I’m fully vaccinated against COVID-19. Isn’t that an extraordinary statement? Twelve months ago nobody had heard of COVID-19. Yet here I am with vaccine-induced antibodies that provide a significant level of protection against a virus that has caused so much illness, death, grief, hardship and loneliness, and made 2020 miserable.
I still can’t quite believe that I’ve benefited from a scientific and human achievement that, to my mind at least, ranks alongside the development of the effective HIV treatments which meant that I didn’t die a premature death in mid-1990s in my twenties but am alive and well today.
These medical breakthroughs are thanks to meticulously conducted clinical trials. Indeed, I know I’ve received both doses of the COVID vaccine because in early November I enrolled in a sub-study of the Oxford/AstaZeneca vaccine that was specifically designed to assess the vaccine’s safety and effectiveness in people with HIV. Everybody in the HIV sub-study has or will receive the vaccine. I received my first dose in the second week of November and the second four weeks later.
Clinical trial development
Clinical trials are essential to test the safety and effectiveness of experimental treatments and vaccines such as I one I’ve just received. After a promising therapy is developed in a lab, it goes through three separate studies to ensure that it won’t cause any serious harm and will be of real medical benefit. Only if it passes all three stages will a new therapy be evaluated by a group of independent experts to assess if it’s safe and effective and can receive a licence for use in the general public. The Oxford/AstaZeneca vaccine is on the verge of such approval.
By the time I joined the trial, the Oxford study was already in its final ‘phase 3’ research involving over 20,000 adults in Brazil, South Africa and the UK. The participants were divided at random into two equal groups. Researchers made sure the composition of the groups was comparable in terms of age, gender, race and underlying health conditions. One group received the experimental vaccine and the other a placebo (a dummy therapy, in this case a vaccine against meningitis that it known to be very safe). Rates of side effects and COVID were then compared between the two groups. At the outset, the researchers set strict criteria to ensure that the new treatment really if safe and works and that they couldn’t be accused of moving the goal posts if their study flung up some unexpected or unwelcome findings.
COVID vaccine HIV sub-study
The same rigorous procedures applied to the HIV sub-study I’m taking part in. I noticed a news item about it on aidsmap.com and immediately phoned the clinic conducting the trial. The process, although very friendly and relaxed, was rigorous from the outset and provided reassurance about the integrity and high ethical standards of the study I was about to sign-up to.
A nurse asked me some questions to see if I was eligible to take part (confirmed HIV infection, CD4 cell count above 350, undetectable viral load, taking HIV treatment). An appointment was then arranged for a ‘screening visit’ at the study clinic with one of the research doctors.
This lasted about an hour and a half. I had a physical examination and answered a seemingly endless set of questions about my health and medical history to make sure I really was eligible to take part in the study. The doctor then explained how the vaccine worked using a deactivated, harmless portion of the coronavirus to stimulate an immune response. The potential side effects were also explained: the main ones are pain at the injection site and feeling fluey for a day or two after being jabbed.
The doctor also provided detailed information about the reason the study was temporarily paused in the summer after a man receiving the experimental vaccine developed a rare nerve condition. However, an independent panel of experts concluded this wasn’t due to the vaccine and gave the green light for the trial to continue.
Importantly, the doctor also emphasised that although the global health emergency caused by COVID meant that vaccines against it were being developed by breakneck speed, corners were most definitely not being cut and the study included all the checks and safeguards that are standard when undertaking research into a new medical treatment.
I was then asked if I understood what I’d been told and had any questions and if I gave my consent to take part in the study.
After saying yes, I had blood tests to check my health. The results came back a week later and were satisfactory, thus enabling me to receive the first dose of the vaccine.
Other than very slight soreness where I was injected, I didn’t experience any side effects. I returned three and seven days after the jab for blood tests to make sure that the vaccine wasn’t having an impact on the health of my kidneys or liver. Everyday, I was emailed a link to an electronic diary and asked to record any side effects or symptoms, no matter how mild or unusual. I’ve had nothing to report.
Study results
In the interval between my first and second doses, interim results from the main study were published showing that the vaccine was very safe and that it reduced the risk of serious COVID-related disease by 70% overall, including a 62% reduction in risk among people receiving the two full doses, increasing to 90% if an initial half dose was followed by a full dose. I was emailed a summary of these findings as soon as they were announced and given the opportunity to ask more questions at my next visit to the clinic.
Around the same time, results from studies of other vaccines were published showing 95% effectiveness. Was I disappointed that the vaccine I received had a seemingly lower rate of effectiveness? Not for one second! To be honest, its effectiveness surpassed my initial expectations and I’d have eagerly have signed up to the trial had I known this information at the outset. Moreover, the fact that not one single person receiving the Oxford/AstaZeneca vaccine who became infected with COVID needed to go into hospital was also massively encouraging.
A number of vaccines will, I’m sure, be needed to bring COVID under control and the one I’ve received will surely have its place.
Further checks to come
I’ll remain enrolled in the trial for months to come and will be regularly checked to see if I’m experiencing any side effects and every week I do a self-test to see if I’ve picked up the coronavirus.
At every stage of the study, I’ve been more than satisfied that the research has been conducted to the very highest standards, that nothing has been hidden about the vaccine’s side effects and protection, and that no corners have been cut in its development.
I get very emotional when I think about my participation in the trial and how lucky I am to be among the very first to know I’m fully vaccinated. Like so many others, have had my world turned on its head because of COVID and have had many a sleepless night worrying about my job. A few weeks ago, I also experienced first hand the devastating human cost of this horrible virus, my dad dying after contracting the disease. It adds poignancy to my participation in the vaccine study and I’d like to thank the scientists, medics and all my fellow study volunteers for helping to develop vaccines that we can be confident are safe and work.
Much as I’m grief-stricken by the loss of my dad, the development and gradual rollout of the vaccines mean that we can all genuinely hope that 2021 will be both happier and healthier than the year we’ve just endured.