Pfizer / biontech submitted the marketing application of the third dose of mRNA new crown vaccine booster to FDAPfizer / biontech submitted the marketing application of the third dose of mRNA new crown vaccine booster to FDA


alopah Date:2021-08-27 10:25:22 From:alopah.com
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On August 25, Pfizer / biontech jointly announced that it had submitted the supplementary license application (SBLA) for the third dose of comirnaty (covid-19 vaccine, mRNA) to FDA. It is used to prevent covid-19 infection in people aged 16 and above. The two companies plan to submit SBLA data by the end of this week.

 

This SBLA data presentation is based on the data of a phase III clinical trial. 306 subjects aged 18-55 years received the third dose of mRNA new crown vaccine booster injection 4.8-8 months after completing the two doses of initial vaccination regimen. The median follow-up time after booster injection was 2.6 months.

 

In subjects infected with sars-cov-2 within 1 month after the third dose of vaccine, comirnaty induced the production of strong neutralizing antibodies against wild-type strains. The neutralizing antibody titer of sars-cov-2 wild-type strain produced one month after the third dose was 3.3 times higher than that one month after the second dose. The neutralization titer produced after inoculation of the third dose met the pre specified 1.5 times non inferiority standard, and reached the superiority standard statistically.

 

third dose of mRNA new crown vaccine booster

 

In addition, 99.5% of the subjects had 4-fold serological reaction after the third dose, compared with 98.0% after the second dose. After the third dose, the antibody titer met the predetermined 10% non inferiority range in terms of the difference of 4-fold serum response rate.

 

Pfizer and biontech plan to submit these data to peer-reviewed journals in the coming weeks and to the European Drug Administration (EMA) and other national and regional regulators around the world.

 

The third dose of comirnaty booster needle has not been widely authorized in the United States. It is only authorized for emergency use (EUA) in immunodeficient individuals aged 12 and over, including solid organ transplant recipients or patients diagnosed with the same degree of immunodeficiency.

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