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US States prepare for their own vaccine safety reviews amid worries about Trump’s influence on the FDA

04:20  21 october  2020
04:20  21 october  2020 Source:   politico.com

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The FDA "respectfully" declined to comment on Trump ' s claims. But generally speaking, agency guidelines do go through the White House Office "What I'm concerned about is there could be a gray zone where a vaccine looks partially protective and it goes on the market without a full formal review

Trump on Saturday accused the Food and Drug Administration of being part of the "deep state " and said regulators were holding up vaccines and 3 election for political reasons. President Trump ' s tweets Saturday asserting that the FDA was slowing approval of coronavirus vaccines and drugs

Several states are setting up their own coronavirus vaccine reviews to counter public safety concerns as the Trump administration pushes the Food and Drug Administration to approve a shot on an aggressive timeline that they fear could be too rushed.

a person wearing a hat: In this Wednesday, June 24, 2020 file photo, a volunteer receives a Covid-19 test vaccine injection. © Siphiwe Sibeko/AP Photo In this Wednesday, June 24, 2020 file photo, a volunteer receives a Covid-19 test vaccine injection.

New York, California, Michigan, West Virginia, Washington D.C. and potentially a handful of others are in the early stages of creating independent panels to review vaccine data as it becomes available – although it’s not yet clear whether all these states would seek to block distribution of a vaccine they deem unsafe or ineffective, or just to broadcast those concerns.

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When a vaccine does become available, Cuomo says states will need independent doctors to test it on their Though he appears to have no faith in the administration or FDA and CDC, Cuomo did Cuomo joins many other Democrats in their criticism of a potential vaccine , including Joe Biden and

President Trump ’ s order came as he grew increasingly frustrated with a warning by Dr. Anthony S. Fauci, left, that a vaccine would take at least a year to But the timing is not completely within their control. Much depends on the success of the trials and review by the Food and Drug Administration .

Most have Democratic governors; in an exception, West Virginia is convening an advisory group of 20 to 25 pharmacists and physicians to review Covid-19 vaccine efficacy data. In addition, Oregon has said it will use its own senior state health advisers to review data. Nearby Washington will watch the FDA vaccine approval process closely to make sure it’s “thorough and transparent.”

“Frankly, I’m not going to trust the federal government’s opinion,” New York Gov. Andrew Cuomo said in announcing his state’s vaccine review panel. California Gov. Gavin Newsom, who announced his state’s 11 member panel of doctors and scientists on Monday said: "Of course we won't take anyone's word for it."

President Donald Trump’s intense push for a vaccine before the election – which is now virtually impossible given that none of the leading vaccine candidates will be ready by then -- on top of administration pressure on the FDA and Centers for Disease Control, have sowed growing public doubt about vaccine safety, particularly as the research into the shots has progressed at an unprecedented breakneck pace.

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President Donald Trump ’ s recovery from COVID-19—and his aggressive advocacy of antibody cocktails as a “cure”—offer few reasons of encouragement for the general public given their relative scarcity, costs and mostly unproven The big unknown on the other side of a successful vaccine .

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A CNN poll from earlier this month showed only about half of Americans might get a vaccine, while a more recent Stat News poll revealed 58 percent of the U.S. public said they would get vaccinated as soon as a vaccine was available – a big decline over its prior poll. If large numbers of people spurn the shot, its power to beat back the pandemic is diminished.

States have not yet released a lot of details about their vaccine reviews. The additional layer of oversight raises questions about whether a state agency could impede use of a federally-approved vaccine, and whether they could end up slowing down the pandemic response, rather than enhancing it.

Even though governors say they are protecting their residents in case pressure from the White House leads the FDA to approve a flawed vaccine, some officials and public health advocates are warning that these state interventions could confuse the public and prevent people from seeking a shot even if it is safe and effective.

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Once in office, Mr. Trump ’ s administration quickly began work on one of its most far-reaching policies — the systematic downplaying or ignoring of On Friday Mr. Trump announced a phased approach to reopening the economy that the White House said is “based on the advice of public health experts.”

States have improved the completeness of their CRF reporting in the past two months; in particular, the percentage of reports that Mitigation and containment of COVID-19 are the key to public health strategies, and CDC is committed to using our expertise and partnering with others on the frontlines.

It is “hard to see how any state could replicate anything like the national, gold standard system” of FDA approval, said former FDA commissioner Mark McClellan, who now heads a major health policy center at Duke.

Critics of the state review panels include both Republicans in Congress as well as nonpartisan public health experts in both the advocacy and academic worlds.

Rep. Greg Walden of Oregon, the outgoing top Republican on the House Energy and Commerce Committee, which oversees the FDA, called the state vaccine panels a “reckless” idea that would “dangerously undermine the FDA” and increase public vaccine hesitancy.

