August 19, 2022

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Pfizer/BioNTech: New COVID-19 vaccine Comirnaty for 12-15 years old people

Pfizer/BioNTech: New COVID-19 vaccine Comirnaty for 12-15 years old people



 

Pfizer/BioNTech: New COVID-19 vaccine Comirnaty for 12-15 years old people. 

New COVID-19 mRNA vaccine! Pfizer/BioNTech submits long-term data of Comirnaty for 12-15 years old people to EMA: Vaccine efficacy reaches 100%!

 

Pfizer and BioNTech recently announced that they have submitted to the European Medicines Agency (EMA) the long-term follow-up data of a key Phase 3 clinical trial of the COVID-19 mRNA vaccine Comirnaty (BNT162b2) for adolescents aged 12-15 years old to further Support Comirnaty’s good safety and effectiveness in this age group.

 

In this trial, long-term follow-up data showed that the 2-shot immunization program (30μg per dose) of Comirnaty’s vaccine against COVID-19 reached 100% (95%CI: 87.5, 100.0) .

Among the 30 symptomatic patients with confirmed COVID-19 with and without evidence of previous SARS-CoV-2 infection , all COVID-19 cases came from the placebo group (n=1129), while the Coirnaty vaccine group (n=1131) did not Cases occurred.

The adverse event profile is usually consistent with other clinical safety data of the vaccine.

A good safety profile was observed in individuals who had undergone safety follow-up for at least 6 months after the second dose.

 

Pfizer and BioNTech also submitted these data to the U.S. Food and Drug Administration (FDA). Last week, both parties submitted a supplementary biological product license application (sBLA) to the US FDA : to expand the vaccinated population of Comirnaty for 12-15 year olds.

In the coming weeks, these data will also be submitted to other regulatory agencies. Pfizer and BioNTech plan to publish the complete data of the Phase 3 trial in a scientific peer-reviewed journal.

 

Pfizer/BioNTech: New COVID-19 vaccine Comirnaty for 12-15 years old peopleComirnaty vaccine (picture source: haber7.net)

 

Pfizer/BioNTech’s COVID-19 vaccine is based on BioNTech’s proprietary mRNA technology and is jointly developed by BioNTech and Pfizer.

BioNTech is the holder of marketing authorizations 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 an application to seek regulatory approval in the country that initially granted the EUA or equivalent authorization.

 

Comirnaty is a COVID-19 vaccine that has been approved by the US FDA as a 2-shot immunization program for immunization of people aged 16 and over to prevent COVID-19.

 

The vaccine has also been granted an emergency use authorization (EUA):

(1) a 2-shot immunization program for immunization of adolescents aged 12-15 to prevent COVID-19;

(2) for those 12 years of age and older with weakened immune function For the population, the third dose of immunization is provided.

 

At the same time, the vaccine has also been granted EUA as a single-dose booster:

(1) For people aged 16 and over who have completed the Comirnaty 2-dose immunization program;

(2) For those who have completed another different COVID-19 vaccine immunization Program for people 18 years and older.

 

 

 

 

 

References:

Pfizer and BioNTech Submit Updated Longer-Term Follow-Up Data of COMIRNATY® in Adolescents 12 Through 15 Years of Age to EMA

Pfizer/BioNTech: New COVID-19 vaccine Comirnaty for 12-15 years old people

(source:internet, reference only)


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