Some ethical questions

I was recently surprised to discover that Canada (my country of birth) had approved the Pfizer vaccine for use in children aged 12 and older. More significantly, Canada intends to start administering it to that age group soon. This is contrary to the WHO’s plea to donate vaccine doses to the COVAX scheme first, as many frontline workers in poorer countries have still not been able to be vaccinated. Not only is this the WHO’s recommendation, but they have noted that research into the safety of these vaccines for children is still incomplete. Of course, ALL of the research on COVID-19 vaccines is incomplete as the clinical trials that have led to their approval and widespread administration will continue to monitor trial participants for two full years (the Pfizer phase 3 trial will be my point of reference everywhere in this post).

Normally, vaccines would be tested first in adult populations to ensure safety before including children. Considering that children are the least likely to suffer seriously from COVID-19 would seem to support this standard protocol.

From my perspective, the number of ethical questions is growing at a rapid pace.

How does a child give informed consent to participate in a clinical trial?

  • In short, a child does not, a parent or guardian does.

Where were children ‘volunteers’ found to participate in the first clinical trial?

  • They definitely were NOT found in the EU, as p. 40 of Pfizer’s clinical trial protocol can confirm. I have not found data to confirm specifically where children participants were recruited, but I suppose they are in the trial’s non-EU countries: Argentina, Brazil, Turkey, South Africa, and the United States. I would be very curious to know how many children were ‘volunteered’ in wealthier nations.

How were parents/guardians encouraged to ‘volunteer’ their children?

  • Many of the nations where the trials took place are poorer than the majority of nations currently offering large-scale vaccination campaigns. Considering that up to $2,000 was offered to trial participants (and I would speculate that this ‘up to’ amount was not the normal offer to participants in poorer countries) we cannot rule out that some people’s decisions may have been financially motivated. I see no major ethical problems with this for consenting adults, although other ethical questions arise as a result (for example Pfizer highlighting the trial’s ‘Participant Diversity’ – 42% in total, 30% in the US – as if this should be celebrated like more diversity in positions of leadership and power, rather than potentially representative of persisting economic inequality). However, I think it poses significant ethical issues related to children.

How much money would you accept to ‘volunteer’ your child in a clinical trial that has not yet been proven safe (in adults)?

  • I guess, if you participated in the first trial, up to $2,000 – piecing together information from various sources noted above.
  • But moving forward, we can say that parents are willing to ‘volunteer’ their children for $0. At least, that will be the case in Canada once children start receiving the vaccine along with the wider public and further data can be collected.
  • It is important for parents to know that the Pfizer trial only included 3,013 participants under 18 years of age (of 46,331 in total). That means that only 1,507 people under 18 years of age actually received the vaccine (as the other half were given a placebo). I believe the WHO’s recommendation that children not be vaccinated at this time is far more ethically than politically motivated.

Is it ethical to vaccinate a low-risk population in a rich country when the high-risk population in a poorer country is still waiting?

and more specifically …

Is it ethical to vaccinate a low-risk population in a rich country (that was not involved in the clinical trials) when the high-risk population in a poorer country (that WAS involved in the clinical trials) is still waiting?

  • I think these are two questions that every parent might ask themselves before signing their children up for their first shot.

Perhaps there are things I have failed to consider in this post, and it would be unethical NOT to vaccinate your child at the first opportunity. Perhaps you feel it IS unethical but still choose to go ahead anyway. If that is the case, then at least own that decision rather than making ridiculous, unsubstantiated justifications to yourselves and others.

As of 18 May 2021 – the percentage (rounded off) of people in countries that participated in the Pfizer phase 3 clinical trial (+ Canada) who have received their first dose of a COVID-19 vaccine.

  • 47% – Canada
  • 47% – United States of America
  • 38% – Germany
  • 18% – Turkey
  • 18% – Argentina
  • 17% – Brazil
  • 1% – South Africa

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