AstraZeneca tipped to restart COVID-19 vaccine trial this week: report

AstraZeneca could resume the U.S. clinical trial of its COVID-19 vaccine this week, according to a Reuters report. The trial has been paused since early September while the FDA reviews the safety of the vaccine in light of a reported case of a rare spinal inflammatory disorder in the wider program.

Regulators in Brazil, India, South Africa and the U.K. supported the resumption of the trials taking place in their jurisdictions in the weeks after the suspected case of transverse myelitis. However, the FDA has taken longer to review the situation, forcing AstraZeneca to wait to resume a U.S. phase 3 trial that only began shortly before the safety concern emerged. 

Now, there are signs AstraZeneca may soon be able to resume the U.S. clinical trial. The article in Reuters is based on comments from four sources. Reuters also accessed a draft letter to participants in the U.K. wing of the clinical development program, dated Oct. 14, that stated the U.S. trial would resume shortly. The draft letter said the FDA “has come to the same conclusion as the other drug regulators including the MHRA.”

The MHRA, also known as the U.K. Medicines and Healthcare products Regulatory Agency, supported the resumption of the COVID-19 vaccine clinical trial after finding there was insufficient evidence to link the investigational product to the illness. Transverse myelitis can be triggered by physical trauma and virus, complicating the task of determining a causal relationship to the vaccine. 

Earlier reports said the FDA wanted to see data from other trials of vaccines based on the same viral vector platform as AstraZeneca’s COVID-19 candidate before making a decision. An official at the National Institutes of Health called for AstraZeneca “to be more forthcoming.”

If AstraZeneca gets the green light to resume the trial, investigators will restart enrolling and dosing participants in a 30,000-subject phase 3 study of a vaccine that was among the front-runners before the hold set back progress in the U.S. Since AstraZeneca’s trial went on hold, Johnson & Johnson has paused a phase 3 study of its viral vector COVID-19 vaccine. 

The travails of the viral vector prospects are extending the lead of mRNA vaccines in development at Moderna and through the Pfizer-BioNTech collaboration. Data on the vaccines are due next month.