Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced plans to extend their rolling submission to the U.S. Food and Drug Administration (FDA) seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine to include children 6 months through 4 years of age, which had been requested by FDA.
The trial in children 6 months through 4 years of age is ongoing and data on the first two 3 µg doses in this age group are being shared with the FDA on an ongoing basis. Cases continue to accumulate according to the study protocol and more data are being generated because rates of infection and illness remain high in children of this age, especially due to the recent Omicron surge.
In December 2021, Pfizer and BioNTech announced that the ongoing clinical study would evaluate a third 3 µg dose at least two months after the second dose of the two-dose series in this age group. Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group. This is also supported by recent observations of three dose booster data in several other age groups that seems to meaningfully augment neutralizing antibody levels and real world vaccine protection for omicron compared to the two-dose regimen. The companies expect to have three-dose protection data available in early April.
The independent Data Monitoring Committee (DMC) for the study supports the continuation of the trial according to the protocol and believe that the data collected to date indicate the vaccine is well tolerated and support a potential three-dose regimen.
The extension allows the FDA time to receive updated data on the two and three-dose regimen, conduct a thorough evaluation of it and facilitate a robust, public discussion.
About the Phase 1/2/3 Trial in Children
The Phase 1/2/3 trial initially enrolled 4,500 children ages 6 months to under 12 years of age in the United States, Finland, Poland, and Spain from more than 90 clinical trial sites. Additional children have been enrolled in all age groups following study amendments and the trial currently includes approximately 8,300 children. It was designed to evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech vaccine on a two-dose schedule (approximately 21 days apart) in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years. Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received a lower 3 µg dose for each injection in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection. On December 17, 2021, Pfizer and BioNTech announced the companies would test a third 3 µg dose given at least two months after the second dose in children under age 5 and a third dose of the 10 µg formulation in children 5 to under 12 years of age.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
About Pfizer Improvements That Change Cases’Lives
At Pfizer, we apply wisdom and our global coffers to bring curatives to people that extend and significantly ameliorate their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative drugs and vaccines. Every day, Pfizer associates work across developed and arising requests to advance heartiness, forestallment, treatments and cures that challenge the most stressed conditions of our time. Harmonious with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we unite with health care providers, governments and original communities to support and expand access to dependable, affordable health care around the world. For further than 170 times, we’ve worked to make a difference for all who calculate on us.
Biopharmaceutical New Technologies is a coming generation immunotherapy company introducing new curatives for cancer and other serious conditions. The Company exploits a wide array of computational discovery and remedial medicine platforms for the rapid-fire development of new biopharmaceuticals. Its broad portfolio of oncology product campaigners includes personalized and off-the-shelf mRNA- grounded curatives, innovative fantastic antigen receptor T cells,bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small motes. Grounded on its deep moxie in mRNA vaccine development and in- house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine campaigners for a range of contagious conditions alongside its different oncology channel. BioNTech has established a broad set of connections with multiple global medicinal collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.