U.S. drug regulators on Sept. 11 cleared new COVID-19 vaccines to try to counter the poor effectiveness provided by the current options.
The U.S. Food and Drug Administration (FDA) cleared shots from Moderna and Pfizer that will be available to Americans as young as 6 months old later this month.
"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," Dr. Peter Marks, a top FDA official, said in a statement. "We very much encourage those who are eligible to consider getting vaccinated."
The FDA approved the Moderna and Pfizer vaccines for people aged 12 and older. Regulators granted emergency authorization for the shots for people aged 6 months to 11 years.
There was no mention of Novavax, whose vaccine is also currently available in the United States.
The authorizations came despite a dearth of data from clinical trials.
Moderna stated that in a trial, its new shot induced immune responses against EG.5, also known as Eris, and other newer variants.
Pfizer stated that preclinical data have shown that antibodies generated by its new vaccine "effectively neutralize" EG.5.
The new shots were authorized based on studies on neutralizing antibody levels that appeared to show "a similar magnitude to the extent of neutralization observed with prior versions of the vaccines against corresponding prior variants against which they had been developed to provide protection," the FDA stated. "This suggests that the vaccines are a good match for protecting against the currently circulating COVID-19 variants."
The CDC plans to meet with its advisers on Sept. 12 to consider which populations it should recommend receive the new vaccines. If the panel recommends a vaccine, the federal government must pay for it.
Many countries have suggested that younger, healthy people not receive COVID-19 vaccinations as the disease has died down.
Number of ShotsThe new vaccinations are cleared for varying numbers of shots, depending on age group and prior vaccination.
People aged 5 years and older, whether or not they've received a vaccine, are eligible to receive a single dose of one of the new shots.
Children aged 6 months through 4 years who have previously been vaccinated can receive one or two doses of one of the new vaccines.
Another ReplacementThe FDA cleared, and the CDC recommended, updated shots in the fall of 2022 amid waning effectiveness.
Those shots were bivalent, containing components of the Wuhan strain and Omicron.
The FDA stated that it expects to update the vaccines on an annual basis, as it does with influenza vaccines.
NovavaxNovavax said its newer shot performed well against newer variants, but the FDA didn't clear it. Novavax said in a statement that its updated vaccine is "under review" by the FDA.
"We still expect to be available this fall and anticipate we will be a player for the season," a Novavax spokesperson told The Epoch Times via email.
CriticismSome experts have criticized U.S. authorities for clearing the new shots without strong data.
"There's essentially no data," Florida Surgeon General Dr. Joseph Ladapo said at a recent press conference. "Not only that, but there are a lot of red flags."
Other papers have found that the vaccines cause cardiac problems such as heart inflammation, the doctor noted.
"It's truly irresponsible for FDA, CDC, and others to be championing something ... when we don't know the implications of it," he said.
"We are best served by targeting these booster doses to those who are most at risk of severe disease," such as people older than 75, Dr. Offit said. "Boosting otherwise healthy young people is a low-risk, low-reward strategy."