FDA employees take no stance, say two doses protect against serious illness

Texas News Today

Food and Drug Administration scientists on Tuesday declined to take a position on whether to endorse Modana’s COVID-19 vaccine booster shot, data that protects against serious illness and death in the United States, saying two doses are currently available. are also sufficient.

“Several real-world efficacy studies have suggested low efficacy of the Moderna COVID-19 vaccine against symptomatic infections or delta variants, but some do not,” the agency’s website said. It is written in a published 45-page document. “But overall, the data show that a COVID-19 vaccine currently licensed or licensed in the United States still provides protection against serious COVID-19 illness and death in the United States.”

Similarly, FDA employees were not taking a stand on Pfizer’s COVID booster shot last month. The agency’s Vaccines and Related Biological Products Advisory Board declined to deliver on Pfizer’s original plan to distribute the third shot to anyone over the age of 16, including the elderly and people with other health conditions. Returned it to those at highest risk. FDA officials later expanded eligibility to include people working or living in high-risk environments, such as medical and grocery workers.

The FDA’s scientific report is intended to outline the committee’s meeting on Thursday. The published document gives a glimpse of the agency’s approach to the third shot.

At this conference, US regulators will use Pfizer and BioNTech Vaccine COVID booster shots for seniors, adults with underlying disease, and people working or living in high-risk environments such as health and food. It will be held less than a month after it was approved by a wide range of Americans, including worker.

The FDA advisory group will discuss data on the safety and effectiveness of J&J booster shots with Moderna Booster taken in adults on Thursday. Officials can make a final decision within days of the meeting and hand it over to the CDC and its Vaccine Advisory Board to make their decision, perhaps next week.

Moderna filed with the FDA on September 1 for approval of the additional dosage. Three clinical trials stated that the third injection, half the dose used for the first two jabs, was safe and that there was a stronger immune response at that level than was seen after the second dose. ..

The Biden administration hopes to continue to provide long-term and lasting protection against serious illness, hospitalization and death as the rapidly growing delta variant continues to spread by delivering additional doses to the US population. Growth.

This strain has led to an increase in hospitalizations in the United States, primarily among non-vaccinated individuals. Still, some vaccinated Americans suffer from so-called breakthrough infections, according to data compiled by the CDC, with just 19,000 (less than 1%) hospitalized in Covid as of September 19. or dead.

This is a developing story. Please check update.

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