Biden's Plan To Release More Vaccine Is A Gamble. Is It Worth The Risk?

President-elect Biden is planning to take a dramatic step aimed at increasing the amount of vaccine available to states.

His transition team says he'll change a Trump administration policy that kept millions of doses in reserve, only to be shipped when it was time to administer people's second doses.

Instead, the Biden administration plans to send most of the currently reserved doses out right away, allowing more people to get first doses. For people who've gotten initial shots, the Biden team is making a bet that new doses could be manufactured in time to keep booster shots on schedule.

The two vaccines that have been authorized so far, made by Pfizer and Moderna, both require two shots several weeks apart. The need for two doses is one reason why the roll-out of the vaccine has gotten off to a sluggish start, and there's been a lot of frustration with the pace of vaccinations.

According to CDC, there have been 22 million doses distributed, but just 6.7 million administered.

"The President-Elect believes we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible. He supports releasing available doses immediately, and believes the government should stop holding back vaccine supply so we can get more shots in Americans' arms now," spokesman T.J. Ducklo said in a statement to NPR, noting more details would be available next week.

Some public health experts and scientists have been pushing for this move, arguing that the most important thing is to get as many people at least one shot as soon as possible, without being too concerned about scheduling the booster. They point out that while the vaccines are authorized as a series of two shots, data from clinical trials suggests that one shot is still protective, and many have argued there's a significant benefit to giving more people one shot.

Dr. Anthony Fauci of the National Institutes of Health — who advises both the Trump administration and the incoming Biden administration on the federal COVID-19 response — tells NPR there's no plan to abandon the two-shot regimen.

The Biden team is "not talking about withholding and not giving the second dose," he says. "They are completely committed to giving the second dose on time. They feel that the importance of getting as many people as possible is worth the risk."

The Biden team is hopeful companies will be able to manfacture more doses quickly.

"We have faith that the manufacturers can produce enough vaccines to ensure people can get their second doses in a timely manner, while also getting more people their first dose," Biden's incoming press secretary Jen Psaki said in a briefing Friday. "The President-elect has said he will use the Defense Production Act as needed to help produce materials and whatever else is needed to ensure supply."

However, Operation Warp Speed, the federal vaccine effort launched by the Trump administration, defends its current policy.

"If President-Elect Biden is suggesting that the maximum number of doses should be made available, consistent with ensuring that a second dose of vaccine will be there when the patient shows up, then that is already happening," wrote spokesperson Michael Pratt in a statement to NPR. "Operation Warp Speed monitors manufacturing closely, with the intent to transition from reserving as many second doses as manufacturing further stabilizes with a consistent flow of vaccines."

A key question is whether public health officials across the country would be able to effectively make use of a larger supply of vaccine doses and quickly bring more people in to get vaccinated. Vaccine hesitancy and disorganization have proven to be problems in many places, not just supply of doses.

The head of the Association of Immunization Managers, Claire Hannan, says in her view, "it's probably a good thing to get more doses flowing." The goal, she says, should be to send doses to the field as fast as possible. "Get it, thaw it, give it. [Then] order the second dose. Don't try to store it at CDC, don't try to store it at McKesson."

Marc Lipsitch, a professor of epidemiology at the Harvard T.H. Chan School of Public Health, agrees that this is a good move. He says it's become even more urgent to get as many people vaccinated as fast as possible because of the emergence of new variants of the virus that appear to be more contagious.

"As the virus continues to spread and as we begin to contemplate the possibility of the new variant or other new variants becoming more of a problem in this country it's a race against time and the faster we get more vaccine out the better," Lipsitch says.

There is a concern that if something goes wrong with manufacturing there may not be a steady supply and booster shots will end up getting delayed. This is worrisome because it's not clear how good the protection from one shot will really be or how long it will last.

The danger of a one-shot regimen "is that the vaccines might actually be — long term — less efficacious than they've been shown to be when using the regimen that's authorized for use," explains Angela Rasmussen, a virologist at the Georgetown Center for Global Health Science and Security. "It could be potentially harmful if we decide to deviate from that just because of a short-term supply issue."

Rasmussen and others worry that a weak immune response could actually lead to the virus developing new mutations that are even more dangerous. The Food and Drug Administration issued a statement earlier this week confirming the importance of the booster shots.

But many approve of the Biden policy announced Friday.

"This strategy makes tons of sense," Dr. Robert Wachter of the University of California, San Francisco wrote in an email to NPR. "We know from the data and models that getting more people vaccinated with their first shots quickly will save the most lives."

Dr. Marcus Plescia, chief medical officer of the Association of State and Territorial Health Officials or ASTHO calls the Biden move "aggressive and responsive" to calls to speed up vaccination. The big question for state health officials is that they "still don't have a lot of information about what kind of supply chain there's going to be for vaccine in the upcoming months," he explains.

"Our hope is that the Biden team has gotten some of that information and feels that we can make this kind of a change and that there's going to be adequate continued supply of the vaccine," he says. "So that when people do come back for their second doses, there will be a second dose for them to have."

If it turns out there are production issues down the line, the Biden decision could be reversed, suggests Julie Swann, a supply chain expert and professor at North Carolina State University.

"I think it is a good idea to send out as much vaccine as possible — as long as there is an indication that the manufacturers will be able to supply more," she says. "[If] that supply becomes jeopardized, it would absolutely be a reasonable strategy to go back to the strategy of reserving some vaccine for that second dose."

Pien Huang contributed to this report. [Copyright 2021 NPR]