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FDA panel urges Pfizer vaccine for kids; COVAXIN US trials: Updates

Orignally published on 2021-10-27 13:12:12 by rssfeeds.usatoday.com

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After a discussion where it was pointed out that more than 40% of American children ages 5 to 11 had contracted COVID-19 by the end of June, a panel of Food and Drug Administration advisers voted 17-0 Tuesday to authorize the Pfizer-BioNTech coronavirus vaccine for kids that age.

The resounding support is a major step forward for making school-age children eligible for inoculation — likely by next week — but there are still three crucial hurdles to clear: The FDA will have to sign off, an independent CDC advisory panel will review the data, and then the CDC director would have to give her clearance.

Pfizer-BioNTech reported 10 micrograms of their vaccine, a third of the dose administered to adults, is 90.7% effective at preventing symptomatic COVID, a growing concern for children. 

One study presented by the CDC found that 42% of children ages 5 to 11 in the U.S. had been infected with COVID-19 as of the end of June. Support for the children’s vaccine comes as a USA TODAY analysis of data from Johns Hopkins University shows that new coronavirus infections are down 56.8% nationwide since the delta variant surge peaked in the first week of September.

Also in the news:

► Australian Health Minister Greg Hunt announced that double-vaccinated Australians will be allowed to travel abroad and/or return home starting Monday. Many families have been split apart by the tight border closure that went into effect in March 2020.

► The North Dakota Department of Health switched off comments on its social media accounts, saying it was doing so to combat the spread of misinformation. The comment ban “will be applied to all posts, and not be specific to any particular topic,” the agency said.

►A Brazilian Senate committee recommended on Tuesday that President Jair Bolsonaro face a series of criminal indictments for actions and omissions related to the world’s second-highest COVID-19 death toll.

►Florida Gov. Ron DeSantis is pushing for the state Legislature to authorize $5,000 bonuses and other incentives to lure police officers from other states. More specifically, DeSantis is aiming to recruit officers from jurisdictions with vaccine requirements who don’t want to comply, encouraging them to relocate to the mandate-less Sunshine State.

📈 Today’s numbers: The U.S. has recorded more than 45 million confirmed COVID-19 cases and nearly 738,000 deaths, according to Johns Hopkins University data. Global totals: More than 244 million cases and 4.9 million deaths. More than 190 million Americans — 57% of the population — are fully vaccinated, according to the CDC.

📘 What we’re reading: Own an iPhone? You can now keep a digital version of your COVID-19 vaccine card right in your phone’s Apple Wallet.

Keep refreshing this page for the latest news. Want more? Sign up for USA TODAY’s Coronavirus Watch newsletter to receive updates directly to your inbox and join our Facebook group.

U.S.-based pharmaceutical giant Merck announced a licensing agreement to provide “affordable” global access to its coronavirus drug molnupiravir. The oral, antiviral medicine is for treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. The agreement with the Medicines Patent Pool (MPP), which works to make medical treatment and technologies globally accessible, will provide 105 low and middle income countries with access to the drug.

“Merck’s mission to save and improve lives is a truly global commitment,” said Frank Clyburn, president of Merck’s Human Health division. “This agreement with MPP is another important element in our multi-faceted strategy to accelerate broad, affordable access to molnupiravir.”

Another COVID-19 vaccine maker is hoping to enter the U.S. market, this time with a traditional type of shot that has already been delivered more than 100 million times in India.

Ocugen Inc., a publicly-traded company based in Malvern, Pennsylvania, announced Wednesday morning that it has submitted an application to the Food and Drug Administration to begin a trial in the United States of its vaccine, COVAXIN.

The vaccine uses a whole-killed virus, meaning it delivers into the body an inactivated form of the coronavirus. This stimulates a broader immune response than vaccines currently available in the United States, and is more similar to the immune protection provided by a COVID-19 infection, according to Dr. Bruce Forrest, Ocugen’s acting chief medical officer.

Although COVAXIN has been used in India since early this year, the FDA prefers to base its approvals on data collected in the U.S. The vaccine also includes a new adjuvant — meant to boost the effect on the immune system — that was developed by the National Institutes of Health.

The company expects to finish its trial in the middle of next year and Forrest said the vaccine could be used as a two-dose initial regimen or as a booster shot.

COVAXIN prevented 93% of cases of severe disease, 78% protective against symptoms of disease and 64% effective against asymptomatic disease, in company-funded research in India.

Contributing: The Associated Press

Orignally published on 2021-10-27 13:12:12 by rssfeeds.usatoday.com

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