FDA Authorizes U.S.’s First Covid-19 Booster Shots

In a statement issued just before midnight on Thursday, the U.S. Food and Drug Administration said it had updated its emergency-use authorization for both Pfizer and Moderna’s Covid-19 vaccines to include a third booster dose for certain people with compromised immune systems.

The update applies to recipients of solid organ transplants, and to people with other conditions that “are considered to have an equivalent level of immunocompromise,” the agency said. In a statement, the acting FDA commissioner, Dr. Janet Woodcock, said that the FDA believed that this “small, vulnerable group” could benefit from a third dose of the Pfizer or Moderna vaccine.

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Woodcock said. “As we’ve previously stated, other individuals who are fully vaccinated are adequately protected and don’t need an additional dose of COVID-19 vaccine at this time.”

The announcement came on the eve of a scheduled meeting of the Centers for Disease Control and Prevention’s vaccine advisory committee, which sets recommended vaccination schedules in the U.S. The committee, known as the Advisory Committee on Immunization Practices, has already signaled support for boosters for immunocompromised people, and is expected to recommend doses for the immunocompromised at its Friday meeting.

Moderna (ticker: MNRA) shares were up 2.1% in premarket trading Friday, on the tail end of a week of extraordinary volatility for the stock. Pfizer (PFE) shares were up 0.3%, while the American depositary receipt of Pfizer’s partner BioNTech (BNTX) was up 2.5%.

Neither Pfizer nor Moderna have publicly said that they had filed requests with the FDA to extend the emergency-use authorizations for their vaccines to include booster doses for immunocompromised people. Neither company immediately responded to a question from Barron’s early Friday asking whether they had requested the updated emergency-use authorization, or submitted data to the FDA to support such an update.

Pfizer CEO Albert Bourla tweeted Friday morning that the emergency-use authorization “will help increase protection for this population.”

In its statement, the FDA said that people who have received a solid organ transplant have a diminished ability to fight infections, and that the agency had determined that a third dose of the Covid-19 vaccines from Pfizer or Moderna could offer them more protection.

At a meeting of ACIP in late July, a CDC staff member presented data on Covid-19 vaccines and immunocompromised people showing that people who had received organ transplants were less likely even than people with other immunocompromising conditions to have any antibody response at all after receiving two doses of messenger RNA-based vaccines. It also presented evidence showing they were more likely to have an antibody response after a third dose.

At ACIP’s Friday meeting, scheduled to begin at 11 a.m. Eastern, CDC officials will present more research on booster doses, and the committee will vote on a question related to “additional doses of mRNA COVID-19 vaccines,” according to an agenda posted online by the CDC.

In a note out early Friday, SVB Leerink analyst Daina Graybosch increased her target price on BioNTech to $293 per share, from $159, in part because of the faster-than-expected move to booster doses. The stock closed Thursday at $374.02. Graybosch has a Market Perform rating on BioNTech.

“We are confident a recommendation for boosting in high-risk groups is imminent, given [ACIP’s] last discussion…and FDA emergency authorization of BNT162b2 and mRNA-1273 boosters for immunocompromised individuals last night,” she wrote.

Yet she said she was keeping her Market Perform rating on the stock. “We don’t foresee the extended durability in the BNT162b2 revenue stream that could support upside to the current market valuation,” she wrote.

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