Could Pfizer's full FDA approval impact your employee policy?
Pfizer is now seeking full approval for its COVID-19 vaccine by the Food and Drug Administration.
It's been 14 months since the pandemic hit, and a lot has happened since then. Not only are there multiple vaccines now but one of them, Pfizer, is seeking to get full approval, with Moderna expected to follow soon after.
There are currently three vaccines available through Emergency Use Authorization.
SEE RELATED STORY: Pfizer and BioNTech begin application for full FDA approval of their COVID-19 vaccine
"To get authorization, the duration of follow-up on the study has to be at least two months," said Dr. Hana El Sahly, the associate professor of molecular virology and microbiology and medicine at Baylor College of Medicine.
Dr. El Sahly said the full approval process is way more detailed than one thinks.
"This includes a longer duration of follow-up, a larger body of data on the safety and efficacy of the vaccine from the clinical trial," she said.
Experts are hoping that getting full approval will help relieve some of the vaccine hesitancy.
"A lot of this data will have more exposure and will provide reassurance for some people. If what's preventing them from getting the vaccine is the acquisition of more data, this data will be shared," said El Sahly.
Once fully approved, El Sahly said employers could require it, much like when hospitals require health care workers to get the flu vaccine.
"Employers can require a vaccine that's licensed and recommended to be a requirement for employees, but that may not be the case for authorized vaccines," she said.
As far as how quickly approval could come, Dr. El Sahly said it often takes months for the process to happen but this could come much quicker.
"I expect it to be really short, because again, COVID-19 is priority number one for all regulatory agencies," said El Sahly.
Meanwhile, Pfizer is expected to get authorization for adolescents from ages 12 to 15 any day now.
"If we can get that age group immunized, we can continue to make a big dent in the number of cases that we're seeing. That's a big portion of the population that if we can get them immunized, we should start to see even faster decreases in rates of hospitalization," said Dr. Michael Chang, a pediatric infectious diseases specialist with UTHealth and UT Physicians.
