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FDA Authorizes New COVID-19 Boosters

The booster will be available to anyone ages five and older regardless of previous vaccine history

The Food and Drug Administration gave its stamp of approval to new COVID-19 vaccine booster shots from Pfizer and Moderna which are designed to target the latest variant of the virus.

The shots could be publicly available later in the week pending approval from the Centers for Disease Control and Prevention. 

The vaccine can be taken by anyone ages five and older – regardless of if they have been previously vaccinated. Children between six months and four years old who have been previously vaccinated can receive one or two doses of the vaccine. 

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, in a Sept. 11 press release. “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.”

The FDA said it was “confident in the safety and effectiveness of these updated vaccines” which are “expected to provide good protection against COVID-19 from the currently circulating variants.”

“Barring the emergence of a markedly more virulent variant, the FDA anticipates that the composition of COVID-19 vaccines may need to be updated annually, as is done for the seasonal influenza vaccine.”

Concerns about the XBB.1.5 subvariant and potential late-summer surge in the prevalence of COVID-19 may increase public interest in the new booster shot. 

According to Yale Medicine, there is no evidence that the variant causes a more severe form of COVID-19 but it is the most transmissible Omicron strain to emerge so far. Yale noted that “Omicron strains have tended to be mostly mild, causing a runny nose, sore throat, and other cold-like symptoms, as opposed to lower respiratory tract symptoms,” but that some infected people “have still developed severe disease and had to go to the hospital, and some died.”

There are multiple documented subvariants of COVID-19 circulating in the United States, including BA.2.86 and XBB.1.16.

Some experts have warned that an increase in hospitalizations and the state of wastewater are clear signs of an impending surge in COVID-19 cases.

“The wastewater is giving us a pretty clear picture that there has been, you know, quite an uptick in cases in these communities that we’re monitoring recently,” Marlene Wolfe, an assistant professor of environmental health at Emory University and program director for WastewaterSCAN, told NBC News. WastewaterSCAN monitors 171 wastewater treatment sites in 34 states.

“We are in a period of higher levels of SARS-CoV-2 in wastewater right now, and that’s associated with an increase in the number of cases in the community,” she said.

The FDA is still reviewing a COVID-19 vaccine from Novavax that, unlike the Moderna and Pfizer options, does not use mRNA technology.

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