If these top-line phase III results were a grade card for 12- to 15-year-olds, they would be on the honor roll: The Pfizer Inc.-Biontech SE COVID-19 vaccine is 100% effective for the age group and produced robust antibody responses.
The new results play out against a backdrop of increased production and big revenue estimates. In its 2020 financial results released March 30, Biontech said it plans to increase vaccine production from 2 billion doses to 2.5 billion doses before 2021 comes to a close. Estimated COVID-19 vaccine revenues to Biontech upon delivery of currently signed supply contracts for approximately 1.4 billion doses is about €9.8 billion (US$11.49 billion).
The strong study data prompted the two companies to say they will ask for permission to bring the younger demographic into the mRNA-based vaccine’s fold. Pfizer CEO Albert Bourla said the breakthrough could mean adolescents could be vaccinated before the school year picks up again in the fall.
The companies said they will submit the results to the FDA and the EMA and ask for an amendment to BNT-162b2’s EUA and the EU’s conditional marketing authorization for Comirnaty (as it’s branded in Europe) to allow 12- to 15-year-olds to be inoculated. As of now, 16 is the youngest approved age to receive the vaccine.
Data from the pivotal study of 2,260 adolescents in the U.S. with or without previous evidence of a SARS-CoV-2 infection were better than that of an earlier study of 16- to 25-year-old vaccinated participants.
“We expect the increased public acceptance of the vaccine that we have seen from the fall until now will continue as more data are generated for the vaccine both in controlled clinical trials and from the real world,” wrote Mizuho Securities analyst Vamil Divan to investors on March 31. “With planned production of up to 2.5 billion doses of the vaccine this year, and the increasingly likely need for booster shots to address emerging variants, we see continued upside to our COVID-19 vaccine sales estimates for Pfizer in 2021 and for at least the next couple years.”
The new Pfizer-Biontech data showed no COVID-19 cases were found in the vaccinated group (n=1,131) and 18 cases were found in the placebo group (n=1,129). Immunogenicity data were strong, too. SARS-CoV-2-neutralizing antibody geometric mean titers (GMTs) of 1,239.5 were induced in those vaccinated with BNT-162b2 in a subset of the group one month after receiving a second dose. Those data are comparable to the 705.1 GMTs found in a previous study of 16- to 25-year-olds, typically a sore arm, fever and fatigue. The administration was well-tolerated and side effects were much the same as those found in the earlier 16- to 25-year-old study group.
Now the companies look to an even younger group. Healthy children in a Pfizer-Biontech phase I/II/III trial of BNT-162b2 were dosed last week. The study puts children ages 6 months to 11 years on a two-dose schedule, each dose three weeks apart.
Vaccine hesitancy will play a role in normal school resumption. A recent study the nonprofit family advocacy group Parentstogether, representing more than 2.5 million parents, found that only 58% of parents or caregivers would vaccinate their children against COVID-19 despite 70% saying they would vaccinate themselves. The study also showed Black parents are hesitant to vaccinate their children against COVID-19 as 26% said they would “probably not” or “definitely not” vaccinate their children. That is nearly twice the rate of white parents (15%) or Hispanic parents (13%).
Money also played a role in the respondents’ decision-making. Those with an annual household income of less than $35,000 were more likely to say that they will “definitely not” or “probably not” vaccinate their children (23%) than those with incomes over $75,000 (8%).
The new clinical data build on March 11 results from Pfizer, Biontech and the Israel Ministry of Health showing real-world evidence demonstrating lower incidence rates of COVID-19 in individuals fully vaccinated with BNT-162b2. The latest analysis from the ministry showed that two weeks after the second dose, vaccine effectiveness was at least 97% in preventing symptomatic disease, severe/critical disease and death.
That data analysis found unvaccinated individuals were 44 times more likely to develop symptomatic COVID-19 and 29 times more likely to die from COVID-19.
Moderna Inc. is studying a similar age group, with a phase II/III study of mRNA-1273 underway in adolescents has completed enrollment of 3,000 participants earlier in 2021.