Access to Covid-19 Booster-Shot may be more limited, CDC committee signals

Text size

A key advisory committee of the Centers for Disease Control and Prevention’s advisory committee may support a more limited approach to Covid-19 enhancers than announced by health officials in the Biden administration.

In a joint statement last week, the heads of federal health agencies, including the CDC and the U.S. Food and Drug Administration, unveiled a plan to begin allowing all Americans to receive booster shots. of messenger RNA – based vaccines developed by

Pfizer

(ticker: PFE) i

Modern

(MRNA) the week of September 20th.

Before this can happen, however, FDA staff must authorize booster doses of the vaccine for widespread administration, and the CDC Advisory Committee on Immunization Practices must make a recommendation. Comments from ACIP members at a meeting on Monday suggested that their approval was not true.

“The process is really important,” said Dr. Beth Bell, an ACIP member and professor at the University of Washington School of Public Health. “I think it’s very important that we continue to highlight what our process is and how we come to make recommendations.”

A presentation at the meeting by a CDC staff member, Dr. Sara Oliver, noted that vaccines continue to offer high protection against serious illness, hospitalization, and death, although protection against asymptomatic and mild infections appears to be lower. .

The presentation, based on the discussions of a working group, suggested that the priority should remain the vaccination of unvaccinated people and that the priority for a booster dose policy should be “the prevention of serious diseases. in populations at risk “.

According to Oliver’s presentation, the CDC working group is discussing a recommendation for a recommended dose of reinforcement aimed at long-term care residents, older adults, and health care workers.

This seems to be setting the stage for a narrower set of recommendations than Biden administration officials have promised. “We hope the rule is simple,” White House coronavirus response coordinator Jeffrey Zients said at a White House briefing last week. “Get the booster shot eight months after you get the second shot.”

In a note released Tuesday morning, SVB Leerink analyst Daina Graybosch wrote that ACIP’s comments should lower short-term expectations of booster doses. “We read the timing of this meeting and the discussion on the additional dose (‘ reinforcement ’) as an indication that the increase in third doses may not come as quickly as investors expected,” Graybosch wrote.

In a separate note, Jefferies analyst Michael Yee wrote that ACIP was taking a conservative approach. “ACIP still seems to doubt itself [additional] doses are needed despite decreasing antibodies and increasing infections, “Yee wrote.” We believe ACIP could lean towards a narrow third-dose recommendation for high-risk people (health workers, the elderly) versus the most general recommendation that the White House favors. “

BioNTech

U.S. deposit income (BNTX) fell 3.8% on Monday and down another 1.2% in premarket trading on Tuesday. Shares of Moderna fell 3% on Monday and rose 0.9% in premarket trading on Tuesday

Pfizer

shares were up 0.3% on Monday and down 0.1% on early Tuesday.

Some ACIP members were critical of the Biden administration’s approach to implementing reinforcement. One member, Dr. Helen Keipp Talbot, a professor of medicine at Vanderbilt University, said “many, many” hospitals in the South had begun giving impetus to patients and health care workers, even though the FDA and CDC have not yet gone sign the session.

“Since he was given a date, many assumed the White House gave him a blessing, and that was the next step,” Talbot said.

Talbot said these health care providers will not be covered by the PREP Act, which gives Covid-19 vaccinators immunity from liability. “A lot of people didn’t read the fine print,” Talbot said.

In his note, Graybosch said comments at the meeting on the question of whether PREP Act protections apply to vaccinators who give third doses before FDA and CDC approval would reduce demand in the short term of reinforcements. “Doctors expressed their surprise” at the time, Graybosch said, and “we expect the initial demand for impetus to backfire until FDA / ACIP action.”

In addition to the discussion on boosters, ACIP also voted to recommend the Pfizer and BioNTech vaccine for people over the age of 16, following the FDA’s decision to fully approve the vaccine last week. “If you’ve been waiting for this approval before receiving the vaccine, now is the time to get vaccinated and join the more than 173 million Americans who are already fully vaccinated,” said CDC director Dr. Rochelle Walensky, in a statement.

Write to Josh Nathan-Kazis at [email protected]