New crown epidemic: 210 million cases!US FDA approves Pfizer/BioNTech mRNA vaccine Comirnaty: for people ≥16 years old!-FDA Information Zone-Biology Valley

1. Pfizer
2. BioNTech
3. Novel Coronavirus
4. Vaccine
5. mRNA
6. Comirnaty

Source: Original Site 2021-08-25 10:18

Comirnaty is the first COVID-19 vaccine approved by the US FDA.

August 25, 2021/Bio Valley BIOON/ –According to Baidu’s “New Coronavirus Pneumonia Epidemic Real-time Big Data Report”, as of 06:00 on August 25, 2021, a total of confirmed diagnoses worldwideMore than 210 million cases (21366 million), More than 4.45 million deaths.

Recently, Pfizer and BioNTech jointly announced that the U.S. Food and Drug Administration(FDA) ApprovedCOVID-19 mRNA vaccine Comirnaty (BNT162b2)Biological Products License Application (BLA):It is used for immunization of people aged 16 and above to prevent COVID-19.

It is worth mentioning that Comirnaty is the first COVID-19 vaccine approved by the US FDA. Comirnaty was approved through the priority review process, which was approved 5 months earlier than the target date. In the United States, Comirnaty will be available through an Emergency Use Authorization (EUA) from December 11, 2020. Since December 2020, Pfizer-BioNTech has provided more than 1.2 billion Comirnaty doses to more than 120 countries and regions around the world.

The approval is based on a comprehensive data package, which includes long-term follow-up data from key phase 3 clinical trials, showing that the vaccine‘s high efficiency and good safety were observed within 6 months after the second dose of vaccination. The BLA also includes manufacturing and facility data required for licensing. Pfizer and BioNTech completed the BLA submission in May 2021, and the BLA received priority review in July 2021.

In the key Phase 3 trial, an analysis of 927 confirmed symptomatic COVID-19 cases observed in the trial showed that Comirnaty was effective in preventing COVID-19 within a period of 7 days to 6 months after the second dose of vaccination. The efficiency is 91.3%. According to the definition of the Centers for Disease Control and Prevention (CDC),Comirnaty is 100% effective in preventing severe COVID-19 disease; According to the definition of the US FDA, the effective rate of preventing severe COVID-19 disease is 95.3%. The safety data of the Phase 3 study, collected from more than 12,000 vaccinators who have been followed up for at least 6 months after the second dose of vaccination, shows that Comirnaty has good safety and tolerability.

Comirnaty vaccine (picture source: haber7.net)

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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 EUA: (1) for the immunization of adolescents aged 12-15 to prevent COVID-19; (2) for people aged 12 and above with immunocompromised immune function, to provide the third booster shot.

As announced on August 16, Pfizer and BioNTech plan to apply for a third or booster dose license for people 16 years of age and older through a supplementary biological product license application (sBLA). For adolescents aged 12-15, once the required data within 6 months of the second dose of vaccination are obtained, the two parties intend to submit a supplementary BLA to support the FDA supervision of this mRNA vaccine in adolescents aged 12-15 approve. (Bioon.com)

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