The FDA could give the green light for new Covid boosters as early as Friday

 

The FDA could give the green light for new Covid boosters as early as Friday

The Food and Drug Administration plans to give the green light to updated versions of the Covid booster as early as Friday, according to four people familiar with the agency’s plans.

The latest shots target the Omicron subvariant XBB.1.5. Even if that particular strain is no longer dominant, the boosters should still provide protection against currently circulating subvariants that are closely related, the drugmakers and experts say.

The schedule for Friday’s approval is yet to be determined and could be pushed back to early next week, two of the sources said.

This could prompt further criticism from some doctors, who say federal health officials are being too slow in rolling out booster shots as the number of Covid cases and hospital admissions surges again.

Two sources who spoke to NBC News said the FDA is exploring the possibility of granting the booster shots a full regulatory license rather than an emergency license, a departure from the approach used in previous Covid vaccine approvals. However, it remains uncertain whether this is still the intended course of action.

After FDA clearance, the Centers for Disease Control and Prevention and its Advisory Committee will make their own recommendations about who should receive the vaccines and how they should be used. The agency’s Advisory Committee on Immunization Practices is expected to vote during a vote scheduled meeting Tuesday. The director of the CDC, Dr. Mandy Cohen, could approve the booster shot shortly after the meeting, allowing vaccinations to begin.

According to government officials, about 97% of adults have some level of protective immunity. But as immunity to previous infections and vaccinations declines over time, authorities are looking to step up protection as people spend more time indoors during the autumn and winter months.

For the first time since there have been Covid vaccines, however, the costs of vaccinations will not be covered by the federal government.

Pfizer and Moderna have said the list price for the vaccines will be $110 to $130 per dose.

If and when someone can take these recordings depends on your insurance coveragesays Jennifer Kates, director of the Global Health & HIV Policy Program at the non-profit KFF.

Most people with private and public health insurance should continue to pay nothing out of pocket for vaccinations, Kates said. However, if a person receives the vaccine outside the network, there may be a cost involved.

Some people without insurance may be able to get a free booster shot from safety net providers, such as e.g. community health centres, but others may have to bear the full cost. The Biden administration has also announced a “bridging program” that would provide uninsured people with access to free booster shots through at least the end of 2024.

Novavax’s vaccine, which has not yet received full FDA approval but is instead available through emergency use authorization, will continue to be covered, Kates said.

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