FDA panel urges Pfizer vaccine for kids; COVAXIN US trials: Updates
After a dialogue the place it was identified that greater than 40% of American kids ages 5 to 11 had contracted COVID-19 by the tip of June, a panel of Meals and Drug Administration advisers voted 17-0 Tuesday to authorize the Pfizer-BioNTech coronavirus vaccine for youths that age.
The resounding help is a significant step ahead for making school-age kids eligible for inoculation — possible by subsequent week — however there are nonetheless three essential hurdles to clear: The FDA must log off, an unbiased CDC advisory panel will evaluation the info, after which the CDC director must give her clearance.
Pfizer-BioNTech reported 10 micrograms of their vaccine, a 3rd of the dose administered to adults, is 90.7% efficient at stopping symptomatic COVID, a rising concern for kids.
One examine offered by the CDC discovered that 42% of youngsters ages 5 to 11 within the U.S. had been contaminated with COVID-19 as of the tip of June. The very best hospitalization charges for kids occurred in September, so many children remained vulnerable after the summer time, the CDC’s Dr. Fiona Havers informed the committee.
Assist for the youngsters’s vaccine comes as a USA TODAY evaluation of information from Johns Hopkins College reveals that new coronavirus infections are down 56.8% nationwide for the reason that delta variant surge peaked within the first week of September.
Additionally within the information:
► Australian Well being Minister Greg Hunt introduced that double-vaccinated Australians will probably be allowed to journey overseas and/or return residence beginning Monday. Many households have been cut up aside by the tight border closure that went into impact in March 2020.
► The North Dakota Division of Well being switched off feedback on its social media accounts, saying it was doing so to fight the unfold of misinformation. The remark ban “will probably be utilized to all posts, and never be particular to any specific matter,” the company mentioned.
►A Brazilian Senate committee really useful on Tuesday that President Jair Bolsonaro face a sequence of felony indictments for actions and omissions associated to the world’s second-highest COVID-19 dying toll.
►Florida Gov. Ron DeSantis is pushing for the state Legislature to authorize $5,000 bonuses and different incentives to lure law enforcement officials from different states. Extra particularly, DeSantis is aiming to recruit officers from jurisdictions with vaccine necessities who do not wish to comply, encouraging them to relocate to the mandate-less Sunshine State.
📈 At the moment’s numbers: The U.S. has recorded greater than 45 million confirmed COVID-19 circumstances and practically 738,000 deaths, in accordance to Johns Hopkins University data. World totals: Greater than 244 million circumstances and 4.9 million deaths. Greater than 190 million People — 57% of the inhabitants — are totally vaccinated, in accordance with the CDC.
📘 What we’re studying: COVID is extra harmful for youths than the season flu — however RSV is perhaps even worse, according to a USA TODAY analysis. Respiratory syncytial virus (RSV) is especially harmful for youths, killing 100 to 500 kids a 12 months.
Preserve refreshing this web page for the newest information. Need extra? Sign up for USA TODAY’s Coronavirus Watch newsletter to obtain updates on to your inbox and be a part of our Fb group.
Maker of COVAXIN vaccine appears to begin US trials
One other COVID-19 vaccine maker is hoping to enter the U.S. market, this time with a conventional sort of shot that has already been delivered greater than 100 million instances in India.
Ocugen Inc., a publicly-traded firm primarily based in Malvern, Pennsylvania, introduced Wednesday morning that it has submitted an utility to the Meals and Drug Administration to start a trial in america of its vaccine, COVAXIN.
The vaccine makes use of a whole-killed virus, which means it delivers into the physique an inactivated type of the coronavirus. This stimulates a broader immune response than vaccines at the moment out there in america, and is extra much like the immune safety offered by a COVID-19 an infection, in accordance with Dr. Bruce Forrest, Ocugen’s performing chief medical officer.
Though COVAXIN has been utilized in India since early this 12 months, the FDA prefers to base its approvals on knowledge collected within the U.S. The vaccine additionally features a new adjuvant — meant to spice up the impact on the immune system — that was developed by the Nationwide Institutes of Well being.
The corporate expects to complete its trial in the course of subsequent 12 months and Forrest mentioned the vaccine may very well be used as a two-dose preliminary routine or as a booster shot.
COVAXIN prevented 93% of circumstances of extreme illness, 78% protecting towards signs of illness and 64% efficient towards asymptomatic illness, in company-funded research in India.
Unvaccinated People will face more durable guidelines for reentry into the US
Unvaccinated People reentering the nation will face stricter guidelines starting Nov. 8, when the U.S. will once more open its doorways to international vacationers – so long as they’re totally vaccinated towards COVID-19.
American residents with out proof of vaccination “must produce documentation of a damaging check inside in the future of departure” to be allowed again within the U.S., the White Home mentioned Monday. The present rule permits the check to be carried out inside three days of journey.
Totally vaccinated People will nonetheless have a three-day window for COVID-19 testing with damaging outcomes so long as they’ll present proof of vaccination.
– Bailey Schulz and Eve Chen
Contributing: The Related Press