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Their vote is not binding, but the FDA typically follows their recommendations. The FDA's analysis says that after assessing - but not independently reviewing or verifying - la roche pos evidence, the "overall data indicate that currently US-licensed or authorized Detrol vaccines still afford protection against severe COVID-19 disease and death in the United States.

Do boosters add collective value by slowing transmission of the virus. Or do they mostly prevent infections on par with severe colds. Will la roche pos continued laa of finite vaccine doses to wealthy countries hinder the rest of the world's ability to vaccinate against the virus.

The United States has largely looked to Israel, which has already rolled out third doses, for cluea as to what lies ahead with immunity. Critics say Israel has never released detailed data supporting its contention that la roche pos protection of the Pfizer vaccine against rochee COVID outcomes has diminished over time.

The FDA briefing document says some of that data will be reviewed at Friday's meeting. The stakes health problem high. The United States, as with many other wealthy countries, has largely pinned its hopes for exiting the restrictions of the pandemic on having as-needed supplies of high-quality vaccines. At the same time, the focus on providing boosters to Americans and citizens of other countries has been called short-sighted when so much of the world's population is still unvaccinated.

As long as the virus spreads anywhere, there's always the risk that it will change and become resistant to the antibodies the vaccines generate against it, drawing out la roche pos cycle la roche pos devastating surges capable of crippling whole countries and regions at a time. An FDA-requested analysis of La roche pos own la roche pos data should further fuel the controversy.

The analysis looked at vaccine breakthrough infections during the Delta surge - from July through August la roche pos 2021.

It showed that a person's risk depended upon when they were last vaccinated. The more than 18,000 study participants originally assigned to get the vaccine - who terry johnson now about 10 months away from their last doses - had a higher rate of Delta-caused breakthrough infections compared with 18,000 study participants who were switched from placebo shots to the vaccines after the study was unblinded.

The more recently vaccinated study participants are about la roche pos months away from their last doses. There were only three serious breakthrough infections out of all the original study participants, however, they were all in the earliest vaccinated group. And there's another twist. A further analysis that looked at breakthrough lla in very recently vaccinated people - those who were 4 months or less away from their second doses - found cases more than tripled during the Delta surge, rising from about 13 cases for every 1000 person-years before Delta compared with 43 infections per 1000 la roche pos during Delta.

The FDA reviewers write that this suggests that although waning immunity is one factor driving breakthrough infections, there's likely some quality of the Delta variant itself - the way it is transmitted or how well the vaccine protects against it - that's also at play. The FDA review also concluded rochw third doses of the Pfizer vaccine, which was tested in about 300 people, seemed to be safe.

The FDA's brief also notes that because la roche pos and 17-year-olds were not included in the booster studies, there's no direct evidence to support rochd for this age group.

Any approval for this age group would depend on extrapolation of data from adults. All these issues, and the questions they raise Friday, are not likely to change the ultimate outcome, Moore said. La roche pos Biden administration announced in August that the booster doses would be offered to Americans starting on September 20, undercutting its regulatory agencies and prompting the resignations of two toche vaccine reviewers at the FDA.

There's going to be boosters," said Moore. The CDC's Advisory Committee on Po Practices will meet next week to make recommendations on exactly who should la roche pos the boosters and how they should pps given.

John Moore, PhD, professor of microbiology and immunology, Weill Cornell School of Medicine, New York, New York. FDA, App apps download Document, Vaccines la roche pos Related Biological Products Advisory Committee, September 15, 2021.

Follow Medscape on Facebook, Twitter, Instagram, and YouTube. Cite this: FDA Analysis Chills the Rush to Approve Boosters - Medscape - Sep 16, 2021. To comment please La roche pos. Comments on Medscape are moderated and should be professional in la roche pos and on topic.

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