Pfizer and BioNTech have asked federal regulators to authorize emergency use of their coronavirus vaccine for kids ages 5 to 11, the companies announced Thursday.
The Food and Drug Administration and the Centers for Disease Control and Prevention will need to sign off on the vaccine before it becomes available to children. An independent expert panel will review the data on Oct. 26.
"With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19," Pfizer tweeted. "We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat."
Pfizer and its German vaccine partner released data from a clinical trial last month indicating their vaccine was safe and effective for children ages 5 to 11 at one-third of the dose given to adolescents and adults. The vaccine could be crucial for elementary schools, where no students have had access to vaccination because of age limits.
The study of 2,268 volunteers ages 5 to 11 showed they mounted the same type of strong immune response to the vaccine as teens and young adults. Because the vaccine has already proved effective in older groups, the companies only had to show that the vaccine led to a similar immune response in children – rather than prove it prevented COVID-19 infections.
Also in the news:
►Kaiser Permanente has put more than 2,200 employees nationwide on unpaid leave who have chosen not to get vaccinated against the coronavirus. The employees have until Dec. 1 to get vaccinated or be terminated, the company said. Kaiser’s overall vaccination rate: 92%.
►Los Angeles leaders have approved one of the nation’s strictest vaccine mandates, a sweeping measure that would require the shots for everyone entering bars, restaurants, nail salons, gyms or sports events.
►High school weight rooms are being renovated and new football fields are getting built. The money for these high school sports was part of a $123 billion infusion intended to help schools reopen and recover from the pandemic. But some districts have used large portions for athletics projects they couldn't previously afford.
► A Texas man who posted on Facebook that he paid someone sick with COVID-19 to intentionally spread the virus was sentenced to 15 months in federal prison. He was found guilty on two counts for violating a federal law that criminalizes false information and hoaxes related to biological weapons after pretending to have someone spread COVID-19 at a San Antonio grocery store.
►In New York, a statewide vaccination mandate for all hospital and nursing home workers will be expanded Thursday to home care and hospice employees.
►The World Health Organization is working to ship COVID-19 medical supplies into North Korea, a possible sign that the North is easing one of the world’s strictest pandemic border closures to receive outside help.
📈 Today's numbers: The U.S. has recorded more than 44 million confirmed COVID-19 cases and more than 707,000 deaths, according to Johns Hopkins University data. Global totals: More than 236.6 million cases and 4.8 million deaths. More than 186 million Americans – 56.1% of the population – are fully vaccinated, according to the CDC.
📘 What we're reading: Schools and parents are still burdened by COVID-19 cases, contact tracing and quarantines. Remote learning has returned in some cases. In others, kids are back to sitting at home without work. Unlike last year, most classrooms are open, but they operate amid shifting health recommendations and frequent fights over masks. When will school be normal again? Many educators, parents and students look past the health hurdles and say: Never. Read more here.
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White House: Mandates will be big boost to vaccination campaign
The White House released a report early Thursday on the effects of vaccination requirements in the U.S., contending that mandating vaccines will lead to millions more Americans getting shots in the arm.
The report was released ahead of President Joe Biden's trip to Chicago – where he will meet leaders who implemented vaccination requirements in public and private sectors, analyzed health care systems, educational institutions, public-sector agencies and private businesses. The report found that businesses instituting vaccine requirements have seen their number of fully vaccinated workers rise above 90%. Nationwide, 63% of adults 18-64 are fully inoculated.
“Without vaccination requirements, we face endless months of chaos in our hospitals, further detrimental impacts on our economy, and anxiety in our schools,” the report reads. According to the White House analysis, vaccine requirements have broad public support and will help boost the economy by bringing workers back to the labor force.
But a number of Republican-led states have remained steadfast in opposing such requirements, going as far as punishing areas that attempt to enlist such directives.
'Huge moment of pride': Hospital system hits 99% vaccination rate
The Detroit-based Henry Ford Health System reported Tuesday that 99% of its workforce is compliant with its COVID-19 vaccination requirement. The figure means team members are either fully vaccinated, on the way to completing a two-dose regimen or received an approved medical or religious exemption.
