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Novavax has joined the ranks of Covid-19 vaccine manufacturers being supported by the U.S. government’s Operation Warp Speed, the Trump administration announced Tuesday. The Gaithersburg, Md.-based biotech has been awarded $1.6 billion to support late-stage clinical trials and expansion of its manufacturing capacity.

In return, Novavax will supply the U.S. government with 100 million doses — likely enough product to vaccinate 50 million people, assuming the product is safe and effective — starting in late 2020. The full amount is expected to be made available by February, Stanley Erck, the company’s president and CEO, told STAT.

“I think it speaks well of our platform that we’ve developed over the last decade, to be able to make vaccines quickly, reliably against emerging infectious diseases,” Erck said.

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Operation Warp Speed, the administration’s ambitious effort to fast-track Covid-19 vaccine development, previously announced it was assessing 14 candidate vaccines with a plan to winnow them down to roughly seven. Among the seven already identified: Johnson & Johnson, Moderna, and a partnership between the University of Oxford and AstraZeneca.

“Adding Novavax’s candidate to Operation Warp Speed’s diverse portfolio of vaccines
increases the odds that we will have a safe, effective vaccine as soon as the end of this
year,” Health and Human Services Secretary Alex Azar said in a statement.

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Novavax, which began a Phase 1/2 trial on May 26, expects to use a two-dose regimen of its vaccine, with the doses given three weeks apart, though the company will generate data aimed at determining if a single dose might be protective.

“Data will determine all of those things and we don’t have those data yet. What we do have are data that show you get a very significant bump on the second dose,” Erck said. Information on the company’s website suggests that “significant bump” is an eightfold rise in neutralizing antibody titers — the type of antibodies thought to correlate with protection.

Studies showed that 100% of mice and non-human primates vaccinated developed an immune response after the first dose. “The question is whether that is sufficient for some level of protection. And I think we’ll try to determine that in these trials,” Erck said. The data are included in a paper that is currently available in preprint, meaning it hasn’t yet been through the peer review process.

Erck said data from the Phase 1 trial should be available by the end of July. Novavax plans to start a Phase 2 trial within a couple of weeks of getting the Phase 1 data, and hopes to launch a large Phase 3 trial, involving roughly 30,000, in the third quarter of the year.

Novavax’s vaccine approach is what’s known as a recombinant nanoparticle vaccine used in combination with a proprietary adjuvant, a compound that boosts the immune response. Synthesized pieces of the spike or surface protein of SARS-CoV-2, the virus that causes Covid-19, are grown in insect cells. The vaccine can be stored at between 4 C to 8 C — refrigerator temperature.

Novavax has not yet brought a vaccine through to licensure, and one of its attempts, a vaccine to protect against respiratory syncytial virus or RSV, failed to achieve its primary endpoint in a Phase 3 trial several years ago. But earlier this year it announced data from a successful Phase 3 trial for a seasonal flu vaccine.

The company has already received $388 million from the Coalition for Epidemic Preparedness Innovations, or CEPI, which requires grantees that receive manufacturing support to give right of first refusal of vaccines to the Covax facility, an entity established by CEPI, Gavi, the Vaccine Alliance, and the World Health Organization to secure Covid-19 vaccines for non-producing countries.

Erck said a recently purchased production facility in the Czech Republic, which the company believes can produce 1 billion doses of vaccine a year, will meet Novavax’s CEPI commitment. The company also plans to produce vaccine in India and Asia. “I think that takes care of a lot of the issues around potential border closings, so that vaccine will be available for the globe,” he said.

  • It would be helpful to have a plot of government strategic inventories at the end of each calendar year for all protective categories/items, including but not limited to:

    masks, clothing, medicines, etc

    to see exactly what levels we have had & what we may need, going forward.

  • A good, to the point, and encouraging article. And, it gives me hope that we have a chance of getting through this pandemic, as well as getting some normalcy to look forward to. Thank you Helen for this positive information. In the mean time, washing hands, social distancing,wearing a mask, and isolation for those that should, are what makes sence.

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