AstraZeneca’s (AZN) Covid-19 vaccine trial is on pause in the United States pending a US investigation into a suspected serious adverse reaction in the UK, sources told Reuters.
AstraZeneca has now resumed its late-stage trial of AZD1222 in the UK following confirmation by the Medicines Health Regulatory Authority that it was safe to do so.
However, sources have told Reuters that enrollment of new patients and other trial procedures for the pivotal US trial were being rescheduled until at least midweek. According to Reuters, these sources said that it was not clear how long it would take for the US regulatory body, the FDA, to complete its investigation.
On 6 September, AZN paused all its global vaccine trials to allow the review of safety data by independent committees, and international regulators. The company said the voluntary move was triggered by its standard review process, but did not disclose any further information.
An AstraZeneca spokeswoman told Reuters that AstraZeneca “will continue to work with health authorities across the world, including the FDA, and be guided as to when other clinical trials can resume.”
So far the Brazil trial has also restarted, but the status of the South African and Indian trials has not yet been confirmed.
Meanwhile the University of Oxford pointed out that globally some 18,000 individuals have received study vaccines as part of the trial. “In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety” it said.
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.
AZN shares have gained 8.3% so far this year as the drugmaker joined the list of companies engaged in the development of a potential coronavirus vaccine. (See AstraZeneca stock analysis on TipRanks)
Overall, the stock scores a bullish Strong Buy consensus from Wall Street with 3 unanimous Buy ratings. Looking ahead, the $92 average analyst price target puts the upside potential at a promising 70% in the coming 12 months.
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