Health professionals fear FDA rush to approve vaccine-News-The Leavenworth Times-Leavenworth, Kansas

Public health experts fear FDA rush to approve vaccine

The vaccine trial, which Vice President Mike Pence kicked off in Miami on July 27, gives the United States the smallest chance to be ready to vaccinate millions of Americans shortly before the election day.

It is the potential to fill many public health professionals with fear.

Among their concerns: Early evidence that the vaccine will work will lead to political pressure from the administration for urgent approval by the Food and Drug Administration. Due to the conflict between science and politics, some people may not trust the vaccine and may refuse it, which would undermine the campaign to stop the pandemic. Or the product may not be fully protected. Confidence in childhood routine immunizations that are already shaken can be further diminished.

“The fear is to reach for a vaccine that (Trump) has already opened (as Trump did),” said Dr. Joshua, former FDA vice chair and professor at Johns Hopkins University in Baltimore. Sharfstein said. “Ask an important and difficult question and politicize it. That’s what you want to avoid.”

At 6:45 am on Monday, the first volunteer in the groundbreaking Phase 3 trial of the Moderna Therapeutics vaccine received an injection at a clinic in Savannah, Georgia. 88 other clinicians from Miami to Seattle were also preparing to provide shots in a trial aimed at enrolling 30,000 people.

The country’s leading infectious disease expert, Dr. Anthony Fauci, did not inform reporters about progress towards that goal, but hopes that 15,000 will be vaccinated by the end of the week. He said he was out. All volunteers will receive a second injection 29 days after the first inoculation. (Half receives placebo with saline.)

Another vaccine produced by Pfizer in collaboration with the German company BioNTech also entered a large phase 3 trial in the US this week. It is tested independently of the National Institutes of Health, which is funding future such as the Moderna trial and the Oxford University / AstraZeneca vaccine trial. AstraZeneca said some doses of the vaccine might be ready as early as September.

Fauch said he expects the Moderna trial to answer whether the vaccine will work by the end of the year, and “will” expect it to come back in October. “I doubt it, but we leave an open mind that it is possible.”

Such a fast pace worries some professionals.

“I don’t know how it can be done remotely unless what I fear most of the time has happened. Phase 3 clinical trials complete with only thoughts of efficacy, common side effects , It will be published,” said Dr. Paul Offit. Director of the Vaccine Education Center at the Philadelphia Children’s Hospital.

On Monday, Pence downplayed such fears and told reporters: “There will be no shortcuts, no cuts.”

Authorities want an open and transparent process.

Raja Krishnamo Orti D-Ill, chair of the House of Representatives and the Reform Subcommittee on Economic and Consumer Policy. Parliamentarians are preparing to issue a bill requiring FDA to be reviewed by the COVID-19 Vaccine Expert Panel and to submit recommendations to FDA. Commissioner Stephen Hahn makes the decision.

For past vaccines, the FDA generally relied on such committees, consisting mostly of vaccine experts and appointed by the FDA committee. They usually carefully examine all evidence before voting by the FDA on whether a vaccine needs to be approved. Commissioners rarely opposed the Commission’s decision.

Hahn weakened FDA’s confidence in independence earlier this year, and many observers said of hydroxychloroquine, a drug used to treat malaria that President Donald Trump and members of his regime continued to falsely advertise. COVID-19 remedy when an emergency authorization use declaration was announced. The FDA later revoked the authorization made without consulting the Independent Committee.

“The issue of hydroxychloroquine threatens the FDA’s independence. There is no doubt,” said Dr. Jesse Goodman, a professor at Georgetown University who headed the FDA’s biopharmaceutical department and later became chief scientific officer. It was

Authorities must give external scientists and the general public an opportunity to see the data and FDA’s reasoning before making such a decision, he said.

When Trump was excited about the vaccine, concerns about political interference recently arose and Treasury Secretary Stephen Mnuthin confidently told reporters that there would be an emergency vaccine by the end of the year.

Indeed, without data showing that the vaccine works and does not cause serious side effects, the FDA is unlikely to be tempted to issue an urgent release.

Large-scale coronavirus outbreaks in Texas and other heavily-hit areas where the Moderna vaccine is being tested are the answer, though the answer is clear at some point.

In theory, scientists might understand the efficacy of a vaccine before all 30,000 have been registered, vaccinated, and studied.

In fact, Fochi said that only 150-160 cases of disease reported among study participants could be answered later. If about two-thirds of those cases occur in unvaccinated people, it would indicate to statisticians that the vaccine is more than 60% effective, he said.

If the vaccine is 80% to 90% effective and has an annual infection rate of more than 4% at the tested site, then only 50 or only 3 scientists will be effective in such trials Ira Longini, a biostatistician at Florida State University and designing a vaccine trial for a few months, said.

The Moderna vaccine trial will reach its three-month threshold on October 27.

Part of the fate of the trial is in the hands of a data and safety oversight committee of 30 members, who identify the actual vaccinated and sick. View real-time, open-label data about participants. The Board warns NIH and vaccine manufacturers if they find surprising data that is either a dangerous side effect or a powerful indication. Some are concerned that the FDA may be pressured to discontinue the trial if the vaccine appears to work in early reviews.

Ofit said NIH should not accept less than 30,000 completed trials. He said the 50 cases used as evidence to release a vaccine that could be administered to tens of millions were “very few.”

People may insist on the release of a vaccine that appears to have worked. Moderna said it has begun production of millions of “endangered” vaccines in lieu of the vaccine’s success. The FDA can release them under the authority provided when the country declared a public health emergency in March.

With more than half of the nations deeply distrusted by Trump, recent public opinion polls have shown that federal decisions could be resisted and even promising vaccines could be widely rejected. Scharstein is concerned about the “kneeling” reaction to the vaccine by Democrats if Trump sells it before the election.

Experts are also worried about releasing vaccines that show some positive effects but are not solidly protective. A slide released earlier this month by FDA Deputy Director Philip Krause of the World Health Organization said a weak vaccine couldn’t adequately protect the public and could give false reassurance to the recipient and complicate testing. Future vaccines mentioned.

Kaiser Health News (KHN) is a national health policy news service. This is an editorial independent program of the Henry J. Kaiser Family Foundation.