“This is a true testament to Team HFHS and how much our team cares about your health, the community’s health, their own health and the health of their teammates,” said Bob Riney, President of Healthcare Operations and Chief Operating Officer, during a briefing with reporters. “We’re really grateful for their dedication.”
Colorado hospital: No vaccine, no transplant
A Colorado health system is requiring "almost all" organ transplant patients to get vaccinated against COVID-19 before they receive their transplant. UCHealth confirmed to USA TODAY that “in almost all situations, transplant recipients and living donors” within the system “are now required to be vaccinated against COVID-19 in addition to meeting other health requirements.” For transplant patients who contract COVID-19, the mortality rate can range from 20% to over 30%, significantly higher than the general population, the health system said.
“These requirements increase the likelihood that a transplant will be successful and the patient will avoid rejection,” UCHealth said in a statement.
– Marina Pitofsky
Children of color lose caregivers to COVID at alarming rate
At least 140,000 children across the U.S. have lost a primary or secondary caregiver to COVID-19, according to a study published Thursday in the journal Pediatrics. The study highlights a pandemic-driven childhood crisis and its disproportionate impact. Researchers found children of color account for 65% of children orphaned from COVID-19 through June. That's more than 91,000 children of color, compared to 51,000 white children.
Hispanic children were twice as likely as white children to lose a caregiver and one in every 412 Hispanic children lost at least one, the study found. Indigenous children, who had the highest risk, were almost five times more likely; about 1 in every 168 Native American children lost a caregiver.
The study's lead author, Centers for Disease Control and Prevention epidemiologist Susan Hillis, called the disparities “disturbing.” Read more here.
– Nada Hassanein
Mississippi hospitalizations high as schools drop mask mandate
As coronavirus cases drop in Mississippi schools, doctors warn children infected with COVID-19 are still filling up the state's only pediatric hospital as some schools are again doing away with mask requirements.
Of 740 schools reporting from 73 of Mississippi's 82 counties, there were more than 800 new COVID-19 cases in Mississippi students statewide from Sept. 27 through Oct. 1, according to the health department's Tuesday report.
Some Mississippi schools have begun to relax mask mandates as community cases have started to decline. The American Academy of Pediatrics Mississippi Chapter wrote a Thursday memo to school leaders and parents that mask-wearing in schools is imperative to lessening COVID-19 transmission.
“Acute COVID hospitalizations are increasing again it seems and it is timed exactly with schools dropping mask requirements," Dr. Charlotte Hobbs, professor of pediatric infectious disease at Children’s of Mississippi states, said in the memo.
– Sarah Haselhorst, The Clarion Ledger
Biden spends another $1 billion to ramp up at-home COVID-19 tests
The Biden administration on Wednesday announced a new $1 billion investment in home coronavirus tests that will quadruple the nation's supply of these rapid tests by early December, officials said. The administration has secured commitments from test manufacturers to supply up to 200 million home tests per month by December, said Jeff Zients, the White House coronavirus response coordinator.
Last month, the Biden administration announced it would spend nearly $2 billion to purchase about 280 million coronavirus home tests to supply long-term-care facilities, community testing sites, homeless shelters, prisons, jails and other centers that serve vulnerable populations. On Monday, the Food and Drug Administration authorized ACON Laboratories' Flowflex COVID-19 home test, a move that would add tens of millions of tests within weeks, an FDA official said.
– Ken Alltucker, USA TODAY
Woman who died after J&J vaccine was opposed to vaccinations
A 37-year-old woman died on Sept. 7 from a rare and severe condition causing blood clots that have been linked to the Johnson & Johnson vaccine. Jessica Berg Wilson, a mother of two, was opposed to COVID-19 vaccinations, according to her obituary. During the last weeks of her life, “the world turned dark with heavy-handed vaccine mandates,” it reads. “Local and state governments were determined to strip away her right to consult her wisdom and enjoy her freedom.”
Three other deaths from the blood clots have been confirmed nationally. The Centers for Disease Control and Prevention paused the J&J vaccine in the spring to investigate, but ultimately lifted the pause and resumed use of the vaccine soon after.
Contributing: Adrianna Rodriguez, USA TODAY; The Associated Press
