Ending the nightmare A ‘Meduza’ special correspondent joins Russia’s coronavirus vaccine clinical trials and catalogs the experience before and after her shot
On August 11, Russia announced the registration of the world’s first coronavirus vaccine, named “Sputnik V” by its developers at Gamaleya National Research Institute of Epidemiology. According to the terms of the drug’s registration, the vaccine’s developers must conduct large-scale “phase III” clinical trials on tens of thousands of volunteers. Meduza special correspondent Svetlana Reiter agreed to be one of these test subjects. We asked her to catalog the vaccine’s effects on her body and describe what it’s like to participate in such a momentous clinical study. Here is her diary.
Why I did it
I completed a questionnaire at mos.ru the same day that my daughter contracted rotavirus. I was in late August while we were staying in the countryside. We were sharing a home with my parents, who were living downstairs. They’re both over 65 and at risk for coronavirus. My daughter was vomiting all night, while I was running up and down the stairs with paper towels, cleaner, Rehydron, water, and clean sheets. I knew that coronavirus can start in kids exactly the same way. I was afraid that my daughter would infect my parents and they would die. If there’s a vaccine, someone has to take the risk or this nightmare will never end, I reasoned.
My daughter recovered after a day, but I still sent off the questionnaire.
I’d learned about the coronavirus vaccine from more than just the news. My colleague, Meduza science editor Alexander Ershov, and I interviewed Denis Logunov, the researcher at the Gamaleya Center who led the vaccine’s development. For what it was worth, I’d actually laid eyes on the person responsible for this vaccine.
It all starts with a phone call: “Ms. Reiter? Your application has been selected for participation in the study. Please come to outpatient clinic number 46 on Kazakov Street for screening.”
It’s clean and virtually empty in the wing where they examine the volunteers. First, there’s a fairly formal examination by a general practitioner: “Let’s listen to your lungs. Does it hurt anywhere? Roll up your sleeve, we need to measure your blood pressure. Do you have any allergies? Are you on any medications?” Then the tests begin. You hand over urine in a jar so they can rule out three factors: alcohol, drugs, and pregnancy. They take your blood, too, to test for coronavirus antibodies, hepatitis C, and HIV. They also do a PCR [polymerase chain reaction] test for coronavirus.
I’m tested on September 14. When I show up, the line of volunteers isn’t very long — just a dozen or so people, all wearing their masks correctly. The clinic wing has its own reception desk, where three young women are working behind the counter. They explain that I’ll be excluded from the study if my test results show coronavirus antibodies. If they find no antibodies, I can come back on September 21 for the vaccination. According to the rules, volunteers are supposed to be vaccinated on the second or third day after their tests, but the lab works slowly, the health workers tell me.
I tried to speak to as many employees at the clinic as I could, and they all said they’d had COVID. One of them spent two weeks in the hospital with a fever above 40 degrees Celsius [104 degrees Fahrenheit], while another simply tested positive for antibodies.
After the examination, I read through the 17-page voluntary consent form. The study will last 180 days. There will be two injections, three weeks apart. The day before the first shot, I can’t consume any alcohol or play sports. For the next six months, I’ll need to curb my physical activity. Smoking more than 10 cigarettes in a day is prohibited.
If I die, the study’s organizers — the Gamaleya Center and the Moscow city government — will pay my relatives 2 million rubles [$25,260]. If the vaccine renders me disabled, the payout is 1.5 million rubles [$18,935].
I tested negative for antibodies. I’ll be back for the vaccine on September 21.
The Russian branch of the Dutch clinical research organization “Crocus Medical BV” is responsible for conducting phase III clinical trials for Sputnik V. The branch is headed by Alexey Butylin, a medical doctor wrote his dissertation about “the effect of angiotensin-converting enzyme inhibitors on the clinical course of coronary heart disease in patients with atrial fibrillation.”
The “Projects” section on the company’s website lists just a single previous clinical study: epidemiological research carried out in 2016 and 2017 for the pharmaceutical company “Nomad” to obtain data about the prevalence of type II diabetes in Kazahstan’s adult population.
