https://finance.yahoo.com/quote/NVAX/community?p=NVAX
1 hour ago
Dear Senator,
As you know, Novavax submitted its protein-based Covid-19 vaccine for EUA with the FDA on Jan 31, 2022.
What you may not know is that they were asked to pre-submit manufacturing (CMC) data a full 30 days earlier, which they did on Dec 31, 2021. Then they had to wait 30 days before submitting for EUA. Neither Pfizer, nor Moderna had to do the same.
The Novavax vaccine has been shown to be very effective, perhaps even best-in-class effective, against the original Wuhan strain (96%) and all subsequent variants. Further, it showed 100% efficacy against both moderate and severe disease.
It's also been shown in numerous large-scale trials to be a very safe vaccine as it has the lowest number of adverse events of any vaccine out on the market today. It does not suffer from the many well-known problems encountered by the mRNA vaccines we're using today.
Finally, this may turn out to be your workhorse vaccine in the future as its efficacy appears to last much longer than the mRNA vaccines (~83% @ 6 months). In fact, it might achieve the Holy Grail of being your first annual Covid vaccination.
Unfortunately, the FDA appears to be dragging its feet ...while it approved the Pfizer vaccine in 21 days, and the Moderna vaccine in 17 days! Those numbers are fantastic!!
The continuing delay is especially disconcerting when you consider that the FDA has had the clinical data in rolling review for 394 days now(!), the CMC manufacturing data for 65 days, and the EUA application for 35 days. The mRNA vaccines were not subjected to this extreme interrogation.
What on earth is taking the FDA so long! It is unconscionable that they would delay this any further.
Novavax has already been approved by the EU, UK, Canada, Australia, India, SK, WHO, and many other countries ...177 to be exact, except in the United States! This is a travesty for the American people who invested $1.6B into its development!!
Please, PLEASE do all you can to cut thru the red tape over at the FDA and encourage the expedited EUA approval of the Novavax vaccine as fast as humanly possible. Strongly encourage them to schedule the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting. It's hard to believe, but there isn't one scheduled at this time. Please do all you can to get this set up THIS WEEK.
I apologize for taking this extreme measure to reach out to my US Senators. Unfortunately, every other approach I've taken seems to fall on deaf ears. And yet, this issue is so critically important.
Kind regards,
Xxxxxx Xxxxxxxx
(very excited to get the Novavax vaccine)