Very happy to say that we have more good news to share. The final efficacy analysis of @Pfizer's Phase 3 study showed that our #COVID19 vaccine candidate met all of the study's primary efficacy endpoints: pfizer.com/news/press-rel…
Most notably, the vaccine candidate was shown to be 95% effective in helping prevent #COVID19 beginning 28 days after the first dose.
We also announced that the safety database required by the @US_FDA for Emergency Use Authorization (EUA) has been achieved.
As a result, we plan to submit a request within days to the @US_FDA for an EUA based on the safety & efficacy data collected to date, as well as manufacturing data relating to the vaccine candidate. These data will also be submitted to other regulatory agencies around the world.
We continue to move at the speed of science, and we know that every day matters in our path to authorization. My thanks to everyone working day and night to help us make this a reality. #ScienceWillWin
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From the bottom of my heart, I want to thank our Upjohn colleagues for their contributions over the years and dedication in helping us achieve this milestone. They have made our company stronger and helped us deliver meaningful value to patients around the world.
I know our Upjohn colleagues will deliver the same value for @ViatrisInc, which will combine best-in-class manufacturing, science experience and proven commercial capabilities to bring quality medicines to patients.
Thank you @margbrennan for the great #COVID19 discussion on @facethenation this morning. Our decision to expand the Phase 3 trial would allow us to further increase population diversity as well as generate even more safety and efficacy data.
Volunteers from all over the country have raised their hands to participate, and now we want to expand to ensure we include more vulnerable populations.
We chose to fund our program without accepting taxpayer money so we could liberate our scientists from bureaucracy and allow them to focus solely on the scientific challenges.