It remains unclear who is paying for the examination of volunteers in Russia’s coronavirus vaccine study. Neither Moscow’s coronavirus task force nor the city’s health department responded to Meduza’s questions about funding for the tests.
The line at the clinic stretches the entire hallway. People registered for shots at 10 a.m. aren’t admitted to the office until 1 p.m., at best. New volunteers are also waiting in the same hallway for their exams.
A tall, gray-haired man of about 60 rushes into the office holding a container of urine. He says he’s in a hurry because he works as a “Gazprom ENT specialist.” The mood is tense. Tests for some volunteers aren’t ready yet, but they’ve already been scheduled to get the vaccine. They turn around and leave.
In line, there are people as young as 30 and others in their 70s. I wait beside a middle-aged brunette woman whose sister and elderly mother have self-quarantined since late March. So she can see them, she’s decided to take part in the vaccine study. Conversations between volunteers often begin with the phrase: “Turns out I don’t have COVID and I’ve even got a certificate to prove it!”
A film crew from Rossiya 24 shows up to record a segment, showing the line of volunteers. “The third phase of research on a coronavirus vaccine is underway in Moscow. We’re looking at the tests now, the results of which the entire country eagerly awaits,” the reporter says. A doctor walks out from one of the offices and mutters, “So they’re showing off again how great everything is?” A nurse leads an elderly volunteer to the exit and says, “Grandpa, you sat down and rest for an hour after your shot. It’s better now if you go. It’s Armageddon here now.”
It’s my turn. The general practitioner conducts another quick examination: temperature, blood pressure, any pain? No? Then it’s time for the shot.
The nurse administers the injection. She checks the number on my signed informed consent form against the number on the list attached to the refrigerator with the vaccines.
The nurse takes a vial from a box labeled “Gam-COVID-Vac” [trade-named “Sputnik V”] and gives me an injection in my left shoulder.
I leave the room and take a seat in the hallway, as instructed, just in case I become suddenly ill.
I go to schedule my second injection.
At the counter, there’s a man, blond, about 40 years old, wearing a mask, and causing a scene. “I was tested! I have the antibodies! And they sent me to you for a vaccination!” he yells. “Who sent you here from where?” the nurse asks him. “They forced me to sign up at work!” he answers.
When I ask the man where he works, he falls silent. The nurse tells me: “Don’t look so surprised. We’ve got a lot of people like this here from state-funded institutions. There are also people who came here on their own, of course.”
After getting the vaccine, they explain at the registry desk, volunteers need to install the app “Check Covid-19” and submit diary entries on certain days. As I leave the building, I see a woman in her 60s complain that she doesn’t understand how to use the app. “Do you have a grandson at home? He’ll set it all up for you,” the health workers tell her.
My head is spinning and I feel weak. The spot where I got the shot is a little sore.
In total, the study involves 40,000 volunteers, a quarter of whom will get a placebo. This is probably the hardest thing psychologically: you won’t know until the end if you were inoculated. You start tracking your symptoms, thinking your head is spinning, and wondering if it’s really spinning. You’ve got a headache, but is it the vaccine or just nerves? You wish you’d exchanged numbers with the other volunteers. It would be great to compare symptoms, now that everyone is in the same boat.
You start reading every news story you can find about all the different vaccines. They’ve halted the AstraZeneca Oxford trials again after a second volunteer developed inflammation of the spinal cord, known as transverse myelitis. Transverse myelitis, the threat of paralysis, damn, damn, damn. You find yourself in a cold sweat, before reassuring yourself that AstraZeneca based its vaccine on the chimpanzee adenovirus, while Russia’s uses the human adenovirus. It’s better understood, but what if it fails? What if it fails on you?
Time to measure my temperature. 36.8 degrees Celsius [98.2 degrees Fahrenheit]. It’s normal. It was a placebo. I’m certain it was the placebo. Yes, I can feel it for sure now.
I change the channel in my head and start reading other news. “In Moscow, the number of new confirmed coronavirus cases nears 1,000.” Four days ago, it was 730 new cases. In a week, the number will be 2,217. My hands are shaking.
