Pandemic vaccine programs cannot tell us whether they will save lives

Highly respected Professor Peter Doshi, Ph.D., has penned an opinion piece in the BMJ pointing out that current COVID-19 vaccine tests are not set up to tell us whether they can save lives.

Doshi, an assistant professor of pharmaceutical health services research at the University of Maryland School of Pharmacy, said: “None of the trials currently underway are designed to detect a reduction in any serious outcome such as hospitalisations, intensive care use, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.”

While being hailed as the solution to the pandemic, Doshi wrote in the BMJ that we can’t fully judge the success of the late-stage vaccine efforts from the likes of AstraZeneca, Moderna, Pfizer and BioNTech if we simply omit these key metrics.

“Many may assume that successful phase 3 studies will mean we have a proven way of keeping people from getting very sick and dying from COVID-19. And a robust way to interrupt viral transmission. Yet the current phase 3 trials are not actually set up to prove either,” said Doshi.

All the ongoing phase 3 trials are evaluating mild, not severe, disease, and they will be able to report final results once around 150 participants develop symptoms.

The BMJ editorial points out that in the cases of Pfizer and Moderna’s trials, individuals with only a cough and positive lab test “would bring those trials one event closer to their completion.”

Yet Doshi argues that vaccine makers “have done little to dispel the notion” that severe COVID-19 was what was being assessed.

Moderna, for example, called hospitalizations a “key secondary endpoint” in statements to the media. But Tal Zaks, M.D., Ph.D., chief medical officer at Moderna, told the BMJ their trial lacks adequate statistical power to assess that endpoint.

“Hospitalisations and deaths from covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30,000 people,” explained Doshi. “The same is true regarding whether it can save lives or prevent transmission: the trials are not designed to find out.”

Zaks confirmed to the London-based medical journal that Moderna’s trial will not show prevention of hospitalization because the size and duration of the trial would need to be vastly increased to collect the necessary data. “Neither of these I think are acceptable in the current public need for knowing expeditiously that a vaccine works,” he said.

Doshi says that: “We still have time to push for changes to ensure the ongoing trials address the questions that most need answering.”

He said this includes why children, immunocompromised people and pregnant women have largely been excluded; whether the right primary endpoint has been chosen; whether safety is being adequately evaluated; and whether gaps in our understanding of how our immune system responds to COVID-19 are being addressed.

“The covid-19 vaccine trials may not have been designed with our input, but it is not too late to have our say and adjust their course. With stakes this high, we need all eyes on deck,” he said.

Oct 22, 2020

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