The National Pharmaceutical Regulatory Agency (NPRA) addresses some questions regarding Comirnaty, the Covid-19 vaccine made by Pfizer-BioNTech.
Q: What types of Covid-19 vaccines have been registered?
A: NPRA’s Drug Control Authority has granted Comirnaty conditional registration on Jan 8. Each dose of Comirnaty contains 30µg of nucleoside modified mRNA strand formulated as an RNA-lipid nanoparticle that encodes the viral spike (S) protein of the SARS-CoV-2, the virus responsible for Covid-19.
Q: What are the conditions for the vaccine’s registration?
A: Since the application was based on rolling submission of the latest data, the Product Registration Holder (PRH) will need to ensure all outstanding documents are submitted and deemed satisfactory by NPRA according to the timeline given. Apart from that, the PRH is required to monitor the safety profile of the vaccine and inform NPRA as soon as possible of any untoward incidents. The PRH is also required to conduct all activities planned under the Risk Management Plan and submit a monthly safety summary report to NPRA.
