Moderna’s half time report...
Today should be a bit easier, as Moderna is requesting emergency authorization for only adults (aged 18+) compared to Pfizer which was requesting approval for 16 and 17 year olds.
The morning started right off with discussion about the two Pfizer allergic reactions in Alaska (one being severe). This follows the two in the UK. Again, scientists are not concerned. This is expected during a global vaccine campaign. In other words, it’s bound to happen given the sheer amount of people getting the vaccine. The FDA said it’s working with Pfizer to update the fact sheet. Giving more details on vaccine guidelines for post-vaccination monitoring and management of allergic reactions. If Moderna is authorized too, the FDA said it will do the same with them.
Then there was a very long discussion regarding placebo people. Moderna stated that they will be giving the placebo patients the vaccine 1-2 weeks after emergency authorization is granted. Their plan is much quicker than Pfizer. The FDA and the advisory panel pressed back as this limits the quality of long term data on side effects. One scientist on the Moderna study fired back stating: “It’s important we carefully consider the volunteer’s viewpoints, without them clinical research cannot function.” Touché.
Second half coming up!
If you want to watch go here: https://youtu.be/I4psAfbUtC0
Agenda is here: https://www.fda.gov/media/144451/download
And a list of scientists on the external review committee is here: https://www.fda.gov/media/144450/download
Love, YLE