WASHINGTON - The first possible vaccine against coronavirus is on its way to human testing.
Just six weeks elapsed between when Chinese scientists released the sequence of the novel virus and when shipped its vaccine to the National Institute of Allergy and Infectious Disease to begin testing.
It's a record-breaking pace for vaccine development. Seveal other companies also are working to get their vaccines into clinical trials.
But testing a vaccine for safety and efficacy will take 12 to 18 months or more, officials say. Whatever product makes it through testing will face another hurdle: manufacturing and distributing enough vaccine to meet demand in what could be a global pandemic.
Moderna's vaccine is one of several candidates employing a new technology that has never been used in people.
Every vaccine until now has contained parts of the germ in question. They alert the patient's immune system to be on the lookout for the germ.
The , contains only genetic instructions for those parts. The patient's own body translates those instructions into the germ parts that alert the immune system.
This kind of genetic vaccine is much quicker to produce than traditional vaccines. All scientists need to know is the germ's genetic code, which was available for the coronavirus within weeks of its discovery.
That's how Moderna can get a vaccine into clinical trials in record time.
But the 10-year-old Massachusetts-based biotech company, has never brought a vaccine to market before. If its vaccine proves safe and effective, global demand could be in the hundreds of millions or even billions of doses. The company did not respond to questions about its manufacturing capacity.
"Some of these very innovative techniques are done by very small companies who don't have experience manufacturing vaccines at the grand scale that you would need to immunize the world," said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. "There will have to be some discussion about how we will develop the manufacturing capacity."
Two other small biotech companies, and , are also working on gene-based vaccines.
Funders are "working to identify potential bulk manufacturers with whom to link our vaccine developers," according to the , an international public-private partnership founded in 2017 to spur vaccine development for emerging diseases. All three biotech companies received funding from CEPI.
For the companies with large-scale manufacturing experience, producing an emergency vaccine is an unwelcome business risk, experts say.
Companies "have to stop work on whatever they're working on," Adalja said. "We don't know how big the market is going to be. We don't know if (the outbreak) is going to go away (by the time a vaccine is ready) like it did with SARS. We don't know who's going to buy these vaccines."
Governments and public-private partnerships have bought vaccines in some previous outbreaks, but every case is different, and not every scenario ends well.
Several companies took financial hits while working to develop vaccines against Ebola during the 2013-2016 outbreak in West Africa.
"There's no question that a lot of them lost a lot of money trying to produce an Ebola vaccine," said Ronald Klain, who coordinated the U.S. government's response to the outbreak under President Barack Obama. Klain was speaking at an event in February.
One has made it to the finish line, developed by U.S.-based pharmaceutical company Merck, with an estimated $175 million backing from the U.S. government. Health officials are using it to help contain the current outbreak in the Democratic Republic of Congo.
Vaccine maker Sanofi, meanwhile, has walked away from developing a Zika vaccine.
The French company was in negotiations in 2017 to conduct clinical trials on a Zika vaccine that the U.S. Army had developed, and to manufacture it should the vaccine prove safe and effective.
Sanofi wanted an exclusive license. But critics, including U.S. Senator Bernie Sanders, now a Democratic presidential candidate, wrote in an op-ed in the that the license would give Sanofi monopoly power and the company "will be able to charge whatever astronomical price it wants for its vaccine."
Since Sanofi had already received $43 million of U.S. taxpayer money and would receive millions more to distribute the vaccine if it worked, critics said the company should guarantee the shot would be affordable for everyone who needed it.
Sanofi and the Army did not reach an agreement, and the vaccine remains undeveloped.
Affordability issues have already come up regarding an eventual coronavirus vaccine.