Pfizer-BioNTech alliance declare success for vaccine against COVID-19
PFIZER AND BIONTECH HAVE PRODUCED BETTER THAN EXPECTED EFFICACY RESULTS BUT WILL AWAIT FOR SAFETY DATA BEFORE FILING LATER THIS MONTH. THE PHIII INTERIM ANALYSIS FINDS VACCINE 90% EFFECTIVE WITH EUA FILING EXPECTED LATE NOVEMBER.
Pfizer and BioNTech have announced positive interim Phase III results
for their mRNA-based COVID-19 vaccine, BNT162b2, suggesting that it is 90% effective in preventing infection, which actually positions the vaccine more effective than the other common vaccines.
While the full data have yet to be published in a peer-reviewed journal, the top-line result is a huge step forward in the battle against COVID-19, and looks to be compelling enough to secure regulatory approval,
which the companies claimed they would file for after the third week of November.
While China and Russia have already granted emergency approval for their own COVID-19 vaccines, this is the first time that any candidate has produced data from a Phase III efficacy trial.
Also, unlike many other frontrunners, the partners did not work under the US government led Operation Warp Speed initiative, but did align on clinical trial protocols including for targets for ethnic diversity in participants.
While the partners have already secured advance contracts around the world for the vaccine, their potential first-to-market status could help them accumulate many more orders.
Newly introduced Secondary Endpoints to align development across players
The trial is continuing and a final analysis is planned when a total of 164 confirmed COVID-19 cases have accrued.
In addition to the primary efficacy endpoint evaluating confirmed COVID-19 cases accruing from 7 days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well.
The companies said these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between novel vaccine platforms being used by
COVID-19 vaccine developers. This will be significant as the first interim results from other vaccine developers read out.
First among these is likely to be Moderna, also using an mRNA platform,
which is also expected to unveil results this month. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose. The companies also confirmed plans to submit data from the full Phase III trial for scientific peer-review publication.
The next day
While it is important to develop and approve an effective treatment in a timely manner for the COVID-19 pandemic, it is also of the utmost importance to maintain the standards of evidence-based efficacy and safety profiles.
Before the partners will enter precise pricing discussions it is expected that they will ensure that the vaccine can be supplied safely to the populations that need it most.
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