Reports out of Ireland that Pfizer/BioNTech’s BNT162b2 Very Close to FDA & EMA EUA

Reports out of Ireland that PfizerBioNTech’s BNT162b2 Very Close to FDA & EMA EUA

Reports out of Ireland suggest that the first COVID-19 vaccine out of the West could be available in Ireland in literally just a matter of weeks. Known as BTN162b2, this mRNA-based vaccine was originally developed by the German biotech known as BioNTech and now is associated with Pfizer as the giant American pharmaceutical company entered into a co-development and commercialization arrangement with the company. Ironically, as TrialSite reported, the Pfizer and BioNTech team didn’t accept U.S. federal money from Operation Warp Speed to subsidize clinical development, yet they appear on track to be first in the vaccine race in the West (e.g. North America, Europe, etc.) as versus the East (China, Russia), the latter of which, have both generated COVID-19 vaccines now in some form of commercial use. In the case of Russia’s Sputnik V, health authorities there “registered” the drug but this was more marketing than anything else as that vaccine and comparable Chinese candidates still must be scrutinized in ongoing Phase 3 trials. Now Pfizer Ireland has revealed to local media that the company could potentially be in the position to receive an emergency use authorization (EUA) within weeks. This would trigger the start of what would be an unprecedented effort to start the distribution process involving 100 million doses of BNT162b2 before the end of 2020.  he vaccine candidate has been tested on 35,000 people thus far with no reports of any adverse reactions.

Pfizer’s country director in Ireland, Paul Reid, most recently shared with Eilish O’Regan with the Irish Independent that “We can have 100 million doses by the end of 2020. If we have an advance purchase agreement with the EU Commission, that is secured. Part of that would include a volume we think we can make available across Europe.”

The country manager shared that Pfizer was moving at “breakneck speed” to make it to the finish line and in the process serve to “lift the nation’s spirits as the country endures six weeks of lockdown.” If the U.S. Food and Drug Administration (FDA) and the European Medicines Agency approve emergency use authorizations (EUA) by the end of October to early November, it would be possible to start inoculating people before the end of the year.

Quality Data Matters

Ultimately, the regulators on both sides of the “Pond” will demand quality data-driven evidence for any EUA. Mr. Reid shared, “The FDA will review the data with their own scientists. It will be reviewed by an external panel of independent experts at a publicly held meeting. We are going to have to demonstrate the quality and consistency of the vaccine.