Photo courtesy Dr. Annie Johnson
Dr. Annie Johnson, shown with her husband Greg and their children (from left) Alice, Liam and Oscar, believes vaccination is the way out of the pandemic. The children are participating in a pediatric COVID-19 vaccine clinical trial.
Six-year-old Alice Johnson brought a stuffed dragon named Khaleesi every time she visited Upstate Medical University in Syracuse, New York, where she and her two brothers are participating in a clinical trial of a COVID-19 vaccine for children. The plush toy was a comfort to Alice as she endured two shots and having her blood drawn twice during the course of multiple appointments.
Giving blood, Alice said, was the scariest part; it hurt more and took longer than getting the shots. Her reason for putting up with some fear and pain? "I wanted to make sure that everyone was safe," she said.
Alice's mother is Dr. Annie Johnson, an Ithaca-based veterinarian, who encouraged her three youngsters to participate. Alice needed little urging. "She wanted to be a hero and help science," Johnson said. That's how Alice is: "If someone gets hurt, she grabs an ice pack and a Band-Aid, so she's definitely [the] empathetic, medically-minded one in the family," her mom explained.
From the start of the pandemic, Johnson understood that vaccines would be essential to a return to normalcy. Now, with her children, she's contributing to the goal of safely vaccinating as many people as possible.
Around the world, thousands of volunteers, veterinarians and their family members among them, are advancing the effort to test the efficacy and safety of COVID-19 vaccines. Schooled in the scientific method and committed to public health, veterinarians are helping to make a difference while getting an inside view of a historic endeavor. A few shared their experiences with the VIN News Service.
A family affair
When Johnson asked her children if they wanted to participate in the trial, she had the well-being of certain friends in mind.
"I've been lucky to have extremely healthy children with no underlying conditions," she said, but she knows children going through cancer treatment or with immune system or heart conditions. "They need the rest of [the] kids in their class to be vaccinated."
She views the two-hour round trip to Syracuse, and the time spent juggling schedules, answering her children's questions and offering encouragement, as her way of helping others make a safe return to school.
As subjects in the clinical trial run by Pfizer-BioNTech, the Johnson children are in an exclusive group: There are 3,500 participants in the vaccine trial for children 11 and under, according to a company spokesperson.
Of the three siblings, 4-year-old Oscar was first to become involved. He joined in April, when the trial was enrolling children ages 6 months to 5 years. His participation entailed three in-person appointments, during which he received two shots, had blood drawn to track his immune response, was tested for COVID-19 and had his vital signs recorded. Weekly since then, Johnson has been using an app to report whether Oscar exhibits any symptoms or has been exposed to COVID-19.
Alice and 8-year-old Liam, in the 5-11 age group, followed a similar regime beginning in June. Unlike Oscar, they were required to sign their own consent forms.
At the beginning of both studies, all participants were blinded, meaning they did not know whether they had received an active dose or a placebo. After one of his shots, Oscar spent the afternoon feeling "off" with a fever, but he was back wrestling with his big brother by bedtime. In September, the Johnsons learned that Oscar received an active dose.
As for Liam and Alice, there is a better than 50% chance they received active doses, since two-thirds of participants in their age group did. However, the family is taking precautions, including wearing masks in public — all of them, like it or not. "Oscar gets mad because I still make him wear one in solidarity," his mom said.
Of the three makers of COVID-19 vaccines authorized in the U.S., Pfizer-BioNTech is furthest along in seeking authorization to use their vaccine in children. The company reported to the U.S. Food and Drug Administration last week that its vaccine had a 90.7% efficacy rate in preventing symptomatic COVID-19 in the trial of children ages 5 to 11. On Sunday, Dr. Anthony Fauci, the nation's top infectious disease official, reportedly said that vaccines for this age group will likely be available in early November. As for children under 5, a Pfizer spokesperson told VIN News last month that data for children in the youngest age group could be submitted to the FDA as early as October.
Moderna announced on Monday that its pediatric trial showed a strong immune response in children 6 to 11 years old. The company said it would submit that data to regulators in "the near term," and is continuing trials in even younger children. Johnson & Johnson submitted plans to the FDA earlier this year that include trials in children and infants but has not announced them yet.
Veterinarians make good subjects
Photo courtesy Dr. Heather Bhakta
The fact that her job brought her into regular contact with others during the pandemic made Dr. Heather Bhakta an especially good fit for a clinical trial testing whether a COVID-19 vaccine was truly protective.
Dr. Heather Bhakta of Knoxville, Tennessee, volunteered in a J&J coronavirus vaccine trial at the University of Tennessee in July 2020. At that time, no vaccine had been authorized in the U.S., and COVID-19 cases in the state were surging.
Since she would be teaching veterinary technicians and pre-veterinary students in person at Lincoln Memorial University College of Veterinary Medicine, Bhakta represented a group of particular interest to researchers. They were looking for volunteers who were not sheltering-in-place and might be exposed to the virus in the natural course of events.
