Corona Daily 243: Dummy Parachutes

At 06.45 UK time this morning, 90-year-old Margaret Keenan became the first person in the West to receive a covid vaccine. The UK government has decided to prioritise 80+ year old patients in the hospitals. Just by way of trivia, the second recipient was an 81-year-old male named William Shakespeare. This is not English humour.

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Last week, Moderna published the interim results of its trials. Out of the 196 corona positive cases, 185 were in the placebo group, only 11 in the vaccine group. (Which makes the vaccine 94.1% effective). All thirty severe cases were in the placebo group. None in the vaccine group. There was one covid-death among the volunteers. It occurred in the placebo group.

As you know, half of the participants are delivered a real vaccine, the other half a placebo. The double-blinded trials don’t let the participants or the medical staff know who has got what.

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Placebo is a major ethical issue in medical science. Though administered with the volunteer’s informed consent, it is essentially deception. When no drug or vaccine exists, such altruism is justifiable in the name of the greater good. What happens when an effective vaccine exists?

It’s almost certain the Moderna volunteer would have been alive today had he received a vaccine instead of a placebo. But neither Pfizer nor Moderna had published their results when he/she died. So, that can be attributed to bad luck. The trials will continue for the next two years to assess long-term effects. Not only that, more than 75 different vaccines are conducting trials, injecting thousands of volunteers with salt water or some other dummy shot. Like the Moderna participant, some placebo recipients may die in the future.

This has posed a huge dilemma, currently being debated in the scientific world.

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The position of ethicists is clear. Once a successful vaccine exists, it is unethical to give a placebo to anyone. The placebo recipients should be unblinded, vaccine shots given to protect them. This is a reward for the risk they took. No participants in future trials can be given a placebo, once an effective Pfizer, or Moderna or some other vaccine exists.

Which, in effect, means all trials worldwide should be halted with immediate effect.

Moncef Slaoui, the chief advisor to Operation Warp Speed, in fact, said the trial participants (meaning placebo group) should be the first in line to be vaccinated. Pfizer had 44,000 and Moderna 30,000 participants in the USA, collectively 37,000 placebo recipients. Ethically speaking, they should be the first 37,000 people (74,000 doses) vaccinated. But with vaccine scarcity, this is not mentioned in any of the US plans.

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Two professors from the University of Lethbridge are opposed to the concept of placebo. They offer an analogy with parachutes. If during wartime, a new type of parachute is urgently needed, sooner or later it must be tried in a real jump. We won’t let that happen until we are quite sure of its safety. And certainly, we will not give dummy parachutes to a randomly selected control group of volunteers.

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The World Health Organisation deliberated over this dilemma and issued a verdict: While vaccine supplies are limited, and the vaccines are investigational, WHO considers it ethically appropriate to continue the blinded follow-up of placebo recipients as well as new recruitment for vaccine/placebo trials. Trial sponsors are not obliged to reveal to any volunteers if they received a vaccine or a placebo.

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WHO was alarmed at the prospect of stopping trials. The long-term effects of the vaccine are unknown, so running them for another two years is essential, even if that means a few deaths among the placebo recipients.

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I will make an unscientific suggestion to continue the trials. The trial sponsor can invite anti-vaccine volunteers and give them a placebo. Give the vaccine to those who believe in a vaccine. In that case, if the placebo recipient dies of covid, there is no ground for complaint or regret.

Ravi