FDA staff does not comment, saying that two doses can prevent serious diseases

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Maryland National Guard expert James Truong (left) injects Moderna coronavirus vaccine at CASA de Maryland Wheaton Welcome Center in Wheaton, Maryland on May 21, 2021.

Chip Somodevilla | Getty Images

Scientists from the US Food and Drug Administration refused on Tuesday to take a stand on whether to support Moderna’s Covid-19 vaccine booster, saying that data shows that two doses are still sufficient to prevent serious illness and death in the United States

They wrote in a 45-page document published on the agency’s website: “Some real-world effectiveness studies have shown that over time, the Moderna COVID-19 vaccine is effective against symptomatic infections or against Delta variants. Efficacy will decrease, while others will not.” “However, overall, the data shows that the COVID-19 vaccine currently licensed or authorized in the United States can still prevent severe COVID-19 illness and death.”

The FDA scientist’s report is intended to inform the agency’s vaccine and related biological product advisory committee, which met on Thursday to review Moderna’s request to remove the adult Covid booster dose. The published document provides a glimpse of the agency’s view of the third gun.

Less than a month after the meeting, the U.S. regulatory agency authorized Pfizer and BioNTech to intensify the injection of Covid vaccines to a wide range of Americans, including the elderly, adults with underlying diseases, and those working or living in high-risk environments such as health and groceries. People workers.

The FDA advisory group plans to discuss data on the safety and effectiveness of Moderna adult booster injections on Thursday with Johnson & Johnson on Friday. The agency may make a final decision within a few days after the meeting, and hand it over to the CDC and its vaccine advisory committee to make its own decision, which may be made next week.

Moderna applied to the FDA for a booster dose authorization on September 1. It stated that the third injection of half the dose of the first two injections was safe and that the immune response was stronger than that seen after the second injection in its phase in three clinical trials.

The Biden administration hopes that as the rapidly spreading delta variant continues to spread, providing additional doses to the U.S. population will also continue to ensure long-term and lasting protection against serious illness, hospitalization, and death.

This pressure has led to a surge in the number of hospitalizations in the United States, mainly those who have not been vaccinated. Nevertheless, according to data compiled by the CDC, as of September 20, some vaccinated Americans had suffered so-called breakthrough infections, of which only more than 19,000 (less than 1%) were hospitalized or died due to the new coronavirus.

This is a story of development. Please check for updates.

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