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A participant in the Oxford University coronavirus vaccine trial in the UK has said that he is undaunted by a pause in the trial, which has been caused by an adverse reaction in a patient, and that he would continue to participate. “in the name of science”.
Joe Walters said he was concerned when news of the trial was suspended. He said that he had reacted with a very high fever after his first injection and was worried about the second.
Walters received the injection in mid-June after testing to make sure he had never had the virus and was healthy. The injection was either the coronavirus test vaccine or a well-established meningitis vaccine, used as a control.
“I didn’t have a great experience with the first round of the vaccine. I have to admit I was very worried about getting the second shot, just because I knew that the first shot basically knocked me out of action for two or three days. “
Before receiving the first dose of the vaccine, you were warned that you might experience pain at the injection site and fever for a few days, which you experienced. But three days after the fever subsided, it came back, she said, and her temperature reached 103 ° F (39.4 ° C).
He called an established hotline for participants and was asked to run further tests. Although he had been mailing weekly coronavirus tests since receiving the vaccine, he was taken to a coronavirus room for further screening and they came back negative. They also told him that he was one of the few participants who had experienced a similar reaction.
The fever subsided and when he received the email about the booster shot a few weeks later, he agreed to take it “in the name of science.”
“If something has gone wrong on a more serious level, I doubt they will continue to manage it,” he said.
He added that he would “certainly” recommend that others participate if more volunteers are needed.
The AstraZeneca / Oxford participant said that he chose to participate in the trial because he felt it was one of the few things people could do to help and it was “something positive to do in the face of something that left everyone quite helpless.”
On the day he spoke to The Guardian, Walters had been at the clinic administering his vaccine for an optional booster injection. He had been informed in late July that “data from the first trial of the Covid-19 vaccine has recently been published in the Lancet and suggests that two doses of the vaccine boost the immune system more than a single dose.”
Upon arrival they told him that the booster doses had been put on hold, as one of the participants had fallen ill.
Later that day, he received a phone call confirming that the vaccine test had been suspended. AstraZeneca announced Tuesday that the late-stage trial had been stopped after a suspected serious adverse reaction in a study participant.
An AstraZeneca spokesperson said that “the standard review process caused a pause in vaccination to allow for review of safety data.” The adverse reaction occurred in a patient participating in the trial in the UK.
The nature of the problem was unknown, although the participant was expected to recover.
The Oxford / AstraZeneca vaccine, a pioneer among more than 170 vaccines in development worldwide, is in phase 3 trials in South Africa and the United States and in phase 2/3 trials in India and the United Kingdom. It is expected to be available from January.
Phase 3 trials involve the vaccine being administered to thousands of people to confirm its safety, including rare side effects, and its efficacy. These trials involve a control group receiving a placebo.
Bill Hanage, a Harvard epidemiology expert, tweeted: “While this is obviously not great news, remember that full investigation of adverse reactions is part of large-scale trials and is essential to ensure confidence in any vaccine. However, it will mean that the results will be delayed. ”
Global coronavirus infections to date number more than 27 million, and more than 890,000 people have died from the disease.
The BBC’s medical editor, Fergus Walsh, reported that the investigation should be complete in a few days.
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