Pfizer seeks full FDA approval for COVID-19 vaccine
Houston, Texas — Pfizer is asking the Food and Drug Administration for full approval of its vaccine for people 16 and older, which would allow direct marketing to consumers and make it easier for employers to require vaccinations for workers.
"The FDA will move as expeditiously as possible without compromising its gold standard for safety," said White House COVID-19 response coordinator Jeff Zients.
The agency is expected next week to authorize giving the Pfizer shot to 12 to 15 year olds. Pfizer is likely to seek emergency use authorization for its vaccine for children as young as 2 in September. But less than a third of parents say they'd get their children vaccinated when they are eligible, according to a recent survey.
Pediatric organ transplant surgeon Thao Galvan got her 16-month-old son, Nathan, vaccinated. He was the first child under 2 to receive the Pfizer vaccine in a study run by Texas Children's Hospital, where Galvan works.
"Having understood the data and the science and the risks involved, we felt that the benefits far outweigh the risks and so that was why the decision was clearer for me," she said.
Nathan was given one-tenth of an adult dose.
"By the end of the day he was having a dance party with his brother so everything was fine," Galvan said. "He had two hives by his knee, but he has hives every other day, honestly."
Her older son, Charlie, is enrolled in phase two of the Pfizer trial for his age group.
As the trial for children progresses at Texas Children's Hospital, the Houston Health Department tells CBS News some 51,000 people who got their first shot have not returned for the second, which could have an impact on herd immunity.
