News this week from Pfizer and BioNTech that their COVID-19 vaccine appears to be safe and effective for children aged 5 to 11, the largest unvaccinated age bracket, was widely welcomed by many. How much of a game changer it might be is a question yet to be answered.
Since its emergency use approval last December, the Pfizer-BioNTech vaccine has proved highly effective in adults 18 and older and more recently in teens aged 12 to 18. Some 20 million strong, children between 5 and 11 years old make up a significant group of unvaccinated Americans.
The Pfizer-BioNTech news follows an initial dip in cases after millions of Americans started getting COVID vaccinations earlier this year, and a subsequent rise in so-called breakthrough infections as the virus rebounds in variants, mutated virus forms called by names like Delta and Mu, that have developed ways to sneak past vaccine-induced immunity.
Despite COVID’s variant-fueled resurgence, experts see the recently developed Pfizer-BioNTech, Moderna and Johnson & Johnson coronavirus vaccines as effectively preventing severe cases and greatly reducing the chance of hospitalization or death for adults and teens who have been dosed. Children younger than 12 generally have not suffered infections as severe as older individuals.
With the spread of variants, COVID infections and severe reactions are rising among unvaccinated children. Nationally, the American Association of Pediatrics reports that from Sept. 2 to Sept. 16, COVID cases among that group saw a 9 percent increase as 469,350 children were newly infected. In Rochester, Golisano Children’s Hospital reported treating only a single child for COVID this week. Still, in a disturbing trend, case numbers among the local 5-to-11 cohort are rising. According to the Monroe County Department of Health, cases among that age group here went from 54 on Aug. 30 to 156 on Sept. 19.
An end to such numbers could be in sight, however.
A hopeful sign
After months-long clinical trials testing its COVID vaccine’s safety and efficacy among children under 12 years old conducted at multiple sites around the globe including Strong Memorial and Rochester General hospitals in Rochester, Pfizer-BioNTech this week announced that the vaccine is “safe, well tolerated and showed robust neutralizing antibody responses.” The company also said that it plans to ask the U.S. Food and Drug Administration for emergency use authorization to allow shots for children 5 to 11 years old before a possibly months-long process for full FDA authorization is completed.
To Jennifer Nayak M.D., Pfizer’s announcement was very good news indeed. A University of Rochester Medical Center infectious disease specialist, Nayak is among the researchers who is overseeing clinical trials of the Pfizer-BioNTech vaccine, which now has full FDA approval, and the similar Moderna vaccine.
Both COVID vaccines use messenger RNA technology, which scientists believe could revolutionize development and production of many vaccines, ones to prevent flu and other diseases including cancer. Made possible only by relatively recent advances in genetics and gene splicing, the technique involves replicating a small sliver of a pathogen’s protein and using it to stir the immune system into producing antibodies to fight that pathogen.
“I’m thrilled,” Nayak says, elated by the Pfizer announcement and by the prospect of a similar announcement from Moderna she expects to follow soon. Part of her excitement stems from her anticipation of seeing her own two young children vaccinated.
Equally pleased is Michael Pichichero M.D., director of RRH’s Rochester General Hospital Research Institute and a pediatric disease specialist. Pichichero eagerly anticipates the possibility of emergency use authorization before October’s end as a “Halloween treat.” He is as eager to see his own grandchildren vaccinated as Nayak is to see her children get the shot.
Exactly how soon emergency use authorization might come is not entirely clear. While Pichichero awaits a “Halloween treat,” Nayak notes that an FDA panel and Centers for Disease Control and Prevention experts must vet vaccines before authorization can be granted. Such processes could push approval to as late as December, Nayak says. However, she is confident that it will come before the year’s end.
The herd immunity challenge
Vaccination is important for children but also for the wider community, Pichichero says, citing a need to reach herd immunity, a state where enough people are immune to pathogens like viruses to deny them sufficient numbers of hosts to spread. Herd immunity contained smallpox, a once deadly scourge that has disappeared thanks to development and worldwide dissemination of a vaccine.
“For our community, we need a higher level of vaccination in order to get herd immunity (to COVID),” Pichichero cautions. “Until we achieve herd immunity, we’re not only going to see the Delta variant; we’re going to see the Mu variant; we’re going to see the Lambda variant. There are variants we don’t even know about yet. They’re going to keep mutating. They’re going to keep happening until we as a community pull ourselves together and get everybody vaccinated who possibly can be vaccinated.”
