FDA Approves New COVID-19 Vaccines

The U.S. Food and Drug Administration (FDA) on Aug. 22 approved new COVID-19 vaccines from Moderna and Pfizer-BioNTech.
The shots, based on messenger ribonucleic acid technology (mRNA), target the KP.2 strain.
“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.”
Critics noted that no clinical trial data has been released for the vaccines.
“Dr. Marks’ statement that ’these updated vaccines meet the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality’ rings hollow when FDA has not required manufacturers of the mRNA biological [products] to provide scientific evidence to the public that safety and effectiveness has been demonstrated,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times via email.
Manufacturers have said that testing in animals shows the shots trigger neutralizing antibodies.
The FDA in the fall of 2023 cleared the previous round of COVID-19 vaccines. But, according to federal data, the protection from those shots plummeted over time.
That data and other information prompted the FDA to follow the recommendation of its advisers and over the summer direct manufacturers to update their vaccines.
Moderna and Pfizer opted to target KP.2. A forthcoming vaccine from Novavax is expected to target JN.1.
“The mRNA COVID-19 vaccines have been administered to hundreds of millions of people in the U.S., and the benefits of these vaccines continue to outweigh their risks,” the FDA said.
Side effects of the vaccines include heart inflammation and headache.
Officials have said they plan to clear new shots every fall, similar to the cadence for influenza vaccines.
Under Thursday’s move, children aged 6 months to 4 years of age who have never been vaccinated can receive three doses of the Pfizer vaccine and two doses of the Moderna vaccine. Those who have previously received a COVID-19 vaccine can receive one or two doses of either shot.
People aged 5 and up can receive a single dose of either vaccine, regardless of prior vaccination.
Pfizer has not yet reacted to the clearance.
Stephane Bancel, Moderna’s CEO, said that the Massachusetts company welcomed the move.
Moderna said it expects its vaccine to be available to the public within days.
The most prevalent variant at this time is KP.3, followed by KP.2.3 and LB.1, according to CDC genomic data. Estimates for the two weeks ending on Aug. 17 pegged KP.3.1.1 as being the most prevalent variant.
A spokesperson for the CDC told The Epoch Times in an email that KP.3.1.1 “is very similar to other circulating variants in the United States, and all current lineages are descendants of JN.1, which emerged in late 2023.”