Moderna says new data supports its COVID vaccine for kids 6 to 11
Speaker 1: (00:00)
Anticipation is growing for the FDA meeting plan tomorrow, which may result in a new emergency use authorization for vaccines in children aged 5, 3 11, and the run-up to the meeting, the white house announced plans on how it will distribute the vaccine quickly. Once authorization is given. Here's what Dr. Anthony Fowchee had to say about it over the weekend.
Speaker 2: (00:22)
So if all goes well and we get the regulatory approval and the recommendation for the CDC, it's entirely possible, if not very likely that vaccines will be available for children from five to 11 within the first week or 2nd of November,
Speaker 1: (00:38)
You to talk more about where things stand with vaccines for children is Dr. Christian Ramers infectious disease specialist with family health centers and a member of San Diego county's COVID-19 vaccine clinical advisory group. Dr. Ramers welcome. Thank you for having me. You just heard Dr. Fowchee on when he thinks vaccines may be available to kids five through 11. Do you share his assessment targeting early November?
Speaker 3: (01:02)
I think that's about right. You know, we have a very methodical and careful process to get these vaccines approved and the companies have submitted their data. I believe almost, uh, almost three, four weeks ago. That's from Pfizer to the FDA, the FDA just put out their initial assessment and writing and they're going to be meeting tomorrow. And then of course, this goes over to the CDC is advisory committee on immunization practices, and they're likely to meet the first week of November. And then it's about the logistics and the implementation of getting those vaccines out there onto shelves. I can tell you that we are already able to put in pre-orders, uh, those who are going to be vaccinating. So we want to be ready. I don't think it's going to happen overnight, but first week of November is a good guess.
Speaker 1: (01:43)
It seems to be a lot of anticipation for the FDA meeting tomorrow. When it comes to the coronavirus vaccine for kids five to 11, what exactly will be discussed and tomorrow's meeting
Speaker 3: (01:54)
Well, these meetings are always based on the data. And so far, all we've seen was the press release from the company from Pfizer, up until today, when the FDA released actually all of its actual data from the clinical trials, including the very important safety data that everybody wants to see, uh, the FDA kind of tip their hat a little bit in their executive assessment here is saying that it looks like the benefits are going to outweigh the risks. And there's one thing on everybody's mind, which is myocarditis or pericarditis is going to be a big factor when we vaccinate younger children
Speaker 1: (02:24)
And approval forthcoming. And if so, what type of approval and for which vaccines specifically.
Speaker 3: (02:30)
So I'd be careful with the word approval, because what they're talking about is an emergency use authorization. Uh, you know, this is what's given first and then an approval usually comes a little bit later, but we are talking about just Pfizer. At this point, we've heard a little bit of preliminary information on the Madonna vaccine, and it's not exactly the same vaccine that was used in adults. It's a lower dose. So an adult Pfizer vaccine as 30 micrograms of material, and this was titrated down very carefully to 10 micrograms for this age group of five to 11. And there are some figures in the data here that show that that actually did result in lower side effects. And yet still seem to provide the same level of immunity, uh, compared to younger adults in the larger trials.
Speaker 1: (03:10)
And as you mentioned, new data related to the modern of vaccine for children in that five to 11 age group was just released. What can you tell us about those findings?
Speaker 3: (03:19)
So this was from a study called the kid Cove study, and I think they recruited close to 5,000 children. They also titrated the dose down, so Moderna and adult, but during the vaccine is a hundred micrograms. They used 50 micrograms or half the dose, and they essentially showed the same thing that the Pfizer data looks like. It shows, which is equivalent immune responses to young adults in the much larger trials. And so far we just have the press release, but the press release says that the safety and tolerability was similar to what they saw in the adult trials as well.
Speaker 1: (03:48)
So now that we've got that data, any idea of when Madonna, uh, versions of the kid's vaccine might be available, and what about J and J as well?
