Federal Panel Recommends Booster Photographs, Opening New Marketing campaign In opposition to the Virus
An influential scientific panel opened a new front in the campaign against the coronavirus on Thursday, recommending booster shots of the Pfizer BioNTech Covid vaccine to a wide range of Americans, including tens of millions of the elderly. However, the experts declined to advocate additional doses for health workers, teachers, and others who may be exposed to higher levels at work.
The decisions were made by the CDC Panel, the Advisory Committee on Vaccination Practices, in a series of votes that tormented the scientists over their decisions. The recommendations revealed deep divisions between federal regulators and outside advisors on how to contain the virus nearly two years after the pandemic began.
Just a day earlier, the Food and Drug Administration approved booster shots for certain frontline workers. But CDC advisers disagreed that so many healthy people needed the doses.
In the next step, Dr. Rochelle Walensky, the director of the CDC, made a formal recommendation. If she follows the directions of the agency’s advisory committee, which is usually the case, the agency’s guidelines may conflict with those of the FDA
An administrative official said Xavier Becerra, the secretary for health and human services, will ultimately have to mediate between the two authorities.
“There is a complexity here because Dr. Walensky was part of the White House’s announcement “to boost boosters,” said Dr. Ashish Jha, Dean of Brown University School of Global Health. “I think she’s going to feel some pressure to approve this for health care workers.”
Depending on what is decided, the White House is likely to begin promoting and rolling out a booster shots plan as early as Friday. This would be in line with the government’s previously announced plan to offer the additional doses in the week of September 20th.
Despite the scientific reservations, millions are expected to look for booster vaccinations. In a recent poll, about three-quarters of Americans vaccinated said they would choose to have a booster dose when the doses were available.
State health officials generally follow the CDC’s recommendations, but many Americans looked for boosters even before the FDA approved, typically by finding a cooperative pharmacist or claiming they weren’t vaccinated.
Responding to what they described – with considerable frustration – as poor research, CDC advisors considered conflicting data points that rarely pointed in one direction.
In the end, the panel unanimously endorsed booster injections for adults over 65 and residents of long-term care facilities who will benefit most.
The committee also endorsed the shots for those between the ages of 50 and 64 with medical conditions who put them at severe risk of Covid-19, as well as those between the ages of 18 and 49 who have certain medical conditions, based on an assessment of their individual needs.
Only Americans who have already received two doses of the Pfizer BioNTech vaccine will qualify for a booster vaccination. The panel was not asked to assess whether individuals who received the Moderna and Johnson & Johnson vaccines should receive the additional doses that were not approved by the FDA
9/25/2021, 5:40 p.m. ET
Several experts on the CDC panel nonetheless pushed for a mix-and-match strategy, saying they could see no reason not to give someone who qualified but received the J. & J. vaccine, for example, a Pfizer Offering BioNTech boosters. Some members warned that giving multiple rounds of booster vaccinations, which are regularly available once approved, would put a strain on an already strained healthcare system.
The CDC panel guidelines followed weeks of internal disagreements and public debates between American health officials and advisors. In mid-August, President Biden announced plans for a booster launch, but scientists and regulators were quick to point out that there was little research on who could benefit from it and how the doses should be distributed.
Acting FDA Commissioner Janet Woodcock said Wednesday that the agency’s approval would allow for booster doses “in certain populations such as health workers, teachers and day care workers, food workers and those in homeless shelters or prisons, among others.”
However, some members of the committee said there was little evidence that vaccinated teachers and even health care workers were at risk of repeated exposure to the virus. The decision reflected fears that such a broad recommendation would open the doors to a booster campaign for all adults.
“I got the feeling that the committee felt like this was some kind of hole you could drive a truck through,” said Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s vaccine advisory panel, told reporters at an online briefing Thursday.
Over the two days, the panel struggled with public expectations for Covid vaccines, the safety of the third dose, and the effects of a booster program on nursing home residents. Some scientists found that booster doses alone would not turn back the pandemic: only vaccinating the unvaccinated would do that.
