Corona Daily 092: Babies in Trials

This week, USA has started vaccinating 12-15 years old, just in time for their summer camps. Pfizer has received an emergency approval. There are 50 million children in America below the age of 12. What about vaccinating them?

In fact, Pfizer and Moderna have started clinical trials among younger kids. Moderna has three age groups: 6-11 years old/ 2-5 years old/ 6-20 months old. The youngest participants for either trial are six months old.

The doses for 12-15 age group are the same as for adults. This stage of trial for the younger children is about finding the right dosage. Pfizer is giving one third of an adult dose to the babies, and scaling up age-wise. The side effects will be monitored, and development of antibodies measured. The objective is to find the optimum amount that doesn’t produce too strong a reaction, but is able to protect.

Participation in the trials is competitive. More than 3,400 have applied for the Moderna trials, but only up to 200 will be accepted. The later bigger trial where kids will be given either a vaccine or a placebo will have 7,300 kids for Moderna and 4,000 for Pfizer. If you live in the USA and have young children, you can still apply for either.

Families monitor the children’s health and side effects, are required to keep an electronic daily diary of any symptoms, and commit to one year of follow-ups either by phone or in person. They must take the children to the sites for blood draws to measure antibody response. So far, apart from sore arms and mild temporary symptoms, Moderna participants are fine.

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Parents and legal guardians must give consent. Children capable of understanding are required to agree as well. They have spent a whole year living in a pandemic; even four-year olds have given verbal consent and the reason why they want to. (e.g. They saw the grandparents take the vaccine).

Unlike adults, children’s concerns are immediate. “How much will the injection hurt?” They also worry about the blood draws. Health care workers are usually enthusiastic about their children taking part in vaccine trials.

The larger trials will begin in late summer, and continue into winter. Last year, pharma companies were lucky. A wave started, and as a result there were lots of cases among the trial participants. The trial closed early. If the USA is corona free, the trials will take a long time. If there is no virus, the vaccine receivers and placebo receivers both have the same reaction, making any conclusion impossible.

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There is a debate on the ethics of America vaccinating its youngest. Of the 583,000 corona deaths in the USA, around 300 were children under 18. Some children have suffered from long covid. Concerning as those facts are, the number of cases, hospitalizations and deaths remain small.

In flu or pneumonia, children play a large role in transmission. That doesn’t appear to be the case with covid. Studies in Iceland and Israel showed children below 10 didn’t usually get infected or transmit to others.

Instead of giving 100 million doses to the 50 million American children, the same vaccines could probably protect 50 million adults in vulnerable countries where the contagion is surging. Once the vaccines are established as safe and effective in the current trials, USA can give them to the small group of children with medical conditions, who are at higher risk. And the remaining vaccines can go to people who need them most. That is the argument of the ethicists.

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Early results available show that fully vaccinated 12-15 year olds developed substantially higher level of antibodies than 16-25 year-olds. Scientists wonder if the youngest children may produce the same or greater immune response with a lower dose.

Currently, it is correct to debate the ethics of vaccinating the youngest Americans in times of global vaccine shortage. However, as I wrote in an earlier article, a coronavirus vaccine becoming a routine childhood vaccine may be the long term solution to prevent pandemics. From that point of view, the baby trials are a welcome step in the march of science.

Ravi