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 official said Wednesday.
“We plan, if all goes well, that the emergency reading and use authorization can be granted somewhere in early April,” Moncef Slaoui, chief adviser to the administration’s Warp Speed operation, told reporters.
Slaoui’s April estimate is a change from earlier this month, when he told reporters he expected an emergency clearance to come in February. The United States has already bought 300 million doses of vaccine.
The UK became the first country in the world to authorize the emergency vaccine on Wednesday, but relied in part on unpublished data due to the way the UK analyzes the process.
In an effort to eliminate as many doses of vaccine as possible, British officials said they would not withhold the doses. Instead, they will prioritize giving the people the first dose and delay the second shot by up to three months.
The vaccine has the potential to be a global difference in the fight against COVID-19. AstraZeneca has promised to make up to three billion doses available in 2021, which is much more than any other manufacturer. The company also promised not to make a profit from the vaccine, so the cost is much cheaper.
The vaccine can also be transported and stored for months under normal refrigeration, unlike the two vaccines authorized by Pfizer and Moderna.
In the US, however, health officials have raised questions after promising early results turned out to be the result of a dosing error.
The image has an effective rate of 62% if administered in two full doses 28 days apart, as was the case for most participants. The company found that the drug was 90% effective when a small group in the study was given the wrong half of the initial dose, followed by a full dose.
Slaoui expressed some concern about the data, but indicated that the final decision will rest with the Food and Drug Administration (FDA).
“The biggest question mark, honestly, is effectiveness in the elderly population. This needs to be further documented just because there weren’t enough … of the subjects recruited in the process,” Saloui said.
Slaoui also questioned the true effectiveness of the drug. AstraZeneca said the combined “grouped” numbers are on average 70% effective, but Slaoui said he believes the FDA would not be happy with the explanation.
“We need a clear and concrete number, more than a number that is, you know, accumulated by putting together different trials with different programs and different materials,” Slaoui said.