Understand US vaccination and mask requirements
- Vaccination rules. On August 23, the Food and Drug Administration fully approved Pfizer-BioNTech’s coronavirus vaccine for people aged 16 and over, paving the way for increased mandates in both the public and private sectors. Private companies are increasingly demanding vaccines for employees. Such mandates are legally permissible and have been confirmed in legal challenges.
- Mask rules. The Centers for Disease Control and Prevention in July recommended that all Americans, regardless of vaccination status, wear masks in public places indoors in areas with outbreaks, reversing the guidelines offered in May. See where the CDC guidelines would apply and where states have implemented their own mask guidelines. The battle over masks is controversial in some states, with some local leaders defying state bans.
- College and Universities. More than 400 colleges and universities require a vaccination against Covid-19. Almost all of them are in states that voted for President Biden.
- schools. Both California and New York City have introduced vaccine mandates for educational staff. A survey published in August found that many American parents of school-age children are against mandatory vaccines for students but are more likely to support masking requirements for students, teachers and staff who are not vaccinated.
- Hospitals and medical centers. Many hospitals and large health systems require their employees to have a Covid-19 vaccine, due to rising case numbers due to the Delta variant and persistently low vaccination rates in their communities, even within their workforce.
- New York City. Proof of vaccination is required by workers and customers for indoor dining, gyms, performances, and other indoor situations, though enforcement doesn’t begin until September 13th. Teachers and other educational workers in the city’s vast school system are required to have at least one vaccine dose by September 27, without the option of weekly testing. Municipal hospital staff must also be vaccinated or have weekly tests. Similar rules apply to employees in New York State.
- At the federal level. The Pentagon announced that it would make coronavirus vaccinations compulsory for the country’s 1.3 million active soldiers “by mid-September at the latest. President Biden announced that all civil federal employees would need to be vaccinated against the coronavirus or undergo regular tests, social distancing, mask requirements and travel restrictions.
“We can move the needle a little bit by giving people a booster dose,” said Dr. Helen Talbot, Associate Professor of Medicine at Vanderbilt University. But she added, “The hospitals are full because people aren’t vaccinated.”
The consultants also struggled with ambiguities when it came to the goal of vaccines: Should all infections be prevented or serious illnesses and hospital stays prevented?
Many suggested that booster doses could only do the latter and that it was impossible to thwart all infections. That reasoning supported the limit on who should receive the doses, the experts said.
On Thursday, CDC scientists presented models suggesting that if booster doses slightly increase people’s protection from hospital admissions, the extra vaccinations could prevent more than 2,000 hospital admissions per million doses administered.
However, it wasn’t clear how long the extra protection from a booster would last, which increased the prospect of repeated use of boosters.
Boosters can reduce infections in nursing home residents, who are among the most at risk. Even so, cases will persist in nursing homes when community transmission is high, according to a model study presented at the meeting.
The advisors also struggled with the practicalities of advocating booster vaccinations only for Pfizer BioNTech recipients, as nearly half of Americans vaccinated have received Moderna or J. & J. vaccines.
“I just don’t see how we can say to people over 65 this afternoon, ‘You are at risk of getting seriously ill and dying, but only half of you can protect yourself right now,'” said Dr. Sarah Long, pediatrician and infectious disease expert at Drexel University College of Medicine in Pennsylvania.
Committee members also expressed concern Thursday that some recommendations – notably that certain younger Americans be allowed booster injections after an individual risk assessment – would mean that only the rich and educated would have access to additional injections.
Some experts appeared to suggest Wednesday that it might be better to withhold recommending booster vaccinations until recipients of all three vaccines could qualify.
Moderna booster approval may arrive in a few days to weeks. The company has filed with the FDA for approval of a booster vaccination containing half the dose given in the first two vaccinations, which has made the agency’s deliberations difficult.
Some global health experts have criticized the Biden government for pushing booster injections even though much of the world has not yet received a first dose. However, analysts noted that even if the United States were to distribute booster vaccines, there should still be a significant surplus of vaccines this year, and urged the government to send the additional doses overseas.
Sheryl Stolberg contributed the reporting from Washington.