AstraZeneca Analyst Flags Lack Of Details In Interim COVID-19 Vaccine Data

AstraZeneca plc AZN announced Monday interim Phase 3 data for its coronavirus vaccine candidate AZD1222 from studies conducted in the U.K. and Brazil, showing efficacy ranging between 62% and 90%.

The AstraZeneca Analysts: SVB Leerink analyst Geoffrey Porges has an Outperform rating on AstraZeneca with a $65 price target. 

BofA Securities analyst Sachin Jain maintained a Buy rating and $69 price target.

Data Disclosure Premature, Insufficient, SVB Leerink Says: The average 70% efficacy after 132 infection events reported by AstraZeneca in the pivotal trial is likely to be criticized, Porges said in a Monday note.

The company did not disclose information on any actual safety event and said "no serious safety events related to the vaccine have been confirmed," the analyst said. 

The company tried to project the 90% efficacy in a relatively small sub-set of subjects — 2,741 participants — who received a half dose of vaccination, followed by a full dose four weeks later, he said. 

AstraZeneca's disclosure was short on details such as the exact number of events in each study or how the company calculated the blended 70% efficacy for the full cohort of 11,636 subjects and efficacy in sub-populations such as the elderly, high risk or minority populations, Porges said. 

"We regard the data disclosure as premature and insufficient, and is likely to attract a raft of criticism," the analyst said.

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The company is positioning the product as suitable for use in less-developed countries, where the relatively favorable storage conditions may be advantageous.

AstraZeneca's vaccine will never be licensed in the U.S. due to pivotal trial designs that are not in conformity with standards set by the FDA, and the occurrence of severe safety events that resulted in an extended clinical hold on enrollment into the trials in the U.S., according to SVB Leerink. 

The firm said it is not very positive on the outlook for an adenovirus-based COVID vaccine, as it appears that the occurrence of pre-existing or post-vaccination immunity to the vector has a significant dampening effect on the efficacy of the vaccines.

These products are likely to be regarded as relatively marginal suppliers in the COVID-19 vaccine market of the future, Porges said.

Vaccine Needed Globally In 2021, BofA Says: Efficacy at the "first dose as half-dose" regimen of 90% is comparable to the 94%-95% efficacy seen with Pfizer Inc. PFE and Moderna Inc MRNA, Jain said in a note. 

The efficacy for the normal dose is at 62%, the analyst said. 

"We look for further details on whether the event split is similar to the split in patients at the two regimens (c25% of patients at the "half-dose" implying only c35 events at this dose), & explanation for better efficacy at lower dosing," he said. 

Beyond efficacy and safety, AstraZeneca's vaccine supply is likely required for global vaccination in 2021, Jain said.

It also has easier logistics than the vaccine candidates from Pfizer and Moderna, the analyst said. 

AZN Price Action: At last check, AstraZeneca shares were sliding by 1.71% to $54.36. 

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