WASHINGTON — No major pharmaceutical company has come forward to say it would manufacture a vaccine for the novel coronavirus currently being developed by the National Institutes of Health, a top U.S. official acknowledged Tuesday, a reality that he called “very difficult and very frustrating.”

The comments by Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, highlight how challenging it could be to translate the NIH’s work, being undertaken in partnership with the biotech company Moderna Therapeutics, into a vaccine that could be marketed. Fauci described the circumstances as challenging. “Companies that have the skill to be able to do it are not going to just sit around and have a warm facility, ready to go for when you need it,” Fauci said, speaking on a panel Tuesday hosted by the Aspen Institute and moderated by STAT’s Helen Branswell.

Fauci said it would be at least a year before a coronavirus vaccine would be available. However, that timeline assumes a large pharmaceutical manufacturer does step up to help make the product.

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The vaccine being developed by the NIH and Moderna uses mRNA technology and is being funded by the Oslo, Norway-based Coalition for Epidemic Preparedness Innovations. CEPI is funding three other efforts to develop a vaccine for the novel coronavirus. None of those partners, however, have the kind of commercial facilities that major pharmaceutical makers have and that would be capable of making the product in bulk.

Johnson & Johnson has announced it is interested in developing its own coronavirus vaccine. On Tuesday, the company’s vaccine division, Janssen, said it would partner with the Biomedical Advanced Research and Development Authority, an agency of the Department of Health and Human Services to develop that vaccine.

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In a statement, the agency’s director, Rick Bright, said “speed is crucial to saving lives and reducing further spread of the virus. Janssen is a proven partner with a flexible, rapid, vaccine platform.”

Major drug makers, including Merck and GlaxoSmithKline, have stepped in to manufacture vaccines for previous public health emergencies. The vaccine against Ebola recently approved by the Food and Drug Administration and European regulators was manufactured by Merck.

At other times, however, companies have responded in public health crises to develop vaccines, only to have those crises fade and to be left with the enormous sunk costs of having to develop products for which there was no longer a market.

“When we were doing this with Ebola, it was a major vaccine company that got burned who’s now pulling out of that,” Fauci added, without naming the company. “It is going to be a challenge to be able to get a major company to do that.”

Speaking alongside Fauci at the event was Ron Klain, who served as Ebola czar in the Obama administration and who echoed concerns that drug makers may be wary of getting involved again.

“I don’t work for the companies, I’m not like a drug company fan,” Klain said, “but there’s no question that a lot of them lost a lot of money trying to produce an Ebola vaccine.”

  • there is little financial incentive for business to develop a vaccine at this point. With a hundred thousand or so infected , the worlds population of 7 billion is not yet at risk enough to bother with the vaccine. If this becomes more widespread, a market develops for next years wave of corona virus.

    You can’t expect a drug manufacturer who will certainly be sued with every anaphylaxis reaction to the vaccine to balance the risk – reward for less than one million or so prescription. Its very expensive to develop. The FDA would clear it without major costs and the law suits will begin.

    Unfortunately , they will have to wait until this is widespread and threatening everyone like the Flu virus to make it financially viable.

  • China will be first in delivering treatment / vaccine against its home-grown WuBat Virus (better name, they deserve it) : with Remdesivir, hijacked from Gilead Sciences. In China there is more urgency than in the US (cuz it ran out of control in the first 2 months of snuffing). If the new stepped-up trials deliver the goods, they have monopoly. That’s how they still win in the end. And we snooze and looze. But we also don’t eat bats, and it seems our immune systems can better handle the WuBat virus (until it mutates).

  • Fauci has blown through bucketloads of money for years and produced absolutely nothing. He should be replaced by someone who can do the homework necessary for his critical post!

  • Politicians should increase NIH budget. Their budget was gutted during Obama administration. There are many agencies you can cut budget from, cutting NIH budget seems stupid. CDC budget should also be increased.

    We are wasting money on so many foreign aid here, foreign aid there, yet we cut our own health agencies budget.

    • I totally agreed with you. It is not a responsibility to take care of the country. They have more money than our thoughts. They have already bought talented people to work for them. As you said, poor health agencies did not help the needed people here for a long time.

  • The moneys that are wasted on only 25% effective (2019 rate) flu shots are far better spent on development of vaccines with at least 80% effective rates. Re-direct funding from the flu shot (based on obviously flawed “educated guess work”) to R & D for sure-fire vaccines that are actually worth the shot. As these viruses are close relatives : this might actually also lead to vastly improved flu shot efficacy.

  • VGXI is already committed to manufacturing enough of Inovio’s vaccine (INO-4800) for phase one clinical trials. In addition, Inovio has already announced that they are collaborating with Beijing Advaccine Biotechnology Co. to advance its development in China. Finally, Kangtai Biological Products “has joined hands” with Advaccine to expedite its development. Western big pharmaceutical companies may sit on their hands, but Chinese companies (collaborating with small, innovative, next-generation biotech companies) will step up to the plate to scale manufacturing as needed.

  • I have no idea with the funding that is available to this man (Fauci)at the NIH that he doesn’t support some of the smaller biotechs that have the backing of CEPI also – notably his direct competition at advancing a DNA vaccine Inovio pharmaceuticals. It is blatantly obvious as he doesn’t even acknowledge this biotech as they step forward to help in this possible Pandrmic situation which is occurring. They also have the capability which he is totally aware of by using VGXI to produce and scale the massive quantities that are going to be needed. He should be held accountable for the NIH billions he has squandered with his FAILURES in producing any viable alternatives in any trials for any products that he’s in charge of ( recently their HIV failure just being one ). His partner Moderna with their huge inflated valuation which has not produced “ANYTHING” of value in a trial yet. Frustrating is an understatement when you watch what’s happening and how they use the funds they are being given every year to produce a big FAT ZERO of Nothing. Please address this situation and stop squandering our tax dollars and spread the funds around to the small biotechs who are on the cutting edge but being strangled by unscrupulous traders.

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