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After a series of approvals last month by scientific panels that advise federal agencies, tens of millions of Americans are now eligible for booster shots of coronavirus vaccines.
But the recommendations—even those that were unanimously approved—mask significant opposition and discontent among these advisors over the need for booster shots in the United States.
In interviews last week, some consultants to the Centers for Disease Control and Prevention and the Food and Drug Administration said the data already did and the vast majority of Americans, with the exception of adults over 65, are well protected against serious illness. No need for booster shots.
All consultants felt they had to make difficult choices, based on sparse research, in the midst of a public health emergency. But some said they felt compelled to vote for the shots because of the way federal agencies framed the questions they were asked to think about.
Other committee experts said they didn’t want to further confuse the public by opposing, or they voted on their view of the evidence and were simply rejected.
D., a pediatric infectious disease specialist and pediatric infectious disease specialist at Drexel University College of Medicine in Philadelphia. “These are not evidence-based recommendations,” Sarah S. Long said. CDC’s Advisory Committee on Immunization Practices.
After a series of votes, the current official position of the FDA and CDC is that older adults, people with certain medical conditions, and those whose work or living conditions regularly expose them to the virus can choose a booster dose of any of the three vaccines. .
The CDC also recommended last week that people in certain high-risk groups who have some type of Covid-19 vaccine may choose a different vaccine for their booster.
Senior researcher and CDC advisory board member at Kaiser Permanente Colorado, Dr. “I don’t think we have evidence that everyone in these groups needs a booster today,” said Matthew Daley.
Dr. Long and Dr. Daley voted in favor of booster vaccines at their committee’s meeting on Thursday, but had reservations about how that decision would be viewed by worried Americans who might mistakenly conclude that vaccines are ineffective.
When the CDC committee reviewed the evidence for the Pfizer-BioNTech booster in September, the consultants unanimously agreed that extra shots should only be given to adults over 65. Two of the 15 panelists voted against supplemental doses for adults over 50 with certain medical conditions.
Approval of boosters for people aged 18 to 49 with other medical risk factors squeaked in a nine-to-six vote. And his empowering advice for people whose professions put them at risk hasn’t passed.
This last category is reserved only for the agency’s director, Dr. Rochelle Walensky is included in recent CDC recommendations. rejected his advisors.
D., director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s vaccine advisory committee. “You can see the hesitation in all this,” said Paul Offit. “Because in our hearts, I think people don’t quite agree with this idea of a booster dose.”
Dr. “The door got bigger and bigger and bigger, wider with each step,” Offit added. “Companies got what they wanted, management got what they wanted.”
In interviews, experts complained about the limited data on the safety and effectiveness of booster shots. CDC scientist Dr. Kathleen Dooling acknowledged at Thursday’s committee meeting that the data supporting extra doses of the Moderna and Johnson & Johnson vaccines are of “very low quality.”
Still, some said they felt they had to vote for the booster vaccines of the Moderna and Johnson & Johnson vaccines because they had already recommended boosters of the Pfizer-BioNTech vaccine and didn’t want to deny other Americans.
D., professor of pediatrics at Tufts University School of Medicine and member of the FDA advisory committee. “The problem that bothers me is that we don’t know if boosters are necessary,” said Cody Meissner.
But he added, “If you’re going to do this for a group, I think justice requires you to do it for all groups.”
At the talks, panelists hesitated to voice their displeasure, saying they did not want to undermine the committees’ final decisions.
An infectious disease physician and CDC committee member at Massachusetts General Hospital, Dr. “It’s hard to show some doubts because we don’t want to have mixed messages,” said Camille Kotton.
But a few panelists who didn’t want to go on record said privately that as soon as President Biden promised all grown-ups, final proposals for supporting shots were inevitable.
One of the few to openly express his unhappiness, Dr. “We are in a very difficult situation to do anything other than what everyone has already declared we do,” Long said.
Some administration officials said it “supposedly serves science and evidence.”
Experts outside of these committees also said President Biden’s promise of support in August made it difficult for agencies to objectively weigh the data in September and October.
Infectious disease specialist at Bellevue Hospital Center, who previously advised the Biden management, Dr. “The perception that the horse is out of the barn and there’s not much you can do at this point,” Celine Gounder said.
Citing mixed signals from the White House and federal scientists, he added, “The truth is, you can’t have this confusing mess – it’s going to create more problems.”
