COVID-19 vaccines are updated and ready for fall, FDA says

Millions of updated COVID-19 vaccines will soon be ready for patients following Food and Drug Administration approval announced on Thursday.

The updated vaccines from Pfizer and Moderna for people ages 6 months and older come amid a summer surge in COVID-19 cases across the U.S. Walgreens and CVS, two of the largest chains, previously told USA TODAY shipments of the vaccines could arrive a few days after FDA approval.

The new vaccines are designed to target the most dominant recent variants of the virus and protect against serious illness. Getting the shot now will offer protection when the anticipated winter surge comes and other respiratory illnesses become more prevalent, as people congregate indoors.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

In June, a federal advisory panel said new vaccines against COVID-19 should target the JN.1 lineage, and the FDA recommended manufacturers also target the JN.1 subvariant KP.2.

Pfizer, Moderna and Novavax previously told federal regulators their vaccines would be available in August pending the FDA's approval. Pfizer and Moderna's vaccines will target the subvariant KP.2 using an updated messenger RNA technology.

Novavax, whose vaccine hasn't yet been approved this year, uses a traditional protein-based vaccine against the JN.1 lineage, which should provide an immune response against circulating subvariants.

In a statement, Novavax said it expected its pre-filled syringes would be available “in time for peak vaccination season.”

People in higher risk groups – including people 65 and up and those with chronic health conditions, organ transplants or cancer – should get their shots as soon as possible, said Dr. James Cutrell, an associate professor of medicine and an infectious disease specialist at the University of Texas Southwestern Medical Center, in Dallas. These groups tend to be at greater risk of serious illness or death from COVID-19. They are eligible for vaccination every four months.

Even if people got last year's shot, COVID-19 vaccine protection wanes over time. Also, experts say it's important to get the updated shot because it targets the latest circulating variants.

"Each time you get a vaccine, it's kind of reminding your immune system of, 'Hey, this is still around,'" Cutrell told USA TODAY. "If we see it, we need to be ready to kind of fight against it."

The KP.3.1.1 subvariant appears to dominate the latest estimates of virus circulating in the U.S. SARS-CoV-2, like any virus, is constantly changing in its genetic makeup to survive. KP.3.1.1 is part of a JN.1 subvariant, so updated vaccines should protect against the circulating variant. Similar to JN.1 and its subvariants, KP.3.1.1 descends from the omicron variant that surged cases and deaths in late 2021.

Last year, updated vaccines targeted XBB.1.5, another offshoot of omicron. Despite continued cases and deaths from COVID-19, the number of people who've gotten vaccinated in the U.S. has fallen dramatically. Just 14% of children ages 6 months to 17 years old were up-to-date with the latest vaccine as of May, a federal panel said. The percentage of adults who got their shots was 22.5%.

COVID-19 cases, hospitalizations and deaths are nowhere near the levels they reached early in the pandemic. However, an infection still presents serious risks to many. Last season, more than 916,300 people were hospitalized with COVID-19, and 75,500 died from the disease, according to the Centers for Disease Control and Prevention.

Dr. David Margolius, director of public health for Cleveland, said questions remain about vaccine supply and recommendations for priority groups. After the public health emergency expired in 2023, there were challenges with the rollout of last year’s updated vaccines due to vaccine supply and insurance coverage. Getting vaccines this year likely won’t be as easy as earlier in the pandemic, he said.

“We tried to learn from mistakes last year about setting expectations, about how quickly things will roll out,” he told USA TODAY. “There’s still going to be a learning curve.”

As the updated vaccines become available, critical routes for people to get free shots may be limited. The $1.1 billion Bridge Access Program, launched last September, allowed uninsured and underinsured people in the U.S. to get free COVID-19 vaccines. The program provided 1.5 million people with shots, but it ends Aug. 31, months earlier than expected.

Instead, the CDC will distribute $62 million of "unused vaccine contract money" to local and state health departments to provide updated vaccines to people who are uninsured and underinsured, an agency spokesperson said.

Until a replacement program can be found, the Galveston County Health District, in Texas, noted in a news release Thursday that "access to free vaccines for adults without insurance will be extremely limited."

Constance Almendarez, manager of immunizations for Galveston County, told USA TODAY this will likely make vaccine access difficult as there is still virus circulating and mutating.

“The concern is that we may have some bumpy roads here for those (who) are uninsured and underinsured," she said.

Contributing: Ken Alltucker, Adrianna Rodriguez

This article originally appeared on USA TODAY: FDA approves updated COVID vaccines for fall