Opening the door to FDA approval of vaccinations for children between the ages of 5 and 11, Pfizer and BioNTech announced Monday morning that their COVID jab has been found to be just as safe and effective for grade-school children as it is for adults. The findings come from a large-scale trial offering some of the first insight into how well the jab works for young kids.
With the new school year starting, pressure to vaccinate children has been intensifying, especially now that an FDA advisory panel recommended last week that booster jabs should be limited to the immuno-compromised, as well as those age 65 and older.
— Meg Tirrell (@megtirrell) September 20, 2021
Pfizer’s CEO celebrated the news via tweet:
Considering the rise in pediatric cases of COVID-19 and the substantial threat the Delta variant poses to children, we are glad to share this news with the world.
We plan to submit our data to @US_FDA and other regulators with urgency and submit for peer-review publication.
— AlbertBourla (@AlbertBourla) September 20, 2021
In the stage 2/3 trial with 2,268 participants, patients who received the vaccine received two shots of a 10 microgram dose (one-third the adult shot) produced antibody levels comparable to those seen in a trial of 16-to-25-year-olds who got the adult dose, the companies said. Side effects were similar to the trials for the 16-25 age cohort.
Pfizer plans to submit the data to the FDA for emergency use authorization soon, though it’s not exactly clear when. Meanwhile, the company will still be collecting “near-term” submission data needed to file for full FDA approval for the age cohort.
Participants’ immune responses were measured by looking at neutralizing antibody levels in their blood and comparing those levels to a control group of 16- to 25-year-olds who were given a two-dose regimen with the larger 30-microgram dose. Pfizer said the levels compared well with older people, who received the larger dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”
“Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age,” the company said.
Notably, a Pfizer spokesperson confirmed that were no instances of myocarditis – a rare type of heart inflammation that has been linked with mRNA vaccines – in any of the younger patients.
Right now in the US, the Pfizer jab is fully approved for people above the age of 16, and emergency authorized for those aged 12 and over. Pfizer now believes it will have data for children as young as six months “as soon as the fourth quarter.”
While on doctor commented that Pfizer is once again doing “science by press release”, but the data are still “favorable”.
Pfizer announces results for Phase II/III vaccine studies in individuals 5-11
Safety and antibody response are favorable with a reduced (10 mcg) dose.
As always, this is science by preliminary press release however the results are encouraging.
— Matthew R. Robinson MDCM, MScCH (@MRobinsonMDCM) September 20, 2021
Another Twitter user noted that the vaccines “will still need to be approved and if the CDC/FDA disagree w/Pfizer then we have quite the conundrum.”
Is Pfizer’s public press release, ahead of CDC and FDA approval, a squeeze tactic versus great medical news … the vaccines will still need to be approved and if the CDC/FDA disagree w/Pfizer then we have quite the conundrum …
— Jedigal007 (@JPERGELRWE) September 20, 2021
While the data doesn’t break down the number of confirmed cases among the placebo or the dosed group, it does show that antibody levels are similar in child with only a fraction of the adult dose.
Read the full release below:
NEW YORK AND MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart, a smaller dose than the 30 µg dose used for people 12 and older. The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses. The 10 µg dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age. These are the first results from a pivotal trial of a COVID-19 vaccine in this age group.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
The data summarized from this Phase 2/3 study, which is enrolling children 6 months to 11 years of age, was for 2,268participants who were 5 to 11 years of age and received a 10 µg dose level in a two-dose regimen. In the trial, the SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) was 1,197.6 (95% confidence interval [CI, 1106.1, 1296.6]), demonstrating strong immune response in this cohort of children one month after the second dose. This compares well (was non-inferior) to the GMT of 1146.5 (95% CI: 1045.5, 1257.2) from participants ages 16 to 25 years old, used as the control group for this analysis and who were administered a two-dose regimen of 30 µg. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.
Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group. A request to the EMA to update the EU Conditional Marketing Authorization is also planned. Topline readouts for the other two age cohorts from the trial – children 2-5 years of age and children 6 months to 2 years of age – are expected as soon as the fourth quarter of this year.
Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-reviewed publication.