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More information and research is needed to understand the difference in effectiveness of AstraZeneca vaccine dosing regimens and whether a new trial is needed to verify the effectiveness of the lower dosage, officials from the World Health Organization said. health during a press briefing in Geneva on Friday.
“The first thing to say is we saw a press release,” said Katherine O’Brien, director of immunization, vaccines and biologics at WHO. “And what’s really the next most important step is that the data really needs to be evaluated on the basis of more than a press release.”
There are only a few things that can be included in a publication, she said, and they need to be looked at based on the data and questions asked about the data that may come up during the review.
“It’s hard to weigh in on that,” O’Brien said. “I think what we can highlight, however, is that from what we understand from 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, including assessments of the immune response in the trial, is needed, she said.
WHO Chief Scientist Dr Soumya Swaminathan agreed with O’Brien, saying that all that is known is from the press release, and it appears that less than 3,000 people received the half dose, then the full dose of the vaccine.
It is also understood that no one over the age of 55 was included in this group. The group that received two full doses was larger in number and had different age groups.
“It’s very difficult to compare these two groups and I would say the numbers are still low to really draw any definitive conclusions,” she said.
“Now, of course, the benefit 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 you get a higher efficacy, but I think that would be speculation at this point, ”she said.
Swaminathan said he heard that AstraZeneca would like to do a full trial of the half-dose full-dose program, “if we’re going to explore this hypothesis of maybe having better efficacy with a lower dose, then we need a trial. . “
Remember: The US Food and Drug Administration requires a threshold of at least 50% effectiveness. However, it is not clear whether the FDA will allow emergency use.
AstraZeneca has not yet tested its half-dose in the United States. But on Thursday, a spokesperson for the company told CNN its goal is to include the half-strength dosage regimen in their US trials, which currently have around 10,000 participants.
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