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FDA approved new COVID-19 vaccines from Moderna and Novavax in May. ICAN is again going after the data—submitting FOIA requests to FDA for all documents relied upon to license the vaccines.
Just as in previous years—when ICAN’s dogged persistence and lawsuits resulted in the release of critical COVID-19 vaccine data from Pfizer, Moderna, and V-safe—we have now turned our attention to getting the Biological License Application (BLA) files for Moderna’s new mNexspike vaccine and Novavax’s Nuvaxovid vaccine. As with the other data, ICAN will release this information to the public as soon as we receive it, so that these vaccines’ clinical trials can be independently evaluated.
Disturbingly, the Phase 3 clinical trial that FDA relied upon to approve mNexspike used Moderna’s older COVID-19 vaccine, Spikevax, for the control arm. So all we know so far is that mNexspike has a “similar safety profile” to Spikevax—which is far from reassuring.
ICAN will keep you posted as these FOIA requests progress. It is unclear whether these requests will be met with any warmer reception than our requests for the licensure data of the original Pfizer and Moderna COVID-19 vaccines (which are still being produced). Regardless, you may rest assured that we will not stop until the data is released.
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