The interim data from Pfizer (PFE) indicated no serious safety concerns, but the data covers a relatively short time period and safety issues could emerge as the company follows trial participants for a longer time. Which is why the U.S. Food & Drug Administration wants to see more data from a longer time period before considering an application for Emergency Use Authorization.
Pfizer said that it will submit an application for Emergency Use Authorization in the third week of November with two months of safety data on half the participants in the trial.
Pfizer and its partner BioNTech (BNTX) hope to have 50 million doses–or enough for 25 million people since the vaccine requires two shots–ready by the end of the year. And to have 1.3 billion doses available in 2021.
Data needs to show how the vaccine performs in high-risk populations such as seniors.
How long does the protection from the vaccine last?
Will the current 90% effectiveness decline as the trial continues? At 90% effectiveness the vaccine is well above the 50% threshold set by the FDA.
Did the vaccine successfully block just mild case or was it effective in preventing severe cases as well. More data–and more published data–will tell.
Pfizer’s vaccine needs to be shipped and stored at an ultra-cold 94 degrees (F) below 0 (or -70 degrees Celsius) Pfizer is working to improve the stability of the vaccine so it can be stored at standard refrigerator temperatures. Will Pfizer be successful? The logistical difficulties presented by a vaccine that needs to be kept at 94 degrees below 0 are immense.
The United States has pre-purchased 100 million doses of Pfizer’s vaccine with an option on 500 million more doses. Will that meet demand and who will get the first doses?