Pfizer asks FDA to allow COVID-19 vaccine for kids under 5
Speaker 1: (00:00)
San Diego marks a new COVID milestone today as the county is set to surpassed 700,000 cases since the pandemic began as more signs point to a gradual slowing of the current Omicron surge vaccines for children as young as six months could be available soon. Joining me now is Dr. Eric topple director of the research translational Institute in LA Jolla. Dr. Topel welcome back to the program.
Speaker 2: (00:25)
Good to be with you G
Speaker 1: (00:26)
So are we seeing the peak of this current OCN surge? Well,
Speaker 2: (00:30)
For now, yes. Uh, is basically, uh, going on descent throughout the country throughout California and San Diego, which is good. Uh, whether it will way down isn't entirely clear, but at least it's reducing the toll on our medical resources and, uh, not spreading like it was. So these are really good signs
Speaker 1: (00:53)
And big news this week, as Pfizer has applied for vaccine approval for children ages six months to five years. Uh, this is a big complic because we already know that Pfizer's two dose regimen for children. Ages two to five was not protective. Um, however, it was found to be protective for children six months to two years. Can you explain what you know about why they are still applying for approval?
Speaker 2: (01:17)
Right. Well, this is a little complicated Jade because the adult dose was 30 micrograms of the mRNA and that was also the dose, um, that was used in teens. And then when they used the dose for five to 11 year olds, they dropped it down to 10. And then when they tried to go from babies to age five, they dropped it down to three. So what happened was they went on too low, which is great for safety. I mean, it's excellent, but it really wasn't enough of the exposure, uh, of the spike mRNA, uh, for, particularly for ages two to five. So a third dose is ongoing to rev that up and, uh, that probably will be all that's needed to give really strong protection, but we're only gonna see those data in the weeks ahead.
Speaker 1: (02:05)
Mm. So then what do you make of this?
Speaker 2: (02:07)
Well, this is unusual because typically you'd have all the data secure and done, uh, reviewed before there would be an approval, but it looks like the interest here is because there's a lot of children younger than age five who are getting sick. Some of them, I actually in the hospital, the idea is to get them at least started with their first dose because by the time the third dose data will be ready and it's likely it'll be, uh, quite good that they would be on their way towards the third dose. To me, Jada would be better if it was just a two dose, uh, program of course, and they still ordered out with a higher dose, but I give, I give 'em credit because they were trying to not, you know, give too much, this is what happened essentially in the teens where we saw, even though it was rare, the myocarditis issue, because they didn't drop the dose down. Whereas in the five to 11 age group, the kids did incredibly well and worldwide, there's like 11 cases of myocarditis out of, you know, 10 million plus kids. And those, all those cases recovered fully. So it is a lot about this dose story. And, uh, here, the compensation is a third dose. Uh, another way to go for it. Would've been just reload with a somewhat higher dose, um, uh, for the young children.
Speaker 1: (03:24)
What do you think the risk is in moving forward with this request?
Speaker 2: (03:28)
I don't think there's any risk because the safety is there's a non-issue the real issue is will the third dose provide the immune protection that we have seen in all the other age groups? I think it's very likely, but, um, this is, this is not typical. It's because we're in a BA a pandemic. And recently, uh, as you know, we had the highest number of children, both infected and hospitalized, uh, in, in the whole pandemic. So in, in a way, this is response to a crisis.
Speaker 1: (03:59)
Can you mind us what the company found in terms of side effects for the vaccine, for children as young as six months?
Speaker 2: (04:06)
Well, for young children, the only side effects were the typical ones that we've seen, which is the soreness in the arm. And, uh, you know, occasional fevers, chills, you know, what we call reactive ity. So the, these are my transient side effects. So that's why the, you know, the, the vaccines were tolerated incredibly well throughout all, uh, children at all ages,
Speaker 1: (04:28)
The issue of childcare and the impact of this on working parents has been a huge issue during the pandemic. How do you see vaccinating this population affecting families with kids in daycare?
Speaker 2: (04:39)
Well, the uptake in ch children overall, including teens has been very low and it's really unfortunate. There's a lot of reasons why it helps. One is it of course, helps to protect those children from getting infection. But of course, it's also the network of all the people that they connect with, whether it's a daycare or preschool or school, you know, it helps to keep that fully functional vent, the spread that uh, can occur. Uh, and also there is an issue about long COVID in children. It's about one half to one. Third is common as adults, but it's a big deal when it occurs and it can be debilitating. So lots of reasons why children of all ages should get vaccinated. Unfortunately, their parents, even though oftentimes their parents war vaccinate, they're, they're not moving forward and getting their, their children done as well. So that's really unfortunate and it defies the data, which we really is strongly supportive of vaccination.
Speaker 1: (05:33)
And you mentioned long COVID, um, has there been any more research on the impact of long COVID in children?
Speaker 2: (05:39)
Yes. Uh, we've seen more in, in recent weeks. Uh, the fact that, uh, as I mentioned, the incidents, uh, in children, there's concerns about, uh, impairing cognitive development. We have issues of fatigue and as well as things like difficulty breathing, joint aches, I mean, a lot of symptoms that can be ongoing for many, many months, even after a mild infection. It's not common. It's certainly in only a few percent of kids, but remember how many kids have been getting infections in recent weeks because of Amron. We don't know the story about Amron and law on, we only really know it from the prior versions of the virus.
Speaker 1: (06:21)
We continue to hear about the next steps of the pandemic and whether it will move into an epidemic or an endemic phase. Um, would the virus itself have to change in order to reach that endemic phase?
