Even though Moderna Inc. quickly stepped up to partner with the National Institutes of Health in January to develop a vaccine against the new coronavirus, they will need a large biopharmaceutical company to take on the risky venture of manufacturing the product if it is successful in human testing, the U.S. government's top infectious disease expert acknowledged.
Given that companies often do not make money — and frequently lose it — on medical countermeasures used for emerging diseases, such as the Ebola and Zika virus outbreaks, "it is going to be a challenge" to convince large manufacturers to join the pursuit for a coronavirus vaccine, said Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases.
One large company in particular "got burned" when it sunk a lot of time and cash into developing a vaccine against Ebola, Fauci noted at a Feb. 11 forum in Washington hosted by the Aspen Institute.
He did not name GlaxoSmithKline PLC as that company, but the London-based manufacturer in August 2019 dropped its pursuit of its Ebola vaccine and some other products and gave the rights to the nonprofit Sabin Vaccine Institute.
GSK had been developing the Ebola vaccine with the NIH for a number of years and had tested it in three phase 2 trials in Africa.
The U.S. government provided Sabin additional funds in October 2019 to continue work on the vaccine.
Merck & Co. Inc. recently won U.S. approval for its Ebola vaccine — a product discovered by Canadian scientists and later funded by the U.S. government.
Merck CEO Kenneth Frazier, whose company licensed the Ebola vaccine from NewLink Genetics Corp., has said the New Jersey manufacturer does not expect to make any profits on the product.
Johnson & Johnson also has a late-stage Ebola vaccine candidate that has been used in the most recent outbreak in the Democratic Republic of the Congo.
So far, J&J is the only large manufacturer that has said it is pursuing a vaccine for the 2019 novel coronavirus, now known as SARS-CoV-2, which has infected more than 45,000 people and killed over 1,100, according to Johns Hopkins University's Center for Systems and Science and Engineering.
The company's subsidiary Janssen Pharmaceuticals Inc. is being helped financially in that endeavor by the U.S. Biomedical Advanced Research and Development Authority, which said on Feb. 11 it would share costs and its expertise to accelerate the product into clinical evaluation.
But the NIH and Moderna will need to find a large company to provide the same type of scale-up and manufacturing capabilities for their product, Fauci said.
The problem, he said, is that most large companies do not want to shift their processes for their moneymaking vaccines over to address an infectious disease outbreak.
WHO Director-General Tedros Adhanom Ghebreyesus
"That is very, very difficult to get someone to do," Fauci said. "The 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. They're going to have to stop making polio vaccines, measles vaccines, hepatitis vaccines to put your particular product in."
While Fauci said he anticipates Moderna's vaccine candidate to be into human safety testing by sometime in April and possibly have a trial completed in a year, he emphasized there are no guarantees.
"I never promised you a rose garden," he said.
While GSK is making its pandemic vaccine adjuvant platform technology available to the Coalition for Epidemic Preparedness Innovations, the company is not pursuing a coronavirus vaccine itself.
An international obligation
The World Health Organization is meeting over two days on Feb. 11-12 to discuss some of the problems drug and vaccine makers confront in developing products for emerging infectious diseases, like with the coronavirus outbreak.
"This outbreak is testing us in many ways," WHO Director-General Tedros Adhanom Ghebreyesus said at the start of that meeting.
On Feb. 11, the WHO also gave the disease caused by the virus a new name — coronavirus disease-19, or COVID-19. A working group for the International Committee on Taxonomy of Viruses has named the virus severe acute respiratory syndrome coronavirus 2, or SARS-CoV-2.
Ronald Klain, who led the Obama administration's response to the Ebola outbreak in West Africa, said governments must do more to derisk the development process for manufacturers.
"We got to find better ways to do public-private partnerships to try to take some of the risk out of this," he said at the Aspen Institute forum.
"I have no grief for the drug companies," Klain said. "I'm not a drug company fan. But there's no question that a lot of them lost a lot of money trying to produce an Ebola vaccine."
While the U.S. has certain liability protections, expedited pathways and government funding available, many other countries do not, Klain noted. So even if a vaccine is successfully developed and approved by U.S. or European regulators, it may run into legal and liability trouble being deployed in other nations "and lives will be lost," he said.
"This is a lingering international policy problem that we need to address," Klain said.