Scientists divided on need for 4th Covid shot after FDA quietly approved another round of boosters
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Cathy Dozal has her second booster shot to combat COVID-19, from Patricia Lizardo (vocational nursing student) at Long Beach City College in Long Beach.
Brittany Murray | Medianews Group | Getty Images
Top U.S. doctors and scientists worry about the FDA’s and CDC’s speed in approving a fourth dose of Covid shots. With little public discussion, it gives vaccine makers too large a stake in determining the distribution pace across the country.
These are the top U.S. health departments last week endorsed a fourth Covid shotSenior adults can be notified without having to hold public meetings. This has drawn criticism from top vaccine experts, who feel that the federal government officials are not being transparent enough about their reasons.
As the scientific community debates whether data are sufficient to justify another round, or whether it is sustainable for public health policies, including because the protection against infection just wears off with time, the authorization of the fourth dose was granted. There is a debate over whether the goal of the vaccines is to prevent severe illness, which they’ve largely achieved, or infection as well — a more challenging proposition.
Last week the Food and Drug Administration approved a second booster shot for those 50 and over. The Centers for Disease Control and Prevention supported their distribution within hours based on Israeli data, which had rolled out fourth doses several months earlier. Shortly after the FDA decision, Dr. Peter Marks (head of the FDA office for vaccine safety & efficacy) stated that another round of boosters will likely be needed in the fall.
Approval in a matter of minutes
Just weeks later, the rapid clearance by regulatory authorities of fourth shots was achieved for older adults. Pfizer ModernaThey asked for permission from the FDA. Pfizer, Moderna, and other top experts said that they are playing too big a part in setting U.S. vaccine policy. Moderna announced the need for fourth doses as well a variant-specific vaccination before public health agencies made any recommendations.
Moderna CEO Stephane Bancel said during a January interview with Goldman SachsThe fourth dose would need to be taken in fall, as the shot’s protective antibodies diminish over time. Pfizer CEO Albert Bourla told CNBCThe company requested a fourth dose in March. He stated, however, that FDA will ultimately decide.
It’s a form of booster mania, I think. “I think that the companies are honestly acting like public health agents,” stated Dr. Paul Offit. Offit is a member on the FDA committee, and is one of the country’s most respected vaccine experts. Offit indicated that the CDC is the ultimate authority in vaccine recommendations. Offit suggested that a clear national strategy be developed to clarify what the CDC means by fully vaccinating all citizens at this point.
Michael Osterholm, an epidemiologist and leading expert, stated that repeatedly boosting was not a viable public health strategy because of the difficulty posed to by decreasing immunity. Osterholm, who is the director of the Center for Infectious Disease Research and Policy of the University of Minnesota said that “we’re not going to be able boosting our way out of it.”
Demand more transparency
Before making their recommendations, top federal officials in the health sector on how to proceed, the FDA and CDC have weighed safety and effectiveness data. The recommendations are not binding, but the meetings offer an opportunity for the public to listen and participate in the debates between top national health officials about vaccine policy.
Wednesday will see the FDA’s Vaccines Advisory and Related Biological Product Advisory Committee meet to discuss future boosters. The FDA says they will not vote to make any recommendations. The Advisory Committee on Immunization Practices at the CDC also didn’t meet last week before Dr. Rochelle Wilensky, Director of CDC, signed off on fourth shots for seniors.
Offit stated that it was “just sort of fait accompli”. We are living in an era of Covid exceptionalism. It is where science precedes recommendation. Offit stated that it is the opposite.
Offit claimed that FDA has been asking people to believe the data supports the fourth dose, by ensuring sufficient protection against severe illness. The American public would benefit from having an open conversation about vaccine decision-making, especially when so many Americans aren’t taking advantage the third dose. Offit, an infectious disease specialist at Children’s Hospital Philadelphia is also a co-inventor for a rotavirus vaccination.
Marks stated that FDA had not called a committee meeting to discuss the FDA’s decision because it was “relatively simple.” Marks said that data from Israel showed that a fourth dose could reduce hospitalizations and deaths in seniors. CNBC was informed by the CDC that it did not have to present its fourth dose as an incremental modification.
ACIP’s non-voting member, Dr. William Schaffner said that the CDC recommendations were an incremental improvement. Schaffner stated that clearing the fourth dose for seniors is a major decision and would have been better served by outside advisers who could provide transparency to the public.
“I think to have this decision made in house behind closed doors without having the transparency of a full debate that a regularly called ACIP meeting would have provided –I think that’s unfortunate,” said Schaffner, an infectious disease expert at Vanderbilt University Medical Center.
James Hildreth is a temporary FDA member who will be attending Wednesday’s meeting. He noted that the FDA didn’t need to call a public hearing before authorizing shots. And the agency’s seasoned experts can assess if evidence is available to support the new authorization. Hildreth noted that it is not advisable to move forward without receiving a recommendation of outside experts.
