How Full FDA Approval of Pfizer Vaccine Could Impact the Fight Against COVID-19
Melissa Harris-Perry: This is The Takeaway. I'm Melissa Harris-Perry. On Monday, the FDA fully approved Pfizer's COVID-19 vaccine for people ages 16 and older. President Joe Biden took this moment to address vaccine hesitancy.
President Joe Biden: If you're one of the millions of Americans who said that they will not get the shot until it has full and final approval of the FDA, it has now happened. The moment you've been waiting for is here. It's time for you to go get your vaccination, and get it today, today.
Melissa Harris-Perry: Today. A poll released by the Kaiser family foundation at the end of June, found that 3 out of 10 un-vaccinated adults said they'd be more likely to get vaccinated if the FDA granted its full approval to one of the vaccines, but the more wide reaching impact of the FDA approval is that employers and schools are likely to be emboldened by the agency's decision.
The Pentagon said on Monday that it will be moving forward with the vaccine mandate for active duty troops. Officials in New York city announced a vaccine mandate for public school employees as well. Amid all of this news, I know that many of you have questions about the vaccines. We're going to start today off by bringing you some answers. Here to help me provide those answers is Nsikan Akpan, who is Health and Science Editor for the WNYC newsroom. Nsikan, great to have you back on the show.
Nsikan Akpan: Thanks for having me back, Melissa. Appreciate it.
Melissa Harris-Perry: Over 200 million doses of Pfizer vaccine, they've already been administered in the US, why did the FDA need until this week to fully approve the vaccine?
Nsikan Akpan: Pfizer filed for a full approval back in early May for what's called a biologics license that basically launched a process where the FDA visited a bunch of clinical trial sites to conduct a massive data audit. They physically went there and made sure that nothing funny happened during the trials in terms of the data collection. We're not just talking about looking at data summaries, they really went down to the individual patients, and we're talking about 22,000 people in a trial.
They followed about 12,000 in terms of safety for at least six months. There's a lot of individual data. Then they also physically visited Pfizer's manufacturing lines to make sure that doses are prepared under the highest quality standards. If Peter Marks, the director of the FDA Center for Biologics Evaluation and Research, who was in charge of this licensing process said that they completed a process that would normally take about 8 months in just over 3 months, I think people may hear that and think that, "Oh, no, they rushed it," but this type of analysis is just about crunching data so you can physically push through it if you have enough hours. It sounded like the FDA team hasn't really slept in the past few months.
Melissa Harris-Perry: They put all of the human hours on it. It's interesting, as you say, that the speed with which they move, which was critical given that we're in a global pandemic, might also still somehow undermine trust. Part of what I'm interested in here is whether or not, even for those 3 in 10 Americans, this FDA full approval really will have the effect of increasing vaccinations.
Nsikan Akpan: Looking at surveys that have been conducted by KFF, formerly known as the Kaiser Family Foundation, we've seen since the vaccines were first authorized, about 13% of the country saying, "Oh, I'm definitely not going to get the vaccine." That's just been solid throughout ever since then, but there's this other group called the wait and see group. That group made up about 40%, 45% of people when the vaccines were first authorized back in December.
Over time, we've seen that come down, and down, down, and down, and down. That could be due to better access, the rollout just improved over time. It could be due to people's comfort levels. The hesitant saying, "Oh, I'm just going to go get this vaccine because it seems like it's safe and effective. My friends got it. My doctor is telling me to get it, my pastor is telling me to get it." We're seeing that wait and see group shrink over time. Hopefully with this approval, even more people will get the vaccine. We'll see it shrink further.
Melissa Harris-Perry: I want to listen to a call from Julia in Portland who is interested, not only in this question of whether or not people will make a different choice, but specifically hear about the idea of mandates. Let's take a listen.
Julia: Will mandates actually help increase the level of vaccination? Are vaccine mandates legal? I think we need to do whatever is necessary to get to a level of immunity that finally stops the spread of the COVID-19 virus and prevents unnecessary deaths from the disease and its complications.
Melissa Harris-Perry: What should Julia know about vaccine mandates?
Nsikan Akpan: I suspect that the mandates will improve vaccination rates. The surveys that I mentioned from KFF, they've found that there's this other group that says I'll only get the vaccine if required. That started about 10% in last December and it's gradually shrunken over time. I think now that you're seeing more mandates come through with the full approval, yesterday we saw it from New Jersey, we saw it from New York City, we saw the state school system in New York, in Minnesota, I think Louisiana state also mandated the vaccines. I think we're going to see a lot more companies, a lot more public organizations mandating it. I would think that the vaccination rates would improve through that.
Melissa Harris-Perry: As you were talking about the various groups, the I'm never going to get it, the wait and seers, you also mentioned the accessibility question. Do we have a sense right now the extent to which accessibility rather than hesitancy is causing the group that is not vaccinated.
Nsikan Akpan: I can speak to New York City in that regard, and I would say in New York city, we don't have a great sense of how much hesitancy is at play versus access. We've been pushing the mayor and his officials to release what's called the COVID vaccine inventory list, which would tell us exactly where vaccine doses were delivered, how many went into each neighborhood, into each zip code. That would give us a really great picture of access.
Then we could say, "Yes you did distribute these doses evenly based on population or based on income level." The city has been really hesitant to give that data to us, even though at one point the mayor said that he would give it to us. On the flip side, there has been a lot of talk about hesitancy. Looking at national surveys that were conducted by health and human services, the hesitancy rates in New York City actually are among the lowest in the country and the same actually applies to New York and it makes sense.
