AstraZeneca (AZN) Tried to Embellish Vaccine Data, SVB Leerink Says
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(Updated - November 23, 2020 9:47 AM EST)
AstraZeneca (NASDAQ: AZN) Covid 19 vaccine efficacy results were characterized as "embellished" by analyst Geoffrey Porges of SVB Leerink.
The pharmaceutical giant reported Monday that after two doses of their COVID vaccine, the vaccine achieved an average 70% efficacy after 132 infection events.
Porges highlighted that AstraZeneca reported 90% efficacy in a relatively small sub-set of subjects in the study who received a modified initial vaccination, followed by a “full dose” four weeks later.
"They did not disclose the exact number of events in each study, or how they calculated the blended 70% efficacy for the full cohort of 11,636 subjects," the analyst commented. "The company did not disclose any information about efficacy against severe disease (“there were no cases”) or in sub populations such as the elderly, high risk or minority populations. The suggestion by the inventors that the small sample given the lower priming dose was evidence of superior efficacy only brings discredit to the program. We regard the data disclosure as premature and insufficient, and is likely to attract a raft of criticism (at least outside Oxford University and the UK). The companies (AZN and Vaccitech) are clearly already positioning the product as suitable for use in less developed countries, where their relatively favorable storage conditions (6 months at 2-8C) may be advantageous."
Porges believes the vaccine will never be licensed in the U.S.
"This belief is based on the design of the company’s pivotal trials (which does not appear to match the FDA’s requirements for representation of minorities, severe cases, previously infected individuals and elderly and other increase risk populations), and based on the occurrence of severe safety events (why take the risk) that resulted in the extended clinical hold on enrollment into the trials in the US," the analyst commented.
The results from AstraZeneca confounds the firm's thesis that “all spike protein vaccines are created equal".
The results put into question the outlook for Johnson & Johnson's (NYSE: JNJ) adenovirus based COVID vaccine, the analyst noted. That said, they remain optimistic about the outlook for adjuvanted protein sub unit vaccines such as those in development at Novavax (NASDAQ: NVAX) and GlaxoSmithKline/Sanofi.
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