After a discussion in which it was pointed out that more than 40% of American children aged 5 to 11 had contracted COVID-19 at the end of June, a panel of advisers from the Food and Drug Administration voted 17-0 on Tuesday to allow the Pfizer-BioNTech coronavirus vaccine for children this age.
The overwhelming support is a big step forward in making school-aged children eligible for inoculation – likely by next week – but there are still three critical hurdles to overcome: FDA will need to approve, independent advisory panel CDC will review the data, and then the CDC director should give permission.
Pfizer-BioNTech reported that 10 micrograms of their vaccine, one-third of the adult dose, is 90.7% effective in preventing symptomatic COVID, a growing concern in children.
A study presented by the CDC found that 42% of children aged 5 to 11 in the United States had been infected with COVID-19 by the end of June. The highest hospitalization rates for children were in September, so many children remained susceptible after the summer, CDC’s Dr. Fiona Havers told the committee.
Support for children’s vaccine comes as a USA TODAY analysis of data from Johns Hopkins University shows new coronavirus infections are down 56.8% nationwide since the delta variant wave hit peaked during the first week of September.
Also in the news:
►North Dakota Department of Health has disabled comments on its social media accounts, saying it is doing so to combat the spread of disinformation. The comment ban “will be applied to all posts and will not be topic specific,” the agency said.
►A Brazilian Senate commission on Tuesday recommended that President Jair Bolsonaro be the subject of a series of criminal indictments for actions and omissions linked to the second highest death toll from COVID-19 in the world.
►Florida Gov. Ron DeSantis is pushing the state legislature to allow $ 5,000 bonuses and other incentives to attract police officers from other states. Specifically, DeSantis aims to recruit agents from jurisdictions with vaccine requirements that don’t want to comply, encouraging them to move to the Sunshine State without a warrant.
Numbers of the day: The United States has recorded more than 45 million confirmed cases of COVID-19 and nearly 738,000 deaths, according to data from Johns Hopkins University. Global totals: Over 244 million cases and 4.9 million deaths. More than 190 million Americans – 57% of the population – are fully immunized, according to the CDC.
What we read: COVID is more dangerous for children than the seasonal flu – but RSV could be even worse, according to a USA TODAY analysis. Respiratory syncytial virus (RSV) is particularly dangerous for children, killing 100 to 500 children a year.
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COVAXIN Vaccine Maker Seeks to Launch US Trials
Another COVID-19 vaccine maker is hoping to enter the U.S. market, this time with a traditional type of vaccine that has already been delivered more than 100 million times to India.
Ocugen Inc., a publicly traded company based in Malvern, Pa., Announced Wednesday morning that it had submitted a request to the Food and Drug Administration to begin a U.S. trial of its vaccine, COVAXIN.
The vaccine uses a fully killed virus, which means it delivers an inactivated form of the coronavirus into the body. 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, acting chief medical officer of Ocugen.
Although COVAXIN has been used in India since the beginning of this year, the FDA prefers to base its approvals on data collected in the United States. The vaccine also includes a new adjuvant – intended to enhance the effect on the immune system – developed by the National Institutes of Health.
The company plans to complete its trial by the middle of next year, and Forrest said the vaccine could be used as an initial two-dose regimen or as a booster shot.
COVAXIN prevented 93% of severe disease cases, 78% protective against disease symptoms and 64% effective against asymptomatic disease, in company-funded research in India.
Unvaccinated Americans will face stricter rules for returning to the United States
Unvaccinated Americans returning to the country will face stricter rules starting November 8, when the United States reopens its doors to foreign travelers – provided they are fully vaccinated against COVID-19.
US citizens without proof of vaccination “will have to produce documentation of a negative test within one day of their departure” to be allowed to re-enter the United States, the White House said on Monday. The current rule allows the test to be completed within three days of travel.
Fully vaccinated Americans will still have a three-day window for COVID-19 tests with negative results as long as they can show proof of vaccination.
– Bailey Schulz and Eve Chen
Contribution: The Associated Press