On November 9, Gregory Glenn, head of research and development at Novavax, was alerted to a news alarm on his family farm: the vaccination of Pfizer and BioNTech was more than 90% effective in preventing Covid-19.
It was incredible news for the world and Glenn congratulated the old friends on the Pfizer-BioNTech team. But he also knew it was complicated news for Novavax.
“I wasn’t surprised that it worked, but to achieve 90, 95% efficiency? That’s very good, “Glenn said Endpoints News. “True, this puts a little more pressure on me in other areas. “
Novavax, a tiny, 33-year-old biotechnology that was caught insolvent before the coronavirus exploded, became one of the most unlikely winners of the epidemic. $ 2.2 billion in new capital, including $ 1.6 billion in the Warp Speed operation, own III. They prepared for their phase experiments and laid the groundwork for producing 2 billion doses a year.
The company’s protein-based technology was older and less showy than the mRNA Pfizer and Moderna, and had previously failed in a notoriously severe disease. But protein-based vaccines are known to have immunity, and data from Novavax Phase I over the summer showed that their vaccine produced more neutralizing antibodies than its rivals.
This suggested that mRNA would be the first, but Novavax might be the best. Shares peaked at $ 178, up nearly 4,000% from the $ 3.44 on January 3rd.
“Before that result, everyone thought Novavax should have the best data,” Glenn said. “And mRNAs can be intermediate, and vectors can lag a little behind that.”
However, the Pfizer-BioNTech and Moderna results all eliminated all but this possibility before Novavax could even launch a pivotal experiment. It is difficult to improve at 95%.
Because all major vaccine developers target the same coronavirus S protein, Pfizer-BioNTech News has given Glenn more confidence in a candidate than it did three decades ago in vaccine design and development. Yet it dramatically changed Novavax’s position in the race. Instead of being the best vaccine, they need to be content, at least in the short term, with being one of the more good people trying to supply the world, but also address all but the inevitable delays that come from a little biotechnology experiment overnight be great.
Glenn, a self-described “grumpy vaccine doctor” who founded his first biotechnology more than two decades ago and has been leading the company’s research and development since 2010, is responsible for redirecting the candidate.
“I thought whatever it was, their vaccination could be just as good or even better – of course if you’re at 95%, it’s going to be hard to beat,” Bryce Chackerian, a vaccinologist at the University of New Mexico, told Endpoints. Nevertheless, “every effective vaccine has a place on the market because it will take some time before it will be enough”.
Novavax suffered another setback on Monday when it was announced that III. The launch of a phase-in U.S. trial is delayed for the second time, potentially postponing until 2021. The Gaithersburg, MD-based company has struggled in the late stages in the past, raising hopes among investors and public health hopes around the RSV candidate, which ultimately failed at a 2016 hearing.
The delay also raised questions about exactly how Novavax could run a III. Phase test. Was it ethical to conduct a placebo-controlled study when two vaccines appear to be very effective? If so, would people register? Sloan Kettering Memorial Peter Bach argued that at this stage, the comparator arm should be a Pfizer or Moderna vaccine.
Ask if the appropriate control group is now either Pfizer or Moderna vaccine as opposed to placebo. I proposed this approach some time ago after we had a positive VE. https://t.co/elRpe8jGl2
– Peter B. Bach, MD (@ Peterbachmd) November 30, 2020
Glenn said the company is working to obtain FDA approval for commercial-scale production. They spent a year coming from behind in this department after selling their manufacturing facilities to Catalent last year to keep the company alive. According to him, the current delays were minimal.
“No one would know,” he said if it weren’t for the Covid microscope. “It’s a normal process to scale up, take tests, and create packaging around it.”
He said that the III. A phase-out U.S. trial will be placebo-controlled as vaccines are still deficient, but acknowledged that the study will never be completed.
The company is also conducting experiments in South Africa and the UK, where enrollment has now been completed. Depending on the timing, he said the FDA could accept efficacy data from these studies, with some immunogenicity and safety data from U.S. experiments that offer a way to approve it, even as vaccines become widely available in the country.
Data from ex-US studies may arrive earlier than expected. Due to data from Pfizer and Moderna, Novavax has shortened studies in the UK and South Africa, Glenn said. They now expect that their own vaccination will be extremely effective and therefore they will need fewer cases to achieve a statistically significant result.
And while these results leave little room for Novavax to show better results against symptomatic disease, Glenn believes there is a chance that his candidate will still be able to last longer or provide better protection against infections.
According to Chackerian, both ideas make sense: The more neutralizing antibodies that develop, for example, immediately after vaccination, the more will be a year later. Nevertheless, these issues remain speculative and he said he was more concerned about the apparent manufacturing issue.
While mRNA has storage requirements that can complicate global transport, the world is already well equipped to vaccinate against protein vaccines. Any delay may delay the administration of much-needed doses.
“Whether it’s a momentary mistake or pointing to fundamental questions about increasing production, I don’t know the answer,” he said. – But it’s definitely worth a look.
A Novavax spokesman did not respond directly to the question of whether production delays would change the amount of vaccine that could be produced next year, and said only that if production became fully online, they would have to produce 2 billion doses a year.
Glenn spends her days in back-to-back meetings to run clinical and manufacturing days. Since founding its first biotechnology, IOMAI, in 1997, it has helped develop candidates for RSV, E. coli, Ebola, and epidemic influenza. Recently, Novavax was assisted by the Seasonal Influenza Vaccine III.
Although none of these were, and not just because of the scale of the crisis. After Pfizer and Moderna came in, he said he was sure they could do the same.
“The probability of success here is so high,” he said. “It feels like we’re climbing a mountain and it’s hard to wait.
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