Now for the best vaccine, and one that will give us lasting immunity
A lot of lives are going to be saved by early Covid-19 vaccines, but the US can do better with proper research answering the many questions remaining
If there is a common theme in the errors of the US response to Covid-19, it has been the astounding amount of squandering. Our leaders squandered time, as well as public trust and people’s economic and emotional resources. And they squandered the chance to do good science — testing drugs and vaccines in a way that serves the public interest rather than the interest of pharmaceutical companies.
There is no question that Covid-19 vaccines and therapies will save many lives. But we are not doing the kind of scientific study needed to determine the best vaccines and therapies to maximise lives saved and minimise the weeks we endure unprecedented social and economic constraints. It is not too late to change course.
It is not too late, for example to test the possibility some have raised that the return to normal could be advanced by months if the Pfizer vaccine is given as a single shot. Although clinical trials determined safety and efficacy for two shots, supplies are running short and there is some evidence that one shot provides some protection.
The company could test the idea by picking a group of volunteers in the early rollout to get one shot, and compare them with those getting two, says Peter Bach, a physician and director of the drug pricing lab at Memorial Sloan Kettering Cancer Centre. A trial would be the only way to justify giving people a single shot.
He says he also stands by a recommendation he made in September that vaccines be tested against one another. There is much valuable data that could be gathered quickly given that there are more than 40 vaccines in the testing stage, with many different technological approaches. Some use inactive virus, others pieces of the virus and still others viral DNA encased in various kinds of harmless viruses. Then there are the two frontrunners, which use messenger RNA.
As researchers told me earlier in 2020, some of these vaccines might be better at preventing high-risk people from becoming fatal cases, while others might be better for keeping lower-risk individuals from spreading the virus. Some will be cheaper and easier to manufacture. Some will induce fewer side effects. Pfizer’s product requires extreme refrigeration; others do not. One candidate might even work as an oral vaccine rather than an injection.
The first vaccines across the finish line of US Federal Drug Administration (FDA) authorisation might not be the best ones for achieving worldwide immunity. As STATnews reported in September, several of the “tortoises” in the race, from Merck and Sanofi, look very strong.
“You don’t lose anything if you do 50,000 people with Pfizer versus J&J,” says Bach. “It’s not like you’re squandering the Pfizer vaccines.” Such tests would be in the public interest, ensuring we get the maximum amount of data in a minimum of time.
The way clinical trials usually work, companies design their own trials within some constraints established by regulators such as the FDA. But it does not have to be that way. In this unprecedented situation, we should have a much more uniform standard for scientific testing. In fact, last June, the FDA did lay out some standard experimental guidelines for vaccine manufacturers, says Bach. “That was completely ignored.”
A mandatory standard might have given us much-needed information on how well those newly approved Pfizer and Moderna vaccines protect against asymptomatic infection and thereby help us all achieve herd immunity. Testing subjects regularly for Covid-19 would have told us this, but Pfizer and Moderna did not collect that data. The AstraZeneca trial did collect data on asymptomatic cases, although the trial was marred by a serious mistake with dosing. And contact tracing subjects might even help us learn if vaccinated people can transmit silent infections to others. Those are not normal procedures, but this is not a normal situation.
The other looming mystery is how long vaccine-induced immunity lasts. The best way to learn about longer-term safety and efficacy is to keep the placebo-controlled trials going. But Pfizer is already talking about ending its trial by giving the people in the control arm the vaccine. The gesture may seem altruistic, but there is a selfish side to it: it undercuts the ability to keep getting data and uncover less common safety issues.
The same idea applies to drugs that could treat Covid-19, which should be tested in a standardised system designed for our benefit. In the northern spring, the antiviral drug Remdesivir was approved, for example, with minimal data on efficacy, timing and dosing. It has proven disappointing.
The public is so worn down that we are grateful for any ray of hope, and disinclined to question something that would end the pandemic — even though pharmaceutical companies are getting a great bargain out of this. They deserve some praise, but not as much as the public deserves the best possible public health campaign. That has not been the standard in 2020, but it is not too late to do better.
Would you like to comment on this article or view other readers' comments?
Register (it’s quick and free) or sign in now.
Please read our Comment Policy before commenting.