[ad_1]
On November 9, Gregory Glenn, head of R&D at Novavax, was woken up on his family farm by an alert: Pfizer and BioNTech’s vaccine was more than 90% effective in preventing Covid-19.
It was amazing news to the world, and Glenn texted some old friends on the Pfizer-BioNTech team with congratulations. But he also knew that it was complicated news for Novavax.
“I wasn’t surprised that it worked, but having an efficiency of 90, 95%? It’s really awesome, ”said Glenn Endpoints News. “Granted, that puts a little extra pressure on me in other areas.
Novavax, a tiny 33-year-old biotech who teetered on insolvency before the coronavirus erupted, had become one of the pandemic’s most unlikely winners. Backed by $ 2.2 billion in new capital, including $ 1.6 billion from Operation Warp Speed, they were preparing for their own Phase III trials and laying the groundwork to produce up to 2 billion doses of the year.
The company’s protein-based technology was older and less flashy than the mRNA used by Pfizer and Moderna, and it had previously failed in a notoriously difficult disease. But protein-based vaccines were known to be particularly immunogenic and over the summer, phase I data from Novavax appeared to show their vaccine produced more neutralizing antibodies than its rivals.
This raised the prospect that mRNA would be the first, but Novavax could be the best. The shares peaked at $ 178, an increase of almost 4,000% from the share price of $ 4.44 on Jan.3.
“Before this result, everyone thought Novavax should have the best data,” said Glenn. “And the mRNAs could be in between and the vectors could be a little behind.”
The results from Pfizer-BioNTech and Moderna, however, all but ruled out that possibility before Novavax could even begin a pivotal trial. It is difficult to improve 95%.
Because all of the major vaccine developers target the same S coronavirus protein, the news from Pfizer-BioNTech gave Glenn more confidence in a candidate than he had in three decades to design and develop vaccines. Yet it also drastically changed Novavax’s position in the race. Instead of bragging about being the best vaccine, at least in the short term, they’ll have to settle for being one of the many good ones trying to deliver to the world, all while facing the almost inevitable delays that come with it. a little attempt at biotechnology. become a big one overnight.
Glenn, a self-proclaimed “cardboard vaccinologist” who founded his first biotechnology more than twenty years ago and has led the company’s R&D since 2010, is responsible for guiding the candidate.
Bryce Chackerian“I thought if anything their vaccine could be as good or maybe even better – of course when you’re 95% it’s going to be hard to beat that,” Bryce Chackerian, Vaccinologist at the University of the New -Mexico, Endpoints said. Yet “any effective vaccine will have its place on the market, because it will take some time before there is enough.”
Novavax was hit by another setback on Monday, when they announced that the launch of the US Phase III trial would be delayed a second time, which could push it through to 2021. The Gaithersburg, MD-based company has struggled at an advanced stage in the past, sparking investor hope and public health hopes around an RSV candidate that ultimately failed a 2016 trial.
The delay also raised questions about exactly how Novavax might conduct a Phase III study. Was it ethical to conduct a placebo-controlled study now that two vaccines seemed to be very effective? If so, would people sign up? Peter Bach of Memorial Sloan Kettering argued that at this point the arm of comparison should be the Pfizer or Moderna vaccine.
Please ask if the correct control group is now Pfizer or Moderna vaccine as opposed to placebo. This is an approach that I came up with some time ago once we had a positive EV. https://t.co/elRpe8jGl2
– Peter B. Bach, MD (@peterbachmd) November 30, 2020
Glenn said the company is simply working to get FDA clearance for commercial scale manufacturing. They spent a year trying to come from behind in this department, having sold their production facilities to Catalent last year to keep the company alive. He said the current delays were minimal.
“No one would even know it,” he says, without the Covid microscope. “It’s a normal process to scale, to create tests, to create packaging around that.”
He said the Phase III trial in the US would be placebo-controlled because vaccines are still scarce, but he acknowledged that the study may never be completed.
The company is also running trials in South Africa and the UK, where they have now completed their registration. Depending on the timing, he said, the FDA could accept efficacy data from these studies, with some immunogenicity and safety data from the US trials, offering a path to approval even after vaccines are widely available in the country.
Data from studies in the United States may arrive sooner than expected. Due to data from Pfizer and Moderna, Novavax has shortened studies in the UK and South Africa, Glenn said. They now expect their own vaccine to be very effective, so they will need fewer cases to get a statistically significant result.
And although these results leave little room for Novavax to show better results against symptomatic illnesses, Glenn believes there is a chance their candidate may still last longer or offer better protection against infections.
Chackerian said both ideas made sense: the more neutralizing antibodies you develop immediately after being vaccinated, for example, the more likely you will have a year later. Still, these questions remain speculative and he said he was more concerned with the apparent manufacturing problem.
While mRNA has storage requirements that can make it difficult for delivery globally, the world is already well equipped to move protein vaccines. Any delay could mean delays in administering much-needed doses.
“Whether this represents a momentary problem or indicates more fundamental problems in increasing production, I don’t know the answer,” he said. “But it’s definitely something worth watching.”
A Novavax spokesperson did not directly respond to whether manufacturing delays would affect the amount of vaccine it can produce next year, only saying that once production is fully on line, they should be able to produce 2 billion doses per year.
Glenn now spends his days in back-to-back meetings trying to make clinical and manufacturing days work. He has helped develop candidates for RSV, E. Coli, Ebola, and pandemic influenza since he founded his first biotechnology, IOMAI, in 1997. He recently helped Novavax achieve positive Phase III results for a seasonal flu vaccine.
None of it, however, has been like this, and not just because of the scale of the crisis. Once the data from Pfizer and Moderna arrived, he said, he was sure they could do the same.
“The chances of success here are so high,” he said. “It feels like you’re climbing the mountain and it’s hard to wait.”
For an overview of all Endpoints News coronavirus stories, check out our special news channel.
[ad_2]
Source link