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Wednesday, January 13, 2021

US No Longer Keeping Reserve COVID-19 Vaccine for Boosters - Healthline


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More COVID-19 vaccines may soon be released to states. Boston Globe/Getty Images
  • Both the Biden and Trump administrations plan to release more COVID-19 vaccine doses without reserving any for boosters.
  • If boosters are delayed, it may change how effective the vaccines are.
  • We talked to experts about the plan and how it might affect the pandemic.

In a response to a sluggish rollout of the first round of COVID-19 vaccines, both President-elect Joe Biden and the Trump administration have pivoted how the vaccine will be released.

Yesterday, the Trump administration said it’s planning to release vaccine doses without reserving any for boosters.

The news comes days after CNN reported that the Biden administration will present a plan to release the vast majority of every available dose of both the Pfizer-BioNTech and Moderna vaccines without holding on to doses for booster shots.

Biden has laid out a timeline indicating 100 million shots in the first 100 days of his presidency.

Both these vaccines are approved by the Food and Drug Administration (FDA).

This move goes against what the FDA advised on Jan. 4, indicating that a reserve of vaccine doses should be saved to ensure that those who received the first dose would be able to receive the booster.

The booster shot ensures the highest level of protection.

“This is a two-dose vaccine. We know it’s given at two doses, and you get 95 percent protection with two doses. That we know,” said Dr. Paul Offit, director of the Vaccine Education Center and attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia.

“People have extrapolated that one dose has a level of efficacy that we should embrace. It is likely that people given one dose will have shorter-lived immunity than those given two. But we don’t know because there are no studies,” he said.

Both vaccines available in the United States are estimated to be about 95 percent effective, but only if both doses are taken.

But the sluggish start to the U.S. vaccination program has pushed officials to look for new ways to protect people quickly as COVID-19 cases surge.

It should be noted that Biden’s plan doesn’t mean forgoing the two-dose regimen.

The new administration is expecting that manufacturers will be able to produce enough vaccine supply to give everyone the booster shot within the recommended 3- to 4-week period.

But some experts are worried that this may not happen, and that booster doses will be delayed.

The FDA released a statement in early January advising that those who receive the vaccine stick to the established dosing schedule because it’s the proven way to obtain 95 percent effectiveness against COVID-19.

However, the Centers for Disease Control and Prevention (CDC) reports that just 10 million adults have been given their first dose in the United States, which is woefully short of the goal to vaccinate 20 million people by the end of 2020.

This is just around one-third of the 29 million total doses that have been distributed to states so far.

With herd immunity established when 80 to 85 percent of the population is vaccinated, the United States is still a long way off.

The decision to provide a single dose with the potential for a delay before getting the booster shot is worrying to experts because it’s not the way the clinical trials were conducted.

There isn’t evidence to indicate long-term effects of delaying the booster shot, but experts agree that a single dose would likely be less effective.

“With Pfizer, in a 3-week time there was a 50 percent effectiveness at preventing disease. In the Moderna trial, it was roughly 80 percent effective,” Offit said. “It may be a matter of a couple months that the immunity fades.”

It’s true that a single dose of the Pfizer-BioNTech or Moderna vaccine likely does provide some level of protection.

But it’s the mentality of “that’s good enough” that experts want to avoid.

From a scheduling standpoint, it becomes an administrative headache to try to get such a high volume of people to return to receive their second dose.

The goal among health experts is to reach herd immunity, and if people don’t return for their booster shot, the chances of optimal immunity decrease.

“In vaccines we have a saying: A dose delayed is often a dose never received,” said Dr. William Schaffner, a Vanderbilt University professor of preventive medicine in the department of health policy and the division of infectious diseases.

“We have to be very attentive in getting people back. If there is a bit of delay [between vaccines], that’s not a problem. The immune system will remember and respond appropriately. But the more you stretch it out between doses, the more you’ll find people drop off. That certainly is something we do not want.”

“There are still two issues that come with stretching the supply,” said Dr. Arthur Caplan, the Drs. William F. and Virginia Connolly Mitty Professor of Bioethics in the department of population health at NYU Langone Health.

“One is that when people get one shot, some will think they are safe when they are not, and will be less cautious with masks and distancing. The other problem is the refusal rates are still pretty high. We have got to resolve that,” he said.

The entire debate of who and how many people to vaccinate hangs on the issue of supply.

Currently there are only two approved vaccines in the United States, but experts believe that another two aren’t far off from receiving FDA approval.

One vaccine is from Johnson & Johnson, and the other is produced by AstraZeneca, which has already been approved in the United Kingdom.

The Biden administration is confident that both Moderna and Pfizer-BioNTech will be able to produce enough of a supply to be able to roll out the second doses within the recommended time frame.

Still, some experts think this is a gamble, while others feel confident that with the introduction of two additional vaccine options, this time of scarcity is temporary.

“The two [FDA-approved] vaccines are not going to be the only ones available,” Offit said. “I am optimistic. We are headed into warmer weather, which does not favor transmission. We have an administration that has a clue about science, and the vaccine is 95 percent effective.

“If we can vaccinate 1,000 to 1,500 people per day, we can vaccinate 150 million people by May,” he said. “There is every reason for hope here, but a system for mass inoculation must be put in place.”

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January 14, 2021 at 07:01AM
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US No Longer Keeping Reserve COVID-19 Vaccine for Boosters - Healthline

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