Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced this morning the topline results coming from its phase 2/3 trial of its COVID-19 vaccine administered to children 5 to 11 years of age, showing “favorable safety profile and robust neutralizing antibody responses”. The companies report that the results are the first from a “pivotal trial of a COVID-19 vaccine in this age group”.
“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,” said Pfizer CEO Albert Bourla.
The partnership’s vaccine is currently undergoing clinical trials in determining the safety, tolerability, and immunogenicity of vaccinating people under 12 years old. The particular results reported today come from 2,268 participants who were 5 to 11 years of age receiving a two-dose regimen of 10 µg of the vaccine administered 21 days apart. This dosage is relatively smaller than the 30 µg currently being administered to people 12 years old and above.
Using a previous study involving people 16 to 25 years of age immunized with 30 µg doses as the control, the clinical trial showed comparable results of antibody responses in the younger cohort of participants given 10 µg doses. The 5-11 years old participants demonstrated a strong immune response one month after the second dose with side effects generally comparable to those observed in the previous study.
The biotech firms 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.
The current clinical trial for the vaccine initially enrolled up to 4,500 children ages 6 months to 11 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. Topline results from the trial concerning the age groups of 2-5 years old and 6 months-2 years old are expected to be released by the fourth quarter of this year. Data from the full phase 3 trial are also expected to be submitted for scientific peer-review publication.
Currently, the partnership has two COVID-19 vaccines: the Comirnaty, which was made by Pfizer for BioNTech and is FDA-approved as a two-dose series for prevention of COVID-19 in individuals 16 years of age and older; and the Pfizer-BioNTech COVID-19 vaccine, which has also received an emergency-use authorization from FDA to prevent COVID-19 in individuals 12 years of age and older like Comirnaty. The companies said these two vaccines are interchangeable to prevent the disease caused by SARS-CoV-2.
Pfizer last traded at US$43.89 on the NYSE while BioNTech last traded at US$359.18 on the Nasdaq.
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