Contribute Try STAT+ Today

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.

advertisement

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.

advertisement

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.

  • Senior parks would be a great place to start along with people who travel out of country whose insurance won’t cover them while they are gone.

  • Another example of who-knows-who in Washington. Other companies are further ahead with vaccine development and better-proven candidates. A Covid vaccine is of utmost importance, but a mediocre one should not be the end goal, as that deters too many from vaccination. But those stubbornly dead-set against a vaccine will prove Darwin right – again. Americans need to start getting seriously worried about health care facility and worker shortage. Another reason to wear a mask, keep social distance, and yes : vaccinate.

    • Sounds to me like a money laundering scheme. A company that’s never put a single product on the market is given a billion + $$ by our government to create a vaccine that several other reputable companies have been working toward perfecting since Day 1 of this pandemic. Only in America and under this administration.

  • I M 78 years old. I received a letter from the hospital in my twenties. I was told I had antibodies in my blood.

    Would those antibodies still be there?

  • This us ridiculous! How much did Gilead get for donating close 2 million remdesivir vials and also investing $1 billion in scaling up manufacturing?

  • I wouldn’t put that garbage in my arm for a trial. Warped mind is more like it.

  • All my prayers and best wishes for the success of this project. I can remember 1970 when Covid would have been a nonspecific “viral pneumonia” beneath the public radar until doctors started chatting, with alarm, about how many cases were showing up in their hospitals. Today, we had the virus’s genome, the structure of its spike protein and knowledge of how it enters cells within a couple months and, if lucky, a vaccine in a year or two.

    • Actually – we need to be grateful to the Chinese doctors who saw 6 viral pneumonia cases in the ICU in the middle of flu season in a large metropolitan hospital and felt that was much higher than normal, so they sent a nasopharyngeal sample for PCR testing and provided the full genome analysis to scientists around the world. And called in their CDC who then shared this information with WHO.

      Here in the US if we see 6 cases of viral pneumonia in the ICU in the middle of flu season in a large metropolitan hospital the doctor responsible for the ICU understands that they are in for a busy few days. We certainly do NOT do PCR tests on every patient who develops flu symptoms during the flu season. The Insurance companies would blow a gasket if we did this volume of testing. Physicians in the US would not do PCR on viral pneumonia cases. Most of these patients do not even require hospitalization. Instead if you develop flu symptoms during flu season in the US your doctor is going to tell you to “stay home, rest, drink fluids, and take supportive medicines for fever, cough, etc. If you get short of breath or more severe symptoms they will suggest that you get a chest x-ray.

      While I do not necessarily believe that the first cases of Covid19 actually originated in China (see the sewage studies who show viral particles in other areas of the world as soon as November 2019), the world was very fortunate that the physician-scientists in China did test and put the rest of the world on notice as soon as they did.

      There are some aspects of Chinese Government and Commerce that are not transparent, the physicians in having a high index of suspicion and expeditiously getting PCR testing, did the world a lot of good.

      Trump’s response to this, which led to a wildly out of control epidemic in the United States while other countries quickly got the spread of disease under control is simply outrageous.

  • Desperate TRUMP has no conscience or soul so whatever he does is perfectly suited for him. Wonder how it gets by the scientific community on a fast track to possibly harm millions before safety protocols are in place.

    • If it was Obama or Biden you would be praising them as gods! Keep your TDS to yourself and let the rest of us be positive and hopeful about a solution to this pandemic. And no, Trump didn’t manufacture Covid-19 in the White House basement either!

  • So you intend to murder the world whith your so called vaccines murder is a two way street I will go down in a hail of bullets before you inject me whith your murdering vaccine I will take you murder’s whith

    • It’s that kind of rhetoric that is ending the America promised. I know you. I live among you. By all means, avoid the vaccine when it comes out. Then, spend some unmasked quality time with your elders. It’ll be just fine…

Comments are closed.