Severe Adverse Event of One Volunteer Puts Oxford Vaccine Trials on Hold

Cambridge-based biopharmaceutical company AstraZeneca released a statement that is putting a temporary hold on their vaccine trials to review safety data which will be conducted by an independent committee. The routine action came after one volunteer in the United Kingdom developed an unexplained illness during phase three of the human trials.

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'Fully investigating adverse reactions is part of large-scale trails and essential to ensure trust in any vaccine,' explained epidemiologist Bill Hanage from Harvard. This means that vaccine results will be delayed, but does not necessarily mean that the company has failed.

UK Health Secretary Matt Hancock said that this was not the first time that the Oxford vaccine was halted. However, the incident is definitely 'a challenge to this particular vaccine trial.'

Operation Warp Speed Companies

AstraZeneca, who is in partnership with Oxford University's Jenner Institute and Oxford Vaccine Group, is one of the companies in the US government's Operation Warp Speed to accelerate vaccine research and developments. Phase three of the Oxford vaccine's large, global trials began in late August with about 30,000 enrollees in the United States as well as testing sites in the U.K., Brazil, and South Africa.

Even with the Accelerating Covid-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, the company was one of eight that signed a joint pledge to not seek premature approval from the government for a SARS-Cov-2 vaccine.

The statement held the biopharmaceutical companies accountable to their 'on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.' Their goals include ensuring the public that the approval of any of their vaccines has gone through rigorous, scientific, and regulatory processes and evaluation.

AstraZeneca Phase Three Trials

Phase three of trials were supported by the National Institutes of Health 'to increase the odds that one or more will be effective in preventing COVID-19 and put us on the road to recovery from this devastating pandemic,' said Dr. Francis Collins. The NIH has invested in multiple vaccines that will prevent the disease.

Typical adverse events from the vaccine trials included mild headache, fever, muscle pain, and soreness, which have all subsided during the trials. However, the UK participant experienced a 'severe adverse event' but is expected to make a recovery.

Typically, the Data and Safety Monitoring Board (DSMB) monitors vaccine trials for adverse events and can order trials to stop or be put on hold. AstraZeneca did not reveal who ordered to pause their trials.

Up to date, only nine companies in the late-stage of phase three trials. AstraZeneca is the first company to pause their trials worldwide. Biontech, who partnered with Pfizer, shared that their vaccine may be ready for regulatory approval by this October.

Other vaccine developers are looking for similar reactions and signs of severe adverse events in their clinical trials. Mr. Hancock said that the vaccine development process of Astrazeneca is not necessarily held back, but would 'depends on what they find when they do the investigation.'

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