Pfizer/BioNTech mRNA Vaccine Comirnaty Demonstrates 100% Efficacy in Adolescents Aged 12–15, Amid Global COVID-19 Cases Surpassing 258 Million

November 24, 2021 /BioValleyBIOON/ -- According to Baidu's "Real-time Updates on the COVID-19 Pandemic"Big DataReport》，As of 00:00 on November 24, 2021, globallyCumulative confirmed cases exceed 250 million (258.64 million), with more than 5.17 million deaths (5.1789 million).

Recently,Pfizer(Pfizer) and BioNTech announced the long-term analysis results of the safety and efficacy of the COVID-19 mRNA vaccine Comirnaty (BNT162b2) in adolescents aged 12-15. From the pivotal Phase 3Clinical TrialThe updated data shows:The vaccine efficacy of the two-dose regimen (30 μg each dose) in preventing COVID-19 reached 100% from 7 days to 4 months after the second dose.The overview of adverse events is generally consistent with other clinical safety data for this vaccine. No serious safety issues were observed among individuals who had at least 6 months of safety follow-up after the second dose.

Analysis of the 12-15-year-old adolescent population: Based onFDAGuidance on evaluating the safety and efficacy of all companies researching COVID-19 vaccines at key milestones, Pfizer and BioNTech provided an updated analysis of the Phase 3 trial conducted in adolescents aged 12-15. Data for up to six months after completing the primary immunization series is required for vaccine licensure. This data was collected from November 2020 to September 2021.

Analysis results from 2,228 trial participants confirmed previously released data:Showed strong protection against COVID-19. From the trial, there were 30 confirmed symptomatic COVID-19 cases, with and without prior SARS-CoV-2 infection.All 30 cases came from the placebo group, while the Comirnaty group had 0 cases, corresponding to a vaccine efficacy of 100% (95% CI: 87.5, 100).Regardless of gender, race, ethnicity, demographics, obesity, and comorbidity status, the vaccine efficacy remains consistently high. Pfizer and BioNTech plan to submit these data to a peer-reviewed journal for publication.

These long-term follow-up data will form the basis of the planned supplemental Biologics License Application (sBLA) to be submitted to the FDA: to expand the use of Comirnaty for vaccination in individuals aged 12 and above. Currently, Comirnaty was approved in May 2021.FDAThe Emergency Use Authorization (EUA) can be used for adolescents aged 12-15. Pfizer and BioNTech also plan to submit these data to seek regulatory approval for this age group in other countries where the EUA or equivalent authorization was initially granted.

Pfizer Chairman and CEO Albert Bourla stated: "As global health organizations work to increase the number of vaccinated individuals around the world, these additional data points provide further confidence in the safety and efficacy of our vaccine among adolescents. This is particularly important as we are seeing a rise in COVID-19 incidence rates within this age group in certain regions, coupled with slow vaccination progress. We look forward to collaborating with...FDA"And share these data with other regulatory agencies."

BioNTech CEO and co-founder Ugur Sahin stated, "This is the first and only publicly available long-term data demonstrating the safety and efficacy of a COVID-19 vaccine in individuals aged 12-15. To date, we have...Clinical Trial"And the growing body of data obtained from real-world monitoring provides strong evidence for the effectiveness and safety of our COVID-19 vaccine in adolescent and adult populations."

Comirnaty Vaccine (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 authorizations in the United States (together with Pfizer), Canada, and other countries. The two parties plan to submit applications in countries where EUA or equivalent authorizations were initially granted to seek regulatory approval.

The vaccine has also been granted Emergency Use Authorization (EUA): (1) a two-dose immunization schedule for the vaccination 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 18 and above who have completed a two-dose vaccination regimen; (2) individuals aged 18 and above who have completed a vaccination regimen with a different COVID-19 vaccine. (Bioon.com)

Source of Original Text:Follow-Up Data From Phase 3 Trial Of Pfizer-BioNTech COVID-19 Vaccine Support Safety And High Efficacy In Adolescents 12 Through 15 Years Of Age