Stanford tests Pfizer vaccine on infants and young children

The youngest research volunteers, accompanied by their parents, arrived at Stanford University on Wednesday to take part in a nuclear study of the COVID-19 vaccine in very young children.

“We want our children to be protected from the virus and not spread it to others if they become infected,” said Zinaida Good of Palo Alto, whose 3-year-old son Andel sat still. to play and take an afternoon nap. The family, Soren, who is 7 months old, was shot next month.

The aim of the trial at Stanford Health Care, the only place on the West Coast to test the Pfizer vaccine in children under 5, is to identify the strongest dose with the least side effects.

As adult vaccinations spread, an increasing number of adults may be sociable, blissfully mask-free. About 75 million American adults are now fully vaccinated.

But children remain unprotected.

The lack of childhood vaccines is affecting the general population, not just individual families, experts said. Because about a quarter of all Americans are under 18, the country will not achieve herd immunity without vaccinating young people.

“We want to make sure that children have access to vaccines not only for themselves but also for the community,” said Dr. Yvonne Maldonado, a professor of pediatrics and infectious diseases at Stanford, and the chief investigator of the trial said.

If the research is successful and vaccines are granted, ‘the children will contribute to the’ community field ‘against COVID, “says Dr. Peter Chin-Hong, a professor of medicine and specialist in infectious diseases at UC San Francisco, involved in Stanford research. “We need everyone in the population vaccinated.”

Chin-Hong, a father of two, said there was another concern: children’s possible vulnerability to new variants.

“COVID is a shape-shifting virus, and there may be a variant in the future that could affect younger individuals,” he said. In Michigan, he noted that the increase in the B.1.1.7 variant in the UK coincides with an increase in cases in young adults, perhaps through youth sports.

Initially, it was thought that children are largely impermeable to the virus. But statistics prove otherwise. Children make up about 13.5% of American infections. Thousands of children were hospitalized and nearly 300 died, Maldonado said.

“We do not know the long-term consequences of infection,” she added.

Vaccines were first tested in adults because older men are more likely to get sick and die, overwhelming hospitals.

Now the attention has shifted to the youth. Last month, Pfizer announced that the vaccine is safe and effective in adolescents as young as 12 years old. The vaccine is therefore now being tested in much younger children.

Pfizer’s nationwide trial of 144 children will unfold in phases. Three different doses are tested – 10, 20 and 30 micrograms – in batches of three different age groups: children from 5 to 11; ages 2 to 5, and ages 6 months to 2 years. After safety and dose studies, research will be extended to more children and the signs of efficacy will be found.

Vaccine manufacturer Moderna has also launched a phase-in trial that will gradually decline from 11-year-olds to infants.

According to dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, said vaccines could be widely available to older teens by this fall. Children and toddlers from primary schools may have to wait until early 2022.

Pfizer has already requested an amendment from the U.S. Food and Drug Administration from the authorization for emergency use to extend the use of the vaccine to teens ages 12 to 15, about 2.5 million Californians.

The Stanford trial will not include infants younger than six months because they do not have an adult immune system and rely on their mother’s breast milk for antibodies.

The university reached out to families through Bay Area pediatricians with Packard Children’s Health Alliance. It is still enrolling potential volunteers.

Good and her husband, Otávio, believe in the importance of research and data collection, she said.

She holds a Ph.D. in immunology from Stanford and is now investigating the design of engineered cell therapies to attack cancer. Otávio is a computer programmer and inventor who works as a software engineer at Google.

Both are vaccinated and look forward to the day when the whole family is safe.

“By participating in a clinical trial, our children could have access to a vaccine much earlier than if we were to wait until it was approved,” she said.