It was just before the New Year when I learned that someone my toddler Theo and I had been spending time with had been exposed to COVID-19. We’d spent time indoors together, shared a meal and watched a Spider-Man movie.
Rapid tests were scarce, but I had some. So I met my mother outside a COVID-19 testing center where I had an appointment for a PCR test to give her two test kits to take home. The person we ate with tested positive.
It was possible that Theo, a participant in Pfizer’s pediatric COVID-19 vaccine trial, was already vaccinated against the virus. Or he could have been given a placebo shot — participants wouldn’t find out until enough data was collected to “unblind” the study.
Two years into the pandemic, around 19.6 million children in the United States are still too young to be eligible for a COVID-19 vaccine. We couldn’t know if Theo was one of them.
At this point in December, with the Omicron variant spreading rapidly, it seemed like everyone was getting a COVID-19 contamination notice, so I felt relatively calm. My husband and I were anticipating a possible holiday rush and had stocked up on quick tests to take home and had our booster shots.
We went through the possible scenarios if Theo and I tested positive. We agreed that despite Theo’s general boisterousness, even when ill, my husband would isolate in the house with us and risk exposure; I would need the help if Theo and I both got sick.
We waited five days for our PCR tests, in the meantime we did quick tests and did more PCRs, all negative. None of the five other people at the dinner tested positive or became ill. All of us but Theo were pumped. My sister was convinced that this meant Theo had received the vaccine, but we still had a month before we would know if her suspicion was correct.
I had documented for this news outlet how Theo received his first shot in mid-July in Stanford University School of Medicine’s COVID-19 vaccine trial for Pfizer, and another three weeks later when he was about 14 months old.
Over the holidays it felt like a race against time. Theo’s glare was only fixed at the end of January. And even if he had been vaccinated over the summer, his immunity would wane.
Given the contagious nature of the Omicron variant, vaccine study investigators decided to avoid unnecessary in-person visits and said they would call us to let us know if Theo had received the vaccine.
Since he didn’t seem to have had any side effects from the shots (apart from a very mild fever the night of his second vaccination), I was surprised to learn on January 27th that he was actually receiving active doses, not the placebo.
They offered participants who chose to remain in the study a third dose as a booster shot to protect against Omicron.
Pfizer had another reason for offering a third shot. In mid-December, the company announced in its study that the vaccine was not as effective in 2- to 5-year-olds compared to the high effectiveness of the vaccine in 16- to 25-year-olds. (The 3 microgram dose appears to be effective for Theo’s age group, aged 6 to 24 months.) It would evaluate a third dose of 3 micrograms for children between 6 months and 5 years.
“These updates were informed by the efficacy data for three doses of the vaccine for people 16 years and older and the early laboratory data observed with Delta and other variants of concern, including Omicron, suggesting that people were vaccinated with three doses of a COVID -19 vaccine could have a higher degree of protection,” Pfizer said in a press release.
On February 16th, Theo got his refresher. This time he was certainly more aware that he was about to have an injection than he had been in the summer, and more fidgety as a result. This time we knew exactly what he was getting because we had already signed a contract stating that they would unblind the study after six months.
After his third injection, he again seemed to have no side effects. We came back a month after the booster for a blood draw from his arm to check for antibodies and are back for another blood draw.
The FDA approved Pfizer’s COVID-19 vaccine for 5- to 11-year-olds in late October 2021, meaning children in that age group could be vaccinated in time for Thanksgiving.
Things weren’t looking so rosy for families with children under the age of 5, but health officials were still hoping there could be gunshots in their arms (or thighs in the case of babies) by February. In mid-February, the FDA was scheduled to review the Pfizer vaccine trial, but announced a week earlier that it would postpone its review and wait until data on a third dose of the drug is available in early April. This was devastating news for many parents of young children.
“It’s frustrating that we’re almost to an endemic phase of this virus and don’t have a vaccine for our little ones, but it’s important to take the time to make sure the vaccine is safe and effective,” research nurse Jamie said Saxena, one of the researchers in the Stanford pediatric study.
A glimmer of hope came last week when Moderna announced that it would submit an application to the FDA “in the coming weeks” for approval of a two-dose COVID-19 vaccine series for children under 6 years old.
But the effectiveness of Moderna’s vaccine was about 40% in children under 6 years old, compared to over 90% in the adult study.
There were other bumps in the road. Last summer, Pfizer put the study on hold while clinics rewrote the consent form with a warning that myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the lining outside the heart, have occurred in some younger people who received mRNA -Vaccines. Both the Pfizer and Moderna vaccines use a copy of an mRNA molecule to elicit an immune response.
But clinicians now agree that the known risks of COVID-19 and its potentially serious complications, such as long-term health problems, hospitalization and even death, far outweigh the potential risks of a rare adverse reaction to vaccination, including both of these heart conditions, according to CDC.
Aside from the Moderna news, Saxena said she hopes to have the Pfizer vaccine approved for children under the age of 5 by the end of April.
Overall, the study participants are doing well, Saxena said.
“I look forward to having COVID-19 vaccines for all ages!” said Dr. Bonnie Maldonado, the lead researcher on the Pfizer study at Stanford, in an email. “The message about the safety and importance of these vaccines for children must continue.”
I feel that given Theo’s immunization status, my family was privileged to have a different experience than most families with babies and young children.
I can get him to visit his great-grandparents without fear of passing the virus on to them.
We felt comfortable attending his friend’s outdoor birthday party. Theo went to Trader Joe’s for the very first time and was a wonderful assistant taking items from us and putting them in the shopping cart.
He is still getting sick, as a recent horrific bout of norovirus reminded us, but we are comforted that he is less likely to get and pass on COVID-19 to others, and if he does get it, he is less likely to be terminally ill will.
We’ve dodged COVID-19 so far, and as he nears his second birthday in May, we’re hoping to throw him an outdoor birthday party if the latest variant doesn’t cause a surge in cases like Delta and Omicron did.
That doesn’t mean we should go back to exactly how things were before the novel coronavirus spread around the world.
If I’ve taken anything away from my experiences over the past two years, it’s that we need to take care of each other. If you don’t feel well, stay home. A negative COVID-19 test still doesn’t mean anyone wants your coughing, runny self to come to potluck or work, especially if you’re around infants or immunocompromised people.