In her day job, immunologist Zina Good crunches data on how well immune system cells can be mobilized to fight cancer.
But after leaving her job at the Stanford Cancer Cell Therapy Program, she’s back to bottles, baths, and bedtime stories as the mother of two cherubic boys. And so she found herself in unfamiliar circumstances—on the patient’s side of the consultation table for a clinical trial.
Good’s 3-year-old son, Andel, became Stanford Medicine’s first young child to receive Pfizer’s COVID-19 vaccine in April as clinical trials for the under-12s get underway in earnest. A week later Goods’s youngest son, Soren, then 7 months old, was also vaccinated.
“We know that at least 4 million children have been infected since the start of the pandemic. There have been several thousand hospitalizations and between 300 and 600 children have died,” said Dr. Yvonne Maldonado, principal investigator and Taube Professor of Global Health and Infectious Diseases at Stanford University School of Medicine.
“We also know that people who have had COVID-19 can have long-term health effects, and vaccination is likely to prevent that,” Maldonado said. “Children under 18 represent a quarter of the US population – if you really want to suppress the virus, you really want to be able to vaccinate children safely.”
Andel Good, 3, laughs at Stanford Medicine’s Clinical and Translational Research Unit on Wednesday. Andel received a COVID-19 vaccine as part of a clinical trial in young children. (Courtesy of Stanford Medicine)
Pfizer’s vaccine is already in use for children ages 12 and older, and Moderna announced last week that the vaccine is safe and also appears to be effective for that age group.
That leaves children under 12 as the last border.
Getting the right dosage for three levels of tiny people — ages 5 to 11, 2 to 5, and 6 months to 2 years — is the first task.
Pfizer’s survey includes more than 4,600 children and is largely complete. Moderna’s study is currently recruiting more than 7,000 children.
Experts expect emergency authorizations – which differ from full approvals – to begin with the Food and Drug Administration by the fall. Then the tough questions about who should get the vaccines—all American kids whose parents want them? only the children most at risk, so that people at greater risk elsewhere get access to the vaccine first? – will be a matter of intense debate.
COVID-19 in children ‘is real’
“The problem of COVID-19 in children is real. I keep trying to emphasize that,” said Dr. Brigham Willis, a professor of pediatrics at UC Riverside. “It’s painful when I hear people say, ‘Oh, kids. They don’t really get COVID. They’re fine.’ ”
Too often, Willis said, they aren’t.
After exposure to the virus, a small number of children develop ‘multisystem inflammatory syndrome’ or MIS-C, a serious condition involving inflammation of the heart, lungs, kidneys, brain, skin, eyes and/or gastrointestinal organs. More than 4,000 children had post-COVID-19 MIS-C in the US, with nearly 40 deaths.
Forty isn’t a huge number, Willis said — unless one of them is your kid.
“It can be a very serious problem and vaccination can help prevent it,” Willis said. “We all want to get past the pandemic. The only way to do that is to include children in the vaccination plan.”
Pediatric COVID-19 cases have reached an all-time high, but according to the American Academy of Pediatrics, the number in the US was still close to 40,000 in just a week at the end of this month.
That is about 20% of new cases.
Experts say it’s important to complete pediatric studies. “We need that data,” Jain said. “And once it’s out, we need to get it approved for pediatric indications as soon as possible.”
Skeptics dispute vaccinations
There are vaccine skeptics who think otherwise.
On May 21, a group of such skeptics — including Dr. Simone Gold of Beverly Hills, who was arrested for occupying the US Capitol on Jan. 6 – urged the federal government to stop the COVID-19 vaccinations in children.
“(T)he injections are dangerous biological agents that have the potential to cause significantly greater harm than COVID-19 disease itself, and numerous laws have been broken while granting these (emergency use authorizations) and forcing these injections on the American people,” the group said in an 80-page petition stating that there is no real emergency, that the number of cases and deaths is “much lower” than what is being reported and that COVID-19 poses no threat. for children under 16 years of age.
“Far from base,” Willis said, shaking his head. “The data to date is astounding for the safety and efficacy of mRNA-based vaccines for any patient population. In teens, the data shows nearly 100% efficacy with, literally, almost no side effects.”
Vaccines, says the US Centers for Disease Control, are the best defense we have against infectious diseases, but no vaccine is 100% safe or effective for everyone, as each person’s body reacts differently. Clinical trials are how scientists figure out what works. Vaccines have been developed for smallpox, for polio, for measles, for COVID-19. Children were part of those trials.
Never before have hundreds of millions of people taken a vaccine in such a short time that works so well, has so few side effects and is monitored so closely, the scientists said.
Vaccine safety ‘unrivaled’
“This one already shows that it’s much safer than any other vaccine we’ve ever had. It’s unmatched,” said Willis, whose own children, ages 14 and 16, have been vaccinated. “The efficacy and safety of these vaccines are a huge advance for humanity.”
Three-year-old Eloise LaCour is getting her COVID-19 vaccination at Stanford. (Photo by Steve Fisch, courtesy of Stanford Medicine)
Stanford’s Maldonado says she’s reading a book called “Extra Life: A Short History of Living Longer,” which tells of how life expectancy has doubled in the past 100 years thanks to the little things people take for granted — sewage, antibiotics, vaccines.
“Just over a year ago, we knew nothing about this virus,” she said. “Now we have several highly effective vaccines, all developed with the right ethical standards. A third of a billion doses have been given in the US and a billion worldwide. They are extremely safe and very effective. These vaccines are great.”
Children should be part of the vaccine plan, she said. Even if they don’t get very sick from the virus, they can still pass it on to others who could become terribly ill — and children can also be the incubators where the virus morphs into more deadly forms.
Some wonder if America’s youngest, lower-risk children should be vaccinated, while the highest-risk seniors and health workers abroad are still waiting their turn.
These decisions need to be weighed carefully, Jain said.
“We need to ensure that high-risk young children are covered — such as those with diabetes and sickle cell disease — especially patients who are disadvantaged and disproportionately affected by this disease,” he said.
“But the largest vaccine makers are still hoping to get 400 million doses per month by the end of December. To hit a target of 70% of the entire world’s population, like we did with polio and smallpox — I don’t think that’s feasible, at least not in the short term.
“What is feasible is to vaccinate enough people to prevent the variants from spreading,” Jain said. “There has to be vaccine sharing.”