WEDNESDAY, March 31, 2021 (HealthDay News) -- Pfizer Inc. announced 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have been anxiously waiting to see, though the companies did not release detailed data from the trial, which has not yet been peer-reviewed or published in a medical journal.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.
But states are rapidly expanding access to coronavirus vaccines, the Times reported. On Monday, at least six more states -- Texas, Kansas, Louisiana, North Dakota, Ohio and Oklahoma -- made all adults eligible for vaccination. New York has said that all adults will be eligible for the vaccines starting April 6.
Still, COVID-19 cases have risen more than 40 percent in nine states over the past two weeks, the Times reported. Michigan has been hit hardest, seeing a 133 percent increase, and the Northeast has also seen an uptick in cases. Connecticut reported a 62 percent jump over the past two weeks, while New York and Pennsylvania have both reported increases of more than 40 percent, the newspaper reported.
Other hot spots included North Dakota, where cases rose by nearly 60 percent, and Minnesota, where cases have risen 47 percent, the Times reported.
Biden administration working on "vaccine passport" initiative
The Biden administration and private companies are working to develop a standard for a "vaccine passport" that could be used as the country tries to reopen in the coming months.
The effort has gained steam following President Biden's pledge that the nation will begin to return to normal this summer and with a growing number of companies saying they will require proof of vaccination before reopening for business, the Washington Post reported.
The administration's initiative has been handled by arms of the U.S. Department of Health and Human Services, including an office devoted to health information technology, said five officials who spoke to the Post on the condition of anonymity. The White House this month took on a bigger role in coordinating government agencies involved in the work, with a goal of announcing updates in the coming days, one official told the newspaper.
The passports are expected to be free and available through applications for smartphones, which could display a scannable code similar to an airline boarding pass, the Post reported. Americans without smartphone access should be able to print out the passports, developers have said.
U.S. officials face numerous challenges, including data privacy and health-care equity. They want to make sure all Americans will be able to get credentials that prove they have been vaccinated, but also want to set up systems that are not easily hacked and design passports that cannot be counterfeited, the Post reported.
Public health experts said the Biden administration needs to tread softly with vaccine passports.
"If it became a government mandate, it would go down a dark road very quickly," said Brian Castrucci, head of the de Beaumont Foundation, a public health group funding research into vaccine hesitancy. "It becomes a credential. It becomes a 'needing your papers,' if you will. That could be dangerous -- and it could turn off people."
"It has to be that everyone can get it, and it's their choice, as it were," said Ezekiel Emanuel, a University of Pennsylvania bioethics expert who advised Biden's transition team on the coronavirus. "The one thing I am concerned [about] is that some people won't be able to get vaccinated for a variety of reasons."
A global scourge
By Wednesday, the U.S. coronavirus case count passed 30.4 million while the death toll passed 550,500, according to a Times tally. On Wednesday, the top five states for coronavirus infections were: California with over 3.6 million cases; Texas with nearly 2.8 million cases; Florida with over 2 million cases; New York with over 1.8 million cases; and Illinois with over 1.2 million cases.
Curbing the spread of the coronavirus in the rest of the world remains challenging.
In Brazil, the coronavirus case count was over 12.6 million by Wednesday, with more than 317,000 deaths, a Johns Hopkins University tally showed. India had over 12.1 million cases and over 162,400 deaths as of Wednesday, the Hopkins tally showed.
Worldwide, the number of reported infections passed 128.3 million on Wednesday, with over 2.8 million deaths recorded, according to the Hopkins tally.
The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.
SOURCES: Washington Post; The New York Times