By: Robin Foster & Ernie Mundell
Pfizer Inc. announced last Wednesday that its coronavirus vaccine is safe and remarkably effective in children as young as 12.
In a news release issued by Pfizer and its vaccine development partner, BioNTech, company executives said data from a trial of the vaccine in nearly 2,300 people between the ages of 12 and 15 will be submitted to the U.S. Food and Drug Administration in the coming weeks.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Pfizer Chairman and CEO Albert Bourla said in the news release. “We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
In the Phase 3 trial, the vaccine was 100 percent effective at preventing symptomatic illness within the trial, with 18 cases of COVID-19 in the group that received a placebo and none in the group that received the vaccine, the companies said. The vaccine triggered immune responses that were even more robust than those seen in young adults.
Akiko Iwasaki, an immunologist at Yale University, told The New York Times that she had expected antibody levels in adolescents to be comparable to those in young adults. “But they’re getting even better levels from the vaccines,” she said. “That’s really incredible.”
The finding is the beginning of what many families have been anxiously waiting to see, though the companies did not release detailed data from the trial, which has not yet been peer-reviewed or published in a medical journal. The Pfizer-BioNTech vaccine is now authorized by the FDA for emergency use for people aged 16 and older.
Last week, Pfizer-BioNTech also started a trial in younger children, aged 6 months to 11 years. That trial will first establish a safe dose first in children 5 to 11, then in 2- to 5-year-olds and then in children from 6 months to 2 years, the companies said.
“We all long for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination,” BioNTech CEO Ugur Sahin said in the companies’ news release.
Moderna is also conducting similar trials to test its coronavirus vaccine in teenagers and young children. Its vaccine is authorized by the FDA for emergency use for people over age 18.
Biden calls for return to mask mandates as cases rise
As new coronavirus cases begin to rise again across America, President Joe Biden on Monday called on governors to bring back state mask mandates.
Just hours earlier, Dr. Rochelle Walensky, head of the U.S. Centers for Disease Control and Prevention, delivered an emotional plea to Americans to keep following social distancing measures to stem the spread of COVID-19.
The former Harvard Medical School professor and infectious disease specialist described “a feeling of nausea” she experienced last year when, caring for patients at Massachusetts General Hospital, she saw the corpses of COVID-19 victims piled up, overflowing from the morgue. She recalled how she stood — “gowned, gloved, masked, shielded” — as the last one in a hospital room before a patient died alone.
“I am asking you to just hold on a little longer, to get vaccinated when you can, so that all of those people that we all love will still be here when this pandemic ends,” Walensky said during a media briefing.
Walensky appeared to fight back tears as she admitted to feeling a sense of “impending doom” about a possible fourth surge in infections.
As of Sunday, the seven-day average of new virus cases was about 63,000, the Times reported. That was up from 54,000 a day two weeks earlier, an increase of more than 16 percent.
Although nearly 1 in 3 American adults have received at least one shot and almost one-fifth have gotten their second shot, the nation is nowhere near herd immunity yet, the Times reported. That tipping point comes when spread of a virus slows because so many people, estimated at 70 to 90 percent of the population, are immune to it.