A vital federal advisory committee assembly has been scheduled, and its timing suggests children age 5 to 11 may begin getting vaccinated towards COVID-19 in time for Halloween.
Within the coming weeks FDA is anticipated to assessment after which authorize Pfizer-BioNTech’s vaccine for kids ages 5-11 at one-third the dose supplied to adolescents and adults.
On Friday, it scheduled a gathering of the unbiased committee, which advises the Meals and Drug Administration on vaccine and drug approvals, for Oct. 26.
Pfizer-BioNTech submitted their scientific trial knowledge to the FDA on Wednesday. The corporate says the info reveals their vaccine is secure and efficient in kids ages 5 to 11 at one-third the dose utilized in adolescents and adults.
If FDA authorizes the use, and if a second federal advisory committee additionally agrees, the vaccine may turn into out there to kids inside days of the ultimate assembly.
“We all know from our huge expertise with different pediatric vaccines that kids will not be small adults,” performing FDA Commissioner Dr. Janet Woodcock mentioned in a press release. The FDA will conduct a complete analysis of scientific trial knowledge submitted in help of the security and effectiveness of the vaccine to be used in kids, she mentioned.
As the speed of Individuals getting their first dose of a COVID-19 vaccine stays at its lowest level this yr, states with larger vaccination charges are seeing far decrease case counts, hospitalizations and deaths in comparison with these with low vaccination charges, the Facilities for Illness Management and Prevention director mentioned Friday.
Additionally within the information:
►Grocery shopping has gotten more expensive. In August, grocery retailer costs crept up one other 0.4%, leaving them 3% above their stage a yr earlier and seven.6% larger than they had been two years in the past, earlier than the COVID-19 pandemic upended the U.S. financial system.
►A bunch of lecturers requested the Supreme Courtroom on Thursday for an emergency injunction blocking implementation of New York City’s COVID-19 vaccine mandate for public schools staff.
►Nearly half of fogeys with kids between ages 12 and 17 mentioned their little one has acquired not less than one dose of a COVID-19 vaccine, a Kaiser Family Foundation survey found. About one third of surveyed mother and father with kids between ages 5 and 11 mentioned they might vaccinate their little one “immediately” as soon as a vaccine is permitted for them.
►Indiana Gov. Eric Holcomb renewed the state’s public well being emergency order for the nineteenth time on Thursday.
►Well being officers in Michigan’s Livingston County are warning of a possible COVID-19 outbreak after a Luke Bryant concert earlier this month. Officers say 27 individuals who attended the nation music live performance have examined optimistic because the present.
📈At present’s numbers: The U.S. has recorded greater than 43.4 million confirmed COVID-19 instances and greater than 698,300 deaths, in accordance to Johns Hopkins University data. World totals: Greater than 233.9 million instances and 4.7 million deaths. Greater than 184 million Individuals — 55% of the inhabitants — are totally vaccinated, in line with the Centers for Disease Control and Prevention.
📘What we’re studying: As Qamil Wright struggled with intense coronavirus signs all through August, she briefly questioned if she would ever perform again.
California will require eligible students to be vaccinated against COVID-19 to attend faculty in-person, however solely after the Meals and Drug Administration totally approves the vaccine for extra school-aged kids, Gov. Gavin Newsom introduced Friday.
“I imagine we’ll be the primary state in America to maneuver ahead with this mandate and requirement,” Newsom mentioned from a college in San Francisco.
He added that scholar vaccine mandates will assist hold extra children secure and studying constantly in school rooms. The vaccine mandate could be rolled out in two phases, pending FDA approval: The primary for college kids in center and highschool, after which for elementary faculty college students.
Newsom mentioned he expects the mandate to be in place for by July 1 of subsequent yr for college kids in seventh via twelfth grade. Read more here.
– Erin Richards
An experimental drug successfully treated half of COVID-19 infections, stopping instances from progressing to hospitalization, in line with a examine launched Friday. The information gives new hope that the virus may quickly be handled by a capsule.
The antiviral drug molnupiravir, made by Merck & Co. and Ridgeback Biotherapeutics of Miami, was given to 385 folks inside 5 days of their prognosis with COVID-19. One other 377 volunteers who examined optimistic got a placebo. All individuals had not less than one danger issue for extreme COVID-19.
Of the individuals who acquired molnupiravir, 7.3% had been hospitalized throughout the monthlong trial. Within the placebo group, 14% had been hospitalized and eight of them died.
