2020-07-12| COVID-19

Novavax to Deliver 100 Million COVID-19 Vaccine Doses by January 2021

by Judy Ya-Hsuan Lin
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By Judy Ya-Hsuan Lin

The clinical-stage biotech which hasn’t launched any product in the market previously is gearing towards an ambitious deadline to counter the COVID-19 pandemic.

Maryland-based Novavax is taking an unconventional approach to developing its COVID-19 vaccine candidate. NVX-CoV2373 is a stable, prefusion protein made by nanoparticles that carry fragments of the coronavirus to prompt host immune response. Sanofi is also using a similar prefusion protein-based approach, for which it received around US$ 31 million in government funding. A crucial difference between the two is that Novavax is a rookie that hasn’t launched any product in the market.

Nevertheless, the U.S. Department of Health and Human Services (HHS) and the Defense Department of Defense (DoD) has awarded Novavax US$ 1.6 billion in funding through “Operation Warp Speed,” a U.S. government program. The investment aims to cover testing, commercialization, and manufacturing of a potential vaccine for an expected delivery of 100 million doses by January 2021. This heartening news spiked the shares of Novavax more than 35% in the premarket on July 7th.

NVX-CoV2373 is produced by Novavax’s proprietary recombinant nanoparticle technology to generate antigen from the coronavirus spike (S) protein. A patented saponin-based Matrix-M™ adjuvant is then added to amplify the immune response and stimulate high levels of virus-killing antibodies. Evidence from preclinical trials suggests that the vaccine effectively produces antibodies that block the spike protein receptor in humans.


Immediate Challenges

The lack of product in the market, however, is Novavax’s biggest shortcoming. Last year, its experimental respiratory syncytial virus (RSV) vaccine, ResVax, failed its Phase 3 evaluations. Besides, the U.S. government has declined to provide details of the full list of companies in the “Operation Warp Speed” program for which it has assigned approximately US$ 10 billion, irking the critics. “It’s a black box,” said Peter Maybarduk, the director of the global access to medicines program at Public Citizen, a public interest group. “This could be one of the most important medical technologies of our time, and we know very little about how that money is being spent, and what conditions are being placed on it.”

So far, Johnson & Johnson (US$ 456 million), Moderna (US$ 486 million), AstraZeneca (US$ 1.2 billion), and Emergent Biosolutions (US$ 628 million) have received funding from the program. Yet, critics demand that the government should release more information to the taxpayers who deserve to know where their money is being spent.

On the other hand, Michael Caputo, assistant secretary for public affairs at the department of health and human services, counterattacked, “Operation Warp Speed leaders analyze all possible therapeutics and vaccine partners, select the most promising candidates and then follow standard protocol on contract awards and spending.” He added, “while these experts are moving quickly and focused on safety, we’re putting a lot of effort into assuring transparency while not tangling them up in constant media inquiries.”

Besides, Alex M. Azar II, the health and human services secretary, shared that having Novavax under Operation Warp Speed could diversify the portfolio of vaccines and increase the odds for obtaining an effective vaccine by the end of this year. This is especially true given that the approach Novavax conducted to develop the COVID-19 vaccine is unconventional, straying away from the mainstream that most other pharmaceutical companies would do.

John P. Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York City, agreed with Azar II and analogized to avoid “all of your eggs in one basket.” Apart from the endorsements and assuring statements made by the government officials and academic scholars, earlier and continued funding strikes a promising note for Novavax’s potential: a $388 million investment in May and a $4 million in March from the Coalition for Epidemic Preparedness Innovation (CEPI), both prior to the U.S. government’s recent funding.


Plans for a Successful Vaccine

Amidst all this, Novavax plans to further fortify and expand its capability by enhancing manufacturing capacity, innovating ways to develop vaccines, and conducting timely clinical trials. It already owns a manufacturing plant in the Czech Republic but is in the process of transferring its vaccine technology to a contract manufacturer with two extensive facilities to scale up capacity.

In order to meet the demand, Novavax anticipates building two manufacturing plants in Europe and one in Asia and also collaborating with a manufacturer in India. In terms of vaccine development, it strives to achieve a strong immune response and high levels of virus-killing antibodies. It is taking extra efforts to culture vaccines in insect cells and create a vaccine that works in conjunction with an adjuvant that helps the body to build a stronger defense against the virus.

Since May, Novavax has commenced early-stage safety trials in Australia, and the results of the Phase 1 safety trial are expected in mid-July, followed by mid-stage trials in August or September and Phase 3 trial in October, according to CEO Stanley Erck.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: COVID-19 Vaccine: Novavax Gets Funding from the US Department of Defense



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