Scientists are increasingly optimistic that a vaccine can be produced in record time. But getting it manufactured and distributed will pose huge challenges.
Companies like Inovio and Pfizer have begun early tests of candidates in people to determine whether their vaccines are safe. Researchers at the University of Oxford in England are testing vaccines in human subjects, too, and say they could have one ready for emergency use as soon as September.
Last week, Moderna announced encouraging results of a safety trial of its vaccine in eight volunteers. There were no published data, but the news alone sent hopes soaring.
Animal studies have raised expectations, too. Researchers at Beth Israel Deaconess Medical Center last week published research showing that a prototype vaccine effectively protected monkeys from infection with the virus. The findings will pave the way to development of a human vaccine, said the investigators. They have already partnered with Janssen, a division of Johnson & Johnson.
Scientists are exploring not just one approach to creating the vaccine, but at least four. So great is the urgency that they are combining trial phases and shortening a process that usually takes years, sometimes more than a decade. More than 100 research teams around the world are taking aim at the virus from multiple angles.
Many of these vaccines will stumble as the trials progress. As more people are inoculated, some candidates will fail to protect against the virus, and side effects will become more apparent.
But from what scientists are learning about the coronavirus, it ought to be a relatively easy target. In other words, there is a lot of hope!
Ensuring that vaccines are safe and effective demands large trials that require careful planning and execution. If successful vaccines emerge from those trials, someone’s going to have to make an awful lot of them. Scaling up will be big challenge!
Almost everyone on the planet is vulnerable to the new coronavirus. Each person may need two doses of a new vaccine to receive protective immunity. That’s 16 billion doses.
“When companies promise of delivering a vaccine in a year or less, I am not sure what stage they are talking about,” said Akiko Iwasaki, an immunobiologist at Yale University. “I doubt they are talking about global distributions in billions of doses.”
Manufacturing vaccines is profoundly more complex than manufacturing, say, vitamins or cough pills. Vaccines typically require large containers in which their ingredients are grown, and these have to be maintained in sterile conditions. Also, no factories have ever churned out millions of doses of approved vaccines made with the cutting-edge technology being tested by companies like Inovio and Moderna.
Facilities have sprung up in recent years to make viral-vector vaccines, including a Johnson & Johnson plant in the Netherlands. But meeting pandemic demand would be an enormous challenge. Manufacturers have the most experience mass-producing inactivated vaccines, made with killed viruses, so this type may be the easiest to produce in large quantities.
But there cannot be just one vaccine. If that were to happen, the company that made it would have no chance of meeting the world’s demand. This is on a scale we’ve never seen since the polio vaccine in the mid-1950s. And then there are the little things like the syringes, the needles, the glass vials. All of that has to be thought about. You don’t want something that seems so simple to be the bottleneck in your vaccination program.
A coronavirus vaccine doesn’t yet exist, but already there is the next challenge, the question about who will be able to afford it.
At the World Health Assembly meeting last week, a proposal from the European Union was adopted recommending a voluntary patent pool, which would put pressure on companies to give up their monopolies on vaccines they’ve developed.
Oxfam, an international charity, has published an open letter from 140 world leaders and experts calling for a “people’s vaccine,” which would be “made available for all people, in all countries, free of charge.”
Does this encourage the researching companies? Somebody will have to pay them well for the contributions they make—the vaccines for a public good.
Let’s hope we can all contribute in addressing the challenges mentioned above. Hope will be a main factor in winning the race for a coronavirus vaccine, which will have to be distributed fairly and with integrity.
Feedback is welcome—e-mail me at Schumacher@eitsc.com