AstraZeneca is still on track to file for approval of its COVID-19 vaccine this year, according to its CEO. Pascal Soriot told attendees at an online event that it is unclear how long the trial will be paused in response to a recent adverse event, but a 2020 approval is still on the cards.
Earlier in the year, AstraZeneca said it was on track to show whether its COVID-19 vaccine worked by September. Hopes of a fall approval had begun to fade long before AstraZeneca placed development of the vaccine on hold after a participant in the program suffered an unexpected illness, but Soriot still thinks AstraZeneca has a shot at being one of the companies that gets to market this year.
“I still think we are on track for having a set of data that we would submit before the end of the year,” Soriot said at an online event hosted by media company Tortoise. Depending on how quickly regulators review the filing, that could enable AstraZeneca to win approval this year.
The prediction is subject to multiple factors that could cause the timeline to slip. While the Financial Times reported AstraZeneca could resume dosing subjects early next week, the timing is outside of the company’s control. Independent experts need to review the case to gauge whether the vaccine is implicated in the adverse event.
It is unclear how long the investigation will take. That is one of many unknowns. While media reports stated the participant had an inflamed spinal cord, a condition known as transverse myelitis, Soriot framed the situation as less clear-cut than those articles suggested.
“We don’t know if it’s transverse myelitis. We don’t know what the final diagnosis is,” the CEO said.
The independent experts reviewing the case will need the results of tests to determine the condition of the participant to make a full evaluation of what role, if any, the AZD1222 vaccine played in the adverse event.
If the vaccine is implicated, even a very small risk of transverse myelitis could pose a problem for the planned rollout. AstraZeneca is working with partners to make 3 billion doses of AZD1222. Working at that scale means even a very rare adverse event could affect large numbers of people. Given the vaccine will be given to healthy people to protect against a virus that rarely kills, candidates are likely to need solid safety data to succeed.