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September 11, 2023

New COVID-19 shots, approved by the FDA, to be available shortly

The vaccines have been updated to provide greater protection against the coronavirus variants that have caused an uptick in hospitalizations

Reformulated COVID-19 vaccines intended to offer better protection against the current subvariants have been approved by the U.S. Food and Drug Administration.  

The updated vaccines, manufactured by Moderna and Pfizer-BioNTech, will become available after the U.S. Centers for Disease Control and Prevention issues its recommendations – some time after a Tuesday meeting of its advisory committee on immunization practices. Moderna said that will occur "in the coming days."

MORE HEALTHWhen to get your flu shot, COVID-19 booster and RSV vaccine this fall

The vaccines were reformulated to target the Omicron subvariant XBB.1.5, which was dominant earlier this summer. The subvariants currently circulating are closely related. 

Here's who is expected to be eligible for the vaccines:

• People older than 5 can receive a single dose at least two months after their last doses of any COVID-19 vaccine. This is also the case for people who have never been vaccinated against COVID-19.

• Children 6 months to 4 years, who have been vaccinated against COVID-19, can get one or two doses of the updated vaccine. The timing and number of doses depends on which vaccine they previously received.

• Unvaccinated children 6 months to 4 years can receive three doses of the updated Pfizer-BioNTech vaccine or two doses of the updated Moderna vaccine. 

The new shots may cause side effects similar to the ones caused by previous COVID-19 vaccines, the FDA said. The federal agency said it is "confident" in the vaccines' safety and effectiveness, adding that COVID-19 shots may need to be updated annually, like flu shots. 

"Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated."

COVID-19 hospitalizations have been trending upward for several weeks, according to the CDC. Officials have attributed the uptick to summertime travel and hot weather forcing people indoors. Late last month, Philadelphia health officials warned residents to take "reasonable precautions" due to a slight increase in COVID hospitalization.

During the fall and winter months, respiratory illnesses like COVID-19, influenza and respiratory syncytial virus (RSV) typically rise. Last year, these three viruses overwhelmed hospitals, leading to the confluence of illness being dubbed the "tripledemic." Vaccines are available for each, though the RSV shot is limited to older adults and pregnant women. 

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