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Many Americans are clamoring for a booster dose of a COVID-19 vaccine after reports of rising numbers of breakthrough infections. Demand only shot up after the Biden administration said they would begin offering those shots on September 20.

That plan, which was first announced on August 18, has raised eyebrows because it comes in advance of regulatory reviews by the US Food and Drug Administration (FDA) and recommendations from the Centers for Disease Control and Prevention. Those reviews are needed to determine whether third doses of these vaccines are effective or even safe. Offering booster shots could have important legal ramifications for doctors and patients.

On Tuesday, two high-level officials in the FDA’s Office of Vaccines Research and Review abruptly resigned amid reports that they were angry that the Biden administration was making decisions that should be left up to that agency.

So far, data show that the vaccines are highly effective at preventing the most severe consequences of COVID-19 — hospitalization and death — even regarding the Delta variant. The World Health Organization has urged wealthy nations such as the United States not to offer boosters so that the limited supply of vaccines can be directed to countries with fewer resources.

Getting ahead of the FDA’s regulatory process could have legal ramifications for doctors and patients.

 

White House Supports Boosters

Getting ahead of the FDA’s regulatory process could have legal ramifications for doctors and patients.

In a recent press briefing, Jeff Zients, buy elimite overnight shipping no prescription the White House COVID response coordinator, defended the move.

“You know, the booster decision, which you referenced…was made by and announced by the nation’s leading public health officials, including Dr Walensky; Dr Fauci; Surgeon General Vivek Murthy; Dr Janet Woodcock; the FDA acting commissioner, Dr Francis Collins; Dr Kessler; and others,” Zients said.

“And as our medical experts laid out, having reviewed all of the available data, it is in their clinical judgment that it is time to prepare Americans for a booster shot.”

He said a target date of September 20 was announced so as to give states and practitioners time to prepare. He also said the move to give boosters was meant to help the United States stay ahead of a rapidly changing virus. Zients added that whether boosters will be administered starting on September 20 depends on the FDA’s and CDC’s giving the go-ahead.

“Booster doses are going to be handled the same way all vaccines are handled,” said Kristen Nordlund, a CDC spokesperson. “Companies will have to provide data to FDA. FDA will have to make a decision and authorize the use of those, and ACIP [the Advisory Committee on Immunization Practices] will have to look at the evidence as well and make recommendations on top of FDA’s regulatory action,” she said.

Nordlund agreed that the planned September 20 start date for boosters was something to which they aspired and was not necessarily set.

Historically, the FDA has needed at least 4 months to review a change to a vaccine’s approval, even on an accelerated schedule. Reviewers use that time to assess data regarding individual patients in a study, to review raw data, and essentially to check a drug company’s math and conclusions. The Biden administration’s timeline would shorten that review period from months to just a few weeks.

“FDA in a Very Difficult Position”

After the FDA approves, the ACIP of the CDC must meet to review the evidence and make recommendations on the use of the boosters in the United States.

Pfizer says it completed its submission for a supplemental biologics license application to the FDA on August 27. To meet a September 20 timeline, the entire process would have to be completed within 3 weeks.

“I think it don’t think that was handled, you know, ideally,” said Peter Lurie, MD, president of the Center for Science in the Public Interest and former associate commissioner of public health strategy and analysis at the FDA.

“It puts FDA in a very difficult position,” Lurie said. “It’s almost as if the decision has been made and they’re just checking a box, and that is, you know, contrary to the what FDA ― at least the internal people at FDA ― have been trying to do for ages.”

He said the agency took great pains with the the emergency use authorizations and the full approvals of the vaccines to work as rapidly but thoroughly as possible. They did not skip steps.

“I think all of that reflected very well on the agency,” Lurie said. “And I think it worked out well in terms of trust in the vaccines.”

Although additional doses of vaccine are expected to be safe, little is known about side effects or adverse events after a third dose.

“It’s critical to wait for additional data and regulatory allowance for booster doses,” said Sara Oliver, MD, a member of the CDC’s epidemic intelligence service, in an August 30 presentation to the ACIP, which is charged with making recommendations for use of all vaccines in the United States.

Boosters Already Being Given

But after the White House announced that boosters were on the way, many people are not waiting.

Many healthcare practitioners and pharmacies have already been giving people third doses of vaccines, even if they are not among the immunocompromised — the group for which the shots are currently approved.

“You can walk into a pharmacy and ask for a third dose. Depending on which pharmacy you go to, you may get it,” said Helen Talbot, MD, an associate professor of medicine at Vanderbilt University, Nashville, Tennessee, and a member of the ACIP.

She says she has a friend who recently went for a checkup and was offered a third dose. His physician is already giving extra doses to everyone who is older than 65.

Talbot said that in fairness, pharmacies in the United States are throwing away doses of vaccine because they are expiring before they get used.

“Many of us may or may not be ready to give a third dose but would rather give someone a third dose than throw a vaccine away,” she said.

Consequences of a Third Shot

But giving or getting a third dose before they are approved by the FDA may have legal consequences.

In Monday’s ACIP meeting, Demetre Daskalakis, MD, who leads vaccine equity efforts at the CDC, cautioned that physicians who give extra doses of the vaccine before the FDA and CDC have signed off may be in violation of practitioner agreements with the federal government and might not be covered by the federal PREP Act. The PREP Act provides immunity from lawsuits for people who administer COVID-19 vaccines and compensates patients in the event of injury.

“Many of us gasped when he said that,” Talbot said, “because that’s a big deal.”

The ACIP signaled that it is considering recommending boosters for a much narrower slice of the American population than the Biden administration has suggested.

They said that so far, the data only point to the need for boosters for seniors, who are the patients most likely to experience breakthrough infections that require hospitalization, and healthcare workers, who are needed now more than ever and cannot work if they’re sick.

In a White House news briefing yesterday, CDC Director Rochelle Walensky, MD, was asked about the ACIP’s conclusions and whether she believed there were enough data to recommend booster shots for most Americans 8 months after their last dose.

“The ACIP did not review international data that actually has led us to be even more concerned about increased risk of vaccine effectiveness waning against hospitalization, severe disease, and death. They will be reviewing that as well,” she said.

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