A promising Oxford University and AstraZeneca coronavirus vaccine trial has been halted due to an adverse reaction in a trial participant. AstraZeneca said “As part of the ongoing randomized, controlled clinical trials of the AstraZeneca Oxford coronavirus vaccine, AZD1222, a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial. This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials. In large clinical trials, illnesses will happen by chance and must be independently reviewed. AstraZeneca is working to expedite the review of the single event to minimize any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.”
Details of the unexplained illness have not been released, but a New York Times report noted that one volunteer in the UK program had developed transverse myelitis, an inflammation across the spinal cord.
While all trials are paused, an independent committee will review the safety data of the virus to determine whether the illness reported in the trial participant can be attributed to the vaccine, or whether it was an unrelated illness they developed. If it proves to be isolated and unrelated to the vaccine, could mean the vaccine’s trials are halted for as little as one week and as long as one month.
AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech. It uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus adenovirus that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
AstraZeneca and the University of Oxford announced on April30th an agreement for the global development and distribution of the University’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2. The collaboration aims to bring to patients the potential vaccine known as ChAdOx1 nCoV-19, being developed by the Jenner Institute and Oxford Vaccine Group, at the University of Oxford. Under the agreement, AstraZeneca was responsible for development and worldwide manufacturing and distribution of the vaccine. The potential vaccine entered Phase I clinical trials to study safety and efficacy in healthy volunteers aged 18 to 55 years, across five trial centres in Southern England. Oxford University later announced the start of a Phase II trial of AZD1222 in about 10,000 adult volunteers. Other late-stage trials are due to begin in a number of countries. The results published in The Lancet confirmed a single dose of AZD1222 resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. In all participants, a T-cell response was induced, peaking by day 14, and maintained two months after injection.
Late-stage Phase II/III trials are currently underway in the UK, Brazil, US and South Africa. Trials will determine how well the vaccine will protect from the COVID-19 disease and measure safety and immune responses in different age ranges and at various doses.
Earlier, the CEOs of nine companies developing different vaccines, including AstraZeneca, as well as BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi, pledged to make a “united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first Covid-19 vaccines”.
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