Brittany Murray | Medianews Team Getty Images Top US scientists and doctors are concerned that the FDA and CDC are moving too fast to approve a fourth round of Covid vaccines, with little public debate giving vaccine manufacturers a huge role in determining the rate at which doses are distributed throughout the country. the country . Leading U.S. public health agencies last week approved a fourth Covid vaccine for older adults without holding public meetings, prompting criticism from top vaccine experts who believe federal health officials have not been transparent enough about their decision. The approval of a fourth installment for adults aged 50 and over comes as the scientific community is divided over whether the data are sufficient to support another round of amplifiers and whether the approval of additional shots is a viable public health policy, especially if protection from infection simply wears out over time. There is debate as to whether the purpose of vaccines is to prevent serious illnesses, which they have largely achieved, or even infection – a more challenging proposition. The Food and Drug Administration approved a second booster dose for people aged 50 and over last week, and the Centers for Disease Control and Prevention quickly backed their distribution hours later based on data from Israel, which released the fourth dose months ago. . Dr Peter Marks, who heads the FDA office responsible for vaccine safety and efficacy, said shortly after the decision that another round of boosters would likely be needed in the autumn.
Quick approval
The quick fix of the fourth shot for older adults came just weeks after Pfizer and Moderna asked the FDA for permission. Several members of the FDA and CDC committees, as well as other top experts, have stated that Pfizer and Moderna have a very important role to play in setting the US vaccine policy agenda, announcing the need for fourth doses and possibly a specific vaccine before public health services made any recommendations. Moderna CEO Stephane Bancel said in an interview with Goldman Sachs in January that fourth installments would be needed in the fall as the protective antibodies against the shots weaken over time. Pfizer CEO Albert Bourla told CNBC in early March, before the company submitted its request to the FDA, that there was a need for a fourth installment, although he said regulators would eventually come to their own conclusions. “I think it’s a kind of commemorative mania. I think companies honestly act like public health services,” he said. Paul Offit, FDA member and one of the country’s leading vaccine experts. Offit said the CDC, which has the final say on vaccine recommendations, needs to develop a clear national strategy to reduce public confusion about what it means to be fully vaccinated at this stage of its pandemic. Covid. Michael Osterholm, a leading epidemiologist, said the repeat boost was not a viable public health strategy because of the challenge posed by reducing immunity to infections. “We will not be able to push it out of it,” said Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
Ask for more transparency
The FDA and CDC vaccine advisory teams weigh safety and efficacy data before making recommendations to top federal health officials for the best course of action. Although the recommendations are not binding, the meetings provide an open forum where the public can hear the country’s leading health experts discuss the pros and cons of vaccine policy and often even participate by calling to express their views. their views. The FDA’s Advisory Committee on Vaccines and Related Organic Products is meeting Wednesday to discuss the future of amplifiers. However, they will not vote on specific recommendations, according to the FDA. The CDC Vaccination Practice Advisory Committee also did not meet before CDC Director Dr. Rochelle Walensky signed fourth shots for seniors last week. “It’s just a kind of accomplished event,” Offit said. “I feel like we are in an age, this kind of exception of Covid, where we do not do things the way we usually do, that is, science precedes recommendation. Here, it is the other way around,” Offit said. Offit said the FDA is essentially asking the public to believe that the data support a fourth dose by providing adequate protection against serious illness. He said the American public benefits from hearing an open discussion about vaccine decisions, especially at a time when many people are not taking advantage of the third dose. Offit is an infectious disease specialist at Philadelphia Pediatric Hospital and co-inventor of a rotavirus vaccine. Marks, during a press conference last week, said the FDA did not convene a committee meeting because the decision was “relatively simple.” He said data from Israel suggest that a fourth dose may reduce the risk of hospitalization and death in older adults. The CDC, in a statement to CNBC, said the fourth tranche was a gradual change that did not need to go to its committee. Dr. William Schaffner, a non-voting ACIP member, disagreed that the CDC’s recommendation was a gradual change. Schaffner said clearing the fourth installment for older adults is a big decision that would have benefited from a meeting of outside counselors to provide transparency to the public. “I think this decision was made in the house behind closed doors without the transparency of a full discussion that would provide a regular ACIP meeting – I think it is unfortunate,” said Schaffner, an infectious disease specialist at Vanderbilt University Medical Center. Dr James Hildrett, who is attending the FDA meeting on Wednesday as a temporary member, noted that the drug regulator was not required to convene a public meeting before approving the shots and the service has experienced experts who can identify to support a new authorization. However, Hildreth said moving forward without recommendation from outside experts creates poor vision. “When the FDA makes such a decision without hiring an outside team of experts, it simply adds to the perspective of the drug companies that influence the decisions that are made,” said Hildreth, president of Meharry Medical College in Nashville. Tennessee. Meharry is a clinical trial site for the Novavax vaccine as well as the Moderna vaccine for younger children.
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‘Declining yields’
While some health experts believe that the central purpose of vaccines is to prevent serious diseases, others believe that it is important to stop viral infections. The protection provided by the Pfizer and Moderna vaccines against infection has been significantly reduced over time, especially in the context of omicron, which has numerous mutations that give it an enhanced ability to cause unprecedented infections and mild illnesses. However, vaccines still provide effective protection against serious diseases. “If you have a mild illness after vaccination, you have won – that’s all. You do not have a serious illness, which is the stated goal of this vaccine,” said Offit, who believes three doses were necessary for the elderly and four for people with weak immune systems, but is skeptical about the need for extra shots right now. But if the goal is also to prevent infection, that means that, at least for now, booster shots are the only tool available to increase antibodies until a longer-lasting vaccine is available. The problem is that vaccines are ultimately declining, according to John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. Moore said a three-dose regimen is quite typical with vaccines that help boost the immune system to its maximum response. The fourth shot, however, begins to hit the ceiling – at least in terms of protecting younger people from infection. The Israeli Ministry of Health and scientists at the Sheba Medical Center found that a fourth dose restored the antibodies that weakened after a third dose to health workers aged 18 and over, but provided minimal protection against infection. Pfizer cited this study, which has not been peer-reviewed, including in its FDA authorization statement, focusing on elevated antibodies without highlighting issues with unprecedented infections.
Different age, different needs
Dr Peter Hotez, a vaccine expert at Baylor College of Medicine in Houston, strongly supports a fourth dose for the elderly, citing a February CDC study that found that the effectiveness of the third vaccine dropped from 91% to 78% after four months. Pfizer, in its public statements on the fourth dose, cited a separate Israeli study that found that a fourth dose reduced mortality by 78% in people aged 60 and over. The study by Ben Gurion University and Clalit Health Services, which has not been peer-reviewed, analyzed the medical records of more than 500,000 people. “We are continuing to collect and evaluate all available data and remain in open dialogue with regulators and health authorities to help update a Covid-19 vaccine strategy as the virus evolves,” Pfizer told CNBC. While the Ben Gurion study may point in the direction of benefit for older adults at the moment, evidence for younger adult support is still scarce as the US considers reducing eligibility for fourth doses sometime later in the year. year. Dr Gili Regev-Yochay and her team of scientists at Sheba said a fourth dose “could only have marginal benefits” for younger people, according to a letter …
