Here's what could happen next with the Johnson & Johnson Covid-19 vaccinehttps://www.cnn.com/2021/01/25/health/johnson-and-johnson-vaccine-covid-19-next-steps/index.htmlLast week, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said that Johnson & Johnson is "right around the corner" from seeking emergency use authorization for its Covid-19 vaccine from the US Food and Drug Administration.
The company said it's on track to have interim data from its clinical trial by the end of January. The company has a shareholder call on its fourth-quarter results Tuesday.
Still, it can take weeks for the vaccine to make it through the US Food and Drug Administration's authorization process and it's not clear yet when any of those key steps will take place.
So, unpacking this a bit:
* JnJ's current Phase III trial began September 23, 2020; FWIW, Novavax started their Phase III on September 24, 2020, so they are not far behind (if they are);
* What will be released shortly is
interim data; this means the trial has accumulated a lot of data, but the full data set and application for EUA will probably be available in 2-4 weeks;
* Projecting from that estimate
application for EUA is likely to happen around the third week of February;
* The FDA's committee doesn't evaluate data efficiently, so that will take 2-3 weeks, landing EUA being given in the 1st or 2nd week of March.
Y'all know what a tenner plus my guesstimates will get you at Starchucks.
1. The OWS people knew this was coming, with reasonable time estimates. There is no surprise in this for them.
2. When JnJ receives EUA that triggers a 100M dose purchase contract. The same will be true when Novavax receives EUA. Novavax is a relatively small company but large-scale production will be by a contract manufacturer ... a partnership assisted by OWS ... of course.
3. AstraZeneca is still "out there", another 300M dose contract when they receive EUA.
