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Biden set to release stockpile of coronavirus vaccines, in a reversal from Trump's policy

USF doctor worries this could be a risky strategy
Joe Biden
Posted at 5:16 PM, Jan 08, 2021
and last updated 2021-01-08 18:37:04-05

HILLSBOROUGH CO., Fla. -- — President-Elect Joe Biden is announcing a new strategy to speed up vaccinations against COVID-19. Currently, The Trump administration reserves doses to ensure Americans who received the first shot will have access to the second. In a reversal, the soon-to-be 46th President of the U.S. would release nearly all available doses immediately.

The U.S. is seeing record-number COVID-19 cases, hospitalizations and deaths. According to Johns Hopkins University data, the nation reported more than 4,000 deaths in a single day for the first time during the pandemic. Right now the death toll climbs past 360,000.

President-Elect Biden believes we need to speed up the process. In early December, Biden announced a goal to distribute 100 million vaccine shots in his initial 100 days in office.

"My first 100 days won't end the Covid-19 virus. I can't promise that," Biden said at the December 8th event in Wilmington, Delaware. "But we did not get in this mess quickly, we're not going to get out of it quickly, it's going to take some time. But I'm absolutely convinced that in 100 days we can change the course of the disease and change life in America for the better."

Right now, the Trump administration has a reserve of millions of doses to guarantee Americans get their second shot and max protection against the virus. Under Biden's plan, they would nearly empty out the reserve to get shots out to the masses faster.

“It's also kind of a calculated gamble," said Doctor Michael Teng, a virologist and associate professor of medicine at the University of South Florida. He worries it's a risky strategy.

“I think right now the issue is really not the availability of doses we're having problems right now getting those doses in people's arms," he said.
Teng emphasizes more shots do not necessarily mean more people vaccinated.

“The departments of health, with all of this vaccine [under Biden's plan], they better be able to store it, they better be able to handle it and they better be able to get to those places in a reasonable amount of time," he said.

A scientific analysis, published Monday, in the journal Annals of Internal Medicine found that prioritizing putting out the first doses to as many as possible may reduce the number of new cases, so long as there is a steady supply of the vaccine. Other countries, like the UK, are already adopting this strategy.

“Depends on how confident you are in the manufacturers that they're going to be able to provide the doses that they say they're going to," said Dr. Teng.

Biden's team doesn’t believe there will be a lapse. They plan to use the Defense Production Act to increase supply.

“It [DPA] will help get the raw materials and supplies that are necessary, but the manufacturing of the vaccine itself has to be done in these special facilities at Pfizer at Moderna. So there's nothing they can do to ramp that up, unless they can really rapidly build new production facilities," said Dr. Teng.

But what happens if people do end up missing the second shot? Dr. Teng says we just don't have enough data to know conclusively.

“We don't really know right because nobody just got one dose of the Pfizer or Moderna vaccine and stayed in the trial," he said.

He also worries about a delay in administering the second dose and what that would mean for turnout.

"If it goes too far people will end up not getting that second dose, and I think that's the danger for me," he said.

Preliminary data shows the first shot gets you around 50% protection from the virus, but Dr. Teng warns there's much more research needed.

Biden’s plan, if the manufacturers fail to produce enough of the vaccine for full delivery of the second dose, goes against the Food and Drug Administration, which emphasizes the importance of the second dose and on time.

The FDA addressed more flexible uses of the vaccines in a January 4th statement, before Biden's announcement.

We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19. These are all reasonable questions to consider and evaluate in clinical trials. However, at this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence. Without appropriate data supporting such changes in vaccine administration, we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.

The available data continue to support the use of two specified doses of each authorized vaccine at specified intervals. For the Pfizer-BioNTech COVID-19 vaccine, the interval is 21 days between the first and second dose. And for the Moderna COVID-19 vaccine, the interval is 28 days between the first and second dose.
Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D.

Despite his trepidation about this vaccine rollout strategy, Dr. Teng is staying hopeful.

“With some proper prioritization, it could work and with some good luck," he said.

Dr. Teng adds another silver lining, that could help, is approving more vaccines beyond Pfizer and Moderna's versions.