Pfizer and BioNTech announced Friday they have submitted an application for full FDA approval of their COVID-19 vaccine for people ages 16 and older.
Like other COVID-19 vaccines available in the U.S., Pfizer-BioNTech is currently being administered under an emergency use authorization. In the midst of a pandemic, the FDA said it was more important to get vaccines to people quickly.
This would make Pfizer’s vaccine the first in the U.S. to be assessed for full FDA approval.
It is unclear how long the review will take, but Pfizer’s CEO Albert Bourla spoke of “the goal of securing full regulatory approval of the vaccine in the coming months,” according to a prepared statement.
After trials and 134 million shots, the vaccine has been shown to safely and effectively prevent COVID-19, and no additional safety issues have come up since the vaccine was authorized, according to the companies and periodic safety reviews by the Centers for Disease Control and Prevention.
Experts say the FDA approval could reduce vaccine hesitancy and empower employers to require their workers to get vaccinated.
Also in the news:
►India recorded a single-day high in new coronavirus cases on Friday. The embattled country recorded 414,188 cases in a single day, a new global high. The country also reported 3,915 additional deaths, and the official daily death count has stayed over 3,000 for the past 10 days.
►French President Emmanuel Macron is joining the Biden administration in saying he supports sharing the technology behind COVID-19 vaccines but said the immediate priority is for wealthier countries to donate more doses to poorer countries.
►Kansas has requested less than 9% of its federal allocation of COVID-19 vaccine doses for this week, as Republican state lawmakers try to revive proposals to ban government vaccine passports and restore limits on tracing the close contacts of people exposed to the virus.
►Initial analysis of Phase 2/3 testing of Moderna’s vaccine in adolescents 12 to 17 years showed vaccine effectiveness of 96%, the company says. The vaccine was “generally well tolerated,” and there were no serious safety concerns identified thus far, the company said.
📈 Today’s numbers: The U.S. has 32.6 million confirmed coronavirus cases and 580,000 deaths, according to Johns Hopkins University data. The global totals: Over 156 million cases and 3.26 million deaths. More than 324.6 million vaccine doses have been distributed in the U.S. and nearly 252 million have been administered, according to the CDC. Almost 109 million Americans have been fully vaccinated.
📘 What we’re reading: Jennifer Price tells herself it wasn’t her husband who died by suicide on one of their farms the morning of Feb. 28. She believes he was taken over by what some health care professionals call “COVID psychosis.”
Keep refreshing this page for the latest updates. Want more? Sign up for our Coronavirus Watch newsletter for updates to your inbox and join our Facebook group.
Pfizer, BioNTech will vaccinate summer Olympians
The troubled Tokyo Games may get a boost from the Pfizer-BioNTech vaccine.
The companies announced Thursday that they will donate COVID-19 vaccines to athletes and officials involved in this summer’s Olympic and Paralympic Games in Japan.
Delivery of initial doses is expected to begin at the end of May to ensure participating athletes and staff receive second doses ahead of arrivals in Tokyo. The Summer Olympics are scheduled to begin on July 23. The Paralympics begin about a month later. The Games had been scheduled for last summer but were postponed one year because of the pandemic.
“The return of the Olympic and Paralympic Games represents a monumental moment of world unity and peace after a grueling year of isolation and devastation,” Pfizer CEO Albert Bourla said in a statement. “We are proud to play a role in providing vaccines to athletes and national Olympic delegations.”
Even though international spectators won’t be allowed at the Olympics because of the pandemic, the large majority of the Japanese public continues to be opposed to the Tokyo Games being held in July out of health concerns.
An online petition calling for their cancellation has gained tens of thousands of signatures in a few days. Tokyo, Osaka and several other areas are under a state of emergency with rising coronavirus infections. The headline in English of the petition reads: “Cancel the Tokyo Olympics to protect our lives.”
Blackfeet Tribe shares vaccine with relatives, neighbors in Canada
On a cloudy spring day, hundreds lined up in their cars on the Canadian side of the border crossing that separates Alberta and Montana. They had driven for hours and camped out in their vehicles in hopes of receiving the season’s hottest commodity — a COVID-19 vaccine — from a Native American tribe that was giving out its excess doses.
The Blackfeet Tribe in northern Montana provided about 1,000 surplus vaccines last month to its First Nations relatives and others from across the border, in an illustration of the disparity in speed at which the United States and Canada are distributing doses. While more than 30% of adults in the U.S. are fully vaccinated, in Canada that figure is about 3%.
More than 95% of the Blackfeet reservation’s roughly 10,000 residents who are eligible for the vaccine are fully immunized, after the state prioritized Native American communities — among the most vulnerable U.S. populations — in the early stages of its vaccination campaign.
The tribe received vaccine allotments both from the Montana health department and the federal Indian Health Service, leaving some doses unused. With an expiration date fast approaching, it turned to other nations in the Blackfoot Confederacy, which includes the Blackfeet and three tribes in southern Alberta that share a language and culture.
“The idea was to get to our brothers and sisters that live in Canada,” said Robert DesRosier, emergency services manager for the Blackfeet tribe. “And then the question came up – what if a nontribal member wants a vaccine? Well, this is about saving lives. We’re not going to turn anybody away.”
Contributing: The Associated Press.