FDA Approves Updated COVID-19 Vaccines
An infectious disease expert explains why it’s important to get the new COVID vaccine that target the circulating variants.
The Food and Drug Administration (FDA) recently approved updated COVID-19 vaccines that target currently circulating variants, such as the KP.2 strain, and provide better protection against severe disease amid a rise in cases during the past few months.
In June 2024, the Centers for Disease Control and Prevention (CDC) issued recommendations for individuals six months and older to get vaccinated with the updated shots once they became available. People can get the vaccines — manufactured by Moderna and Pfizer-BioNTech — at their doctor’s office or at local pharmacies.
“It is important to get vaccinated with one of the updated formulations to stay protected from COVID and stay up to date with other vaccines, such for the flu and RSV,” says Dr. Magdalena Sobieszczyk, chief of the Division of Infectious Diseases at NewYork-Presbyterian/Columbia University Irving Medical Center. “Compared to older formulations, the updated shots improve protection by creating an immune response in our bodies against new variants.”
Dr. Magdalena Sobieszczyk
According to the CDC, older adults are at highest risk of severe disease from COVID-19 – more than 81% of COVID-19 deaths occur in those over 65. People who are immunosuppressed or who are taking medications that weaken their immune system may not be protected, even if they are up to date with vaccinations, the CDC also notes. “Older adults and immunocompromised people should talk with their healthcare provider about getting additional doses of the new vaccines, instead of just one,” advises Dr. Sobieszczyk. “This will better protect against new variants as the virus continues to evolve.”
For people who got vaccinated with a previous formulation recently, clinicians can help determine the best time to receive one of the updated vaccines. And if they had COVID-19, the CDC recommends delaying vaccination by three months since they first had symptoms or a positive test.
Who is Eligible for the Updated COVID-19 Vaccine
- People 12 years of age and older are eligible to receive a single dose. If they were previously vaccinated, the dose is administered at least two months since the last one.
- Additional doses are authorized for certain immunocompromised individuals ages six months through 11 years of age.
- For those six months through four years of age who have previously been vaccinated, they are eligible to receive one or two doses of the updated vaccines. Timing and number of doses to administer depends on the previous vaccine received.
- Children five years through 11 years of age are eligible to receive a single dose regardless of previous vaccination. If they were previously vaccinated, the dose can be given at least two months after the last dose.
- Unvaccinated individuals six months through four years of age can receive three doses of the updated Pfizer-BioNTech vaccine or two doses of the updated Moderna vaccine.
Source: FDA
A CDC report released in February 2024 shared that previous updated vaccines have provided 54% protection against symptomatic infection, compared with no receipt of updated vaccines. “We have seen good data that updated vaccines can elicit robust antibodies against current and emerging SARS-CoV-2 variants,” says Dr. Sobieszczyk. “That is good news for effectiveness of the vaccine in preventing some degree of infection and severe disease.”
In recent months, there has been a surge in COVID-19 cases, and the increase has been due to new variants that spread more easily. In June 2024, the FDA issued guidance to vaccine manufacturers to update their formulation targeting the KP.2 strain, which descends from the JN.1 lineage of the Omicron variant. The KP.2 strain is one of several that have accounted for most of the cases recently.
Similar to the yearly flu vaccine, the FDA will meet on an annual basis to understand how COVID is evolving, review data on circulating strains, and advise manufacturers on which strains should be selected for the vaccine each year.
“Updating the vaccine composition might be a continuous process given that COVID is mutating a lot,” says Dr. Sobieszczyk. “Getting vaccinated with an updated shot will not only benefit the individual but also the community around them. While the vaccine does not eliminate the risk of getting COVID, it makes the virus mild, shortens the duration of infection, lowers the risk of transmitting it to others, and protects those who are more vulnerable from severe disease.”
Magdalena Sobieszczyk, M.D., is the chief of the Division of Infectious Diseases at NewYork-Presbyterian/Columbia University Irving Medical Center and is the Harold Neu professor of infectious diseases in medicine at Columbia University Vagelos College of Physicians and Surgeons. Dr. Sobieszczyk is also a clinical virologist and the principal investigator of the Columbia Collaborative Clinical Trials Unit, funded by the National Institutes of Health, which has been advancing the science of infections like SARS-CoV-2 and HIV.