FDA Clears New COVID-19 Vaccines in Bid to Counter Waning Effectiveness
U.S. drug regulators on Sept. 11 cleared new COVID-19 vaccines to try to counter the poor effectiveness provided by the current options.
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 shots target XBB.1.5, a subvariant of the Omicron virus variant. That subvariant has already largely been displaced by newer strains, including EG.5, according to the U.S. Centers for Disease Control and Prevention (CDC).
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.
The United Kingdom, for instance, in August, said that vaccination this fall was recommended only for select groups, including people designated as at-risk.
The CDC scaled back its recommendations earlier this year for some populations.
CDC Director Dr. Mandy Cohen said earlier this year that the CDC was poised to recommend annual COVID-19 shots.
Pfizer and Moderna have said the new shots will cost about $110 to $130.
Number of Shots
The 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.
Children in that age group who haven't been vaccinated can receive three doses of the new Pfizer vaccine or two doses of the new Moderna vaccine.
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