[ad_1]
Trials of the Oxford coronavirus vaccine are back on track after being suspended for an urgent investigation because a volunteer reportedly suffered potentially dangerous side effects.
The Medicines Health Regulatory Authority (MHRA) has said that it is now safe to continue the trial.
In a statement, the University of Oxford said: “Ongoing randomized controlled clinical trials of the Oxford CHAdOx1 nCoV-19 coronavirus vaccine will be resumed at all UK clinical trial sites.
Briton who suffered potentially dangerous side effects is expected to recover
“Globally, about 18,000 people have received the study vaccines as part of the trial. In large trials like this one, some participants are expected to feel unwell, and each case must be carefully evaluated to ensure a careful safety assessment.
“On Sunday, our standard review process caused a pause in the study of vaccination in all of our global trials to allow for review of safety data by an independent safety review committee and national regulators. All citations Routine follow-up continued normally during this period.
“The independent review process has been completed and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, trials will resume in the UK.
The Briton who suffered the potentially dangerous side effects is expected to recover, but the University of Oxford says it “cannot reveal medical information about the disease for reasons of confidentiality of the participants.”
Earlier this week, a New York Times report suggested that the patient had been diagnosed with transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often caused by viral infections.
It’s not uncommon for trials to be suspended, but scientists are under pressure to develop a vaccine to help curb the pandemic.
The most serious adverse reactions that occur after vaccination are not related to the injection and are coincident health problems, the World Health Organization (WHO) said.
The UK government’s top scientific adviser, Sir Patrick Vallance, also told a Downing Street news conference that what happened at the Oxford trial is not unusual.
When a vaccine is given to a large number of people, some people are likely to experience a medical problem at the time of vaccination, but this does not prove any cause and effect.
In July, the first results of the trial showed that the vaccine was safe and produced strong immune responses in volunteers.
No unexpected adverse reactions were recorded at that time, although more than half of the 1,000 participants reported mild or moderate side effects including fever, headaches, muscle aches, and pain at the injection site.
Phase three trials of the Oxford vaccine had recently expanded to the US, recruiting up to 30,000 adults.
Experts believe that finding a vaccine is the only way to get the world back to normal in the future and there are currently nine candidate vaccines in larger phase three trials.
But how well a vaccine will work is not known, and America’s leading infectious disease expert Dr. Anthony Fauci recently warned that the chances of it being nearly 100% effective “are not great.”
“We still don’t know what the efficacy might be. We don’t know if it will be 50% or 60%. I would like it to be 75% or more,” he said.
