Pharma

FDA greenlights new Covid-19 boosters, which will be available later this week

The CDC recommended that everyone over the age of 6 months get the updated vaccine.
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Francis Scialabba

· 3 min read

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Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.

Time to add another vaccine to your seasonal to-do list.

The FDA this week approved reformulated Covid-19 boosters from Moderna and Pfizer–BioNTech, as cases and hospitalizations for coronavirus continue to rise across the country.

The nationwide rollout will start in the coming days following a CDC advisory committee’s recommendation on Tuesday that all eligible patients get vaccinated ahead of fall and winter.

“We have more tools than ever to prevent the worst outcomes from Covid-19,” CDC Director Mandy Cohen said in a statement. “CDC is now recommending updated Covid-19 vaccination for everyone six months and older to better protect you and your loved ones.”

The guidelines

Anyone over the age of five can get a single dose of the updated booster, regardless of prior vaccinations and at least two months after their last dose, according to the FDA. Patients may be able to receive their Covid booster at the same time as their annual flu shot in preparation for the upcoming respiratory virus season, a Pfizer executive said.

“Studies about confirmed viral infections suggest that Covid-19 adopts a seasonal pattern with peaks in fall and winter, similar to other respiratory viruses,” Uğur Şahin, CEO and co-founder of BioNTech, said in a statement.

In clinical trials, Moderna’s updated vaccine demonstrated “an 8.7-fold increase in neutralizing antibodies in humans against [the latest Covid strain,] BA.2.86 (Pirola),” the drugmaker said in a statement earlier this month. Public health officials are monitoring the variant, which may be more transmissible than previous Covid strains.

Rolling it out

Getting shots into patients’s arms may be more difficult this time around, however. Prior to the public health emergency ending in May, the US government bought and distributed Covid vaccines at no cost to patients. Now, the commercial price for Moderna is expected to be $129 a dose, and $120 for a dose of the Pfizer–BioNTech vaccine, Reuters reported.

Adults and children with private insurance or on government plans such as Medicare, Medicaid, or the Children’s Health Insurance Program will still have access to Covid vaccines at no cost, Healthcare Brew previously reported.

Those without insurance aren’t totally out of luck. In April, the Department of Health and Human Services announced a $1.1 billion “bridge” partnership between pharmacies and the CDC to help provide free vaccines to uninsured patients. However, the CDC is still finalizing contracts, and the program is not expected to be up and running until mid-October, Politico reported.

Officials are “working to push that [date] up,” Claire Hannan, executive director at the Association of Immunization Managers, told Healthcare Brew.

“The pharmacy program is a replacement model. So [pharmacies] would be using their own vaccines and getting credit for it; it doesn’t involve actually shipping vaccines,” Hannan said. “As soon as they get those contracts signed, it’s a go. We’re looking for that to be sooner rather than later.”

Navigate the healthcare industry

Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.