening, the Food and Drug Administration authorized booster shots of the vaccine for people over 65 who received their second vaccine at least six months earlier. The agency has also authorized recalls for adult Pfizer-BioNTech beneficiaries who are at high risk of severe Covid-19, or who are at risk of serious complications due to exposure to the virus in their work.
About 22 million Americans are at least six months after their second dose of Pfizer, according to the CDC. About half are 65 years of age or older.
But who exactly is at risk of getting seriously ill? What does it mean to be exposed at work? Are teachers seen as exposed or just frontline health workers? And what about the Americans who got the Moderna and Johnson & Johnson shots?
These are questions scientists at the CDC’s Advisory Committee on Immunization Practices are debating on Thursday, and their decisions will shape the direction of the federal government. The committee’s recommendations are not binding, and state officials sometimes implement their own criteria. Yet its decisions are likely to influence who receives the booster injections in practice.
At the start of Thursday’s meeting, Dr. Rochelle Walensky, director of the CDC, described the types of patients she hoped would benefit from the booster shots – an attempt, perhaps, to define the categories of people that the leadership of the agency wishes to receive the additional doses.
She notably mentioned not only older Americans and those at high risk of severe Covid, but also the example of a 35-year-old pregnant emergency doctor. She’s the kind of person whose high-risk job the FDA says should make her eligible for a recall. By allowing the boosters, the FDA has included health workers, teachers, grocers, and people in homeless shelters and prisons among those who should now be eligible for additional injections.
“You are charged with making tough decisions, weighing the risks against the benefits, extrapolating from sometimes a wealth and sometimes a lack of available data,” Dr. Walensky told committee members. She urged them to consider fairness, their own frontline experiences and most importantly their “commitment to follow the science”.
Following other recommendations from the Covid vaccine panel, Dr Walensky endorsed the committee’s guidance.
In its deliberations on Wednesday, the CDC’s advisory committee focused on the unanswered questions.
A third dose undoubtedly increases antibody levels, the experts concluded. But it is not known so far how long this increase lasts, if it translates into significant additional protection against serious illnesses and if it can significantly reduce the transmission of the virus.
Scientists on the committee also noted the lack of data on safety, especially among young people. And several advisers said they believe the goal of the reminders should be to prevent serious illness, hospitalizations and death, rather than to prevent infection.
“I don’t think there is any hope that vaccines like the ones we have will prevent infection after the first, maybe, few weeks that you have these extraordinary immediate responses,” said Dr Sarah. Long, pediatric infectious disease expert at Drexel. Philadelphia University College of Medicine.
Understanding the mandates of vaccines and masks in the United States
- Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people 16 years of age and older, paving the way for increased tenure in the public and private sectors. Private companies increasingly require vaccines for their employees. Such warrants are authorized by law and have been confirmed in court challenges.
- Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of immunization status, wear masks in indoor public places in areas affected by epidemics, a reversal of guidelines it offered in May. . See where the CDC guidelines would apply and where states have instituted their own mask policies. The battle for masks has become controversial in some states, with some local leaders defying state bans.
- College and universities. More than 400 colleges and universities require students to be vaccinated against Covid-19. Almost all of them are in states that voted for President Biden.
- Schools. California and New York City have both introduced vaccination mandates for educational staff. A survey released in August found that many American parents of school-aged children are opposed to mandatory vaccines for students, but were more in favor of mask mandates for students, teachers and staff who don’t. don’t have their vaccines.
- Hospitals and medical centers. Many hospitals and large healthcare systems are requiring their employees to be vaccinated against Covid-19, citing an increase in the number of cases fueled by the Delta variant and stubbornly low vaccination rates in their communities, even within their hand -work.
- New York City. Proof of vaccination is required from workers and customers for indoor meals, gyms, shows and other indoor situations, although enforcement does not begin until September 13. Teachers and other education workers in the city’s vast school system will need to have at least one vaccine dose by September 27, with no possibility of weekly testing. Employees of the city’s hospitals must also get vaccinated or undergo weekly tests. Similar rules are in place for New York State employees.
- At the federal level. The Pentagon has announced that it will seek to make coronavirus vaccination mandatory for the nation’s 1.3 million active-duty soldiers “no later than” mid-September. President Biden announced that all civilian federal employees should be vaccinated against the coronavirus or undergo regular testing, social distancing, mask requirements and restrictions on most travel.
The advisers also looked at the practicalities of approving a vaccine booster from Pfizer, but not Moderna or Johnson & Johnson. Recipients of these vaccines may hear that boosters are needed, but they cannot yet receive them.
“It’s a big public health panic that we would like to avoid,” said Dr Long.
Moderna sought FDA clearance for the booster shots, but at half the dose given in the first two.
Mixing the first shots of the Moderna vaccine with a Pfizer booster – or vice versa – is untested ground, and federal agencies are still reluctant to take action that the evidence does not explicitly support.
Some global health experts have criticized the Biden administration for pushing the booster shots when much of the world has yet to receive a first dose. But on Wednesday, Jen Psaki, the White House press secretary, argued that it was a “false choice”.
On Wednesday morning, President Biden said the United States would purchase an additional 500 million doses of the Pfizer-BioNTech vaccine to be donated worldwide, doubling a purchase in July.
“We now give the world three hits for every hit we put in an American’s arm, and our view continues to be that we can do both,” Ms. Psaki said. “Our view also continues to be that frankly the rest of the world needs to step up and do more.”
Sharon LaFraniere and Noah Weiland contributed to Washington reporting. Daniel E. Slotnik contributed to New York reporting.