Walden told a recent committee hearing that the FDA had ample safeguards, including an independent data safety monitoring board for each vaccine trial, as well as the outside experts that serve on the FDA’s Vaccines and Related Biological Products Advisory Committee. FDA Commissioner Stephen Hahn has said the advisory panel, which meets for the first time to discuss Covid-19 vaccines this Thursday, will review every vaccine prior to an emergency authorization or approval.

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States “would be hard-pressed to find more qualified experts” than those already on the FDA and CDC advisory panels, said Amy Pisani, executive director of the nonprofit Vaccinate Your Family. Their “recommendations will speak for themselves,” she said.

Traditionally the states have been more involved with planning and overseeing vaccine distribution, rather than evaluating efficacy and safety. That’s where the focus should stay, said Jason Schwartz, a vaccine expert at the Yale School of Public Health, who fears the state panels “would only create confusion.” He said the scientists involved with the FDA review will make clear themselves whether the FDA review process has been tainted. If they stay involved, it will be a signal that science is prevailing over politics.

But some governors and state health officials remain worried — either because they have lost confidence in the FDA’s independence or because they believe the public has. Much of the White House’s pressure on the FDA has played out in public, with Trump’s statements and tweets on both drugs and vaccines.

The White House attempted to block FDA from spelling out additional vaccine safety requirements for emergency authorizations, yielding only it when it became clear the agency would not back down. The FDA has also signed off on emergency authorizations under White House pressure for some treatments with sparse data, including Trump-championed hydroxychloroquine, and more recently with convalescent plasma. The FDA later reversed the emergency authorization of hydroxychloroquine as data mounted that the malaria drug did not help with the coronavirus.

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States had to submit their vaccine distribution plans to the U.S. Centers for Disease Control and Prevention by Friday. More details on those plans and the vaccine data review panels are likely to trickle out in the coming weeks. California has publicly released more information than most.

The FDA experts can interpret raw data provided by vaccine developers; whether any or all of the states will have that same data is not yet known. Nor it is clear what powers the state will have to restrict vaccine distribution or use if the panel reaches a different conclusion than the FDA-appointed experts. Even if they can’t bar the vaccine from their state, a public assessment that the state doesn’t find a vaccine safe or effective would almost certainly dampen use.

Patti Zettler, a former FDA attorney who is now an associate law professor at Ohio State University, said that states can legally restrict the use of FDA-approved or authorized products, such as a vaccine, but that could be challenged in court. She noted that in 2014, Massachusetts tried to ban a powerful new opioid that the FDA had approved, but the opioid manufacturer got a court to overturn it.

“States interested in these independent evaluations underscores how much public trust in FDA has been lost,” Zettler said. “That loss is hugely problematic as a public health matter.”

States and vaccine developers have offered few specifics on how the reviews will be conducted.

“We would hope there would be transparency at the federal level regarding that data so we can make an informed decision,” said a spokesperson for the Michigan Department of Health and Human Services. Michigan aims to independently evaluate the efficacy and safety data for any approved vaccines.

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Mark Ghaly, secretary of the California Health and Human Services department, said the speed with which vaccines were moving through trials was one trigger for California’s planned vaccine safety committee. “Once it’s established, it will be made public and their charge and mission will be clarified” on a state website, he said.

Arthur Reingold, a professor of epidemiology at the University of California at Berkeley who’s chairing the California vaccine review panel, said in a phone interview that state reviews could cut both ways. Some people might “feel gratitude to the government for looking after their interests, with added reassurance, and other people might go across the border to another state to get a vaccine.”

The Washington, D.C., health department said its panel will rely on publicly available information for its reviews of vaccines.

Not surprisingly, the biopharma industry, which in general prefers consistent national and international guidance and standards, lambasted the proposed state vaccine reviews.

“This is more than a little perturbing,” Michelle McMurry-Heath, the new president and CEO of the Biotechnology Innovation Organization, told the Food and Drug Law Institute conference last week. “To put in place one or even 50 individual extra levels of review to second guess FDA decisions is a huge mistake.”

A spokesperson for Moderna, one of the two leading vaccine candidate developers, said that “nothing is far enough along in this area for us to be ready to comment.” Pfizer Chief Business Officer John Young told the Business Council of New York State’s annual meeting that the company “will cooperate with all levels of government and will be transparent with all our data.”

Two other leading candidates — AstraZeneca and Johnson & Johnson — have paused their U.S.-based Phase III trials due to safety concerns. A spokesman for Oxford University, which is working with AstraZeneca, said their ongoing Covid-19 trials in the U.K., Brazil and South Africa have enrolled almost 20,000 participants so far.

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usr: 14
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