Speaker 3: (03:57)
I follow the same timelines and Madonna in their press release says this data is going to be submitted to the FDA right away. And so that would be in the next couple of days, I would presume. So we're looking at maybe three weeks from now that the Madonna data will be reviewed that's up to the FDA and their committee structure. And then J and J I don't think we've seen much of anything. So, you know, we, we may not get there with J and J we'll have to sort of wait and see what, what they say
Speaker 1: (04:20)
Last week. The white house announced their plans to roll out vaccines to children, aged five to 11 in anticipation of the FDA's approval, or at least emergency authorization. Here's white house coronavirus response coordinator. Jeff zines
Speaker 4: (04:34)
Kids have different needs than adults. And our operational planning is geared to meet those specific needs, including by offering vaccinations and settings that parents and kids are familiar with and trust do we need
Speaker 1: (04:47)
Where kids will be able to get the vaccine
Speaker 3: (04:51)
Hearing? There is really an acknowledgement that parents don't want to bring kids and sit in the parking lot at Petco and have mass vaccination lines. There they're much more comfortable getting vaccines in their pediatrician's office or in their family medicine doctor's office. You know, look, kids, vaccinating kids is a major part of preventative health care in pediatrics. And so why not use what's already there? And so they've had to make some adjustments in terms of the shipping, the vaccines authorizing the vaccinators and an even in something as simple as what the vial looks like and, uh, and how many doses can be given. So really focusing more on pediatrician's offices, where families trust their pediatrician for all the other vaccines that their children receive.
Speaker 1: (05:29)
You mentioned the concern about myocarditis associated with the vaccine. What can you tell us about what the data is currently saying about that?
Speaker 3: (05:39)
Just looked it over. This is from the FDA document and that's derived from data that Pfizer submitted to them. There were actually no reports of myocarditis or pericarditis or anaphylaxis or death in this entire trial of, I think I said that almost 3000 children in the, in the Pfizer data. So there was a concern based on what we saw, uh, the rare episodes of myocarditis in young adults and teenagers and, and, uh, those in their twenties. But again, by titrating the dose down, it looks like they've avoided that almost completely in this five to 11 age group,
Speaker 1: (06:09)
Vaccine hesitancy has presented major challenges to health officials, uh, in the last year, how are you approaching potential vaccine hesitancy when it comes to younger children,
Speaker 3: (06:20)
We've learned a lot in the last year and a half about what people need in order to feel comfortable proceeding with the vaccine. And really the number one thing is to have that discussion with their own healthcare provider. And so I think we're prepared and we're ready to have those one-on-one conversations. I think everybody expects that there's a group of parents that are just waiting to go and, and I've already made up their minds. They're ready to get their children vaccinated. There's a group in the middle who are hesitant and kind of want to wait and see, maybe see a little bit more of the data or have that conversation with their pediatrician. And then those are groups that are really on the other side, and really don't want to go there yet. And maybe they need a little bit more attention and to get their questions answered. And that's fine. That's a spectrum of hesitancy across the board, but suffice to say, what needs to happen is these conversations between parents and families with their own health care provider.
Speaker 1: (07:06)
I've been speaking with Dr. Christian Ramers infectious disease specialist with family health centers of San Diego and a member of the San Diego county vaccine clinical advisory group. Dr. Ramers.
Speaker 3: (07:17)
Thank you. Thank you so much for having me
Speaker 5: (07:21)
Moderna says a study in kids 6 to 11 found two doses of the company's COVID-19 vaccine given 28 days apart produced a strong antibody response.
The study, conducted in collaboration with the National Institutes of Health, used shots containing a 50 microgram dose of the vaccine, half the dose of the Moderna shots authorized for adults. More than 4,700 children ages 5 to 11 took part in the study.
The most common side effects were fatigue, headache, fever and pain at the site of injection. The company says the analysis showed a "favorable safety profile."
The summary of the study results was made available in a press release. The information hasn't been peer reviewed or published, but Moderna said it plans to submit them to a scientific journal for publication.
The company also said it plans to submit the data to regulators, a move that would support the authorization of the vaccine for kids 6 to 11.
The release of the data comes a day before a panel of advisers to the Food and Drug Administration will review use of the Pfizer-BioNTech COVID-19 vaccine in children 5 to 11 years of age.
In June, Moderna submitted study results involving nearly 2,500 adolescents ages 12 to 15 to the FDA. The agency hasn't yet issued a decision on whether to expand use of the Moderna vaccine to that age group.
In May, the FDA expanded authorization of the Pfizer-BioNTech vaccine to include adolescents 12 to 15 years of age.
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