"They were choosing people who were at-risk so they could confirm the protection was from the vaccine and not isolationism," she said. "They wanted you to work face-to-face and go out in public."
Joined by her husband, Bhakta said that she wanted to do her part to help get a vaccine out as quickly as possible.
"I knew that they needed people to volunteer for the trial so that we could actually get a vaccine out there for people like my parents who are in a high-risk group," she said. "I was healthy enough to where if there were problems, I'd be OK."
She also appreciated the possibility of being vaccinated sooner rather than later.
The screening — to rule out possible past COVID-19 infections and otherwise determine eligibility — was extensive. It required a physical, two different types of nasal swab tests, urinalysis, and having somewhere between eight and 10 vials of blood drawn — Bhakta can't quite remember how many. She also had to have a pregnancy test.
Deemed eligible, the Bhaktas were eager for their first shot, only to be foiled when a paperwork processing issue led to the cancellation of that appointment. They had to repeat all the screening tests. Still, they never considered dropping out.
The Bhaktas each got one shot in July 2020 and a second shot one month later. (The trial included one- and two-dose regimens; the J&J vaccine later was authorized as a single shot. Last week, the federal government recommended boosters for all adult recipients of the J&J vaccine.) After the Bhaktas' vaccinations, they made eight follow-up visits, for a total of 10 each. As volunteer subjects, they were paid $100 per visit to offset the cost of travel and lost work time. Most COVID-19 vaccine studies in the U.S. similarly provide some form of compensation to participants.
Because they developed fevers and sore arms, Bhakta suspected they'd received active doses. Once the FDA granted emergency-use authorization for Pfizer-BioNTech vaccine, the first in the U.S., the J&J study was unblinded, and the couple's hunch was confirmed. Bhakta explained that it's generally considered unethical to keep participants in the dark about their vaccination status once an authorized vaccine is available to them.
Reflecting on the experience, Bhakta said participating behind the scenes made her more confident about the vaccine development process.
"I never thought about it a lot other than for animals," she said about all the legwork involved. "It'd be impossible for something to be done the wrong way because there's so many people with eyes on it."
The winding path of a Novavax trial participant
Dr. Amanda Guthrie
Photo courtesy of Zoological Society of London, London Zoo
Dr. Amanda Guthrie, an American zoo veterinarian practicing in London, received live doses of a trial Novavax vaccine in the U.K. late last year. Novavax has not yet applied for government approvals of the vaccine.
Sometimes participating in a vaccine trial is inspired by pragmatism.
Dr. Amanda Guthrie, an American veterinarian serving as the head of Wildlife Health Services at the Zoological Society of London and its London and Whipsnade zoos, enrolled in a trial for a Novavax vaccine in the United Kingdom to increase her chances of being vaccinated before traveling home to the U.S. to see her parents during Christmas 2020.
She got shots in October and November, and hoping for the best, flew home in December with the requisite negative COVID-19 test.
In early spring, her study was unblinded and she learned she'd received active doses of Novavax.
"I think it's been a huge advantage," she said. "I've had the vaccine since last October, and there's a good chance that's prevented me from getting COVID and giving it to other people."
There's been a bit of a wrinkle for Novavax study participants, however. The company has not filed for approval for use in any country yet, despite the fact it provided 89.7% protection against the virus in the U.K. trial, according to a paper published in the New England Journal of Medicine.
A Novavax spokesperson said in a Sept. 28 email to VIN News that the company is working on completing its submissions to regulatory agencies in the U.K., Europe, and the U.S., as well as the World Health Organization. "There is additional work underway, and we now expect that these final filings … will occur in close proximity to each other in the next couple of months," the spokesperson said.
As a Novavax vaccine recipient, Guthrie said she is now at "somewhat of a disadvantage" because her vaccine isn't recognized by authorities screening out unvaccinated individuals from activities such as travel. "There's a lot of parts of Europe where I'm not considered vaccinated, like in France," she said.
U.K. and U.S. governments have said that those who received the Novavax vaccine should be treated from a public health perspective like those who have received an authorized vaccine. The U.K. reportedly recognizes recipients of Novavax shots as vaccinated. The U.S. Centers for Disease Control and Prevention updated its guidance in August to say participants in a U.S. Novavax trial should be considered fully vaccinated two weeks after receiving their shots.
Guthrie pondered the value and cost of staying in the trial. Had she dropped out, she could have gotten a recognized vaccine. But she opted to stick with it.
"We are so lucky in the Western world to have access to the vaccine," she explained. "We have people who are working all around the world, and they'd give anything to have that protection and protect their family. I think it's incredibly selfish not to contribute, and we all have to do our part to get back to normal."
Guthrie's last trial appointment is Nov. 5, after which she will get an approved vaccine. The U.K. has announced that volunteers who received the Novavax vaccine are eligible for two doses of the Pfizer-BioNTech vaccine.