The examine was presupposed to enroll one other 750 individuals, however an unbiased monitoring board determined the drug was so efficient it will be unethical to proceed giving anybody a placebo. The corporate plans to use for emergency use authorization as rapidly as potential.
Dr. Anthony Fauci, head of the Nationwide Institute of Allergy and Infectious Ailments, known as the info “spectacular.”
– Karen Weintraub
Supreme Courtroom Affiliate Justice Brett Kavanaugh tested positive for COVID-19 simply days earlier than the justices had been set to return to the courtroom to start a brand new time period, the court docket introduced Friday.
Kavanaugh, who together with the opposite Supreme Courtroom justices has been vaccinated, is just not experiencing signs, the court docket mentioned. He was examined Thursday forward of an investiture ceremony for Affiliate Justice Amy Coney Barrett set for Friday.
– John Fritze
With 56,662 reported deaths by COVID-19, the US’ September was greater than twice as lethal as its August. It was far deadlier than June, July and August mixed.
America fared barely higher on instances, with 4.14 million instances reported in comparison with August’s 4.28 million. The numbers made September America’s fifth deadliest month of all the pandemic, and the fifth-worst for instances.
The deaths had been worse within the South and America’s outlying territories. Florida reported 10,448 deaths and Texas reported 8,159 deaths, every about twice as many as August’s. Florida’s deaths had been about 90% worse than the earlier month on document.
Hawaii and Alaska additionally set data and noticed a few 58% worse loss of life toll than their earlier worst months.
– Mike Stucka
The NFL, NBA, NHL and Main League Baseball all have required sure key workers to be vaccinated towards COVID-19, particularly those that may come into shut contact with their most necessary property – the gamers. However the one huge exception: the gamers themselves.
Gamers unions have opposed or averted such vaccine mandates in what has become a delicate subject in pro sports.
Some, together with former NBA Gamers Affiliation government director Charles Grantham, say gamers union management is failing its members if it is not pushing for vaccine mandates.
Others see it in another way. In these instances, vaccine mandates for gamers must be collectively bargained between league administration and the gamers unions. Gamers unions have fought to win different rights and advantages in collective bargaining, and so they typically don’t need to give an inch for a shot if it means league administration may begin to suppose it will possibly take a mile later for one thing else. Read more here.
– Brent Schrotenboer
A bunch representing faculty board members across the nation requested President Joe Biden on Thursday for federal help to research and cease threats revamped insurance policies, together with masks mandates, likening the vitriol to a type of home terrorism.
The request by the Nationwide Faculty Boards Affiliation demonstrates the extent of unruliness that has engulfed native schooling conferences throughout the nation throughout the pandemic, with board members recurrently confronted and threatened by indignant protesters.
“No matter you’re feeling about masks, it shouldn’t attain this stage of rhetoric,” NSBA Interim Government Director Chip Slaven advised The Related Press by telephone.
White Home press secretary Jen Psaki mentioned accountability for safeguarding faculty boards falls largely to native regulation enforcement however “we’re persevering with to discover if extra could be completed from throughout the administration.”
The affiliation requested for the federal authorities to become involved to research instances the place threats or violence might be dealt with as violations of federal legal guidelines defending civil rights. It additionally requested for the Justice Division, FBI, Homeland Safety and Secret Service to assist monitor menace ranges and assess dangers to college students, educators, board members and college buildings.
Home flyers inside the US could quickly have to show they’re doubtless COVID-free if a proposed bill Wednesday becomes law.
The U.S. Air Journey Public Security Act, launched by California Sen. Dianne Feinstein, would require all U.S. passengers to be totally vaccinated, totally recovered or take a look at detrimental for the coronavirus earlier than boarding a home flight.
“We all know that air journey throughout the 2020 vacation season contributed to final winter’s devastating COVID-19 surge,” Feinstein mentioned in a Wednesday information launch. “We merely can’t enable that to occur once more.”
Whereas testing and or displaying proof of vaccination is frequent for worldwide air journey, home U.S. air passengers don’t undergo the identical stage of scrutiny.
The invoice may face an uphill battle to changing into regulation regardless of Democrats, a lot of whom are behind COVID-19 associated mandates, holding a slight majority in Congress.
– Bailey Schulz, Daybreak Gilbertson and Christal Hayes