FDA eyes younger ages for vaccines

Agency is expected to authorize Pfizer shots for children 12-15 by next week as parameters expand

By The Associated Press

WASHINGTON» The U.S. Food and Drug Administration is expected to authorize Pfizer’s COVID-19 vaccine for youngsters ages 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year.

The announcement is set to come a month after the company found that its shot, which is already authorized for those 16 and older, also provided protection for the younger group.

The federal official, speaking on the condition of anonymity to preview the FDA’s action, said the agency was expected to expand its emergency use authorization for Pfizer’s two-dose vaccine by early next week, and perhaps even sooner. Another person familiar with the process confirmed the timeline and added it is expected that the FDA will approve Pfizer’s use by even younger children sometime this fall.

The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-yearolds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days.

Pfizer in late March released preliminary results from a vaccine study of 2,260 U.S. volunteers ages 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.

Kids had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety. Pfizer isn’t the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.

But in a sign that the findings were promising, the FDA already allowed both companies to begin U. S. studies in children 11 and younger, working their way to as young as 6 months old.

More than 131 million doses of Pfizer’s vaccine have already been administered in the U.S., where demand for vaccines among adults has dramatically slowed in recent weeks.

While younger people are at dramatically lower risk of serious side effects from COVID-19, they have made up a larger share of new virus cases as a majority of U.S. adults have been at least partially vaccinated and as higher-risk activities like indoor dining and contact sports have resumed in most of the country. Officials hope that extending vaccinations to teens will further accelerate the nation’s reduced virus caseload and allow schools to reopen with minimal disruptions this fall.

The U.S. has ordered at least 300 million doses of the Pfizer shot by the end of July, enough to protect 150 million people.

Restrictions easing

Air travel in the U.S. hit its highest mark since COVID-19 took hold more than 13 months ago, while European Union officials are proposing to ease restrictions on visitors to the continent as the vaccine sends new cases and deaths tumbling in more affluent countries. The improving picture in many places contrasts with the worsening disaster in India.

In the U.S., the average number of new cases per day fell below 50,000 for the first time since October. And nearly 1.67 million people were screened at U.S. airport checkpoints on Sunday, according to the Transportation Security Administration, the highest number since mid-March of last year.

Las Vegas is bustling again after casino capacity limits were raised Saturday to 80% and person- to-person distancing was dropped to 3 feet. New York Gov. Andrew Cuomo announced that New York City’s subways will begin running all night again and capacity restrictions on most businesses will end statewide in mid-May. And Los Angeles County reported no coronavirus deaths on Sunday and Monday, some of which may be attributable to a lag in reporting but was nevertheless a hopeful sign that could move the county to allow an increase in capacity at events and venues, and indoor-service at bars.

EU officials also announced a proposal Monday to relax restrictions on travel to the 27-nation bloc this summer, though the final decision is up to its member countries.

“Time to revive EU tourism industry and for cross-border friendships to rekindle — safely,” European Commission President Ursula von der Leyen said. “We propose to welcome again vaccinated visitors and those from countries with a good health situation.”

But with more-contagious variants taking hold, efforts are underway to boost vaccination efforts, which have begun to lag. The average number of doses given per day fell 27% from a high of 3.26 million on April 11 to 2.37 million last Tuesday, according to the Centers for Disease Control and Prevention.

Herd immunity

Millions of Americans are receiving vaccine doses every day, but one medical expert thinks the nation may not reach herd immunity this year if more people can’t be persuaded to get a shot.

“What I really worry about is that those people who are already on the fence don’t get vaccinated (and) we don’t reach herd immunity come the fall,” CNN medical analyst Dr. Leana Wen told CNN.

“And then with the winter ... we have a big resurgence, maybe we have variants coming in from other countries, and we could start this whole process all over again and have another huge pandemic come the winter.”

Experts including Dr. Anthony Fauci have estimated between 70% to 85% of the US population needs to be immune to the virus -- through vaccination or previous infection -- to control its spread.

So far, 44.4% of the population has received at least one COVID- 19 vaccine dose and 31.8% are fully vaccinated, according to data from the Centers for Disease Control and Prevention.

But the average daily rate of vaccinations has been declining for about two weeks. The CDC reported Monday that 246 million total doses of vaccine have been administered, about 79% of the 312.5 million doses delivered. That’s roughly 1.2 million more doses reported administered since Sunday, for a seven-day average of about 2.3 million doses per day. The seven-day average was 3.1 million on April 19. The Associated Press and CNN contributed to this report.

East Hartford High School senior Sudeen Pryce, right, center, receives support from classmate Alexia Phipps, left.  East Hartford High School intervention coordinator Mark Brown, second from left, and emergency medical technician Katrinna Greene of Manchester, top right, as nurse Kaylee Cruz of Bristol administers the first dose of the Pfizer vaccine to Pryce at a mass vaccination site at Pratt & Whitney Runway in East Hartford, Conn.  The U.S. Food and Drug Administration is expected to authorize Pfizer’s COVID-19vaccine for children ages 12and older by next week, setting up shots for many before the beginning of the next school year.  JESSICA HILL — THE ASSOCIATED PRESS

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  • Posted On: 5/4/2021 6:57:31 AM
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  • Last Modified On: 5/4/2021 6:57:31 AM
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