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First on CNN: Updated Covid shot should be ready by ‘latter part of September,’ HHS secretary says in letter to manufacturers

<i>Lea Suzuki/San Francisco Chronicle/AP/FILE</i><br/>The FDA has recommended that Covid-19 booster shots for this fall and winter target only the Omicron subvariant XBB.1.5.
Lea Suzuki/San Francisco Chronicle/AP/FILE
The FDA has recommended that Covid-19 booster shots for this fall and winter target only the Omicron subvariant XBB.1.5.

By Jacqueline Howard, CNN

(CNN) — US health officials are moving forward with plans to sunset the federal government’s Covid-19 vaccine distribution program next month and move the vaccines to the commercial market this fall, and they are laying out their expectations to manufacturers about what that transition should look like.

On Thursday morning, US Department of Health and Human Services Secretary Xavier Becerra sent a letter to the CEOs of Pfizer, Moderna and Novavax detailing how, after the transition to commercialization, HHS expects “that vaccines will remain available in the types of locations where the public currently receives them – including pharmacies, clinics, healthcare provider offices, health departments, and other points of care – to maximize access.”

Those three companies, which manufacture the only Covid-19 vaccines currently available in the US, are advised that they should plan for this fall’s vaccine supply and regulatory submissions in enough time for the US Food and Drug Administration to take action and the US Centers for Disease Control and Prevention to make recommendations on the vaccinations “by the latter part of September,” Becerra wrote in a draft of the letter obtained by CNN.

He added that HHS expects manufacturers planning to offer the vaccines this fall, which will be updated from the currently available bivalent boosters, are preparing an ample supply of doses for the 2023-24 Covid-19 vaccination campaign.

“Further, we expect that vaccine manufacturers will remain ready to support potential surges in demand and evolving circumstances of COVID-19,” Becerra wrote.

“Updated COVID-19 vaccines entering the market this fall should be priced at a reasonable rate, reflective of the value that you have obtained through U.S. government investment. Price gouging behavior takes advantage of the trust the American people have placed in you through the COVID-19 response,” he wrote.

The US government’s distribution of Covid-19 vaccines will begin phasing out on August 3 in preparation for a September transition.

“In the coming weeks and months, we anticipate that you will work with the Centers for Medicare & Medicaid Services (CMS) and other payors to ensure that they have the required information to make payments for the updated vaccines this fall,” Becerra wrote. “As ordering and distribution transitions to more traditional pathways, HHS asks you to find sustainable ways to enable continued visibility of the provider network and availability of vaccines.”

Free Covid shots for the uninsured

The CDC detailed in a transition guide last week that it will provide access to Covid-19 vaccines for people who do not have health insurance coverage after the vaccines become commercially available.

Children who are uninsured will be eligible to receive Covid-19 vaccines at no cost through the CDC’s Vaccines for Children program, which has been around since 1994.

Adults who are uninsured will be able to receive free vaccines through a new temporary program called the Bridge Access Program for Covid-19 Vaccines and Treatments.

The US Bridge Access Program will allow the CDC to purchase and distribute Covid-19 vaccines and allocate them through its network of state and local health departments, said Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials. Another component of the program involves enabling pharmacy chains to continue offering free Covid-19 vaccinations to the uninsured through their network or retail locations.

“The bridge program is temporary, beginning in the fall of 2023,” Freeman said, adding that the program can help ensure that everyone may have access to the updated vaccine this fall.

In his letter to the vaccine manufacturers, Becerra wrote that HHS and manufacturers “have been in numerous conversations” and that HHS will continue to provide vaccine manufacturers with details to facilitate their partnership on the program.

Updated Covid-19 vaccines in the works

While about 69.5% of the total US population has completed a primary series of Covid-19 vaccine, only around 17% has received a dose of the updated booster shot that was released last fall, according to data from the CDC.

In June, the FDA recommended that Covid-19 vaccine manufacturers make single-strain booster shots for this fall and winter that would target the currently circulating Omicron subvariant XBB.1.5. Those updated vaccines are expected to be made available in mid- to late September, should the FDA authorize them and the CDC recommend them. They will be the first Covid-19 vaccines made available directly from the manufacturers as part of the commercial market, rather than through the US government.

Pfizer, Moderna and Novavax have been working on updated versions of the vaccines, even manufacturing them in advance. Moderna and Pfizer, along with its partner BioNTech, make mRNA Covid-19 vaccines while Novavax makes a protein-based Covid-19 vaccine, an older technology that typically takes longer to manufacture at a larger scale.

Pfizer has estimated that it would be the dominant provider of vaccines this year, with a projected 64% market share of its first-quarter earnings report in May. It expects about a quarter of the US population to get vaccinated this year against the coronavirus that causes Covid-19.

CNN’s Meg Tirrell contributed to this report.

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