Food and Drug Administration scientists on Tuesday declined to take a stance on whether booster shots of the Covid-19 vaccine should be supported by Moderna, saying the data shows that two doses are still enough to last in the U.S. protect against serious illness and death
“Some real-world efficacy studies have shown that the Moderna-COVID-19 vaccine wears off over time against symptomatic infections or against the Delta variant, while others have not,” they wrote in a 45-page publication Document published on the Agency’s website. “However, overall the data shows that COVID-19 vaccines currently licensed or approved in the United States still provide protection from severe COVID-19 illness and death in the United States.”
FDA staff also did not take a stance on Pfizer’s Covid Booster vaccinations last month. That hasn’t stopped the Agency’s Advisory Committee on Vaccines and Related Biological Products from recommending third vaccinations. The committee rejected Pfizer’s original plan to distribute the boosters to everyone aged 16 and over, narrowing it down to those most at risk from Covid, including the elderly and those with other health problems. FDA officials later expanded eligibility to include those who worked or lived in environments that put them at high risk of exposure, such as healthcare workers and grocery store workers.
Maryland National Guard specialist James Truong (L) administered Jan.
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The report by FDA scientists is set to brief the committee, which will meet on Thursday to review Moderna’s application to clear the Covid booster doses for adults. The published documents give an insight into the agency’s perspective on third recordings.
The meeting comes less than a month after U.S. regulators approved Covid booster shots of Pfizer and BioNTech’s vaccine for a wide variety of Americans, including the elderly, adults with pre-existing medical conditions, and those in high-risk environments like health and Grocery store worker.
The FDA advisory group is due to discuss data on the safety and effectiveness of the booster vaccination of Moderna in adults on Thursday and that of Johnson & Johnson on Friday. The agency could make a final decision within days of the meetings and hand that over to the Centers for Disease Control and Prevention and their Vaccine Advisory Committee, likely to make their own decision next week.
Moderna applied to the FDA for approval of a booster vaccination on September 1st. The company said the results are based on a clinical study of about 170 adults, fewer than the 318 people screened for Pfizer’s booster vaccination. Moderna said a third shot at half the dose used for the first two injections was safe and elicited a stronger immune response than after the second dose in its phase 3 clinical trial.
Moderna is asking the FDA to release boosters for the same vulnerable groups eligible to receive the third dose of Pfizer – people 65 and over, adults at high risk for severe Covid cases, and workers over 18 who are at an increased likelihood of occupational exposure to it the virus.
The side effects of Moderna’s boosters were similar to those after the second dose, the company wrote in a separate document released Tuesday by the FDA. Most of the side effects were of minor severity, and Moderna reported no cases of rare heart inflammation, myocarditis, or pericarditis in subjects for up to 29 days after receiving the booster.
The Biden administration hopes the extra dose will continue to provide long-term, permanent protection from serious illness, hospitalization and death for the U.S. population as the fast-paced Delta variant continues to spread.
The exposure led to an increase in hospital admissions in the US, mainly among the unvaccinated. Still, some vaccinated Americans have suffered what are known as breakthrough infections and, according to the CDC, only more than 19,000 of them – less than 1% – had been hospitalized or died of Covid by September 20.