The US Food and Drug Administration on Monday revoked its authorization for two monoclonal antibody treatments made by Regeneron and Eli Lilly.
In a news release, the FDA said the antibody treatment is "highly unlikely to be active against the Omicron variant," which accounts for more than 99% of cases in the country, the Centers for Disease Control and Prevention estimates.
"These remedies are not authorized for use in any US states, territories, and jurisdictions at this time," the FDA said.
The Florida Department of Health said it had received no advance notice that the treatments would be unauthorized, and that the FDA failed to provide the clinical evidence needed to legally block access to the treatment. The FDA said the new versions of the drugs could be reauthorized if they prove effective against them.
"In the future, if patients in certain geographic areas are likely to be infected or susceptible to these treatments, the use of these treatments may be authorized in these areas," the FDA said.
Other drugs, including Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir, are still expected to work against Omicron, according to the federal agency.
Pfizer, BioNTech announce Omicron-specific vaccine trials for adults
Vaccine makers Pfizer and BioNTech announced plans early Tuesday to test an Omicron-specific COVID-19 vaccine in people.
The companies will run three simultaneous trials in adults aged 18-55 to determine whether the Omicron-specific vaccine is more effective than current shots.
The existing vaccine was developed to target the original or "ancestral" strain of COVID-19. While the three shots seem to provide some protection against Omicron, the vaccine, called Comirnati, is not as effective as it was against earlier strains.
While vaccines continue to protect well against severe disease, recent studies suggest that protection against mild to moderate disease declines more rapidly with Omicron than with other types.
BioNTech's CEO and co-founder said, "This study is part of our science-based approach to developing a variant-based vaccine that achieves the same level of protection against Omicron as was done with the earlier variants." was, but (a) with a longer period of protection." Usoor Sahin said in a statement.
Immune patients eligible for fourth COVID shot are being turned away
Patients with weakened immune systems - who are at high risk from COVID-19 - say pharmacies are turning them away when they want additional vaccine doses recommended by federal health officials.
Alison Smith became eligible for a fourth vaccine dose this month because her drugs weakened her immune system.
Although the Centers for Disease Control and Prevention encourages most adults to receive a total of three mRNA vaccines -- two "primary" vaccinations and one booster -- the agency now recommends people with weakened immune systems get three primary shots and one booster. , of four doses in total.
As Smith learned, many pharmacists are unaware that the CDC's vaccine guidance has changed.
Smith booked his vaccine appointment online. But when she showed up at Chicago-area Walgreens for a January 19 appointment, an employee told her the pharmacy chain wasn't giving anyone a fourth dose.
"I don't know any provider who wants to turn a patient away," Rothholz said. “CDC continues to update, and it is becoming increasingly difficult for grassroots providers to keep up with it.”