What percentage of parents will be amenable to having their young children dosed is unknown. Some are as enthusiastic as Nayak and Pichichero. Others are opposed for a variety of reasons including religious and political objections. Some aren’t sure what to think.
“There are always unknown risks,” Pichichero says, acknowledging fears that might keep some parents in the no-vaccine camp. “We face those with all the vaccines that we’ve given to children.”
Even so, he predicts, “I expect that with FDA review and approval and a vote by the committee, we’ll have enough confidence to proceed to vaccinate our children.”
Mehmet Dilek and Nancy Miano are parents of Max. Now six and going on seven, Max attends the Harley School. Though he does not like wearing a mask at school, he has obeyed the private school’s strict masking and social distancing requirements.
Dilek, who is on immune-system suppressing medication to control plaque psoriasis, cannot be vaccinated. But he also has no desire to get a shot. Currently on a break from a job to which he plans to return shortly, Dilek says that during much of the pandemic he worked closely with colleagues he will soon be working with again and never got sick. He is certain that he will continue to be COVID-free when he goes back to work.
“I think it’s overblown,” says Dilek of the pandemic.
While he does not see vaccination as an invasion of his personal liberty, he is wary of the COVID vaccines, which he sees as developed on a short timeline, possibly fraught with yet-to-be-revealed dangers and might be less effective than advertised. His parents, who live in Turkey, were double-vaccinated during a visit to Florida, yet found out that they were COVID positive on their return to Turkey and had to self-isolate.
In spite of that, Dilek says, if Miano wants Max to be vaccinated, he will bow to her wishes.
“She’s the boss,” says Dilek, gesturing toward Miano.
Miano, who is herself double dosed with the Pfizer vaccine, is undecided about seeing Max inoculated. She says she decided to get vaccinated because Max urged to get the shot and because an uncle died of COVID and she feared a similar fate for herself.
Yet, Miano shares some of Dilek’s trepidation. Though less than inclined than Dilek to dismiss the vaccines, she continues to harbor doubts. Like Dilek, Miano worries about the speed with which COVID vaccines were developed and distributed. A mortgage broker who works from home, Miano says she has not paid enough attention to the news to get a clear picture of what the vaccines are or how they work.
“I don’t really understand the vaccines,” Miano confesses. “People tell me they know of someone who died after being vaccinated.”
Miano concedes that tellers of such tales virtually never cite a specific source or verifiable case. Nevertheless, she says, the seeds of doubt they plant linger and sprout.
Parents of Max’s neighborhood playmates have not helped Miano make up her mind. She says one set of parents of the three families whose kids play together on Miano’s Highland Park-area block, vacillates, sometimes adhering strictly to COVID protocols but at other times flaunting them. The other couple “probably wears masks when they’re in the house alone together,” Miano says.
If Max’s school requires vaccination, Dilek says he will not let his scruples stand in the way. Nodding her affirmation, Miano unhesitatingly agrees.
What schools might or might not require of elementary students is far from clear, however. New York public health law currently demands that all public, parochial and private-school students be vaccinated against a variety of ills students. Required immunizations include shots to forestall diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, hepatitis B and chickenpox.
Partly due to their newness, COVID vaccines are not on that list. But since some political actors have cast any government COVID vaccination mandates as an unacceptable incursion on personal liberty, the subject of COVID mandates has become a political hot potato. An August survey from the Kaiser Family Foundation found that four in 10 parents of children under 12 planned to “wait a while to see how it is working,” after a vaccine is authorized, before getting their child vaccinated. About half of parents, regardless of their child’s age, said they are very or somewhat worried about their child getting seriously sick from coronavirus.
When asked whether COVID vaccines should be required, Pichichero says “we’ll have to see how the politics evolve (as to) what’s going to happen regarding any kind of vaccine mandate for children. That includes the politics for school districts, state politics and national politics.”
Still, for parents pondering whether to see their young child vaccinated for COVID, the physician sees a powerful argument in favor.
“Every patient who I’m aware of who contracted the virus, who became very ill (and) unfortunately ended up on ventilators or died, looks back and wishes they had been vaccinated or encouraged a loved one to get vaccinated,” Pichichero says.
He is certain that parents who face illness or death of an unvaccinated child would feel the same way.
For some, the divide between pro and con might seem less stark.
Asked if he would like to get a COVID shot, Max, who once urged his mother to get the shot, after sitting quietly and listening while his father detailed his COVID vaccine doubts, says, “I don’t know.”
Will Astor is Rochester Beacon senior writer.