U.S. The Food and Drug Administration regulates vaccines, and it is OK to put them on the market. Physicians fear, however, that after many government mistakes during the epidemic, a level of independent review is needed to convince Americans that the government is safe and effective from the shots.
Dr. Harvard Medical School Assistant Professor. Catherine Stephenson said many colleagues told her they did not want to be vaccinated when the coronavirus vaccine became available, so they considered an independent panel to increase confidence in the vaccine.
“I hear this from my colleagues, doctors and nurses. They are not anti-vaccines. They are pro-vaccine. They have vaccinated their children. But they are skeptical about this vaccine,” said Stephens. Clinical trials unit at the Virus and Vaccine Research Center at Beth Israel Decones Medical Center.
Unlike Stephenson, biostatist Arthur Kaplan came to the same conclusion.
“We’re used to this world where the FDA or the CDC or the NAS says something is safe and effective, that’s enough, but I don’t think that’s enough to dispel people’s suspicions this time around,” Caplan said. U.S. for Centers and the National Academy of Sciences. “I think we desperately need an independent national commission.”
Confirmations from the FDA
Hahan has repeatedly given such assurances to the public.
“I can promise you that when the data is available, the FDA will review it using the rigorous and deliberate scientific process it established,” Hahn told Dr. Susan Bailey, president of the American Medical Association, in a video briefing earlier this month. Was. “We all understand that only by participating in an open review process and relying on good science and sound data, as the public and as a provider, can we trust the integrity of our decisions.”
More than half of the panel members are academic specialists employed by universities and research centers.
To some experts, Hahn’s words about the advisory committee are at least somewhat reassuring and reject the need to create another panel.
“An independent commission already exists. We are not FDA employees,” said Dr. John H. Snyder, a vaccine expert at the University of Pennsylvania. Paul Fite, who is a member of the FDA’s advisory committee, said. “We don’t need a second level of bureaucracy.”
But Kaplan, an NYU ethicist, said he’s concerned that many Americans no longer trust experts, no matter how prestigious they are.
“We will continue to rely on expert support. This is an old-school way of thinking from pre-covid days,” he said.
‘Sounds like a hot pot’
Stephenson, Kaplan, and others say that while they respect the scientific and ethical rigor of researchers like It Fit, they believe many Americans will doubt the FDA committee’s findings, especially since some of its members work for pharmaceutical companies and government agencies. Does, according to the roster currently on the FDA website.
A number of factors have intensified people’s suspicions about the vaccine, doctors told CNN.
First, the name of the government’s vaccination program – “Operation Operation and War Speed” – can give the impression that research is being done quickly, and therefore give unsafe vaccines.
The FDA approved the drug hydroxychloroquine for emergency treatment of Covid-19, only to revoke that authorization after less than two months. More recently, the agency has authorized the use of condensed plasma, although many experts believe there is not enough data to show that it works.
The head of infectious diseases at Massachusetts General Hospital, Dr. “Given the premature authentication of hydroxychloroquine and convulsive plasma, the FDA is considered by many stigmatized people,” said Rochelle Valensky.
Three, the statements of government officials did not generate confidence. Earlier this month, Hahn made a statistical error that the next day apologized for the mistake, dramatically increasing the effectiveness of convulsant plasma for the treatment of Covid-19.
A few days later, the U.S. Assistant Secretary of Health and Human Services Dr. Brett Giroire said the White House Coronavirus Task Force has discussed and approved a broad critical decision to amend the CDC Covid-19 test guidelines. Later that day, a member of the task force, Dr. Anthony Fawcett said he underwent surgery during a discussion at the White House on guideline changes.
Stephenson says it’s not that she doesn’t trust the vaccine approval process. In fact, he’s on a team at Harvard researching a vaccine developed by Johnson and Johnson.
“I believe in the power of vaccines and I am hopeful that we will get a safe and effective vaccine. I still have to fight for it and I want people to come with us on this journey,” Stephenson said. “And being an apolitical and independent group, people can be very reassuring during partisanship.”
Looking at the UK for example
With an additional level of review the entire vaccine approval system is less likely to be upset.
But that has not stopped doctors from advocating for it.
He said he already knew he would want the US independent panel to look different. The British committee is made up of experts, but Tucker envisions coronavirus survivors, as well as the trusted community and any U.S. Religious leaders on the panel, as well as vaccine experts.
Tucker said, “I really want to have a body that is really trustworthy. What would members say if they were like, Oprah? People in the US who are fair and big-headed and not political and widely recognized as thoughtful,” Tucker said. Said.
Vans Lensky, an infectious disease specialist at Massachusetts General Hospital, likes the idea, and thinks about the early days of the HIV epidemic, when gay men opposed participating in policy decisions.
“Let them come in, I want to hear what they have to say,” said Dr. Fawcett as they were dying in front of the NIH, “said Vans Lensky, referring to the National Institute’s top infectious disease doctor. “Their voice was on the table.”
Something similar can happen to Covid-19 decisions, which include reviews of coronavirus vaccines.
The panel will have the best interest of the community, he said. “It’s not the scientists who speak to the community, but the community that speaks to the community.”
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