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Scientists are alarmed by signs of an “October vaccine surprise”



President Donald Trump, who appears to intend to announce a Covid-19 vaccine before Election Day, could legally approve a vaccine against objections from experts, Food and Drug Administration officials, and even vaccine makers who have pledged not to release a vaccine It has been shown to be safe and effective.

On podcasts, public forums, social media, and medical journals, more and more prominent health professionals fear that Trump – who has repeatedly signaled his desire for a vaccine to get a vaccine approved quickly and his displeasure with perceived delays with the FDA – will put matter into his own hands , beyond the usual regulatory process.

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Concerns intensified over the weekend after Alex Azar, the government̵

7;s secretary for health and human services, asserted his agency’s authority to the FDA. The fear is that Trump’s pressure on HHS could affect the speed of an authorization. HHS spokeswoman Caitlin Oakley said Azar’s decision did not affect the vaccine approval process.

Intervening in the process would signal another injection of policy into a sensitive public government decision in the area of ​​public health. Trump has repeatedly contradicted the advice of senior scientists on Covid-19 and pushed forward controversial treatments for the disease.

Reversal of the FDA’s scientific judgment could lead to the rushed release of a vaccine with limited efficacy and, worse, unknown side effects.

Vaccines are usually FDA approved. However, Azar, who reports directly to Trump, can issue emergency clearance even before vaccines have been shown to be safe and effective in late clinical trials.

“Yes, this scenario is legally and politically possible,” said Dr. Jerry Avorn, professor of medicine at Harvard Medical School, who outlined one such event in the New England Journal of Medicine. He said it “seems frighteningly more plausible every day.”

Vaccine experts and public health officials are particularly hard hit by the possibility, as it could ruin the public’s fragile trust in a Covid-19 vaccine. This could put the scientific authorities in a position to urge people not to get vaccinated after leading reluctant parents to ignore unfounded fears for years.

Doctors could refuse to give an approved vaccine with insufficient data, said Dr. Preeti Malani, Chief Health Officer and Professor of Medicine at the University of Michigan at Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that nobody would want to take.” A recent KFF poll found that 54 percent of Americans would not get an approved Covid-19 vaccine before election day.

After the story was released Monday, an HHS official said Azar “will submit to the FDA in full” as the agency is considering approving a vaccine made under the government’s Operation Warp Speed has been.

“The idea that the secretary would approve or approve a vaccine over the FDA’s objections is absurd and betrays ignorance of the transparent process we are following for the development of the OWS vaccines,” wrote Brian Harrison, HHS chief of staff in an email.

White House spokesman Judd Deere dismissed the scientists’ concerns, saying Trump only cares about the safety and health of the public. “This false narrative that the media and Democrats have created that politics affects permits is not only false, but a danger to the American public,” he said.

Typically, the FDA does not approve vaccines until companies have provided years of data to show that a vaccine is safe and effective. However, a 2004 law allows the FDA to grant emergency approval with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”

Many scientists doubt that a vaccine could meet these criteria before choosing. However, the terms could be legally vague enough to allow the administration to take such action.

Moncef Slaoui, chief scientific advisor to Operation Warp Speed, the government program to accelerate the development of Covid-19 vaccines, said it was “extremely unlikely” that the results of the vaccine trials will be available before the end of October.

However, Trump has repeatedly insisted that a vaccine be distributed starting next month for the pandemic that has killed more than 200,000 people in the US, according to NBC News. He repeated the claim at a campaign rally in Fayetteville, NC on Saturday

The vaccine will be ready “in a few weeks,” he said. “We will end the pandemic from China.”

Although pharmaceutical companies in the US have started three clinical trials, no one can say for sure when those trials will have enough data to determine whether the vaccines are safe and effective.

  • Officials at Moderna, whose vaccine is being tested on 30,000 volunteers, said their studies could produce a result by the end of the year, although the final analysis could take place next spring.
  • Pfizer executives who expanded their clinical trial to 44,000 participants say they could know their vaccines by the end of October.
  • AstraZeneca’s US vaccine study, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation into a possible vaccine-related disease.

Scientists have been warning for months that the Trump administration could try to win the election with an “October surprise” by approving a vaccine that has not yet been fully tested. “I don’t think people are crazy to think about all of this,” said William Schultz, an associate in a Washington, DC law firm who served as former FDA policy commissioner and general counsel for HHS.

“You have a president who says you will have a permit in October. Everyone is wondering how this could happen. “

In a statement published in the Wall Street Journal, Conservative Former FDA Commissioners Scott Gottlieb and Mark McClellan argued that President intervention was unlikely because the FDA’s “thorough and transparent process is not conducive to interference. Any deviation would be quickly recognizable. “

However, the administration has shown a willingness to submit the agency to its will. The FDA has been criticized for issuing emergency approvals for two Covid-19 treatments that were reinforced by the president but lacked strong evidence: hydroxychloroquine and convalescent plasma.

Azar has incapacitated the FDA in other ways, such as preventing the agency from regulating tests developed by laboratories, including tests for the novel coronavirus.

Although FDA Commissioner Stephen Hahn told the Financial Times he was ready to approve the use of a vaccine in an emergency before large-scale studies are completed, agency officials have pledged to ensure the safety of Covid-19 vaccines.

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A senior FDA official overseeing vaccine approvals, Dr. Peter Marks said he would quit if his agency stamps an undetected Covid-19 vaccine.

“I think there would be an unsurpassed public health outcry about what is my worst nightmare – my worst nightmare – because we are going to confuse the public so much,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, on his weekly podcast.

“Even if a company didn’t want to, even if the FDA didn’t want to, it could still do it,” Osterholm said on his podcast. “I hope we would never see that, but we need to talk to each other that this is a possibility.”

In the New England Journal editorial, Avorn and co-author Dr. Aaron Kesselheim on whether Trump could invoke the Defense Manufacturing Act of 1950 to force reluctant drug companies to manufacture their vaccines.

But Trump would have to sue a company to enforce the Defense Manufacture Act, and the company would have a strong case to oppose it, said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law in Georgetown.

He also noted that Trump could not invoke the Defense Manufacturing Act if a vaccine was not “scientifically justified and FDA approved.”

KHN (Kaiser Health News) is a non-profit health news service. It is an editorially independent program of the KFF (Kaiser Family Foundation) that is not affiliated with Kaiser Permanente.

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