Pfizer Inc. [NYSE: PFE] and BioNTech SE [NASDAQ: BNTX] disclosed that it has decided to submit a change to the Conditional Marketing Authorization (CMA) in the EU to the EMA for the Pfizer-BioNTech vaccine COMIRNATY (BNT162b2) to ask for a delay of the suggestion for use in adolescents 12 to 15 years of age.
It has been disclosed that if the modified version of CMA will be authorized by EMA then it will be valid in all the 27 member states of the EU. Furthermore, the firms have already filed a related application to the U.S. FDA for the EUA. Moreover, it is planning to ask for further changes with other regulatory agencies around the world.
Additionally, it has been uncovered by the firms that their submission is dependent on the pivotal Phase III clinical study. The Phase III study has registered 2,260 applicants aged 12 to 15 years. Earlier on March 31, 2021, the firms have revealed the results of the study. The outcome of the study indicated the 100% potency in volunteers with or without before SARS-CoV-2 infection and vigorous antibody responses.
Furthermore, the volunteers have also easily tolerated the vaccine. The firm has decided to monitor the volunteers for safety for an extra two years after their second dose. The Pfizer-BioNTech’s vaccine is based on BioNTech patented mRNA technology. It was established by both BioNTech and Pfizer. Moreover, BioNTech is the possessor of MA in the EU. It also holds emergency use authorizations or equivalent in the UK, Canada, and the US.