Some people have criticized Novavax by claiming the same management team and same science have failed for 30 years to get a vaccine approved. They claim this is a serious risk and reason to not invest. However, almost all of management has been there for only 10 years or less, as you can see here. The CEO and the president of R&D have been there 10 years. Their chief commercial officer, VP of commercial strategy and head of corporate development have been there for 7 years.

The chief medical officer and the heads of manufacturing, sales, operations, compliance, IT, and global program management have been there for under 4 years. The Nanoflu manager, chief legal officer and head of CMC have worked there for 11 years. Only 2 of the 19 members of upper management have been there for longer than 11 years: their head of HR for 13 years and VP of discovery for 17 years.

The science that the new management switched to using is very different than before. Here are 3 major changes:1) Their main platform used to be virus-like particle (VLP) and the new management switched to a subunit protein platform 7 years ago. This article from 2009 shows they were using VLP. When Googling Novavax VLP, nearly all the results are from 2008 to 2014. 2) The Novavax Covid vaccine uses a breakthrough that was only patented in 2017. 3) Seven years ago Novavax acquired the company that created Matrix M.

Half the vaccines it worked on during the last decade were for viruses that looked like they had a solid likelihood of becoming major problems but did not. These included MERS and Zika. They had no market or very little market. So the reason those didn’t get approved was that they weren’t needed, and not because they failed. But they gave the team valuable knowledge that prepared it for Covid.

It takes an average of 12 years for a company to get a vaccine to approval, including giant companies with huge resources. E.g., GSK spent almost 30 years working on one vaccine. SVB Leerink published a report showing that for more than 10 key vaccines now widely used, the time from pathogen discovery to approval was 10 to 100 years.

When the Novavax vaccine is approved in the coming weeks, it will mean the current team got a vaccine over the finish line two years faster than the 12-year average. In addition, they should also beat the 12-year mark with their Nanoflu vaccine. It beat the leading flu vaccine Fluzone in 3 head-to-head trials, including a phase 3. The FDA has given it both: 1) fast track status; and 2) an accelerated approval pathway. It is near certain to be approved.

For a small clinical stage biotech to get 2 blockbusters approved in 12 years of work is a huge accomplishment. Yet some claim the team has failed for 30 years. That’s like blaming the new owner and coach of a sports team for previous owners and coaches not winning a championship. For 50 years, the Patriots were terrible. When a new owner hired a new coach in 2000, some fans glumly and irrationally claimed the failures would continue based on the failures of past people. In the 20 years since, it has 17 division titles, 9 Super Bowl appearances and a record 6 championships.

Also, if you view the biographies of Novavax management, you’ll find it has numerous people very experienced at manufacturing, compliance and other needed areas. It has also attracted high quality talent in the last year to augment their team. E.g., they landed Dr. Henrietta Ukwu, formerly head of Merck’s vaccine regulatory development and affairs. She also had similar roles at PPD and a Pfizer subsidiary.

They also hired Troy Morgan who had senior compliance roles at Sanofi, Merck and Biogen. They also got Dr. Lyn Caltabiano, the former head of global project and alliance management for Merck Research, and head of GSK’s alliance management. It got Dr. Filip Dubovsky as chief medical officer, pulling him from AstraZeneca. He’s also been the head of clinical development at MedImmune.

Bill Gates said: “As we look ahead into the next century, leaders will be those who empower others.” I think Novavax has empowered its staff to develop strong vaccines, successfully move them through trials and ramp up production in what is becoming one of the greatest ramp-ups in pharma history. As Endpoints News editor Jason Mast notes, Novavax is in the process of “one of the most herculean feats in the history of industry.” Mast is saying of all industry, not just the vaccine industry. “Amazingly, it’s largely been a success,” he said. “Factories on three different continents are now churning out or preparing to churn out different components of Novavax’s vaccine.”