Much of the opposition in recent hearings stemmed from one central contention: that coronavirus vaccines, like nearly all other vaccines, should be used to prevent illness severe enough to require medical attention, not a milder infection.
Most of the evidence available to federal advisers only showed that the original immunizations were less effective against infections. Vaccines seem to hold steady against severe Covid-19 and death, except perhaps for older Americans.
What You Need to Know About Covid-19 Booster Shots
The FDA has allowed booster shots for millions of buyers. Pfizer-BioNTech, modern and Johnson and Johnson vaccines. Pfizer and Moderna recipients who qualify for support include people aged 65 and over, and young adults at high risk of serious Covid-19 because of medical conditions or where they work. Eligible Pfizer and Moderna recipients can receive a boost for at least six months after their second dose. All Johnson & Johnson recipients will be eligible for a second shoot at least two months after the first.
Yeah. The FDA has updated its mandate to allow medical providers to empower people with a different vaccine than the one they originally received. “Mix and Match.” You can get a booster for any other vaccine, whether you’ve received Moderna, Johnson & Johnson, or Pfizer-BioNTech. The regulators did not recommend any vaccine over the other as a booster. They also remained silent on whether it would be preferable to stick to the same vaccine whenever possible.
The CDC said conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood diseases; weakened immune system; chronic lung, kidney, or liver disease; dementia and some disabilities. Pregnant women and current and former smokers are also eligible.
The FDA has allowed boosters for workers whose jobs put them at risk of exposure to potentially infectious humans. The CDC says the group includes: emergency health workers; education workers; food and agricultural workers; manufacturing workers; correction workers; US Postal Service employees; public transport workers; grocery workers.
Yeah. The CDC says the Covid vaccine can be administered regardless of the timing of other vaccines, and many pharmacy sites allow people to schedule a flu shot at the same time as a booster dose.
Dr. “I don’t think we’re seeing 100 percent protection from any vaccine,” Kotton said. “The goal of reaching zero is temporary and unfortunately not really achievable.”
He added, “People are using it because they’re very worried about Covid and they’re worried about the way things are going in the world,” he added, referring to the reinforcement shots.
Generally, scientists on the two committees are asked to vote yes or no to questions put to them by the federal agencies they advise. In some cases, committee members said they voted one way or another simply because of the way these questions were worded.
In December, when FDA advisors evaluated the Pfizer-BioNTech vaccine for people aged 16 and older, evidence for its use in 16- and 17-year-olds was limited.
Dr. Archana Chatterjee and three other committee members voted against the vaccine and were criticized for it. However, Dr. Chatterjee said he would vote differently if the FDA wanted the vaccine to be allowed in adults 18 years and older.
Pediatric infectious disease specialist and dean of the Chicago School of Medicine, Dr. “We’re basically told, ‘The question is and say yes or no,'” Chatterjee said. We were not given the opportunity to explain the vote,” he said.
At subsequent meetings, the FDA allowed science advisors to request changes to the question and announce their votes. But they are still limited to voting only on data submitted by a company.
For example, at a recent meeting, some FDA advisors said they would like to recommend that Johnson & Johnson recipients have the option of choosing any vaccine for their boosters. However, the FDA only asked the panel to vote for the booster of the Johnson & Johnson vaccine.
One of the panelists, Dr. Stanley Perlman said he voted yes because it was clear that Johnson & Johnson buyers would benefit from a second shot. But Dr., an immunologist and coronavirus expert at the University of Iowa. Perlman noted that the unanimous vote gave him much more confidence in the Johnson & Johnson vaccine than he felt as a booster.
Dr. Perlman said she was initially against backers for teens, but voted in favor for other reasons. In the example of healthcare workers, she said, “I didn’t want any nurses or doctors to stay at home because they were asymptomatic.”
A few experts said they tried to be clear about the limitations of the data and the rationale behind their decisions. But communicating in the midst of a pandemic has proven difficult.
Dr. “While it was nobody’s intentional fault, the messaging was tough – and then there’s a lot of misinformation, which is tragic,” Kotton said.
Some experts, when approving the boosters, said, reluctantly, that federal agencies and their advisers may have given Americans the impression that two doses weren’t protective enough.
Dr. “While they should have said something extraordinary, they continue to unintentionally curse the vaccine,” Offit said. “This is a miracle vaccine.”
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