In her day job, immunologist Zina Good crunches data on how well immune system cells can be mobilized to battle cancer.
But after leaving work at the Stanford Cancer Cell Therapy Program, she’s back to bottles, baths and bedtime stories as mom to two cherubic boys. And that’s how she found herself in unfamiliar circumstances — on the patient side of the consultation table for a clinical trial.
Good’s 3-year-old son, Andel, became Stanford Medicine’s first young child to get the Pfizer COVID-19 vaccine in April, as clinical trials for the under-12 set get underway in earnest. A week later, Good’s younger son, Soren, then 7 months old, was vaccinated as well.
“We know that at least 4 million children have been infected since the beginning 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 the Stanford University School of Medicine.
“We also know that people who’ve had COVID-19 can have long-term health effects, and vaccination will probably prevent that from happening,” Maldonado said. “Children under 18 represent a quarter of the U.S. population — if you really want to suppress the virus, you really want to be able to safely vaccinate children.”
Pfizer’s vaccine already is in use for children 12 and older, and Moderna announced last week that its vaccine is safe and appears effective for that age group as well.
That leaves kids under 12 as the final frontier.
Getting the dosage right for three tiers of small people — ages 5 to 11, 2 to 5, and 6 months to 2 years — is the first order of business.
Pfizer’s study will involve more than 4,600 children and is mostly full. In California, trial sites are at the Center for Clinical Trials in Paramount and the Bayview Research Group in the Valley Village section of Los Angeles, as well as at Stanford.
Moderna’s study is currently recruiting more than 7,000 kids. Trial sites are at the Emmaus Research Center in Anaheim, Family Medical Clinic and Sera Collection Research Services in El Monte, Altman Clinical and Translation Research Institute in La Jolla and the Ventura pediatric office of Dr. Carey Chronis.
Experts expect emergency use authorizations — which are different from full approvals — to start rolling out from the Food and Drug Administration by fall. The tough questions about who should then get the vaccines — all American children whose parents are willing? just the most at-risk kids, so people at greater risk elsewhere can access vaccine first? — will be a matter of intense debate.
COVID-19 in kids ‘is real’
“The problem of COVID-19 in kids is real. I keep trying to stress that,” said Dr. Brigham Willis, pediatrics professor 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’re not.
After exposure to the virus, a small number of children develop “multisystem inflammatory syndrome,” or MIS-C, a serious condition involving inflammation of heart, lungs, kidneys, brain, skin, eyes and/or gastrointestinal organs. More than 4,000 kids had post-COVID-19 MIS-C in the U.S., with close to 40 deaths.
Forty isn’t a huge number, Willis said — unless one of them is your child.
“It can be a very serious problem, and vaccination may help prevent it,” Willis said. “We all want to get past the pandemic. The only way to do that is to include kids in the vaccination plan.”
40,000 kids infected in one week
Pediatric COVID-19 cases have hit record low numbers, but still tallied nearly 40,000 cases in the U.S. in just one week late this month, according to the American Academy of Pediatrics.
That’s about 20% of new cases.
“Since the beginning of this year 2021, we have lost about 20 children a month to COVID,” said Dr. Akshat Jain, director of the Inherited Bleeding Disorders and Hemoglobinopathies Program at Loma Linda University School of Medicine. “The dilemma is real.”
Experts say it’s important to finish pediatric trials. “We need that data,” Jain said. “And once it’s out, we need to get it approved for pediatric indications as soon as possible.”
There appears to be appetite for the shots.
In Los Angeles County, 15% of youth ranging in age from 12 to 15 got their shots within the first few days of eligibility, the Department of Public Health said. That’s in addition to 41.2% of the county’s 16- and 17-year-olds.
“Across the world and here in California, we remain troubled about the proliferation of variants of concern,” said a DPH spokesperson. “The identification of these variants and the news of spreading variants from across the globe highlights the need for L.A. County residents to continue to take measures to protect themselves and others: This is particularly true for those who are not vaccinated who can end up unknowingly being incubators of variants of concern.”
