Besides safety and efficacy data, there is the CMC (Chemistry, Manufacturing, and Controls) section of the BLA. This is the section where the vaccine and its ingredients are discussed, their specifications and storage and stability specifications and the manufacturing process among others. This is the type of work that I do for a living.Looks like Pfizer is going to apply for full FDA approval as they now have 6 months worth of data.
Pfizer-BioNTech COVID-19 Vaccine is 91% Effective at 6 Months
The companies are now seeking a Biologics License Application with the FDA, which would allow it to become more greatly available for adults in the US.www.contagionlive.com
Pfizer, BioNTech eye full FDA approval for COVID-19 vaccine as efficacy stands strong, including against aggressive variant
Pfizer and BioNTech offered an updated look at the efficacy of their COVID-19 vaccine, BNT162b2. | Pfizer and BioNTech offered an updated look at the efficacy of their COVID-19 vaccine, BNT162b2. The number stayed high at 91.3%, and the shot showed it can protect against a notoriously...www.fiercepharma.com
Here's an interesting article on the origins of the vaccines.
Science | AAAS
science.sciencemag.org