The Food and Drug Administration on Monday expanded the Emergency Use Authorization of a booster dose of the Pfizer-BioNTech coronavirus vaccine to include youths 12 to 15.
The booster dose is the same strength as the dose approved in the primary series. A booster dose was previously authorized by the FDA for emergency use for those 16 years of age and older.
“Today’s decision by the FDA to further expand the Emergency Use Authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,” said Pfizer CEO Albert Bourla. “We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations.”
The Centers for Disease and Control and Prevention still must sign off on the authorization. Dr. Rochelle Walensky, the CDC director, is expected to make the final decision this week.
The latest booster authorization comes as health care systems report record hospitalizations among children amid a coronavirus surge driven by the highly transmissible omicron variant. During the week of Dec. 22 to Dec. 28, an average of 378 children age 17 and under were admitted per day to hospitals with the coronavirus, a 66% increase from the week before, the Centers for Disease Control and Prevention reported last Thursday.
The previous high over the course of the pandemic was in early September, when child hospitalizations averaged 342 per day, the CDC said.
The FDA also authorized a third dose at least 28 days following the second dose for kids ages 5-11 who have who have certain kinds of immunocompromise. And the agency reduced the time for administration of a booster dose from at least six months to at least five months following completion of the primary series everyone 12 years of age and older.
– Adrianna Rodriguez
Also in the news:
►Nearly 2,000 U.S. flights have already been canceled Monday and more than 1,300 have been delayed as of 9:30 a.m. ET, according to the tracking service FlightAware. The cancellations come as a winter storm that walloped the Midwest over the weekend slams the East Coast and airlines grapple with continuing crew shortages tied to the omicron variant of COVID.
►The British government pledged to rush ventilation units and enough COVID test kits to schools to ensure they can reopen later this week despite soaring infection rates in the United Kingdom.
📈 Today’s numbers: The U.S. has recorded more than 55 million confirmed COVID-19 cases and more than 826,000 deaths, according to Johns Hopkins University data. Global totals: More than 290.3 million cases and 5.4 million deaths. More than 205.8 million Americans – 62% – are fully vaccinated, according to the CDC.
📘 What we’re reading: Transgender adults are having a much more difficult time than the overall population in getting adequate nourishment during the COVID-19 pandemic, according to a new study. The gap was even more severe for transgender people of color, who were six times as likely to experience food insufficiency as cisgender white adults. USA TODAY’s Keveney writes.
Keep refreshing this page for the latest news. Want more? Sign up for USA TODAY’s free Coronavirus Watch newsletter to receive updates directly to your inbox and join our Facebook group.
The Centers for Disease Control and Prevention is considering amending its new, five-day isolation guidance for asymptomatic patients to include testing as soon as today, Dr. Anthony Fauci said Sunday. Last week, the CDC cut in half the amount of time it recommends asymptomatic people should isolate after testing positive. The recommendation does call for wearing masks in public for the next five days but dropped any requirement of a negative test.
President Biden’s chief medical adviser, speaking Sunday on ABC News’ “This Week,” said the CDC is aware of “pushback” against dropping a requirement that the patients also test negative. The new rules involve isolation – for people who have tested positive – but do not involve quarantine rules for those exposed to infected people.
U.S. Defense Secretary Lloyd Austin has tested positive for COVID-19 after exhibiting symptoms while at home on leave, he announced on Twitter Sunday night. “I will quarantine myself at home for the next five days,” said Austin, adding: “I plan to attend virtually this coming week those key meetings and discussions required to inform my situational awareness and decision making.”
His last meeting with President Joe Biden was Dec. 21, Austin said, and he tested negative that morning. Austin said he hasn’t been in the Pentagon since Thursday. Austin, 68, said he was fully vaccinated and received a booster in October.
“The vaccines work and will remain a military medical requirement for our workforce. I continue to encourage everyone eligible for a booster shot to get one. This remains a readiness issue,” he said.
– Celina Tebor, USA TODAY
Testing positive for COVID-19 starts a confusing, disruptive and at times frightening process – one that millions of Americans will likely go through in the coming weeks.
There is a difference between isolation and quarantine. Quarantine means keeping someone who was in close contact with someone who has COVID away from others. Isolation means keeping someone who is sick or tested positive for COVID-19 without symptoms away from others, even in their own home, according to the CDC.
If you are fully vaccinated you do not need to quarantine unless you have symptoms. But the CDC says isolating is a necessary step if you test positive whether you’re vaccinated or unvaccinated, and whether you have symptoms or feel fine.
Everyone who tests positive for COVID-19 should monitor their symptoms. And people who are unvaccinated or at high risk for severe disease should be extra-vigilant for symptoms that might require emergency care. Call your doctor for early treatment options.
The CDC in late December shortened the time it recommends people isolate, saying: “People with COVID-19 should isolate for 5 days and if they are asymptomatic or their symptoms are resolving (without fever for 24 hours), follow that by 5 days of wearing a mask when around others.”
Read the CDC’s updated guidance on isolating and quarantining.
Contributing: Mike Stucka, USA TODAY; The Associated Press
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