Skeptics challenge vaccinations
There are vaccine skeptics who feel otherwise.
On May 21, a group of such skeptics — including Dr. Simone Gold of Beverly Hills, who was arrested for occupying the U.S. Capitol on Jan. 6 — sued the federal government to halt COVID-19 vaccinations in children.
“(T)he injections are dangerous biological agents that have the potential to cause substantially greater harm than the COVID-19 disease itself, and numerous laws have been broken in the process of granting these (emergency use authorizations) and pushing these injections on the American people,” the group said in an 80-page petition that asserts there is no real emergency, case and death numbers are “far lower” than what is being reported and that COVID-19 presents no threat to children younger than 16.
Anti-vaxxer Robert F. Kennedy, Jr.’s group filed a citizen petition with the FDA to revoke EUAs for the vaccines as well.
“Way off base,” Willis said, shaking his head. “The data so far has been stupendous for the safety and efficacy of mRNA-based vaccines for every patient population. In teenagers, the data shows near 100% efficacy with, literally, almost no side effects.”
Vaccines, the U.S. Centers for Disease Control says, 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. It’s how vaccines were developed for smallpox, for polio, for measles, for COVID-19. Kids were part of those trials.
Never before have hundreds of millions of people taken a vaccine within such a short frame of time, that works so well, has proved to have so few side effects, and has been so closely monitored, the scientists said.
Vaccine safety ‘unparalleled’
“This one is already showing it’s way safer than any other vaccine we’ve ever had. It’s unparalleled,” said Willis, whose own children, ages 14 and 16, have been vaccinated. “The efficacy and safety of these vaccines are a huge advance for humankind.”
Stanford’s Maldonado said she is reading a book called “Extra Life: A Short History of Living Longer,” which notes how life expectancy has doubled over the last 100 years thanks to little things people take for granted — sewers, antibiotics, vaccines.
“A little over a year ago, we didn’t know about this virus,” she said. “Now, we have several highly effective vaccines, all developed with the proper ethical standards. A third of a billion doses have been given in the U.S., and a billion around the world. They’re extremely safe and highly effective. These vaccines are amazing.”
Children must be part of the vaccine plan because, even if they don’t get terribly sick from the virus, they can still pass it on to others who can get terribly sick — and they could be the incubators where the virus morphs into more lethal forms.
“If we didn’t have these vaccines — we all remember what it was like at Christmastime,” Maldonado said, recalling lockdowns and hospitals overrun with COVID-19 patients. “These are remarkably well-studied vaccines. In the history of mankind, we haven’t studied anything this well. I have full confidence these are going to show the way to protect our children, keep them safe and keep our communities safe.”
If every fully vaccinated person in L.A. County helped just one unvaccinated person get a first dose, “We’d have 3.9 million more vaccinated people — and we’d reach the level of community immunity we need to insulate and protect all of us as we fully reopen,” the Department of Health spokesperson said.
Some question whether America’s youngest children, at lower risk, should be vaccinated while the highest-risk seniors and health care workers abroad are still waiting for their turn.
These decisions need to be weighed carefully, Jain said.
“We should make sure that young children at high risk get covered — like those with diabetes and sickle cell anemia — especially patients who are disadvantaged and have disproportionately borne the brunt of this disease,” he said.
“But the biggest vaccine producers are still hoping to get to 400 million doses per month by the end of December. To get to a 70% goal of the entire world population, like we did with polio and smallpox — I don’t think that’s achievable, at least in the short-run.
“What is achievable is to vaccinate enough people to keep the variants from spreading,” Jain said. “There has to be vaccine sharing.”By TERI SFORZA | email@example.com | Orange County Register
PUBLISHED: May 30, 2021 at 8:00 a.m. | UPDATED: May 30, 2021 at 1:53 p.m.