Not quite alarmed

There’s a Herald story, from the NYT headlined Covid 19 coronavirus: Vaccine-makers keep safety details quiet, alarming scientists.

The headline  is a bit misleading. The lead says

Researchers say drug companies need to be more open about how vaccine trials are run to reassure people who are skittish about getting a coronavirus vaccine.

which is much more accurate. In fact, the information being sought isn’t mostly about safety but about how effectiveness will be judged

Another front-runner in the vaccine race, Pfizer, made a similarly terse announcement Saturday: The company is proposing to expand its clinical trial to include thousands more participants, but it gave few other details about its plan, including how it would determine the effectiveness of the vaccine in its larger study.

I wrote a bit about early stopping of trials last week. One of the main pieces of information being sought is just how the various trials will handle an unexpectedly good vaccine: how dramatic will the effect of the vaccine have to be to stop the trial early?  Normally, this wouldn’t be public information; there isn’t any compelling reason why it has to  be, but there isn’t any very good reason why not.  This case is different: the political situation has raised a real possibility that  the President of the USA would try to make the FDA authorise a vaccine without convincing evidence that it works. I don’t use words like ‘disaster’ lightly, but this would be a  disaster, both for COVID prevention and for the long-term credibility of vaccination.  We need a vaccine that works, and we need people to know that it works.

Fortunately, the FDA and the pharmaceutical companies are a bit more long-sighted (Pharma, considered as multinational public-stock corporations, is greedy, but they’re not stupid).  If the current administration tries to push a vaccine through without displaying good evidence, there will be resistance from scientists inside and outside the FDA. There are even encouraging signs that the drug companies wouldn’t ask for authorisation without evidence that at least looks moderately convincing from a safe distance.

Even so, it would be good to know the details in advance. We have the FDA Guidance document, which goes some way to nailing the FDA’s colours to the mast. There’s some public information about an NIH working group that seems to have made sensible design recommendations. But in this particular setting it would be helpful to release the details of how the trials will define success — measurements, diagnosis definitions, guidelines for early stopping — so that dozens of scientists with no connection to the trials could say, hand on heart, “that’s not exactly how I would have done it, but it’s 100% a reasonable way to define a successful vaccine”.

Update: in case it isn’t clear, I’m not saying it’s impossible for President Trump to push an ineffective vaccine through the FDA. I’m saying it’s impossible for him to do it without it being obvious to researchers in the US and around the world who he doesn’t control. And that if he doesn’t and the vaccine really works, it’s important for you and everyone else to know that.