Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for COMIRNATY COVID-19 Vaccine in Children Aged 5 to 11

October 30, 2021 /BioonBIOON/ --According to Baidu's 《Novel Coronavirus Pneumonia Epidemic Real-TimeBig DataReport》，as of 24:00 on October 30, 2021, the global cumulativeOver 246 million confirmed cases (246.94 million)，Over 5 million deaths(5,007,900).

Recently,Pfizer(Pfizer) and BioNTech announced that the U.S. Food and Drug Administration (FDA) GrantedEmergency Use Authorization (EUA) for the COVID-19 mRNA Vaccine Comirnaty (BNT162b2): For Children Aged 5 to 11 Years (Also Referred to as 5 to Less Than 12 Years of Age)。For this age group, Comirnaty will be administered as a two-dose regimen, with 10 micrograms (μg) per dose given 21 days apart. The 10 μg dose level was carefully selected based on safety, tolerability, and immunogenicity data.

It is worth noting that,Comirnaty is the first COVID-19 vaccine product authorized in the United States for use in children aged 5 to 11 years.。FDA...action is an important milestone, with the potential to help protect millions of school-aged children from COVID-19 infection. Clinical data show that,During the period when the Delta variant was the dominant circulating strain, Comirnaty demonstrated a favorable safety profile in children aged 5 to 11 years, with a vaccine efficacy of up to 90.7%.

Pfizer Chairman and CEO Albert Bourla said, "This is a day that many parents have eagerly awaited to protect their children from the virus."Since the onset of this pandemic, more than 6 million children in the United States have beenDiagnosisCOVID-19 Positive, a large number of young people are still being infected every week. ThroughFDAWith this authorization, we have achieved another key milestone in our ongoing efforts to help protect families and communities and control this disease.”

BioNTech CEO and Co-Founder Dr. Ugur Sahin said: “Today’s Emergency Use Authorization is supported by clinical data that demonstrates the favorable safety profile and high vaccine efficacy of Comirnaty in children, highlighting its potential to address current public health needs. As children aged 5 to 11 readjust to the new school year both inside and outside the classroom, our goal is to help keep them safe and protected, enabling a return to normalcy.”

The FDA's decision was based on data from a Phase 2/3 randomized controlled trial. The trial included approximately 4,500 children aged 5 to 11 years (2,268 from the original cohort and 2,379 from the supplemental safety cohort).FDAThe Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviewed the results of the trial. In the trial,Measured starting 7 days after administration of the second dose, the vaccine demonstrated a favorable safety profile, robust immune response, and a vaccine efficacy of 90.7% in children previously uninfected with SARS-CoV-2.The Data Monitoring Committee (DMC) for this study reviewed the data and found no serious safety concerns related to the vaccine.

At the direction of the U.S. government, Pfizer and BioNTech will immediately begin shipping the 10 μg pediatric dose (ages 5 to <12 years on the vial, ages 5 to <12 years on the carton).Eligible U.S. residents will continue to receive vaccines at no cost., this aligns with the U.S. government's commitment to ensuring free public access to COVID-19 vaccines.

As a next step, the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) will convene next week.Conference, to discuss potential recommendations for the use and administration of vaccines in children aged 5 to 11. Pediatric vaccination is expected to begin following CDC approval of the ACIP recommendations.

Pfizer and BioNTech have submitted applications to other regulatory authorities worldwide, including the European Medicines Agency (EMA), for the authorization of Comirnaty for this age group (5–11 years). Pfizer and BioNTech are currently conducting pediatric`Clinical Trial`inThe other two age groups (2 to <5 years; 6 months to <2 years)preliminary data, expected to be available as early as the fourth quarter of 2021 or early first quarter of 2022.

Comirnaty vaccine (Image source: haber7.net)

The Pfizer/BioNTech COVID-19 vaccine is based on BioNTech's proprietary mRNA technology and was co-developed by BioNTech and Pfizer. BioNTech is the marketing authorization holder for the United States, the European Union, and the United Kingdom, and also holds the Emergency Use Authorization (EUA) or equivalent authorization for the United States (with Pfizer), Canada, and other countries. Both parties plan to submit applications in countries where the EUA or equivalent authorization was initially granted to seek regulatory approval.

The vaccine has also been granted Emergency Use Authorization (EUA) for: (1) a two-dose regimen for active immunization to prevent COVID-19 in adolescents aged 12 to 15 years; (2) a third dose for individuals aged 12 years and older who are immunocompromised.

Additionally, the vaccine has also been granted an EUA for use as a single-dose booster: (1) for individuals aged 65 years and older; (2) for individuals aged 18–64 years at high risk of severe COVID-19; (3) for individuals aged 18–64 years with frequent institutional or occupational exposure to SARS-CoV-2; (4) for individuals who have completed primary vaccination with a different COVID-19 vaccine. (Bioon.com)

Original Source:Pfizer and BioNTech Receive First U.S. FDA Emergency Use Authorization of a COVID-19 Vaccine in Children Ages 5 Through 11 Years