More information needed on different AstraZeneca vaccine dosing regimens, WHO officials say



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(CNN) – More information and research is needed to understand the difference in the efficacy of AstraZeneca vaccine dose schedules and whether a new trial is needed to verify the efficacy of the lower dose, World Health Organization officials said during a press conference in Geneva on Friday.

“The first thing we have to say is that what we have seen is a press release,” said Kate O’Brien, WHO Director of Immunization, Vaccines and Biologics. “And what’s really the next most important step is that the data really needs to be evaluated based on more than a press release.”

There’s a lot that can go into a release, he said, and it needs to be reviewed in terms of the data and the questions about the data that may come up during the review.

“It’s hard to comment on this,” O’Brien said. “I think what we can emphasize, however, is that from what we understand about the press release, there is certainly something interesting that has been observed, but there are many reasons that could underlie the differences that were observed.”

More information is needed, including assessments of the immune response in the trial, he said.

Dr Soumya Swaminathan, WHO chief scientist, agreed with O’Brien, saying that all that is known is from the press release, and it appears that fewer than 3,000 people received half the dose and then the full dose of vaccine.

It is also understood that no one over 55 was in that group. The group that received two full doses was older and had different age groups.

“It is very difficult to compare these two groups and I would say that the numbers are still small to reach definitive conclusions,” he said.

“Now of course the advantage of using a smaller dose, especially if you get a higher efficacy, is great and you can save on the vaccine and at the same time benefit from higher efficacy, but I think that would be speculation on this point, ”he said.

Swaminathan said they have heard that AstraZeneca would like to do a full trial of the half dose full dose schedule, “if we are going to explore this hypothesis of perhaps having better efficacy with a lower dose then I would need a trial.”

Remember: The US Food and Drug Administration requires a threshold of at least 50% effectiveness. However, it is unclear whether the FDA will authorize emergency use.

AstraZeneca has yet to test its medium dose in the US, either. But on Thursday, a company spokesperson told CNN its goal was to include the half-potency dose regimen in its US trials, which currently have around 10,000 participants.

This story was first published on CNN.com, “More information needed on different AstraZeneca vaccine dosing regimens, WHO officials say”



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