A Politico report suggests NVAX is having issues meeting FDA CMC manufacturing requirements for submission of its CV-19 vaccine in the US. We had a chance to catch up w/ mgmt to discuss the report and progress. The co reiterated (1) it is making high-quality and safe vaccine at all its sites, (2) plans to file to the UK, EU and others within the next two wks and (3) it is actively working on completing the CMC requirements to support US EUA filing before YE.
What happened? Yesterday evening, Politico published a report suggesting NVAX is struggling to produce vaccine at a purity level that consistently meets FDA standards for regulatory approval, citing unnamed sources familiar with discussions between NVAX and the Biden Administration. The report says FDA works out vaccine purity requirements with each vaccine manufacturer, but generally purity should be at least 90% and NVAX has only produced vaccine at 70% purity levels. The piece goes on to say the unnamed individuals are unsure NVAX has the expertise to address the CMC manufacturing requirements and approval of its vaccine could be delayed to late 2022.
Mgmt expects to file to UK, EU and other countries within the next couple of weeks....With regard to EU, UK and other exUS submissions, NVAX reiterated it has validated the CMC assays, and notably the parameters for the assays, with regulators. While not providing exact numbers on purity levels, they remain confident in the comparability of the vaccine they are producing at commercial scale with the Phase II/III product, and plan on filing "within the next couple of weeks," which is in line w/ mgmt updated September guidance. We note NVAX and its partner Serum Institute of India (SII) have already filed EUA/EUL packages to WHO, India and the other countries suggesting they can make the vaccine consistently. Other exUS partners, Takeda and SK Bioscience, remain bullish on the vaccine based on public comments.
Mgmt remains confident in their ability to produce high quality vaccine and submit an EUA to the FDA before YE... On the Q2 call and subsequent public presentations, mgmt. has generally positioned the US filing requirements as different from what other regulatory agencies, including the UK/EU, have wanted to support regulatory submissions. In our discussion w/ mgmt, they note exUS standards are not lower per se, but it is more just a matter of coming to agreement on what needs to be demonstrated in order to support submission w/ FDA. Moreover, mgmt imptly highlighted each EUA application is tied to a specific supply chain (i.e. FDA is only reviewing US supply chain). Thus, in our view, if there were issues with vaccine production in the US, it would be exclusive to that application. NVAX remains in discussion with the FDA on the CMC package and continues to plan to file in the US before YE, although we think there could be some risk to achieving that timeline. However, considering the oppty for NVAX is mostly exUS over the near-term, a delay in the US filing should not be material.