U.S. will stop buying vaccines, vaccines by fall, official says

The White House COVID 19 Response Team coordinator Dr. Ashish Jha said Tuesday that the U.S. government will stop buying treatments, tests and vaccines by the fall.

I hope that in 2023 you're going to see the commercialization of almost all of these products. Some of that is going to begin this fall, in the days and weeks ahead. "You're going to see commercialization of some of these things," Jha said at a U.S. Chamber of Commerce Foundation event.

Tests have already been available in pharmacies, grocery stores, and online, and treatments are pivoting to commercialization for 2023.

Two of the four vaccines available in the U.S. have regulatory approval to go commercial: Moderna MRNA and Pfizer BioNTech PFE BNTX Both companies have U.S. government orders for booster doses this fall, but have not announced details such as coverage, coverage by insurers, and details of how to transition logistics away from the government partnership.

Moderna is already working on commercialization, according to Moderna.

The commercial organization has engaged with both channel distributors and the channel, as well as key pharmacies in anticipation of this shift. Arpa Garay, chief commercial officer, said during an earnings call this month that public health authorities are expected to remain key purchasers of vaccines, but they are also looking for markets where there may be a private commercial market as well.

Novavax NVAX is only getting emergency use authorization and is filing for booster approval in adults, and Johnson Johnson JNJ does not have approval.

Novavax intends to pursue full approval by the end of 2022, and pricing will be similar to the premium-priced influenza market in the U.S. J&J faced waning demand in recent months as the Centers for Disease Control and Prevention warned against potential blood clot risks, and advised Moderna and Pfizer doses be used to boost protection against emerging variants. J&J did not respond to a request for comment Wednesday.

Insurers are waiting for guidance from the government, as well as the official end of the public health emergency, which is set to expire October 13 and has a 60 day notice if the Biden administration is going to lift it. There are signs that another extension would leave coverage for vaccines, treatments, tests, and even provisions for telehealth and other pandemic-related shifts in policy and operations.

Once the emergency declaration is lifted, it opens the floodgates to a myriad of complexities. Who will be paying out of pocket costs and copays, including Medicare, remains unclear. A request for comment was not responded to by the Centers for Medicare and Medicaid Services CMS on Wednesday.

The U.S. is facing a potential cliff in vaccine availability because Congress is unwilling to budge on ongoing funding. The U.S. has ordered booster doses for adults in the fall, but not enough for all.

The government has ordered 105 million Pfizer doses for delivery through the end of 2022, with an option to purchase 195 million more and 66 million doses from Moderna through the end of 2022. The 171 million doses are about two-thirds of the more than 250 million needed to give each adult an additional booster.