Another temperature check. Now it’s 36.9 [98.4 degrees Fahrenheit]. Now we’re in business. Vaccine, vaccine, let it be the vaccine. I can feel that it’s the vaccine.
I spend the whole day repeating this routine. A runny nose becomes a headache, which leads to muscle soreness and pain down my spine. It’s nothing extreme, though, and I handle it with an acetaminophen pill. Is it the vaccine or was it a placebo?
I know who could help me — a doctor. When they gave me the shot, they promised that a doctor would call every day or contact me through the Check Covid-19 app. I check my phone and the app constantly, but there’s nothing.
Then I get a push notification from the city’s coronavirus task force. It’s a news story about how officials at the World Health Organization marvel at Moscow’s telemedicine center:
A delegation from the World Health Organization visited Moscow’s telemedicine center today, where operators are monitoring the health status of volunteers in the post-approval study of Russia’s coronavirus vaccine. A WHO representative praised the well-crafted system for medical supervision.
At the telemedicine center, the delegation inspected the work of operators monitoring city residents who have received the vaccine.
“I’m very impressed with the telemedicine center. I’ve never seen anything like it in my life, said WHO Regional Director for Europe Hans Kluge. “The fact is that someone at this center is at the center of everything, with everything else — technology and so on — surrounding them. And this is very important to establishing trust — trust between the patient and the doctor.” […] From the moment of vaccination, doctors will monitor the study’s participants’ health for six months. Volunteers can decide what means of communication is the most convenient for them: a mobile app, telemedicine technologies, or the phone.
On the day of vaccination, specialists will help volunteers install a special mobile app, which is simple and easy to use. In the first three days after being vaccinated, specialists will contact volunteers either by telephone or telemedicine conference to find out how they are feeling. Subsequently, they will remain in regular contact with the research participants.”
I’m very disappointed with Hans Kluge. I’m very sorry that he doesn’t see me and my phone, which hasn’t received a single call from a doctor.
A volunteer, I’m carrying something unknown inside me. Let’s say it’s the vaccine. By the evening of the second day, I’ve now decided that I definitely got the vaccine, not the placebo, because, right on cue, I start feeling everything at once: a headache, muscle pain, sore throat, stomach pain, fatigue, anxiety, insecurity, and hope. I fill out my volunteer’s diary honestly, but nobody responds. If I pass out, nobody will know about my side effects.
I look for a TV show about anyone participating in a clinical study, but I find nothing. In the thick voluntary consent form, however, I find the number of a hotline in case of emergency.
I’m anxious but falling asleep. I wasn’t able to get through to the hotline. The call dropped several times.
I’m flying to Perm for work and feeling great. The plane is packed and everyone is seated close together without masks. If the vaccine is inside me, it won’t start working for another month. If it was the placebo… Best not to start thinking about it.
In the evening, the doctor finally calls.
They’ve called! Yay! They’ve called! They said there was some mix-up yesterday and they simply forgot about me! They called and asked about all my symptoms and promised to call back tomorrow.
Runny nose. Muscle soreness. I feel like I’ve definitely got a cold. The Check Covid-19 app keeps freezing. The volunteer’s diary I set up before won’t let me upload new data or submit complaints. My head is aching again. I feel weak. The doctor calls in the evening and says the side effects can last for several days if it’s the vaccine. “I can hear through the phone that you’re congested and your voice sounds very tired,” the doctor says.
Moscow announces 1,560 new cases. I feel weak, and I’ve got the chills and muscle pain. I can’t get out of bed. My head hurts. Maybe this is COVID? Yes, I must have caught it — probably in the week between my tests and the first shot.
The doctor calls me and says COVID is possible, unfortunately, and tells me that I can do another PCR test if I want. The doctor also says this is the last phone call and there won’t be further contact until after the second injection.
I decide to take an express PCR test for coronavirus. I cancel all my meetings (I’m still too exhausted to go to them, anyway) and I call up my friends. I call my parents and warn my children. I buy two cartons of cigarettes, in case I have to quarantine.
I take the PCR test.
The coronavirus test results are negative.
I have no symptoms whatsoever.
Moscow announces 1,792 new cases. My next shot is on October 12.
Translation by Kevin Rothrock