Pfizer/BioNTech: New COVID-19 vaccine Comirnaty for 12-15 years old people
- Mifepristone: A Safe and Effective Abortion Option Amidst Controversy
- Asbestos Detected in Buildings Damaged in Ukraine: Analyzed by Japanese Company
- New Ocrevus Subcutaneous Injection Therapy Shows Promising Results in Multiple Sclerosis Treatmen
- Dutch Man Infected with COVID-19 for 613 Days Dies: Accumulating Over 50 Virus Mutations
- Engineered Soybeans with Pig Protein: A Promising Alternative or Pandora’s Dish?
- Severe Fever with Thrombocytopenia Syndrome (SFTS): A Tick-Borne Threat with High Mortality
Pfizer/BioNTech: New COVID-19 vaccine Comirnaty for 12-15 years old people
- Red Yeast Rice Scare Grips Japan: Over 114 Hospitalized and 5 Deaths
- Long COVID Brain Fog: Blood-Brain Barrier Damage and Persistent Inflammation
- FDA has mandated a top-level black box warning for all marketed CAR-T therapies
- Can people with high blood pressure eat peanuts?
- What is the difference between dopamine and dobutamine?
- How long can the patient live after heart stent surgery?
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.
Comirnaty 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)
Disclaimer of medicaltrend.org
Important Note: The information provided is for informational purposes only and should not be considered as medical advice.
