Updated COVID vaccines: FDA announces emergency approval and authorization

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The U.S. Food and Drug Administration (FDA) announced on Monday that it has approved and authorized updated versions of mRNA COVID-19 vaccines for emergency use.The updated vaccines, which are manufactured by Pfizer and Moderna, are “formulated to more closely target currently circulating variants,” particularly the Omicron variant XBB.1.5.The vaccines have also been formulated to “provide better protection against serious consequences of COVID-19, including hospitalization and death,” according to a news release from the agency.COVID-19, FLU AND RSV VACCINES ARE ALL AVAILABLE THIS FALL: SEE WHAT SOME DOCTORS RECOMMEND AND WHYAnyone 5 years of age and older can receive a single dose of the updated vaccine as long as it is administered at least two months after their last COVID shot, the FDA stated.Children between 6 months and 4 years of age who have previously received a COVID vaccine can get one or two doses of an updated vaccine, depending on the timing and details of their previous doses. The U.S. Food and Drug Administration (FDA) announced on Monday that it has approved and authorized updated versions of mRNA COVID-19 vaccines for emergency use. (iStock)Unvaccinated children between 6 months and 4 years of age can receive three doses of the updated Pfizer vaccine or two doses of the updated Moderna vaccine, per the FDA.YET ANOTHER COVID VACCINE? AS BIDEN CALLS FOR NEW FUNDING, HEALTH EXPERTS SOUND OFF: ‘A SLIPPERY SLOPE'”Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” said Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research, in the agency’s announcement. “We very much encourage those who are eligible to consider getting vaccinated.” “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality,” he continued. “We very much encourage those who are eligible to consider getting vaccinated.” The vaccines have also been formulated to “provide better protection against serious consequences of COVID-19, including hospitalization and death,” according to the FDA. (Photographer: Michael Nagle/Bloomberg via Getty Images)The FDA’s actions “make the vaccine available for those who may need it because they are immunocompromised or have chronic diseases, cancer, obesity or heart or lung disease,” noted Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor.”The target group should be the elderly, obese, those with chronic illness and the immunocompromised.” “For most young, healthy people who have had previous vaccination, booster and COVID, however, the booster will not be necessary, in my opinion,” Siegel told Fox News Digital.”The target group should be the elderly, obese, those with chronic illness and the immunocompromised.” “For most young, healthy people who have had previous vaccination, booster and COVID, however, the booster will not be necessary, in my opinion,” Siegel told Fox News Digital. (iStock)Regarding the safety of the updated COVID vaccine, the FDA stated that “the benefit-risk profile of previously authorized and approved mRNA COVID-19 vaccines is well understood, as these vaccines have been administered to hundreds of millions of people in the United States.”CLICK HERE TO SIGN UP FOR OUR HEALTH NEWSLETTERThe agency also noted that although “serious outcomes from COVID-19 are less common in younger individuals, they do occur, and it has been demonstrated that recently receiving a COVID-19 vaccine reduces the risk of such serious outcomes.”Dr. Siegel noted that “the vaccine is a tool of prevention, and taking it or not should be a matter of personal choice.” With Monday’s announcement, “the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States,” the FDA said. (iStock)With Monday’s announcement, “the bivalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States,” the FDA said.It is expected that the updated vaccines will be available in the “near future,” the agency stated. The manufacturers have announced a timeline of this fall for availability.CLICK HERE TO GET THE FOX NEWS APPThe U.S. Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices plans to meet on Tuesday to discuss “clinical recommendations” for the updated vaccine, along with guidance for high-risk groups. Melissa Rudy is health editor and a member of the lifestyle team at Fox News Digital. 

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