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US: FDA panel recommends Pfizer vaccine for kids 5-11; maker of COVAXIN looks to start US trials of vaccine: COVID-19 updates

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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 says COVID-19 vaccine more than 90% effective in kids

  Pfizer says COVID-19 vaccine more than 90% effective in kids Kid-size doses of Pfizer’s COVID-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday as the U.S. considers opening vaccinations to that age group. The shots could begin in early November — with the first children in line fully protected by Christmas — if regulators give the go-ahead. Details of Pfizer's study were posted online. The Food and Drug Administration was expected to post its independent review of the company's safety and effectiveness data later in the day.

The Pfizer-BioNTech COVID-19 vaccine for children, being labelled and packaged at a European manufacturing facility. © Photo provided by Pfizer,Inc. The Pfizer-BioNTech COVID-19 vaccine for children, being labelled and packaged at a European manufacturing facility.

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.

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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. The highest hospitalization rates for children occurred in September, so many kids remained susceptible after the summer, the CDC's Dr. Fiona Havers told the committee.

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.

Younger kids could be getting a Covid-19 vaccine within weeks

  Younger kids could be getting a Covid-19 vaccine within weeks Some 28 million children ages 5 to 11 in the United States may soon be eligible for the Covid-19 vaccine, and plans are already underway to help them get it. © Pfizer The Pfizer vaccine for children ages 5 to 11 has an orange label, rather than the purple label on the vaccine for those age 12 and older. The US Food and Drug Administration's independent vaccine advisory board will meet Tuesday to discuss whether Pfizer and BioNTech's Covid-19 vaccine should be authorized for younger kids. If authorized, it would become the first vaccine available for younger children.

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►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.

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  COVID Now a 'Major Cause of Death' in Kids But Many Parents Remain Hesitant on Vaccine The risks of COVID for kids may be higher than previously believed. But many parents are reluctant to get their child vaccinated—even as FDA approval seems imminent.But she won't be first in line if, as expected, the U.S. Food and Drug Administration (FDA) approves COVID-19 vaccines for children under 12 early next month. She's not sure if she'll get in line at all.

???? What we're reading: COVID is more dangerous for kids than the season flu — but RSV might be even worse, according to a USA TODAY analysis. Respiratory syncytial virus (RSV) is particularly dangerous for kids, killing 100 to 500 children a year.

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.

Maker of COVAXIN vaccine looks to start US trials

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.

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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.

Unvaccinated Americans will face tougher rules for reentry into the US

Unvaccinated Americans reentering the country will face stricter rules beginning Nov. 8, when the U.S. will again open its doors to foreign travelers – as long as they're fully vaccinated against COVID-19.

American citizens without proof of vaccination "will have to produce documentation of a negative test within one day of departure" to be allowed back in the U.S., the White House said Monday. The current rule allows the test to be conducted within three days of travel.

Fully vaccinated Americans will still have a three-day window for COVID-19 testing with negative results as long as they can show proof of vaccination.

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– Bailey Schulz and Eve Chen

Contributing: The Associated Press

This article originally appeared on USA TODAY: FDA panel recommends Pfizer vaccine for kids 5-11; maker of COVAXIN looks to start US trials of vaccine: COVID-19 updates

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