Eager as we are for a COVID vaccine, we need to be realistic about possible harms – and about a plausible timeline.
There’s a phrase being tossed around with abandon these days. Everywhere we turn, there’s talk of a “safe and effective” COVID-19 vaccine.
USA Today quotes infectious disease chief Anthony Fauci: “We feel cautiously optimistic that we will be able to have a safe and effective vaccine.”
Two days ago, former US Food and Drug Administration (FDA) commissioners, Scott Gottlieb and Mark McClellan, used the phrase safe and effective three times in a Wall Street Journal opinion piece about vaccine development.
Canada’s Prime Minister, Justin Trudeau, similarly declared recently: “Canadians must have access to a safe and effective vaccine against COVID-19…”
Let us now turn to Vaccines: Truth, Lies and Controversy, a book written by Peter Gotzsche, a Danish physician who has spent decades evaluating the quality of published medical research. 27 years ago, he was among those who founded the Cochrane Collaboration, an organization that systematically assesses healthcare interventions.
In the context of discussing Japanese encephalitis, Gotzsche writes:
according to the WHO “safe and effective vaccines are available.” You should never believe such reassuring statements, which is [drug] industry jargon. Nothing is both safe and effective; effectiveness always comes with a price.
In healthcare, people rarely use the term harms. They talk about side effects, which is a euphemism for the inevitable – some people will be harmed and in rare cases even die after having received a vaccine.
Generally speaking, Gotzsche considers vaccines “the most valuable interventions and the best buy for money we can offer.” But the overriding message of his book is that every vaccine must be judged on its own merits. In his view, some vaccines promoted by health authorities are “marginal at best.”
He’s skeptical, for example, of annual flu vaccines, to the point of accusing the website of the US Centers for Disease Control (CDC) of promulgating a “massive amount of misinformation” on this topic. When discussing whether medical personnel and others should be forced to get an annual flu shot, he says:
No vaccine is entirely harmless, and in the worst case, the healthcare worker might die, e.g. because of an anaphylactic shock caused by the vaccine, or fainting with head trauma after the injection, or development of the Guillain-Barre syndrome…
…A common argument for mandatory flu shots is that they prevent transmission of the virus to other people. However, there is no evidence that the vaccine does this…
…Many people will think that their chance of benefitting from the vaccination exceeds 50%, but it is less than 2%…Furthermore, the vaccine does not reduce admission to hospital or days off work…
…It has never been shown in reliable research that flu shots reduce deaths.
Which brings us to COVID-19. The fact that 160 different teams are currently working on a vaccine is immensely encouraging. Surely one of them will hit the target. On the other hand, we must be sensible.
In a July interview, Kenneth Frazier, the CEO of Merck pharmaceutical company, had some words of caution:
What worries me the most is that the public is so hungry, so desperate to go back to normalcy, that they are pushing us to move things faster and faster. But ultimately, if you’re going to use a vaccine in billions of people, you better know what that vaccine does.
…There are a lot of examples of vaccines in the past that have stimulated the immune system, but ultimately didn’t confer protection. And unfortunately, there are some cases where it stimulated the immune system and…actually helped the virus invade the cell…
…I think when people tell the public that there’s going to be a vaccine by the end of 2020, for example, I think they do a grave disservice to the public. I think at the end of the day, we don’t want to rush the vaccine before we’ve done rigorous science. We’ve seen in the past, for example, with the swine flu, that that vaccine did more harm than good. We don’t have a great history of introducing vaccines quickly in the middle of a pandemic.