FDA approves new COVID vaccines for fall

Update: On Thursday, Aug. 22, the Food and Drug Administration approved Pfizer/BioNTech and Moderna vaccines for Americans to receive updated COVID-19 shots.

As COVID-19 settles into a permanent presence in our lives, annual vaccinations are becoming the norm.

Earlier this month, an official from the Centers for Disease Control and Prevention (CDC) declared COVID-19 “endemic,” indicating that the virus is here to stay. As of the Aug. 13 update, COVID-19 cases are on the rise in 25 states, including Pennsylvania, according to the CDC’s latest report.

On Aug. 10, the percentage of positive COVID cases in the U.S. reached its highest level since January 2022. However, the number of people dying of COVID in the United States are currently in the low hundreds compared to January and February 2022, when more than 10,000 people were dying of COVID every week

COVID is still the 10th-highest cause of death in the U.S., down from third in March 2020, as the pandemic was starting.

Paul Offit, an internationally recognized pediatrician specializing in infectious diseases, said these low number of deaths despite high percentage of positive cases is the goal with vaccination.

“The goal of this vaccine is to keep people out of the hospital, out of the intensive care unit, and out of the morgue,” said Offit, who is director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “Because antibody responses are relatively short-lived, four to six months, it’s possible you’re going to get COVID again. Most people you know have probably had COVID more than once, but they’re still alive because of vaccines and immunological memory.”

This year, the CDC advised vaccine manufacturers to develop vaccines that target the KP.2 strain of COVID-19, a subvariant of JN.1-lineage strains, including KP.3.1.1, KP.3, and KP.2 variants, which are now responsible for most infections in the U.S., according to the CDC.

KP.3.1.1 is now the predominant COVID-19 variant.

“In theory, both the mRNA and Novavax vaccine should be available shortly,” Offit said several days ago, accurately predicting the FDA’s approval on Thursday of this year’s vaccine.

Shipments will begin soon from Moderna and Pfizer/BioNTech of mRNA vaccines; those have a three-month production timeline that necessitates that manufacturers and the CDC meet in June each year to have vaccines produced by the fall.

The Novavax vaccine takes longer to produce.

Once the vaccines are approved by the Food and Drug Administration, the CDC recommends that everyone 6 months and older receive the updated 2024-2025 COVID-19 vaccine, including those who have previously been vaccinated.

Many of the CDC guidelines people got used to years ago are no longer in place. The CDC now generally recommends staying up-to-date on vaccinations, staying home when sick, and seeking health care if you are at risk for severe illness.

COVID-19 cases are no longer required to be reported to or tracked by Pennsylvania’s Department of Health. However, officials recommend testing for COVID-19 when sick and seeking treatment if at risk.

When you’re sick:

When you can go back to normal activities: