Pfizer and BioNTech said Monday they submitted an application to the FDA for an updated COVID-19 booster that targets the Omicron BA.4 and BA.5 subvariants.
The big picture: The Biden administration has been pressing to have updated boosters widely available by mid-September.
But it's still unclear whether an invigorated booster campaign cuts through months of public apathy and confusion and can prime the public for potentially more COVID-19 waves this fall.
What they said: The companies said the data supports emergency use authorization of a 30-microgram booster dose for individuals 12 years of age and older.
The "bivalent" shot contains mRNA encoding the original COVID spike protein that's present in the current Pfizer-BioNTech vaccine, along with mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariants.
Preclinical data showed a booster dose "generated a strong neutralizing antibody response against Omicron BA.1, BA.2 and BA.4/BA.5 variants, as well as the original wild-type strain."
The companies plan to launch a clinical study in individuals 12 and older this month.
NIAID director Anthony Fauci said Monday that he plans to retire from government service in December, saying he is leaving "to pursue the next chapter of my career."
Why it matters: Fauci, 81, emerged as the face of the nation's pandemic response and has been a mainstay at the National Institute of Allergy and Infectious Diseases, serving as leader since 1984.
The CDC needs to start opening itself up to working with the private sector and more transparently communicating how it makes recommendations, Deborah Birx, former President Trump's coronavirus response coordinator said on CBS News' "Face the Nation" on Sunday.
Why it matters: Her comments came in the aftermath of CDC director Rochelle Walensky's plans to reform the agency.
Amazon is among the reportedbidders for Signify Health, a Dallas-based health tech company whose market cap has climbed to nearly $5 billion.
Why it matters: This reflects Amazon's emergence as a major player in health care M&A, having recently bested CVS for One Medical. It also may open a new front for antitrust regulators.
A year and a half after Congress protected patients from surprise medical bills, the Biden administration has finalized the process for deciding who'll actually pick up the tab.
Why it matters: Billions of dollars are at stake — either for providers or for insurers and employers.
Why it matters: The news could be a boon for unvaccinated people who prefer a shot that is not based on the mRNA technology used by Pfizer and Moderna.
First lady Jill Biden has ended her period of isolation after testing negative for COVID-19, her communications director, Elizabeth Alexander, said in a statement Sunday.
