FDA Approves New COVID Shots as Cases Rise

The US Food and Drug Administration on Monday approved new COVID booster shots from both Pfizer and Moderna as cases have been rising in the US. The updated boosters take aim at an omicron subvariant known as XBB.1.5.

If the boosters are cleared on Tuesday by the Centers for Disease Control and Prevention, which recommends who should get a shot, they could be available in the coming days. The CDC usually makes special considerations for specific groups like older adults and immunocompromised people.

The FDA says people ages 5 or older can take the new booster, regardless of previous vaccination status and if it’s been at least 2 months since the last dose of a COVID vaccine shot. Those aged 6 months though 4 years who have been vaccinated previously against COVID can receive 1 or 2 doses of the new, updated vaccine, depending on which vaccine they received previously. If they haven’t been previously vaccinated, then they’re eligible to receive three shots of Pfizer or two shots of Moderna. 

The new vaccines have full approval for people 12 and up and are authorized under emergency use for children 6 months through 11 years. 

Just like with previous vaccines, people should expect body aches, headaches and general tiredness. 

“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality.”

Unlike previous COVID spikes, there isn’t expected to be a “tsunami of hospitalizations and deaths the way we saw a year or more ago,” Dr. Anthony Fauci, formerly the White House’s top pandemic advisor, said in an interview with ABC News last week. Given that there’s a large number of people who’ve been vaccinated or have previously contracted the disease, the widespread immunity means that “chances of this being an overwhelming rush of cases and hospitalizations is probably low,” Fauci said.

For those who recently contracted COVID, the CDC currently suggests waiting three months from when their symptoms started to get a booster. 


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