State preps for coronavirus vaccine in Nov.

Federal officials recently told Tennessee leaders to prepare to distribute a coronavirus vaccine as early as Nov. 1, starting by inoculating medical professionals who are most exposed to the virus.

The potential for a November vaccine – months earlier than expected – both raises hope for a new defense against the pandemic and exacerbates concerns the Trump Administration may truncate research to deliver a vaccine before Election Day. An administration official denied any political pressure on vaccine research on Thursday.

Tennessee Health Commissioner Dr. Lisa Piercey said the state expects to receive hundreds of thousands of doses of one or two vaccines in November and December. Federal officials haven’t identified the particular vaccines that will be available but specified they won’t be recommended for children or pregnant women, Piercey said.

Gov. Bill Lee and Piercey each said the decision to receive this vaccine would be a “personal choice” and urged Tennesseans to consult their doctors to assess the safety of the new vaccines for themselves. The vaccines won’t have completed a traditional clinical trial at the time of the rollout, Piercey said.

“There has been this balance all along of trying to get something out quickly for very obvious reasons but also doing it in the safest and most effective manner possible,” Piercey said. “... Every one’s personal decision when it comes to vaccine should be a full assessment of their belief of safety and efficacy of that.”

The Centers of Disease Control and Prevention sent letters last week setting a Nov. 1 deadline for state governments to be prepared to receive and distribute the first doses of coronavirus vaccines. Numerous vaccines are in clinical trials across the globe, including at least three in Nashville, but even the most promising drugs only recently began large-scale testing.

Clinical trials were expected to last years, and although they can be cut short, it would be highly unusual for any vaccine to be ready for use in November. Vaccines can be given conditional approval by the U.S. Federal Drug Administration while a clinical trial is ongoing, but this is reserved for drugs that show compelling results very quickly.

The decision to approve a vaccine before the end of a trial should fall to the National Institutes of Health’s Data and Safety Monitoring Board, an independent panel of medical experts who are not government employees. The FDA has released guidance establishing that a coronavirus vaccine should at a minimum prevent infections or reduce symptoms in at least 50% of people who are vaccinated. The possibility of a vaccine being distributed by Nov. 1 – two days before Election Day – prompted some to question if the White House is rushing research for political purposes. President Donald Trump, whose handling of the pandemic damaged his approval rating, said earlier this year a coronavirus vaccine may be ready before Election Day. Experts said at the time it was more reasonable to expect a vaccine in 2021.

Dr. James Hildreth, an infectious disease expert who leads Meharry Medical College and is a member of the Nashville coronavirus task force, said in a Thursday interview on Yahoo Finance a November vaccine seemed “scientifically infeasible.” Hildreth levied similar criticisms last week when the CDC revised coronavirus guidelines so they no longer recommended that everyone who is exposed to the virus be tested.

“The prospect of having a vaccine ready to be injected into arms in November seems to be a bit ambitious,” Hildreth told Yahoo. “We need to wait for the science to prove that such a vaccine is effective. Keep in mind the phase three trials are just getting underway, and it’s going to take some time to know if the vaccine is working.”

Dr. Alex Jahangir, leader of the Nashville coronavirus task force, said he suspected the earliest vaccine would be dispersed from the federal government to state governments to individual hospitals, where it would be available to medical professionals who are frequently exposed to the virus, himself included.

Jahangir, who confirmed he recently met with state officials about the potential of a November vaccine, expressed confidence in the government structure that reviews vaccines without political interference – and said he “hopes it stays that way.”

“Vaccines are critical for us to get over this virus,” Jahangir said. “Everyone needs to get vaccinated. And it needs to happen when there is a vaccine that has been proven through the proper channels that have been established in our country.” The Trump administration has insisted there is no political pressure on vaccine research. Health and Human Services Secretary Alex Azar said Thursday in an interview on “CBS This Morning” the Nov. 1 deadline has “nothing to do with elections.”

“This has to do with delivering safe, effective vaccines to the American people as quickly as possible and saving people’s lives,” Azar said on CBS. “Whether it’s Oct. 15, whether it’s Nov. 1, whether it’s Nov 15, it’s all about saving lives but meeting the FDA standards of safety and efficacy.”

Although multiple vaccines are in development, it is not yet clear which ones might be available by November. The New York Times reported Thursday that CDC planning documents sent to public health agencies suggested the vaccines under consideration may be those being developed by Moderna and Pfizer.

Each of these vaccines have already undergone animal testing and smallscale human testing but only recently began broader human testing designed to measure effectiveness.

This broader testing, called a “phase 3 clinical trial,” began in Nashville and other cities in August and was originally planned to span multiple years.

Dr. Stephan Sharp, who leads a clinical trial of the Pfizer vaccine at Clinical Research Associates in Nashville, stressed the importance of dutifully testing drugs for years. During an interview last month, Sharp said a vaccine may produces a strong defense to coronavirus, still might not be safe for everyone. Clinical trials often reveal that good drugs can cause some people to have bad reactions for unexpected reasons, he said.

“You need to know where the warts are,” Sharp said. “You always need to know who should not get a drug or a vaccine, too. That’s just as important as getting it out there for the masses.”

The Associated Press and Kaiser Health News contributed to this article.

Source: Knoxville News Sentinel, by Brett Kelman

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Published September 9, 2020