COVID vaccine policy remains cloudy as cases rise

• That could drive down already low uptake, even while the virus is surging in parts of the West and still killing people.

No one knows how this fall will go given uncertainty over further approvals, the new restrictions and the partisan environment. One report suggested the Trump administration could soon remove COVID-19 vaccines from the market. Health and Human Services declined to comment.

• Food and Drug Administration commissioner Marty Makary and top vaccine regulator Vinay Prasad wrote in the New England Journal of Medicine in May that "the FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk."

Picture this: Public health officials in Texas are gearing up their annual outreach for fall immunizations, including social media campaigns and vaccine clinic schedules.

• But there's no clarity on whether federal funding for the outreach will materialize the way it has in the past, said Philip Huang, director of Dallas County Health and Human Services.
• "This year, there's just so much more uncertainty ... because of all of the chaos that's going on at the federal level," he said.

State of play: Both Moderna and Pfizer still are awaiting FDA approval for updated COVID-19 boosters targeting the LP.8.1 strain.

• Sources close to the deliberations tell Axios approval could come as early as this week.
• Manufacturers and pharmacies have generally been able to make the shot available within days once they get the green light.

Yes, but: Among the questions is whether the shots will be licensed for children 6 months to 4 years old.

• A likely outcome is they'll only be available to high-risk groups like seniors or those with underlying conditions predisposing them to severe COVID, as was the case when Moderna's mNEXSPIKE shot received approval in May.
• "Almost as many kids died this year from COVID as flu this year and it was one of the worst flu seasons in years," Michael Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy.

COVID vaccines may not be available for people with average risk, even though they may spend parts of the fall and winter near friends and relatives who are at increased risk.

• Shots are still important for the general public, who remain at risk for severe outcomes as well as long COVID.
• "There is waning immunity. That's the challenge," Osterholm said, adding that the vaccines are similar in nature to what we see with flu vaccines that require annual boosters. "The protection against serious illness, hospitalization and death is reduced over time."

Reality check: The recent prevalent COVID strains in the U.S. haven't been deadlier or caused more serious disease. Mortality rates are lower than the surges seen during the height of the pandemic.

What to watch: Individuals who aren't part of the recommended groups may not be covered by insurance and have to pay out of pocket — no small matter when a COVID shot can cost around $140.

• "These are questions that are yet to be to be answered," said Richard Besser, CEO of the Robert Wood Johnson Foundation. "Will health departments be able to provide free vaccination to those people who don't have insurance if it's not recommended by the CDC?"
• "I think we're going to increasingly see a divide between those individuals who either have the insurance that will cover it or the dollars to pay for it ... and individuals who are uninsured having that choice be made for them by a secretary who does not believe in vaccination."