New FDA-approved COVID vaccines from Pfizer, Moderna target latest varients

Aug. 22 (UPI) -- The Food and Drug Administration on Thursday approved updated COVID-19 vaccines for people 6 months and older that target new circulating variants.

The mRNA COVID-19 vaccines are manufactured by Pfizer-BioNTech and Moderna, who plan to have them available in a few days. The formula will "more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death," the FDA said in a news release.

On June 5 , an FDA advisory panel recommended updating the formula for COVID-19 vaccines. They advised manufacturers they should make monovalent JN.1 vaccines. The lineage for the COVID-19 vaccines is the KP.2 strain, which is a descendant of the Omicron subvariant.

The FDA says vaccines will need to be assessed annually, like for seasonal influenza vaccines.

"Vaccination continues to be the cornerstone of COVID-19 prevention," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said. "These updated vaccines meet the agency's rigorous, scientific standards for safety, effectiveness, and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants."

KP.2 was the dominant strain in May and accounts for roughly 3% of all U.S. cases as of Saturday, according to the latest Centers for Disease Control and Prevention data .

The CDC no longer tracks cases but examines SARS-CoV-2 levels in sewage, and limited data from hospitals and states. Cases now are hard to track because most people get tests at home and the results are not reported to state health agencies.

In the last cases update from the CDC on May 11, 2023, there were more than 103 million infections with more than 1.1 million deaths.

Pfizer said it plans to begin shipping its new vaccine immediately and expects it to be available in pharmacies, hospitals and clinics throughout the United States "beginning in the coming days," the company said in a statement .

And Moderna also said it expects its vaccines to be available in the coming days, as well.

"Staying up to date with your COVID-19 vaccine remains one of the best ways for people to be protected and prevent severe illness," Moderna CEO Stephane Bancel said in a statement . "We appreciate the U.S. FDA's timely review and encourage individuals to speak to their healthcare providers about receiving their updated COVID-19 vaccine alongside their flu shot this fall."

Updated vaccines include Comirnaty and Spikevax, which are approved for individuals 12 years of age and older. They vaccines are authorized for emergency use for individuals 6 months through 11.

The FDA lists vaccines dosages level for age groups.

Like with the other vaccine versions, the FDA said individuals may experience similar side effects as those reported by individuals who previously received mRNA COVID-19 vaccines.

About 22.5% of U.S. adults received the latest round of shots that rolled out last fall, according to the CDC in May .

The FDA issued Emergency Use Authorization for the Pfizer-BioNTech vaccine on Dec. 11, 2020, and for the Moderna vaccine on Dec. 18, 2020.

In RNA technology, cells are taught to make proteins that trigger an immune response against COVID.

Earlier this month , Health and Human Services announced a national campaign to increase public awareness of common respiratory viruses and available vaccines. Health officials said they hope the campaign, called "Risk Less. Do More," will reduce serious illnesses from the flu, COVID-19, and respiratory syncytial viruses in high-risk populations, as well as limit the spread of the virus in the United States.