FDA Authorizes Updated COVID-19 Boosters; CDC To Make Recommendation Shortly.
The Washington Post (8/31, McGinley) says CDC advisers will meet Thursday to review the authorization. If the outside advisers “recommend the shots, and CDC Director Rochelle Walensky agrees, some boosters may be available starting this weekend, with more showing up in pharmacies, doctors offices and clinics after Labor Day.” Califf said the “updated boosters meet the FDA’s rigorous standards and are expected to help restore immune protection against COVID-19,” and NIAID Director Anthony Fauci said, “Any boost of immunity will have some degree of cross-reactivity even against a new variant.” However, the Post says it remains unclear “whether the American public, which has been slow to embrace boosters, will show more enthusiasm for the newest crop of shots, which will be free to the public. Some experts, including Paul A. Offit, one of the FDA’s most prominent vaccine advisers, have criticized the agency for moving too quickly, saying it is not clear the new booster is better than the current shot. And others say the FDA’s lack of human data on the shots’ effectiveness – it is relying heavily on mouse studies – could fuel skepticism.”
The New York Times (8/31, A1, Weiland, LaFraniere) reports Califf cautioned at a “Wednesday briefing that regulators did not know exactly when they might see robust clinical data on how well the bivalent boosters work. ‘If we jump to preliminary data, we can be easily misled one direction or the other,’ he said. ‘No one’s more anxious than we are to have the data available and to get it out there once we have solid data to talk about.’” Still, according to USA Today (8/31, Weintraub, 12.7M), Califf added he is comfortable with the new boosters’ safety and efficacy.
The AP (8/31, Neergaard) says the FDA’s decision “tweaks the recipe” of the booster shots. According to the AP, “The hope is that the modified boosters will blunt yet another winter surge – and help tamp down the BA.5 omicron relative that continues to spread widely. ‘These updated boosters present us with an opportunity to get ahead’ of the next COVID-19 wave, said” Califf.
HHS Official Says Biden Administration Could Run Out of Funding For COVID-19 Vaccines By January.
BioPharma Dive (8/31, Halleman) reports, “Americans may have to pay for their COVID-19 vaccinations as early as January as federal funding for vaccine purchase and distribution runs out and the shots shift to the commercial market, according to a federal health official.” The announcement came after HHS met Tuesday with “over 100 representatives from state and local governments, including various stakeholders, insurers and pharmaceutical companies.” HHS Assistant Secretary for Preparedness and Response Dawn O’Connell wrote in an ASPR site post, “While the federal government has been pleased to play this role, we have always known that we would not be in this business forever. Unfortunately, the timeline to make the transition has accelerated over the past six months without additional funds from Congress to support this work.” Funding will run out for the antiviral pills Paxlovid and Lagevrio in 2023, “along with the preventive Evusheld.”
Updated COVID-19 Booster Shots For Omicron Subvariants Could Soon Be Available.
Science (8/30, Vogel) reports, “For the first time since the start of the pandemic, COVID-19 vaccines look set to receive an update” in the form of “boosters reformulated to protect against the Omicron variant.” The updated vaccines “may get deployed on both sides of the Atlantic Ocean as early as this month.” The United Kingdom “has already authorized a shot produced by vaccinemaker Moderna against the Omicron subvariant BA.1 and may start using it soon.” In June, the FDA “asked manufacturers to develop a booster specifically targeting those two subvariants, and last week, both Moderna and the Pfizer-BioNTech collaboration said they have submitted data about their BA.4/BA.5 vaccines to FDA.” President Biden’s Administration “has already placed an order for 170 million doses of such vaccines.” Pfizer and BioNTech “have also submitted the data to EMA; the European Union could first approve a BA.1-based booster and switch to BA.4/BA.5 vaccines later.”