After seeing ‘lot of sorrow,’ he became test subject
Respiratory therapist at LVHN describes being among 1st to be vaccinated
As a respiratory therapist with Lehigh Valley Health Network, Kenneth Miller has witnessed from the front-lines the physiological and psychological damage caused by COVID-19.
“I’ve seen a lot of people, unfortunately, pass away. And I’ve seen a lot of people that have survived struggle to breathe for quite a while until they finally get back to a healthy state. It’s been a varied, horrific, horrible situation to witness,” Miller said.
“I’ll be very honest with you,” he added. “I’ve seen a lot of sorrow over the last almost nine months.”
So when LVHNsent an email to employees about a clinical trial for a COVID-19 vaccine, Miller jumped at the opportunity to help end the pandemic, signing up half an hour later.
He was one of the roughly 75 LVHN employees, patients and community members who participated in the phase three clinical trial for Pfizer and BioNTech’s two-dose vaccine to protect against the coronavirus. The trial Miller took part in occurred in September and was a double-blind study, meaning that neither the experimenters nor the subjects knew who received a real dose of the vaccine and who received a placebo.
On Thursday, the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee reviewed a report on Pfizer and BioNTech’s vaccine, finding that evidence showed the benefits outweighed the risks. The favorable review means the FDA will now decide if the vaccine should get emergency use authorization. That’s what’s needed for it to be distributed to the public.
Considering what was at stake, Miller confronted his fear of needles and his nervousness about participating and volunteered. A respiratory therapist for 45 years, he’d been a part of studies as a researcher, but never as a test subject.
“But I really felt it was imperative that I do something for society and try to help out in some way to try and prevent this, to try to put an end to this terrible pandemic,” he said.
Potential subjects received medical and lifestyle assessments to determine if they met the criteria to participate. Researchers wanted subjects who had preexisting health conditions but were not infirm, he said. They also wanted people in situations that put them at risk for contracting the virus, such as working in a hospital.
Miller has asthma and hypertension, which made him a good fit for the trials. Once assessed and approved, he had blood work done, was swabbed for COVID-19 and received the first injection on Sept. 3.
It was like getting a flu shot, he said, and he experienced mild side effects — a sore arm and tiredness — common with many vaccines. About 48 hours later, his arm no longer hurt and his energy level had returned.
The second injection was much the same. Soreness and fatigue following injection can occur even from a placebo, so Miller does not know if he got the real vaccine.
“I continued to do exactly what I’ve done after I got the second injection,” he said. “I continue to go to the gym. I continue to work. I continue to chop wood. I continue to go to the grocery store, continue to go to church. All the different things that I did prior, I continue to do.”
He also continues to wear full protective equipment at work, wear a mask in public and follow social distancing rules.
Pfizer’s newvaccine is significant not just because it offers a potential way to curb spread of COVID-19 but because it takes a novel approach to inoculation. Unlike typical vaccines made from viruses, Pfizer — and competitor Moderna — use messenger RNA to trigger an immune response. The FDA has never approved an mRNA vaccine, meaning Miller’s contribution could spur a new method for combatting disease.
Whenever a COVID-19 vaccine is approved, whether it’s Pfizer’s or another, supplies will be limited early on. According to the Centers for Disease Control and Prevention’s COVID-19 Vaccination Program Interim Playbook, the vaccine will be given to health care workers and residents of long-term care facilities first. Remaining doses will be given to “essential workers” and individuals at high risk of severe COVID-19 illness, such as those older than 65.
Data provided by the FDA in advance of the Thursday meeting shows that the first dose of Pfizer’s vaccine decreases the risk of getting COVID-19 by about 52%, with the second dose decreased risk by 95%. Side effects such as fatigue and headache were common in the trials, especially in people 18 to 55 years old. However, severe adverse reactions were rare.
The vaccine already is in use in the U.K., with specific batches having received temporary authorization on Dec. 2. Since then, thousands in the U.K. have been vaccinated with Pfizer’s shot, Matthew Edwards, a spokesman for the U.K.’s National Health Service, said Wednesday.
However, two NHSemployees suffered adverse reactions after they were injected on Tuesday. Stephen Powis, national medical director of the NHS, said both employees had histories of significant allergic reactions and both were recovering after receiving treatment.
Newguidance there suggests that anyone with a history of severe allergic reaction to a vaccine, medicine or food should not get the Pfizer BioNTech vaccine, and anyone who experiences a severe reaction from the first dose should not receive the second. That guidance also states vaccine recipients should be monitored for 15 minutes after injection and vaccination should only be carried out in facilities where resuscitation measures are available.