LONDON/MANILA - Britain asked its regulator on Friday to assess AstraZeneca's COVID-19 vaccine for a possible rollout, while the Philippines and Thailand secured millions of doses, giving the shot a vote of confidence after experts raised questions about trial data.
The announcements came after some scientists raised doubts about the robustness of results showing the shot was 90% effective in a sub-group of trial participants who, by error initially, received a half dose followed by a full dose. AstraZeneca said the administering of the half dose had been reviewed and approved by independent data safety monitors and the UK regulator, adding the regulator publicly confirmed there was "no concern".When the full dose was given twice, as it was for most trial participants, the success rate was 62% - still above the 50% required by U.S. regulators. Europe's drug regulator has said it will not set a minimum level of efficacy.
"It has largely to do with the race drugmakers are engaged in currently, which leads them to present vaccine candidates in the best possible way and not release full protocols and results. It is the opposite of what is needed in our view." "Sub-group analyses in randomised controlled trials are always fraught with difficulties," said Paul Hunter, a professor of medicine at Britain's University of East Anglia.
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