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FDA approves new COVID-19 vaccines. What you should know

Updated COVID-19 vaccines from Moderna and Pfizer-BioNTech should be available in the next few days. The U.S. Food and Drug Administration on Thursday approved the shots to combat the virus, which is surging in some areas.
The FDA said the vaccines have been updated to “better protect against currently circulating variants,” including KP.2, a subvariant of the easily spread JN.1. The virus keeps changing, hence the need for updated vaccines.
“The mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death,” the FDA said in an announcement.
NPR reported that “the Novavax vaccine, which is based on an older technology, targets an earlier strain called JN.1 and is expected to get the FDA’s stamp of approval soon, too.”
NPR noted that both vaccines take aim at strains that have recently been replaced by newer variants, but since all are part of the omicron group, “the hope is the vaccines are close enough to boost immunity and protect people through the rest of the surprisingly big summer wave and the surge expected this winter.”
“Vaccination continues to be the cornerstone of COVID-19 prevention,” Dr. Peter Marks, director of the agency’s Center for Biologics Evaluation and Research, said. “These updated vaccines meet the agency’s rigorous, scientific standards for safety, effectiveness and manufacturing quality. Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”
The FDA believes the risk of getting COVID-19 is reduced by as much as 70% for those who are current on vaccination, while the risk of being hospitalized or becoming severely ill is cut by as much as 90%.
The FDA has said that vaccination is a good idea for those 6 months and older, but timing can make a difference. For most people, given viral patterns in winter, the recommendation has been to get the shot in September or early October. A flu shot can be safely taken at the same time.
The updated mRNA shots are fully approved for anyone 12 and older. But there’s also an emergency use authorization for those 6 months to 11 years old.
Moderna’s just-approved updated vaccine is called Spikevax. Prizer-BioNTech’s is Comirnaty. Here’s the recommendation from the FDA:
The Centers for Disease Control and Prevention has reported “high” or “very high” levels of COVID-19 in wastewater pretty much nationwide, which is one way to see how widespread virus activity is in the U.S.
“Meanwhile, the CDC said about 4 people are being hospitalized for COVID for every 100,000 people in a given area. That’s up from about one COVID hospitalization for every 100,000 people in May, which was the lowest level since the pandemic began,” CNBC reported.
The CDC said just 22.5% of U.S. adults got the last round of updated shots, so it’s not clear what the reception will be for the latest shots.
According to The New York Times, “Even older Americans, who are at far greater risk of being severely sickened, largely spurned the shots, with only 40% of people 75 and older taking last year’s vaccine.”
But the FDA said new vaccine formulas should be expected annually as the virus continues to change.

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