“We believe that this product will never be licensed in the U.S.”
– Biotech investment bank SVB Leerink
Nov 26, 2020
CNBC – AstraZeneca and the University of Oxford are defending the results and methods used in their phase three vaccine trials on the back of criticism from experts in the U.S., stressing the “highest standards” were used and that “additional analysis will be conducted.”
AstraZeneca shares are down by around 6% this week after questions were raised over its vaccine candidate, for which the company said combined results revealed it to be 70% effective.
The figure came from combining a smaller group of people who received an unintentionally lower dose of the vaccine — and by what a company spokesperson has called “serendipity” — produced 90% effectiveness, and a larger group who received a higher dosage, showing only 62% effectiveness.
Chief of the White House’s Operation Warp Speed, Moncef Slaoui, and others in the U.S. have expressed concern over the age group tested, saying 90% efficacy was only shown for the lowest risk group, which numbered 2,741 people below the age of 55. The group whose results displayed 62% effectiveness numbered 8,895.
AstraZeneca pushed back against the criticism, emphasizing monitoring of the study by the external Data Safety Monitoring Board (DSMB) and the fact that the data released Monday constituted mere interim results and that more data would follow.
A spokesperson for AstraZeneca told CNBC on Thursday:
“The studies were conducted to the highest standards. An independent DSMB safety monitoring committee oversees the studies to ensure safety and quality. The DSMB determined that the analysis met its primary endpoint showing protection from COVID-19 occurring 14 days or more after receiving two doses of the vaccine.”
“More data will continue to accumulate and additional analysis will be conducted refining the efficacy reading and establishing the duration of protection.”
The University of Oxford, for its part, explained the discrepancy between dosage allotments. It said an initial over-estimation of the dose of the new vaccine batches had resulted “in a half dose of the vaccine being administered as the first dose” due to a “difference in the manufacturing process.”
“The methods for measuring the concentration are now established and we can ensure that all batches of vaccine are now equivalent,” it added.
Particularly harsh criticism came from U.S.-based health care and biotech investment bank SVB Leerink, whose analysts wrote Monday:
“We believe that this product will never be licensed in the U.S.” … Read more.