IT looks like Moderna has gained FDA agreement on the COVID vaccine trial.
https://www.fiercebiotech.com/biotec...ead-july-start
* Uses their RNA technology for the coat protein rather than actual virus
* Will start next month - wow
* 30,000 patients, placebo-controlled.
* 2 shots 28 days apart
* Two different strengths will be tested - 50 ug and 100 ug
* Test for antibody response as the primary endpoint
* but ALSO real-world follow-up on participants contracting the virus over time or not (measured by infection rates and hospitalizations of both groups). They are silent on how long this follow-up time period is.
Moderna has also contracted with Lonza in case the vaccine is looking good. They may even Manufacture while the application for approval is under review at FDA, which is highly unusual. Lonza has a number of plants in the world but we know that the one here in Portsmouth will be for sure one of the manufacturing sites.
Of the 60+ companies developing a vaccine there are 3 front-runners. The other two are Inovio (also a US company and also not using virus, but their DNA plasmid technology) and the Bejing Institute of Technology (although they are way behind Moderna and Inovio) We know that neither Moderna nor Inovio has yet to get a vaccine approved by FDA and they are using new technologies (although many vaccine candidates for both companies are nearing the end of trials). That is a draw-back. Moderna has a manufacturing contract with a world leader (Lonza) but Inovio is a little involved in a "tiff" with their manufacturer (Creative Biolabs). So from that perspective Moderna may be considered better-positioned.
Fingers crossed!
In the meantime stay as safe as you can. But now we know why there is hope in having a vaccine by Q1 of next year!