U.S. drug regulators on Sept. 11 authorized new COVID-19 vaccines to try to counter the poor effectiveness the current slate provide.
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 of age 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 of age.
There was no mention of Novavax, whose vaccine is also available in the United States.
The authorizations came despite a dearth of data from clinical trials.
Moderna says its new shot in a trial induced immune responses against EG.5 and other newer variants.
Pfizer says preclinical data has shown antibodies generated by its new vaccine “effectively neutralize” EG.5, also known as Eris.
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 said. “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 Tuesday to consider to which populations it should recommend receive the new vaccines. If the panel recommends a vaccine, the federal
Many countries have suggested younger, healthy people not to receive COVID-19 vaccinations as the disease has died down.
Pfizer and Moderna have said the new shots will cost approximately $110 to $130.
Number of Shots
The new shots 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.
Children in that age group who have not been vaccinated can receive three doses of the new Pfizer vaccine or two doses of the new Moderna vaccine.
The 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 said it expects to update the vaccines on an annual basis. That’s currently done for the influenza vaccines.
Other common reasons included wariness about side effects, belief the booster would not add protection, and belief the booster would not protect against infection.
Novavax had said its newer shot performed well against newer variants, but the FDA did not clear it. Novavax said in a statement that its updated vaccine is “under review” by the FDA, which did not respond to a request for comment. “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.
Some 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 told a recent press conference. “Not only that, but there are a lot of red flags.”
Other papers have found the vaccines cause cardiac problems like 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 over 75 years of age, Dr. Offit said. “Boosting otherwise healthy young people is a low-risk, low-reward strategy,” he added.