Hildreth of Meharry Medical College, Nashville, Tennessee, said that FDA making a decision without consulting outside experts only adds to the perception that pharmaceutical companies have an effect on the decisions being made. Meharry hosts both the clinical trials for Novavax’s vaccine and Moderna’s shot for children younger than five years.
‘Diminishing returns’
Although some experts think that vaccines should be used to prevent severe illnesses, other health professionals believe they are important for preventing the spread of disease. Pfizer and Moderna have seen their protection from infection decrease over time. This is especially true when it comes to omicron which contains many mutations that increase its ability to cause mild and breakthrough illnesses. Still, vaccines provide significant protection against serious illness.
“If you’ve gotten a mild illness after you’ve been vaccinated, you’ve won — that’s it. “You’re not at risk of serious illness. That is what this vaccine is all about,” Offit said. Offit believes that four doses are necessary for seniors and four for people with weaker immune systems. However, he is skeptical about the necessity for more shots.
If the ultimate goal is to reduce infection, then booster shots will be the best option to boost antibodies, until longer-lasting vaccines are available. The problem is that the vaccines eventually run into diminishing returns, according John Moore, a professor of microbiology and immunology at Weill Cornell Medical College. Moore stated that a 3-dose vaccine regimen was the most common to boost immunity to peak levels. The fourth shot, however, begins to hit a ceiling — at least in terms of protecting younger people against infection.
Scientists at Sheba Medical Center and the Israeli Health Ministry found that although a fourth dose can restore antibodies lost after a previous dose, it does not provide protection from infection. Pfizer mentioned this study in its FDA approval statement. It hasn’t been peer reviewed and focuses on increased antibodies but not on breakthrough infections.
Different needs, different ages
Doctor Peter Hotez is a Baylor College of Medicine vaccine expert in Houston. He strongly supports the fourth dose for seniors, pointing out that there are many other options. CDC study from FebruaryThe effectiveness of the third shot against hospitalization fell from 91% down to 78% in four months.
In its statements about the fourth dose of Pfizer’s drug, Pfizer cited an Israeli study which found that a fourth dose could reduce mortality by 78% for people over 60. Clalit Health Services and Ben Gurion University analyzed more than 500k medical records. The research was not peer reviewed.
Pfizer stated in a statement that it continues to gather and evaluate all data, and remains in dialogue with regulators to inform the development of a Covid-19 vaccine strategy.
Although the Ben Gurion Study may be pointing in the right direction for seniors at present, evidence to boost younger adults in this regard is sparse as the U.S. contemplates decreasing eligibility for fourth doses later in 2012.
According to the New England Journal of Medicine, Dr. Gili RegevYochay’s team of Sheba scientists stated that a fourth dose of the drug “may only provide marginal benefits” for young people. Moderna requested that the FDA approve a fourth dose of Pfizer for people 18 years and over. Moore called Moderna’s submission “aggressive” and argued that the FDA didn’t make a distinction between older adults who could benefit from an additional dose of Viagra, and younger adults whose data was less persuasive.
Moderna CEO Stephane Bancel told CNBC last monthThe company wanted the FDA to have the flexibility to determine which age groups would be most benefit from the fourth shot. Moderna pointed out data from Israel in the company’s public statements regarding its request for a fourth shot, but did not cite any specific studies.
Hotez said that he supports a fourth dose of vaccines for older adults. But, he pointed out that FDA and CDC did not do a good job communicating the goals of vaccines. Instead, vaccine makers filled the void by releasing data from clinical trials and laboratory studies. Hotez, along with a group of Texas scientists, developed Corbevax, which is a Covid vaccine. It was based upon traditional, protein-based technology, and has been approved in India.
Hotez was also frustrated that the U.S. relies so heavily on data imported from foreign countries, particularly Israel. Offit wondered why the U.S. relied on data taken from countries smaller than the U.S.A. as well as with different demographic backgrounds.
Need a long-term strategy
Hildreth stated that the U.S. should delay the administration of additional booster doses until the health system permits. That way, the United States can better define its protection from the virus and devise a long-term strategy. Hildreth stated that if people are asked for boosters every few months, they will stop listening.
Hildreth stated that they don’t have a way to determine if a person is protected or not. Hildreth stated that there is no way to determine if a specific level of antibody protection will protect individuals.
Moderna and Pfizer are working together to develop shots for omicron, in addition to the existing vaccines. As the FDA’s chairman of the committee on booster strategies, Dr. Arnold Monto said Wednesday that the FDA needs to come up with a consensus regarding the content of the future vaccines. Monto stated that collaboration is essential between vaccine manufacturers and government, however industry has begun to play a larger role in the decision-making process about which vaccines are needed for specific Covid varieties.
“Industry is pursuing a double-headed goal. Like us, they want to serve the public interest. Monto added that stockholders are also part of the equation and that we must keep in mind public health benefits.
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