A healthcare worker prepares a shot of the Pfizer COVID-19 vaccine last year. (AP)
Four updated covid-19 shots earned approval from the Food and Drug Administration Thursday, setting the stage for the shots to reach the arms of millions of Americans this fall, when respiratory diseases tend to see the most dramatic spikes
The shots were approved for those age 65 and older and for younger people affected by a high-risk health condition. It marks the second year of a shift to the more narrow approval range for the covid-19 vaccines, which were previously available to everyone 6 months and older
Still, this year’s set of shots — made to fight the XFG strain of the virus — should be fairly accessible, according to health experts
Here’s what to know about the new vaccines:
The FDA’s approval covered four different vaccines — ModernaTX’s MNEXSPIKE and SPIKEVAX, Pfizer-BioNTech’s COMIRNATY and Sanofi’s NUVAXOVID
While each is available to those 65 and older, the FDA approved the shots for high-risk patients beginning at different ages
MNEXSPIKE and NUVAXOVID are approved for high-risk patients starting at 12; SPIKEVAX is approved for high-risk patients starting at six months; and COMIRNATY is approved for high-risk patients starting at 5
Several medical conditions are classified as high-risk, including diabetes, heart diseases, cancer and obesity
Moderna and Pfizer-BioNTech’s shots are mRNA vaccines, a relatively new and rapidly advancing class of vaccines that were first rolled out to the public in the wake of the covid-19 pandemic
The shots work by giving the body genetic instructions to produce a protein capable of eliciting antibodies to fight a virus
Traditional vaccines like NUVAXOVID, however, often include a weakened form of a virus, allowing the body’s immune system to learn how to respond in the case of a real infection
Because medical experts don’t have to spend time growing a virus, they can develop and deploy mRNA vaccines much more quickly
In addition to covid-19, mRNA vaccines have been approved to treat respiratory syncytial virus (RSV) and the flu
This year’s strain
Like the flu, health experts spend months prior to the fall studying which strain of covid-19 is likely to be most prominent
This year, it’s called XFG
It comes from the same JN.1 lineage as last fall’s strain before it underwent a “recombination,” resulting in XFG dean of the National School of Tropical Medicine at Baylor University and a prominent national vaccine advocate
The strain is currently responsible for about 40% of circulating covid-19 cases, said Dr. Brian Lamb, an internal medicine doctor with Allegheny Health Network
Also like the flu, covid-19 seems to have become endemic, meaning covid-19 will likely remain a regular feature each year
“It’s something we’re going to have to live with,” Lamb said. “Think of it like the yearly flu shots.”
Pharmacies will soon have the vaccines
Pfizer said it will begin shipping the vaccine immediately, while Moderna said its vaccines will be available “in the coming days.”
The nation’s two largest pharmacy chains — CVS and Walgreens — also said the vaccines would be available within days
Many local pharmacies will also have the vaccines available
Holly Ross, a pharmacist at Adzema Pharmacy in McCandless, said the drug store had ordered the shots and expected them arrive within a few weeks
Medicap Pharmacy in Millvale will also have the vaccines available, though pharmacy technician Cece Cosio said she was unsure the exact date they would arrive
De facto access
Though the FDA approved the shots only for older or high-risk populations, Lamb said he expected that most of the people who want to receive the vaccines will be able to get them
“There’s a lot of leeway for what’s called off-label use,” he said
It’s a common practice where clinicians offer an FDA-approved drug to a patient for an unapproved use, including to someone outside the agency’s prescribed age parameters
Lamb said he expected many AHN facilities would carry the vaccines in-house
Hotez said a doctor could also write a patient a prescription for a patient to receive the vaccine at a pharmacy
“I’ll get it as soon as I can,” Hotez said
When asked how CVS would verify whether a person had one of the FDA’s high-risk condition, Roslyn Guarino, a CVS spokeswoman, said in a statement that patients would be “offered guidance as to the list of high-risk conditions.”
“The pharmacist will answer any questions they have and decisions are made through a shared clinical decision-making process that supports informed individualized care,” the statement said
Insurance will cover the shots
Most insurers seem likely to cover the costs of the vaccines
AHIP, a trade group representing numerous health insurance firms — including Highmark and UPMC Health Plans — said companies are “planning to cover them without cost sharing.”
The vaccines would also be covered under Medicaid and Medicare Part B, according to the National Council on Aging
About the Writer
James Engel is a TribLive staff writer. He can be reached at jengel@triblive.com
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