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Update From FUJIFILM Diosynth Biotechnologies And Novavax About Their Pandemic Vaccine Candidate

The corporate office of FUJIFILM Diosynth Biotechnologies (FDB) sent WTAW News an update on the development of a pandemic vaccine candidate with Novavax.

What FDB describes as “additional required analytical work” is underway.

Both companies expect to submit the vaccine candidate for emergency use authorization in the United States sometime between October 1 and the end of this year.

The update also says the companies are collaborating to advance commercial manufacturing that involves restarting manufacturing at FDB’s facility in the Bryan/College Station biocorridor.

According to the news release, their vaccine candidate has demonstrated a robust safety profile and high efficacy in two large phase three clinical studies.

WTAW News asked FDB if the vaccine candidate has or will be tested on patients under 12 and between 12 and 18 years old…and if the tests have included the Delta, Lambda, or any other COVID variants. FDB referred WTAW News to Novavax. We are waiting for a response from Novavax.

News release from FUJIFILM Diosynth Biotechnologies and Novavax:

FUJIFILM Diosynth Biotechnologies and Novavax continue to collaborate on the manufacture of Novavax’ recombinant nanoparticle COVID-19 vaccine candidate, and both companies anticipate this partnership extending well into the future. As previously announced by Novavax, submission for Emergency Use Authorization (EUA) in the U.S.A. is now expected to occur in the fourth quarter of this year due to additional required analytical work. FUJIFILM Diosynth Biotechnologies does not perform this analytical work. Novavax expects to deliver initial vaccine doses to the U.S. Government upon authorization.

To ensure access of Novavax’ vaccine promptly upon emergency use authorization, Novavax and FUJIFILM Diosynth Biotechnologies are collaborating to advance commercial manufacturing of Novavax’ vaccine candidate, including restarting manufacturing at the FUJIFILM Diosynth Biotechnologies’ site in Texas. Novavax’ vaccine has demonstrated high efficacy and a robust safety profile in two large Phase 3 clinical studies.

https://wtaw.com/update-from-fujifilm-diosynth-biotechnologies-novavax-about-their-pandemic-vaccine-candidate/

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Both companies expect to submit the vaccine candidate for emergency use authorization in the United States sometime between October 1 and the end of this year. The update also says the companies are collaborating to advance commercial manufacturing that involves restarting manufacturing at FDB’s facility in the Bryan/College Station biocorridor. According to the news release, their vaccine candidate has demonstrated a robust safety profile and high efficacy in two large phase three clinical studies. WTAW News asked FDB if the vaccine candidate has or will be tested on patients under 12 and between 12 and 18 years old…and if the tests have included the Delta, Lambda, or any other COVID variants. FDB referred WTAW News to Novavax. We are waiting for a response from Novavax. 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