We've been one of the leaders in doling out these vaccines. If you look at the difference between Manhattan and Brooklyn in those surveys, there's only about a 2% difference in hesitancy rates. I think it's like 8% versus 6%, but then if you look at the division in terms of the number of people who are vaccinated, Manhattan has a 20% more coverage than Brooklyn, which tells me that maybe Brooklyn is more hesitant or maybe there's something going on with the number of mass vaccination sites in Brooklyn, the number of small vaccination sites and mobile clinics in Brooklyn. I would love to get that data from the city so that way we can answer that question.
Melissa Harris-Perry: Any sense in your hypothesis around this that race, ethnicity, language barriers might be part of this? Immigration status.
Nsikan Akpan: Yes. Early on we saw some pretty big gaps in terms of race and vaccine coverage, but lately we've seen those gaps shrink. Right now in New York city, about 50, I want to say 47% of white New Yorkers are fully vaccinated. Looking at Hispanic and Latino populations, it's 45%, so pretty close. You look at Black populations, it's further behind, it's 33%. Back in February, those gaps were much larger. They were very, very big.
I think the other thing that's interesting in the data right now is that we're really having an issue getting past 50%, 60% coverage. We've really hit the ceiling. I think that's a place where the mandates might come into play in terms of increasing vaccination rates because if you have to do it in order to go back to work, or to go to restaurants, to go to Broadway, it's going to create a social norm around the vaccine that will potentially increase vaccination rates.
Melissa Harris-Perry: Clearly it was the Pfizer Vaccine that gained full approval, but many Americans have Moderna. Let's listen to a call here from Frank from Glendale who has a question about that.
Frank: I'm calling to ask when is Moderna being fully approved and are we able to compare the Pfizer and Moderna vaccines? Also, are the two comparable? Are they more like apples or oranges or they're more like navel oranges to juice oranges?
Nsikan Akpan: I like that orange analogy.
Melissa Harris-Perry: I know, right? It was good. Frank is good.
Nsikan Akpan: Yesterday, it sounded as if Moderna hasn't actually filed for a full approval yet. That's what director Marks said from the FDA. These companies, I think, are jockeying for positions. Pfizer was first out of the gate and they were able to amass enough data to get this full approval for people over 16. Moderna might be saying, "Oh, we're just going to try to collect all the data we can for the adolescents to adults, 12 and up, and then maybe we'll apply for the full approval," or maybe they're going to apply with five and up. They're just going to go for the whole shebang. Right now it sounds like Moderna hasn't filed for a full approval. The timeline is a little unclear.
Melissa Harris-Perry: Some folks are hesitant and some of us are like, "When can I get my third, fourth and fifth vaccine shot?" Let's take a listen to some questions about booster shots.
Speaker 6: I'm wondering what the best way is to get the booster shot. Should I go to my primary physician? Will there be community vaccination centers or is there something else that will be offered to the general public? It just seems like there's a lot of uncertainty around this whole issue right now.
Melissa Harris-Perry: What should people know about this process?
Nsikan Akpan: Yes. The uncertainty may result from the fact that the federal plan for booster shots for everyone actually hasn't been approved yet. The FDA and the CDC still need to, I guess, figure out the plan and ratify the plan. The only people who could get booster shots right now are actually the immunocompromised and those folks can go anywhere you can get a vaccine. You might want to consult with your doctor first, but once you can show like, "Hey, I'm immunocompromised," then you can go get the vaccine, but for everybody else, we're in a wait and see moment in terms of the boosters.
I think the other thing that people should know is even before the boosters were approved for immunocompromised people, I think like 1.1 million people had already gotten unauthorized booster shots. I think that's less of a risk for adults but you are flying into a Bermuda triangle in terms of what we know about the safety of the vaccines. We know with the first and second doses of Pfizer and Moderna for instance, that you want to wait three to four weeks in order to be perfectly safe.
If you're taking a booster at some unknown time after your second dose, it's hard to say how that dose might behave in terms of even generating protection against the virus. We really should wait for the guidelines from the CDC and FDA before starting to seek those booster shots.
Melissa Harris-Perry: That's super helpful. One more really critical question for all of us who are parents with children under 12. Let's listen to this call from Rebecca in South Carolina.
Rebecca: What I'd like to know is when parents can anticipate vaccines for children five and over. As a parent in South Carolina that prohibits mandatory masking in public schools, we've got legislators who refuse to follow the CDC and AAP guidelines. Being able to protect my kindergarten age child feels impossible without a vaccine available for children.
Nsikan Akpan: It's extremely refreshing to hear people rejecting the use of masks when we've really been able to show that they help protect against the spread of the virus. In terms of vaccine approvals for kids under 12, essentially, that authorization could happen any time between now and the beginning of next year. That's been the timeline that was outlined by the FDA.
The drug companies will have to apply for those authorizations. Then I imagine that once they do, they'll go through pretty quickly. The thing I like to remind people about when they ask this question is that we actually don't need to vaccinate kids from 5 to 12. If we could get the vaccination rates high enough in adults, it would naturally drive down the spread of the virus to such a degree that it wouldn't be able to get to children.
A lot of the studies that we've looked at have shown that the virus often spreads from adults into children. If we could just break transmission in adults, we would be able to protect those young kids. I think the reality of the United States, we've had real struggles with getting adults to want to protect themselves from disease and death during this pandemic. It is extremely frustrating. We're in limbo right now in terms of the timing on the authorization for kids under 12.
Melissa Harris-Perry: All right, adults, do you hear that? We can form a vaccine wall around our young people to protect them because right now they do not have an option to get the vaccine. Nsikan Akpan is the health and science editor for the WNYC newsroom. Nsikan, thanks so much for joining us.
Nsikan Akpan: Thanks for having me.
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