Pfizer and BioNTech Submit Long-Term Follow-Up Data to EMA for COMIRNATY® in Adolescents Aged 12–15, Demonstrating 100% Vaccine Efficacy
Dec 26, 2021 01:44
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01:44
Pfizer
Pharmaceutical R&D Developer
BioNTech
Developer of Novel Biologics
European Medicines Agency
The European Medicines Agency (EMA) is a decentralized agency of the European Union (EU), located in London. It began operations in 1995. The agency is responsible for the scientific evaluation, supervision, and safety monitoring of medicines developed by pharmaceutical companies for use in the EU. By ensuring that all medicines available on the EU market are safe, effective, and of high quality, the EMA protects public and animal health in the 28 EU Member States and countries of the European Economic Area.
December 25, 2021 /BioValleyBIOON/ --Pfizer(Pfizer) and BioNTech recently announced that they have submitted the pivotal Phase 3 data for the COVID-19 mRNA vaccine Comirnaty (BNT162b2) for use in adolescents aged 12-15 to the European Medicines Agency (EMA).Clinical TrialThe long-term follow-up data to further support the good safety and efficacy of Comirnaty in this age group.
In the trial, long-term follow-up data showed:During the period from 7 days to 4 months after the second dose, the vaccine efficacy of the 2-dose regimen (30 μg each) of Comirnaty in preventing COVID-19 reached 100% (95% CI: 87.5, 100.0).. InIn 30 confirmed COVID-19 symptomatic patients with and without prior evidence of SARS-CoV-2 infection，All COVID-19 cases were from the placebo group.(n=1129), while no cases occurred in the Comirnaty vaccine group (n=1131). The adverse event profile is generally consistent with other clinical safety data for this vaccine. A favorable safety profile was observed among individuals who were followed up for safety for at least 6 months after the second dose.
Pfizer and BioNTech have also submitted these data to the U.S. Food and Drug Administration (FDA). Last week, the two parties submitted them in the United States.FDASubmitted a Supplemental Biologics License Application (sBLA): to expand the vaccination population for Comirnaty to include adolescents aged 12-15. In the coming weeks, these data will also be submitted to other regulatory authorities. Pfizer and BioNTech plan to publish the complete data from this Phase 3 trial in a peer-reviewed scientific journal.
Comirnaty Vaccine (Image Source: haber7.net)
The COVID-19 vaccine developed by Pfizer/BioNTech is based on BioNTech's proprietary mRNA technology and was co-developed by BioNTech and Pfizer. BioNTech is the marketing authorization holder in the United States, the European Union, and the United Kingdom, as well as the holder of Emergency Use Authorization (EUA) or equivalent authorization in the United States (together with Pfizer), Canada, and other countries. The two parties plan to submit applications in countries where EUA or equivalent authorization was initially granted to seek regulatory approval.
Comirnaty is a vaccine that has been approved in the United States.FDAThe approved COVID-19 vaccine, administered as a 2-dose immunization schedule, is indicated for the prevention of COVID-19 in individuals aged 16 years and older.
The vaccine has also been granted Emergency Use Authorization (EUA): (1) a two-dose vaccination regimen for immunization of adolescents aged 12-15 to prevent COVID-19; (2) administration of a third booster dose for individuals aged 12 and above with weakened immune systems.
At the same time, the vaccine has also been granted an EUA as a single-dose booster for: (1) individuals aged 16 and above who have completed a two-dose series of Comirnaty; (2) individuals aged 18 and above who have completed a different COVID-19 vaccination regimen. (Bioon.com)