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Coronavirus Vaccine

The US government is working not only to expedite development of a new vaccine targeted at SARS-CoV-2, the novel coronavirus at the heart of the outbreak that began in China in late 2019, but also taking steps to develop a universal vaccine directed across coronaviruses.

At a 13 February meeting, the National Vaccine Advisory Committee heard several presentations on efforts by federal agencies and academic researchers to develop vaccines and treatments for the COVID-19 disease, which has sickened approximately 60,000 people in China and started spreading across the globe. To date, 15 people in 7 US states have been diagnosed with the disease.

Government officials discussed vaccine development work in the context of two other coronavirus-related disease outbreaks in the past 20 years – Severe Acute Respiratory Syndrome (SARS) in 2002, and Middle East Respiratory Syndrome (MERS) in 2012.

“Efforts are already underway, not specifically for this outbreak, but to think about universal-like approaches in the same way that we’re talking about them for influenza vaccines.” – NIAID’s Allen Embry

Coronaviruses have pandemic potential and novel coronaviruses likely will continue to emerge, said Allen Embry, chief of the respiratory diseases branch at the National Institute of Allergy and Infectious Diseases (NIAID).

“Because we’ve seen three coronavirus outbreaks in the past two decades, I think it’s also important to be thinking longer term about how we deal with these coronaviruses that will continue to emerge from animal reservoirs,” Embry said.

“Efforts are already underway, not specifically for this outbreak, but to think about universal-like approaches in the same way that we’re talking about them for influenza vaccines,” he said.

The NIAID’s Vaccine Research Center “is already … making strides in optimizing antigen design of these kinds of vaccines to increase the potency and breadth, displaying multiple coronavirus spike antigens on nanoparticles, and using gene-based delivery approaches for rapid response,” he said.

Mark Denison, who runs a coronavirus research lab at Vanderbilt University, cautioned that development of a universal vaccine will be difficult and potentially with gaps, or not possible at all.

Benefiting From Advances Since SARS, MERS

Denison and others agreed that the vaccine development stimulated by the current outbreak is benefiting from the foundation laid by the earlier outbreaks as well as technological advances.

“The global coronavirus emergency is a resounding reminder of the critical need to continue innovating in vaccine development as well as vaccine manufacturing in preparation for and in response to emerging disease events,” said Brett Giroir, the US Department of Health and Human Services assistant secretary for health.

“Although there are currently no vaccines available to protect against the new novel coronavirus, I think we all understand that significant advances in technology have occurred since the SARS coronavirus outbreak,” he said. “As a result, the vaccine development timeline has been compressed significantly and I would even say remarkably.”

Thanks to technological advances since SARS, “the vaccine development timeline has been compressed significantly and I would even say remarkably.” – HHS’ Brett Giroir

During the SARS outbreak, it took approximately 20 months to get a vaccine candidate into early-stage testing, he said.

In contrast, Moderna Inc.’s messenger RNA vaccine candidate against the novel coronavirus could be ready for clinical testing in just two months.

Moderna and NIAID are collaborating on the vaccine’s development, with funding also coming from the Coalition for Epidemic Preparedness Innovations (CEPI), a public-private partnership. (Also see "Coronavirus Efforts Could Benefit From Little-Used Medical Countermeasures Incentives" - Pink Sheet, 29 Jan, 2020.)

During a 7 February press conference, NIAID Director Anthony Fauci said there have been no problems in preparing the vaccine candidate for human studies. (Also see "For Coronavirus, US FDA Is At The Podium But Not On The Task Force" - Pink Sheet, 9 Feb, 2020.)

Embry said GMP-quality vaccine is expected in March, and NIAID will support the first Phase I study through its infectious disease clinical research consortium comprising nine sites.

This abbreviated development timeframe for the Moderna candidate “is possible because we had sharing of genetic sequences of the virus very early in the outbreak and of course we’ve been able to adapt approaches used with investigational SARS and MERS vaccines to dramatically improve this timeline,” Giroir said.

NIAID also is working with extramural and intramural scientists to evaluate potential cross-reactivity with existing SARS and MERS vaccine candidates, as well as existing monoclonal antibodies, Embry said.

“Because of sequence divergence, particularly with MERS, we don’t anticipate a high level of cross-reactivity with the new coronavirus, but we are going to be looking at some SARS candidates that may be available for cross-reactivity,” he said.

BARDA Priorities Include Proven Platforms

Vaccine development is one of the medical countermeasure priorities for the HHS’ Biomedical Advanced Research and Development Authority, said Robert Johnson, director of BARDA’s division of influenza and emerging infectious diseases.

When it comes to vaccines, BARDA is interested in proven platforms that have large-scale vaccine capacity. The agency also is emphasizing speed and the need to take multiple approaches.

“There’s a lot we don’t know about this virus, and really looking at the past outbreaks still a lot remains unknown about coronaviruses in general in these outbreaks,” Johnson said. “We all recognize, I think, the need to lay a broad base and not come in immediately on a very narrow base. We need to be looking at several different approaches to identify the ones that will work best as we move forward.”

Platform and speed were highlighted by BARDA in a same-day press release announcing an R&D agreement with Janssen R&D LLC to accelerate the company’s investigational novel coronavirus vaccine into clinical evaluation. (Also see "Coronavirus: Can Companies Achieve Vaccine Ambition? " - Scrip, 28 Jan, 2020.)

“With emerging infectious diseases such as COVID-19, speed is crucial to saving lives and reducing further spread of the virus,” BARDA Director Rick Bright said in the release. “Janssen is a proven partner with a flexible, rapid, vaccine platform which gives us an edge in the race to protect people in the US and worldwide from the health security threat posed by this novel coronavirus."

Thinking Ahead On Manufacturing

Janssen also will work to scale-up production and manufacturing capacities needed to manufacture the candidate vaccine, BARDA said.

Ensuring domestic-based manufacturing capacity for medical countermeasures – vaccines, therapeutics and diagnostics – against the novel coronavirus is another BARDA priority.

“We have to start thinking about manufacturing scale-up early on,” Johnson said. “We can’t wait until we have a vaccine that’s licensed and then go back and say, ‘Oh, what about manufacturing? How are we going to get out enough doses to have a meaningful impact?' We need to be thinking about that in parallel.”

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