After a dialogue the place it was identified that greater than 40% of American youngsters 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 teenagers that age.
The resounding assist is a serious step ahead for making school-age youngsters eligible for inoculation — probably by subsequent week — however there are nonetheless three essential hurdles to clear: The FDA should log off, an impartial CDC advisory panel will assessment 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 kids ages 5 to 11 within the U.S. had been contaminated with COVID-19 as of the tip of June. Help for the youngsters’s vaccine comes as a USA TODAY evaluation of information from Johns Hopkins College exhibits 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 shall 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 “shall be utilized to all posts, and never be particular to any explicit subject,” the company mentioned.
►A Brazilian Senate committee really useful on Tuesday that President Jair Bolsonaro face a collection of legal indictments for actions and omissions associated to the world’s second-highest COVID-19 demise 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 this time’s numbers: The U.S. has recorded greater than 45 million confirmed COVID-19 instances and almost 738,000 deaths, in accordance to Johns Hopkins University data. International totals: Greater than 244 million instances and 4.9 million deaths. Greater than 190 million Individuals — 57% of the inhabitants — are totally vaccinated, in keeping with the CDC.
📘 What we’re studying: Personal an iPhone? Now you can maintain a digital model of your COVID-19 vaccine card right in your phone’s Apple Wallet.
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U.S.-based pharmaceutical big Merck announced a licensing agreement to supply “inexpensive” international entry to its coronavirus drug molnupiravir. The oral, antiviral medication is for therapy of mild-to-moderate COVID-19 in adults who’re in danger for progressing to extreme COVID-19 and/or hospitalization. The settlement with the Medicines Patent Pool (MPP), which works to make medical therapy and applied sciences globally accessible, will present 105 low and center revenue international locations with entry to the drug.
“Merck’s mission to avoid wasting and enhance lives is a really international dedication,” mentioned Frank Clyburn, president of Merck’s Human Well being division. “This settlement with MPP is one other necessary aspect in our multi-faceted technique to speed up broad, inexpensive entry to molnupiravir.”
One other COVID-19 vaccine maker is hoping to enter the U.S. market, this time with a standard 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 the US 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 present accessible in the US, and is extra just like the immune safety offered by a COVID-19 an infection, in keeping 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 information 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 instances of extreme illness, 78% protecting towards signs of illness and 64% efficient towards asymptomatic illness, in company-funded research in India.
Contributing: The Related Press