The coronavirus vaccine, developed by AstraZeneca and Oxford University, is likely to be approved for use in the U.S. only in April, a top official from the Trump administration in health said Wednesday.
“We plan, if all goes well, that the lecture and emergency use authorization can be granted somewhere in early April,” Moncef Slaoui, the chief scientific adviser to the government’s Operation Warp Speed, told reporters.
Slaoui’s estimate in April is a change from earlier this month, when he told reporters he expected an emergency permit to arrive in February. The US has already bought 300 million doses of the vaccine.
Britain on Wednesday became the first country in the world to authorize the vaccine for emergency use, but it was based in part on unpublished data due to the way the UK is reviewing the trial.
In an effort to push out as many doses of the vaccine as possible, British officials have said they will not keep the doses. Instead, they will prioritize giving the first dose to people and postponing the second admission for as long as three months.
The vaccine could make the biggest difference in the fight against COVID-19. AstraZeneca has promised to make as many as three billion doses available in 2021, far more than any other manufacturer. The company has also promised not to make a profit with the vaccine, so the cost is also much cheaper.
The vaccine can also be transported for months and stored with normal refrigeration, unlike the two authorized vaccines from Pfizer and Moderna.
In the US, however, health officials asked questions after early results promised to be the result of a dosing error.
The shot has an effective rate of 62 percent when given in two full doses, 28 days apart as for most participants. The company found that the drug was 90 percent effective when a small group in the trial mistakenly initially received half a dose, followed by a full dose.
Slaoui expressed concern about the data, but indicated that the Food and Drug Administration (FDA) would make the final decision.
“The biggest question mark is honestly the effectiveness of the elderly population. It needs to be further documented simply because there were not enough … of the subjects recruited in the trial,” Saloui said.
Slaoui also questions the real effectiveness of the remedy. AstraZeneca said the combined “combined” numbers averaged 70 percent efficiency, but Slaoui said he thought the FDA would not be happy with the statement.
“We need a clear and concrete number, more than a number you know, collected by putting together different trials with different schedules and different materials,” Slaoui said.