Speaker 2: (06:33)
I mean, we would've been there a long time ago in terms of containing the virus, had we gotten to 90% vaccinated and all those people vaccinated, boosted, uh, we're still far from that. So we're highly vulnerable, uh, here in San Diego and, and actually throughout California and United States. Uh, and we did much, uh, worse than Northern California in the bay area where they had a much higher rate of both vaccination and used of boosters. So we are vulnerable, uh, that we're gonna get into a more quiet phase, but the containment of getting, you know, unusual infections, we're not gonna get there unless we get, uh, higher levels of vaccination and boosting because there is, uh, a problem throughout the world of a large proportion of people, uh, have never had a vaccine, particularly in Africa. Uh we're in this together. And so unless we get the whole world high level of vaccinated, uh, or the protection from prior COVID that can be seen, we're not gonna have containment and it's not. This containment is really the story that we're after, which is it's unusual to know of someone who has an active COVID infection or is having, you know, real getting really sick from one we'll get there eventually. But, uh, we would get there much faster if we had the vaccination rates up.
Speaker 1: (07:52)
I've been speaking with Dr. Eric Topel director of the scripts research translational Institute, Dr. Topel. Thank you very much.
Speaker 2: (07:59)
Pfizer on Tuesday asked the U.S. to authorize extra-low doses of its COVID-19 vaccine for children under 5, potentially opening the way for the very youngest Americans to start receiving shots as early as March.
In an extraordinary move, the Food and Drug Administration had urged Pfizer and its partner BioNTech to apply earlier than the companies had planned.
The nation’s 19 million children under 5 are the only group not yet eligible for vaccination against the coronavirus. Many parents have been pushing for an expansion of shots to toddlers and preschoolers, especially as the omicron wave sent record numbers of youngsters to the hospital.
“I would say the parents in my office are desperate” to get their youngest kids vaccinated, said Dr. Dyan Hes, who runs a pediatrics practice in New York City where vaccination rates are high. For many, “that’s the first thing they ask when they walk through the door: ‘When do you think the shot is going to come out?’”
If the FDA agrees, Pfizer shots containing one-tenth of the dose given to adults could be dispensed to children as young as 6 months. Pfizer said Tuesday it had started submitting its data to the FDA and expects to complete the process in a few days.
An open question is how many shots those youngsters will need. Two of the extra-low doses turned out to be strong enough for babies but not for preschoolers in early testing. Pfizer is testing three shots, and the final data is expected in late March.
That means the FDA may consider whether to authorize two shots for now, with potentially a third shot being cleared later if the study supports it.
The FDA said Tuesday it will convene a panel of independent researchers and physicians in mid-February to help review the Pfizer data. The agency isn’t required to follow their advice, but their input is a key step in publicly vetting vaccine safety and effectiveness.
The question of how long to wait for new vaccine data — and how much to require — is a concern for FDA regulators, who face pressure to be more proactive against a virus that has repeatedly confounded health experts.
The FDA asked Pfizer to begin submitting its application now due to omicron's “greater toll on children,” an agency spokeswoman said, citing record cases among children under 5.
“In light of these new data and the rise in illnesses and hospitalization in this youngest age group, FDA believed that it was prudent to request that Pfizer submit the data it had available,” agency spokeswoman Stephanie Caccomo said in an emailed statement.
The FDA’s ultimate decision could come within the month but that isn’t the only hurdle. The Centers for Disease Control and Prevention also has to sign off.
The Biden administration has been trying to speed the authorization of COVID-19 shots for children, contending vaccinations are critical for opening schools and day care centers and keeping them open, and for freeing up parents from child care duties so they can go back to work.
Yet vaccination rates have been lower among children than in other age groups. As of last week, just 20% of kids ages 5 to 11 and just over half of 12- to 17-year-olds were fully vaccinated, according to the American Academy of Pediatrics. Nearly three-quarters of adults are fully vaccinated.
While young children are far less likely than adults to get severely ill from the coronavirus, it can happen, and pediatric COVID-19 infections are higher than at any other point in the pandemic.
“What we’re seeing right now is still a lot of hospitalizations and unfortunately some deaths in this age group,” said Dr. Sean O’Leary of the University of Colorado, who is on the AAP's infectious disease committee. If the FDA clears vaccinations for these youngsters, “that’s going to be really important because all of those hospitalizations and deaths essentially are preventable.”
For kids under 5, Pfizer’s study is giving participants two shots three weeks apart, followed by a third dose at least two months later. The company is testing whether the youngsters produce antibody levels similar to those known to protect teens and young adults.
In December, Pfizer announced that children under 2 looked to be protected but that the antibody response was too low in 2- to 4-year-olds. It's not clear why, but one possibility is that the extra-low dose was a little too low for the preschoolers.
Since the preliminary results showed the shots were safe, Pfizer added a third dose to the testing in hopes of improving protection.
Chicago health officials have been trying to prepare parents for months for the day the shots are available, said Dr. Nimmi Rajagopal, a family medicine physician for Cook County Health, which oversees the public hospital system. Some parents wonder how rigorously the shots will be evaluated or have other questions that she said are critical to address.
Rajagopal is excited about getting her own 2-year-old son vaccinated if FDA clears the way, so it will be safer for him to play with other children.
“I have been waiting and waiting and waiting,” she said.
Associated Press journalists Emma H. Tobin and Mike Stobbe contributed to this report.