The coronavirus vaccine developed by AstraZeneca and Oxford University is unlikely to be authorized for use in the United States until April, a senior Trump administration health official said Wednesday.
“We project, if all goes well, that the emergency reading and use permit can be granted somewhere in early April,” Moncef Slaoui, chief scientific adviser to the administration’s Operation Warp Speed.
Slaoui’s April estimate is a change from earlier this month, when he told reporters he hoped an emergency clearance could arrive in February. The US has already bought 300 million doses of the vaccine.
On Wednesday, Britain became the first country in the world to authorize the vaccine for emergency use, but relied in part on unpublished data due to the way the UK reviews the trial.
In an effort to remove as many doses as possible from the vaccine, British officials said they would not withhold the doses. Instead, they will prioritize giving people the first dose and delay the second vaccine by up to three months.
The vaccine has the potential to be a factor of global difference in the fight against COVID-19. AstraZeneca is committed to making up to three billion doses available by 2021, which is much more than any other manufacturer. The company has also pledged not to make a profit with the vaccine, so the cost is also much cheaper.
The vaccine can also be transported and stored for months under normal refrigeration, unlike the two authorized vaccines from Pfizer and Moderna.
In the United States, however, health officials have raised questions after the first promising results turned out to be the result of a dosing error.
The intake has an effective percentage of 62% if given in two full doses 28 days apart, as was the case for most participants. The company found the drug to be 90% effective when it was initially mistaken for a small group of the half-dose trial, followed by a full dose.
Slaoui expressed some concern about the data, but indicated that the final decision rested with the Food and Drug Administration (FDA).
“Frankly, the biggest question mark is effectiveness in the elderly population. This needs to be further documented because there weren’t enough … of the subjects recruited to trial,” Saloui said. .
Slaoui also questioned the true effectiveness of the drug. AstraZeneca has said the combined “clustered” figures equate to an average effectiveness of 70%, but Slaoui said he believes the FDA would not be satisfied with that explanation.
“We need a clear and specific number, rather than a number that, as you know, accumulated by bringing together different tests with different schedules and different materials,” Slaoui said.