Sunday, September 19, 2021

Key data on U.S. J&J, Moderna COVID-19 boosters weeks away, Fauci says

The leading expert on infectious diseases, Dr. Anthony Fauci, responds to allegations made by Senator Rand Paul (R-KY) as he testifies before the Senate Health, Education, Labor, and Pensions Committee on Capitol Hill in Washington, DC, the United States, on July 20, 2021 J. Scott Applewhite / Pool via REUTERS

WASHINGTON, Sept. 19 (Reuters) – The data needed to determine the advisability of booster vaccines for COVID-19 vaccines from Moderna Inc (MRNA.O) and Johnson & Johnson (JNJ.N) remains few Weeks away, President Joe Biden’s senior medical advisor said Dr. Anthony Fauci on Sunday.

Health officials signaled that they expected boosters to ultimately be recommended for a large segment of the population, but urged Americans not to apply for booster doses until they have FDA approval.

“We recommend that people wait until you get to the point where you fall into the category where it is recommended,” he told CNN.

On Friday, an advisory panel to the Food and Drug Administration recommended a third vaccination of the Pfizer (PFE.N) / BioNTech (22UAy.DE) vaccine with two doses for people 65 years of age or at high risk for severe COVID-19, but declined To advocate boosters for the wider population. Continue reading

Although the FDA is not bound by the panel’s recommendation, it will consider it when deciding whether to recommend a third round of vaccination.

“This is not the end of the story,” Fauci told CNN’s State of the Union. “You will continue to literally watch this in real time,” added Fauci.

People who have received the two-dose Moderna vaccine or the one-dose J&J vaccine are still waiting for guidance on possible booster vaccinations.

“The actual dates we’re getting (on) the third intake for the Moderna and the second intake for the J&J are literally a few to a few weeks away,” Fauci told NBC’s Meet the Press program.

“We are working on getting the data to the FDA so they can investigate and make a decision about the boosters for these people,” added Fauci.

More data could also show a wider need for booster syringes across the U.S. population, Fauci said.

The United States leads the world in total reported COVID-19 cases and deaths. Nearly 676,000 people died during the U.S. pandemic, figures compiled by Reuters showed. A surge in cases and deaths in the US in recent months has been most acute in areas with lower vaccination rates, even when federal health officials urge vaccines to get their vaccinations.

In August, Biden announced the government’s intention to introduce booster vaccinations for people aged 16 and over pending approval from the FDA and the experts at the Centers for Disease Control and Prevention.

The FDA’s decision-making process doesn’t negate the White House’s position of favoring boosters, Fauci said, saying the plan is always dependent on the FDA’s regulatory process.

Dr. Francis Collins, director of the US National Institutes of Health, said on Fox News Sunday that he expects that “it will become clear in the next few weeks that booster administration may need to be expanded,” citing available data from the United States and Israel, suggesting that the vaccine may be less effective over time.

Officials also signaled that the schedule for vaccine approval for children ages 5-11 is in the coming weeks.

“For children between the ages of 5 and 11, the data is due in by the end of this month and the FDA will be working around the clock to go through it,” said Collins. “So we all hope this can be done in weeks, not months.”

Reporting by Sarah N. Lynch, David Lawder, and Chris Prentice; Editing by Will Dunham and Lisa Shumaker

Our Standards: The Thomson Reuters Trust Principles.



source https://www.bisayanews.com/2021/09/19/key-data-on-u-s-jj-moderna-covid-19-boosters-weeks-away-fauci-says/

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