INDIANAPOLIS (WISH) — Monday marked a major breakthrough in the fight against the coronavirus pandemic, as the U.S. Food and Drug Administration gave full approval to Pfizer’s vaccine.
Dr. Jerome Adams, former U.S. surgeon general and WISH-TV’s medical expert, talked to Phil Sanchez about the impact of that announcement.
What’s your reaction to the news, and can you explain exactly what the difference is between full approval and emergency use approval? This is the exact vaccine they’ve been using for months already.
“Well I’m ecstatic. I really am. I’ve been clamoring for this. Many of us experts out there have been saying we can’t wait for this day to occur. And to your to your question, this is the exact same vaccine have been administered throughout the last last year, essentially. And for the EUA — that’s emergency use authorization — that’s what previously the status was. And that meant that the benefits were thought to outweigh the risk. It only requires two months follow-up of people who have been fully vaccinated, and it expires when the emergency goes away. So it’s only a temporary status. Full approval means that this has been seen as followed in people for six months after vaccination. It means that the drug is approved, and it doesn’t go away after the after the emergency goes away, and I think it’s going to give a lot of people confidence to go out there and get that shot,” Adams said.
So we’ve heard people coming out and saying they’re not getting the vaccine until it’s FDA approved. Now that it is, do you hope that’s going to change some minds?
“What we know is that about a third of people who are unvaccinated have said that the fact that the vaccine was not fully approved with a major part of their reason for this trust. So if you’re one of those people out there, I encourage you go to vaccines.gov and make an appointment today. It’s not going to convince everybody, but it will give a lot of people more confidence. And it’s one less reason that people have to be concerned about the vaccine. The other side of this — and you’ve heard me and others talk about it — is that I think it’s going to give more organizations, more businesses the confidence to be more aggressive in terms of getting their employees vaccinated, and that’s going to include mandates,” Adams said.
So that’s a good thing in your opinion?
“I think it is a good thing when you look at the fact that we have five vaccines now that are mandated within schools, and many of them don’t work as well as the COVID-19 vaccine works. I think it’s going to be important for us keeping schools open, keeping businesses open and getting over this current surge, particularly in health care settings and in settings like colleges and universities, where you’re bringing large numbers of people together and they’re at risk for being super-spreaders,” Adams said.
Does this put us any closer to full approval for other vaccines or any closer to approval for kids under the age of 12?
“The FDA says that these are completely separate pathways and that one doesn’t impact the other. Here’s what I would say to you. I think full approval for adults actually is going to give people more confidence when authorization comes for kids. Now that we’re over this hurdle, we know the FDA has limited bandwidth. There will be more people available to help review those studies and children. So I do think it will help us get to where we want to be faster, in terms of getting authorization and approval for younger people and in terms of continuing to build confidence,” Adams.