FORT WORTH, Texas — Update: The FDA gave full approval to the Pfizer COVID-19 vaccine Monday morning. Read more here.
More than eight months after COVID-19 vaccinations began in the United States, the FDA is expected to give full approval to Pfizer’s vaccine as early as Monday, according to multiple reports.
“It's about time, because we've been waiting for this for quite some while,” said Dr. James McDeavitt, the Dean of Clinical Affairs at Baylor College of Medicine in Houston. “I think it'll make a difference.”
McDeavitt hopes the biggest impact from approval is help with vaccine hesitancy. A recent study from the Kaiser Family Foundation found 30% of adults said full approval would make them more likely to get vaccinated.
“To the FDA's credit, I think they don't seem to have caved to any sort of political pressure, and I'm sure there must have been intensive political pressure,” McDeavitt said. “They stuck with their process.”
More than 170 million Americans are fully vaccinated, according to CDC data, but all three vaccines are under emergency use authorization (EUA). 92 million Americans have received Pfizer’s vaccine. Full approval requires more time, more information and substantial evidence of safety from the manufacturers.
“[Once approved], this now has the same level of approval that every single medication that you take the doctor prescribes, it's met those same safety requirements.”
More than 13,000 Texans are hospitalized due to COVID as of Sunday, nearing the winter record of just over 14,000. ICU beds in North Texas are dwindling, with just 53 available for a region that covers more than 8 million people.
“The average age of the hospitalized patient has dropped by 10 to 15 years,” McDeavitt said. “This is no longer a disease of the 60s and 70s and 80-year-olds. It's a disease of the 30 and 40 and 50-year-olds.”
Full approval for the vaccine also opens the door for more vaccine requirements for both private and public employers in Texas. Texas Gov. Greg Abbott has banned vaccine requirements for vaccines under EUA, but not full approval.
“A private daycare center, taking care of our kids, is it a competitive advantage in that market to be able to say to parents, 'Come into your daycare center that 100% of our employees and staff are vaccinated'?” McDeavitt said. “I think it is.”
Full approval also allows companies, like Pfizer, to now begin advertising its vaccine.
“As much as drug company commercials annoy me when I’m watching TV, I'm going to be very, very pleased when I see commercials for the coronavirus vaccine on TV,” McDeavitt said.
The same Kaiser Family Foundation study found 14% of adults said they definitely would not get vaccinated, a number that hasn’t changed since vaccinations started in December. 10% of Americans said they’d wait and see. McDeavitt points out there’s never been a vaccine where a serious side effect was discovered more than two months after vaccination started.
Moderna’s vaccine approval could come in a couple of weeks and Johnson & Johnson’s could follow in just a couple of months.
“I really do think this is the impetus that people will need to get over the finish line to get as many people vaccinated as we possibly can,” McDeavitt said.
Parents with children under 12 are still waiting for an EUA. McDeavitt believes the 6-12-year-old age group will likely be able to get vaccinated by the end of the year, but kids below 6 will likely have to wait until next year.