Moderna CEO Stephane Bancel opened an e-mail on his cellphone Monday afternoon and smiled. Up popped a picture of a box that had just been placed inside a refrigerated truck bound for Bethesda, Md. The package held a few hundred vials, each containing an experimental vaccine for the new coronavirus, manufactured at the Cambridge biotech’s $130 million plant in Norwood.
A mere 42 days. That’s how long it had taken the high-flying biotech to produce the shipment after receiving the genetic sequence of the virus that causes the Covid-19 illness. The Maryland-based National Institute of Allergy and Infectious Diseases, or NIAID, plans to begin testing it on 45 people next month, making Moderna the first company to enter clinical trials with something that could prevent the disease that has stoked fears and rattled financial markets worldwide.
But Bancel took pains Friday to dampen any hope that the vaccine, if approved, will be injected in millions of exposed shoulders any time soon.
Dr. Anthony Fauci, director of NIAID — which helped Moderna design the vaccine — said this week that it would be at least 12 to 18 months before it could be deployed. Bancel is coming down on the conservative end of that time frame.
“I think it’s very, very low probability that it would be [next] February,” Bancel, 47, said. “I’m not aware of any vaccine that’s been approved in a year."
The vaccine, which relies on custom-built messenger RNA to produce an immune response, will be tested first on 45 healthy volunteers and then will likely undergo two more phases of testing on many more people, he said. Even if all goes well, it would take time to clear regulatory hurdles and to make enough vaccine to inoculate millions.
“You can’t go from 45 people in Phase 1 to selling it to millions of people,” Bancel said. “You need to make sure the vaccine is safe and is working. There’s a very high bar for safety.”
Still, Moderna clocked a blistering first mile in what might be considered a marathon.
Consider that after a 2002 outbreak of an older coronavirus, severe acute respiratory syndrome, or SARS, in China, it took roughly 20 months for NIAID to get a vaccine into the first phase of human testing.
Moderna, which went public in December 2018 and raised $600 million in the largest initial public offering in biotech up to that point, isn’t the only drug maker seeking to develop a vaccine for the new coronavirus.
There are at least a dozen efforts underway at large pharmaceutical companies, biotechs, and academic laboratories. Several scientists in the race to develop a vaccine say their work will proceed even if Moderna appears to have the inside track.
Dr. Peter Hotez, codirector of the Texas Children’s Hospital Center for Vaccine Development, is trying to get two potential vaccines for the coronavirus into clinical trials.
One is a SARS vaccine he helped develop at the Baylor College of Medicine, where he is dean of the National School of Tropical Medicine. It was shelved after that epidemic receded and funding dried up. The potential vaccine has since been stored in a freezer in Houston, he said.
Although it was developed for a different coronavirus, Hotez believes the vaccine has the potential to protect patients against the new disease, which has caused 83,000 global cases and killed more than 2,800 people since emerging in China. He’s looking for government funding to get the vaccine and another that his laboratory has developed into clinical trials. Both rely on recombinant proteins, a scientific approach that predates Moderna’s.
“Everyone wants Moderna to succeed because it could be important technology,” Hotez said, although he characterized the news about Moderna’s delivery of the first possible vaccine to NIAID as “a bit of hype.”
He said mRNA vaccines and DNA vaccines such as one under development by Pennsylvania-based Inovio Pharmaceuticals have been discussed for years, but none has been approved. It’s imperative, he said, that scientists working on other vaccines receive the financial support they need to get them into clinics.
“You need to get four or five shots on goal instead of one shot on goal,” said Hotez, who is seeking funding from the National Institutes of Health, the federal Biomedical Advanced Research and Development Authority, and other sources.
Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, agreed. His laboratory is also working on two vaccines, one DNA-based and another that uses the common cold virus to deliver a coronavirus antigen into cells. Work on multiple potential vaccines and drugs to treat Covid-19 must continue, he said, because no one knows which approach will work best.
Like many biotechs in the state’s booming life sciences sector, Moderna hasn’t yet brought a product to market since the company was founded 10 years ago. And Bancel acknowledged that winning approval of the coronavirus vaccine is hardly a foregone conclusion. Nonetheless, he seems confident about its prospects.
Moderna has had positive results in early-stage clinical trials over the past four years for six other vaccines, to prevent influenza, respiratory infections, a virus that can cause birth defects in pregnant women, and other diseases. All use the same mRNA approach.
Beginning around March 6, the vaccine for the virus that causes Covid-19 will be tested on healthy volunteers between the ages of 18 and 55 in the first phase of the trial, according to the federal website ClinicalTrials.gov. The volunteers will be divided into three groups, each of which will receive a different dosage. The first phase of the trial is expected to conclude around June 1.
Bancel said the trial will determine whether the vaccine is safe and whether blood drawn from volunteers who received it contains antibodies that neutralize the virus.
“I think it has a good chance of working,” said Bancel, a native of France who ran bioMérieux, a diagnostics company, before he joined Moderna.
He said Moderna hasn’t even considered how much the vaccine would cost, but public health experts say a vaccine must be widely accessible to be effective.
Founded by the Flagship Pioneering venture capital firm and given a name whose last three letters refer to the company’s scientific underpinnings, Moderna wants to use custom-built mRNA to turn the body’s cells into medicine-making factories.
mRNA is a single-stranded molecule that carries genetic code from DNA in a cell’s nucleus to the cell’s protein-making machinery. Vaccines and drugs based on mRNA give instructions to cells in the body to make proteins to prevent or fight disease.
Moderna raised billions of dollars from private investors, and then pushed through its record-breaking initial public offering. But the firm struggled to convince the public markets of its game-changing potential, and the company’s stock price slumped 30 percent in the months after the 2018 IPO, wiping out about $2 billion in market value.
Through the years, the firm has also weathered criticism by current and former employees. A 2016 investigation by STAT, a publication of Boston Globe Media Partners, described Moderna’s work environment as caustic and said it had driven away top talent.
But after the news about the shipment of the coronavirus vaccine, shares of Moderna had their biggest one-day gain Tuesday. Alan Carr, an analyst for Needham & Co. said the public health crisis represents a terrific opportunity for the biotech.
“It’s a great way to pressure-test technologies to see if you can actually develop and produce vaccines really quickly,” he said.
Jonathan Saltzman can be reached at firstname.lastname@example.org