A vaccine trial usually begins with tests for safety in animals. Cambridge-based Moderna’s test for a vaccine for COVID-19 in mid-March started with 45 humans.
Neal Browning, who resides in Seattle, was one of the first to get the injection. He said he had no side effects and described the experience matter-of-factly as “much like getting a flu shot.”
But it was a dramatic early signal: the COVID-19 vaccine hunt would move with unprecedented speed.
Safety testing is usually followed by years of research to see if a vaccine is effective. But in the COVID-19 crisis, regulations have been eased, the usual sequential steps are being done in parallel and, years before there is certainty that any vaccine candidate will work, highly specialized facilities are being readied to produce millions of doses of vaccine.
Given the enormity of the need, the capacity to manufacture a vaccine has to be an early focus.
“Because we never quite know if a drug is going to work, we literally go in very small steps. Here, you know, we're willing to take on risk because there's such an emergency that we're trying to solve,” said Remo Colarusso, vice president of Janssen Supply Chain, a division of Johnson & Johnson. He oversees the global supply chain and manufacturing of the company’s pharmaceuticals.
Johnson & Johnson is now scaling up global manufacturing to be able to make 1 billion doses of their vaccine for global supply by the end of 2021. Scaling up for potential vaccines now, means having a running start if the right vaccine is found.
“Our goal is to get to the billion,” Colarusso said. “We're going to have to take some risk and make some products, not knowing if we actually have a product yet.”
This “at risk” manufacturing means vaccines will be produced even as data is being gathered and before any final Food and Drug Administration approvals. But even with an early start, some warn there are many roadblocks to churning out vast numbers of vaccines to meet global demand.
Vijay Samant, who oversaw vaccine manufacturing at global pharmaceutical giant Merck, calls it an “insurmountable task.” Samant noted that U.S. vaccine manufacturing is normally stretched each year to capacity just to produce the annual flu vaccine, which will still be needed in the fall. There’s also still a need for other vaccines like scheduled pediatric and adolescent vaccines. And pumping out billions of vaccines means there will be competition for even basic materials like glass vials.
“Every country is going to want to make that vaccine and is going to be buying supplies.There's no capacity to produce all of those things right now,” Samant said.
Johnson & Johnson’s Colarusso predicted any initial shortages will ease as competitors in the vaccine race are weeded out. But they’re now staking out what they need.
“So we got out early and we started identifying partners and securing contracts with folks to which we have to pay,” Colarusso said. “Because if we didn't, someone else would.”
Pharmaceutical company Pfizer is also gearing up and plans to do test runs of potential vaccines this summer at their facility in Andover, MA. Their goal is tens of millions of doses by the end of this year and hundreds of millions next year.
Pfizer, partnered with German company BioNTech, is testing four variations of a vaccine. Their Andover site is now focused on “equipment availability, the equipment configuration, the raw material purchasing, [and] the training,” said Jon Tucker, Pfizer Andover’s site leader.
“When we get the green light for which of the variations is best, we're ready to go to produce those tens of millions of doses. And then the hundreds of million doses in 2021,” said Tucker.
It’s a bit like putting a lot of horses in one race to up your odds of getting a winner. Other companies are testing various candidates simultaneously, and the U.S. government is investing in five different vaccines, including Johnson & Johnson’s. And some predict there could be several winners.
But even a winner might not provide the total protection some might imagine. It could be more like our current flu vaccine, meaning it would require an annual dose and in some cases, provide only partial protection.
National Institute of Allergy and Infectious Diseases Director Anthony Fauci recently said he still thinks a vaccine could be deployed by January 2021 . But those early vaccine doses would likely be used on an emergency basis and given to those with high risk of exposure, like front-line workers. And the data gathering for safety and efficacy will continue; knowing how long a vaccine remains effective against the virus is one timeframe that can’t be rushed.
“It's very surreal knowing that three months ago, there were questions [of] whether this was going to hit the world as hard as it did. And now we're in the middle of it,” said early test subject Browning. “And now it's a race for a cure.”
