Breaking News – The Pfizer COVID vaccine for children aged 2-5 years has been delayed. (see below)
Pfizer’s COVID-19 vaccine is the only one that has been authorized for kids, but only those who are at least 5 years and older.
So does that mean you can expect your younger kids to be able to get a vaccine soon?
When Will New COVID-19 Vaccines Be Approved for Kids?
We thought we were getting close…
Now that vaccination is open to everyone, not just those in high risk groups, we are just waiting for the age indication to be lowered. And for other COVID vaccines to be authorized for children…
When can we expect more kids to be able to get vaccinated and protected against COVID-19?
We were told that it likely won’t be until more clinical trials are completed that include kids.
“Manufacturers first tested their shots in adults, then teens, and most recently kids as young as 2. Pfizer is also running a pediatric trial for the youngest children, aged six months up to 2 years old. Bourla did not specify a timeline for this cohort, but expect results sometime after those from the 2-to-4-year-old group.”
Vaccine Data for Kids Under 5 Are Coming ‘Before the End of the Year’
And that all of those trials had already started and should be competed by the end of the year.
Unfortunately, they have had to modify the initial studies…
“Pfizer Inc. (NYSE: PFE) andBioNTech SE (Nasdaq: BNTX) today shared that following a routine review by the external independent Data Monitoring Committee (DMC), the companies will amend the clinical study evaluating the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine in children 6 months to under 5 years of age. The study will now include evaluating a third dose of 3 µg at least two months after the second dose of the two-dose series to provide high levels of protection in this young age group.”
Pfizer and Biontech Provide Update On Ongoing Studies of Covid-19 Vaccine
Why?
“While the study is ongoing and remains blinded, a pre-specified immunogenicity analysis was conducted on a subset of the study population one month following the second dose. Compared to the 16- to 25-year-old population in which high efficacy was demonstrated, non-inferiority was met for the 6- to 24-month-old population but not for the 2- to under 5-year-old population in this analysis. No safety concerns were identified and the 3 µg dose demonstrated a favorable safety profile in children 6 months to under 5 years of age.”
Pfizer and Biontech Provide Update On Ongoing Studies of Covid-19 Vaccine
The dose given to 2-5 year old kids, at 3 µg, while safe, didn’t provide an effective immune response. And they will now give these kids a third dose and see if that works.
Why not just give a higher dose?
They did!
Just like the clinical studies in older kids.
“During the phase 1 study, a total of 48 children 5 to 11 years of age received 10 μg, 20 μg, or 30 μg of the BNT162b2 vaccine (16 children at each dose level). On the basis of reactogenicity and immunogenicity, a dose level of 10 μg was selected for further study.”
Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age
Did they settle on the 3 µg dose because there were more side effects at the higher doses?
That seems likely, as that’s one of the goals of phase I trials in vaccine development.
While the booster will hopefully be effective, what about a 5 or 7 µg dose though? While I suspect this is being considered, a booster dose is a much faster option.
Since the 3 µg dose worked for infants and toddlers aged 6 months to 2 years, can we expect that COVID vaccine to be authorized soon? Keep in mind that this trial isn’t complete yet, but we may end up in a situation where a vaccine is available for infants and toddlers before preschoolers, and that hopefully happens in the first quarter of the new year.
For now, we can get all of the kids who are at least five years old vaccinated and protected.
And everyone who is at least 16 years of age can get a booster.
More on COVID-19 Vaccines for Kids
- Adding Dependent Children to Your V-Safe Account
- How Many Kids Have Gotten a COVID Vaccine?
- What’s Different About COVID Vaccines for Kids?
- Off-Label Use of COVID Vaccines for Kids
- Kids and Young Adults Should Get a COVID-19 Vaccine
- Where Can I Find a COVID-19 Vaccine for My Kids?
- The Truth About COVID-19 Vaccines
- Are Kids Dying With COVID-19?
- Pfizer and Biontech Provide Update On Ongoing Studies of Covid-19 Vaccine
- Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age
- FDA – Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) Emergency Use Authorization (EUA) of the Pfizer-Biontech Covid-19 Vaccine to Prevent Coronavirus Disease 2019 (Covid-19) for 5 Through 11 Years of Age
- FDA – Vaccine Information Fact Sheet for Recipients and Caregivers About the Pfizer-Biontech Covid-19 Vaccine to Prevent Coronavirus Disease 2019 (Covid-19) for Use in Individuals 5 Through 11 Years of Age
- CDC – Interim Clinical Considerations for COVID-19 Vaccine in Children Ages 5–11 Years
- CDC – Prevaccination Checklist for COVID-19 Vaccines
- CDC – V-safe After Vaccination Health Checker
- ACIP Presentation Slides: November 2-3, 2021 Meeting
- Pfizer’s COVID-19 vaccine for kids would require different doses, dilution, storage
- Vaccine Data for Kids Under 5 Are Coming ‘Before the End of the Year’
- Find your COVID-19 Vaccine CPT® Codes