FDA advisers call for specific consideration of JN.1 strain in fall COVID vaccine formulation
Government advisers said it is time to update the formula of the COVID-19 vaccines that Americans will receive in the fall, with the goal being a version called JN.1.
Scripps News
People ages 6 months and older should get their COVID-19 and flu vaccinations updated this fall, the Centers for Disease Control and Prevention announced Thursday.
The unanimous decision by a CDC advisory panel suggests that the federal health agency’s guidance on the SARS-CoV-2 pandemic will be similar to that for other respiratory diseases, such as seasonal flu and respiratory syncytial virus (RSV), for the foreseeable future. The CDC’s Advisory Committee on Immunization Practices (ACIP) also recommended routine seasonal flu vaccinations for people 6 months of age and older to combat three strains of influenza A that were prevalent last winter season.
“Our most important recommendation to protect yourself and your loved ones from respiratory illness is to get vaccinated,” said Dr. Mandy Cohen, director of the CDC, which supported the recommendations, in a statement. “Make a plan now for yourself and your family to get both up-to-date flu and COVID vaccines this fall, before respiratory virus season.”
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More than four years after the COVID-19 pandemic began, fewer people are receiving new vaccines. As of May, less than a quarter of American adults have received the latest COVID-19 shot, according to CDC data. Panelists expressed concern that the CDC’s Bridge Access Program, which provided free COVID-19 vaccines to the uninsured and underinsured, will end in August before the rollout of the updated COVID-19 shot.
Although the number of cases is nowhere near what it was in 2020 or 2021, the virus continues to mutate to survive, and the U.S. is currently seeing a surge in cases with new subvariants. COVID-19 and the flu should be taken seriously, the agency said. In 2023, over 916,300 people were hospitalized with COVID-19, according to the CDC, and 75,500 died from the disease. In contrast, nearly 45,000 people died from flu complications in 2023.
According to the CDC, people who have received the last COVID-19 vaccination are better protected from emergency room and hospital visits than people who have not received the vaccination. The COVID-19 vaccination also reduces the risk of developing long COVID, which can occur after severe illness.
Updated vaccines provide targeted protection because immunity from previous vaccination or infection wanes over time. The last vaccine targeted a specific variant, so a new vaccine targeting newer dominant strains is needed. At its last ACIP meeting in February, it recommended that adults 65 and older receive a booster shot with the fall 2023 version of the vaccine.
Health experts believe COVID-19 is here to stay. A dose of the updated vaccine before the expected winter peaks in viral spread may help prevent illness and serious complications from COVID-19.
“The virus is not over,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of a Food and Drug Administration panel that recently advised which COVID-19 lineage the new vaccines should target. “This virus will now join other respiratory diseases that cause hundreds of thousands of cases and tens of thousands of deaths each year.”
Offit added that people in high-risk groups should consider getting vaccinated to avoid severe illness or death. These include people 65 and older, immunocompromised people and pregnant women.
In March, the CDC released updated guidelines on COVID-19 isolation that are more consistent with its recommendations on other respiratory illnesses. The reasoning is that COVID-19 spreads and causes illness in the same way as the seasonal flu and RSV. On Wednesday, the CDC also updated its guidelines on RSV vaccinations for people ages 60 and older. People ages 75 and older should get vaccinated against RSV, and people ages 60 to 74 should get the shot if they are at increased risk for RSV because of lung or heart disease or other chronic medical problems, or if they live in a nursing home, the CDC said.
The number of recommended vaccinations could confuse the public, said Dr. Steven Furr, president of the American Academy of Family Physicians, a non-voting organization in ACIP. Part of the idea for the future is for health experts to establish a routine vaccination cycle so people can get used to getting vaccinated against COVID-19, he said.
“We’re going to get everyone on a regular schedule,” Furr said. “You can understand that every fall I get my flu shot and I get my COVID update.”
In early June, an FDA advisory panel recommended developing vaccines against the JN.1 lineage of SARS-CoV-2. JN.1 dominated case numbers last winter, although its subvariants – known as FLiRT, named for genetic mutations – now account for the most cases. In an update, the FDA recommended that vaccine makers also target the JN.1 subvariant KP.2.
The updated COVID-19 vaccine is expected in August or September.
