Pomerantz Appointed Co-Lead Counsel in AstraZeneca Securities Litigation

On April 28, 2021, U.S. District Judge J. Paul Oetken of the Southern District of New York appointed Pomerantz LLP as Co-Lead Counsel on behalf of Co-Lead Plaintiff Nuggehalli Balmukund Nandkumar in In re AstraZeneca plc Sec. Litig., 21-cv-722 (S.D.N.Y.), a securities action brought on behalf of a class of defrauded investors concerning allegations that AstraZeneca plc (“AstraZeneca” or the “Company”) failed to disclose to investors that its clinical trials for AZD1222, a COVID-19 vaccine, were flawed in design and execution and failed to properly coordinate with regulatory authorities resulting in the likelihood that it would not be approved for commercial use in the U.S. in the short term.

AstraZeneca is one of the largest biopharmaceutical companies in the world and is primarily known for its development of drugs to treat cancer, asthma, and other chronic conditions. Until recently, it had not specialized in vaccine development.

Allegations include that: (i) AstraZeneca’s initial clinical trials for AZD1222, its COVID-19 vaccine, had suffered from a critical manufacturing error, resulting in a substantial number of trial participants receiving half the designed dosage; (ii) clinical trials for AZD1222 consisted of a patchwork of disparate patient subgroups, each with subtly different treatments, undermining the validity of the clinical data; (iii) certain clinical trial participants for AZD1222 had not received a second dose at the designated time; (iv) the Company had failed to include a substantial number of patients over 55 years of age in its clinical trials for AZD1222, despite this patient population being a large at-risk group; (v) AstraZeneca’s clinical trials for AZD1222 were flawed in design and execution and failed to properly coordinate with regulatory authorities; (vi) as a result of all the foregoing, the clinical trials for AZD1222 had not been conducted in accordance with industry best practices and the data was of limited utility; and (vii) as a result of all the foregoing, AZD1222 was unlikely to be approved for commercial use in the U.S. in the short term.

On May 21, 2020, AstraZeneca issued a press release announcing that they had “received support of more than $1billion… for the development, production and delivery of the vaccine” and that the “development programme includes a Phase III clinical trial with 30,000 participants and a pediatric trial.” The Company further stated that they had “concluded the first agreements for at least 400 million doses and [had] secured total manufacturing capacity for one billion doses so far and will begin first deliveries in September 2020.”

On August 31, 2020, AstraZeneca issued a press release in which it touted that the AZD1222 clinical trials, involving 50,000 volunteers, would “adhere to the highest scientific and clinical standards” and that the “Company’s submissions for market authorisation will meet the stringent requirements established by regulators everywhere around the world.”

The truth began to emerge on November 23, 2020 when AstraZeneca issued a press release revealing that its interim analysis of its ongoing trials for AZD1222 involved two smaller scale trials in disparate locales — the U.K. and Brazil — that, for unexplained reasons, employed two different dosing regimens. One clinical trial provided patients a half dose of AZD1222 followed by a full dose, while the other trial provided two full doses. Counterintuitively, AstraZeneca claimed that the half dosing regimen was substantially more effective at preventing COVID-19 at 90% efficacy than the full dosing regimen, which had achieved just 62% efficacy. AstraZeneca highlighted the blended “average efficacy of 70%” among the two trials. On this news, AstraZeneca’s share price fell $1.13 per share, or 2%, to close at $53.57 per share on November 24, 2020.

On November 25, 2020, Wired published a report titled “The AstraZeneca Covid Vaccine Data Isn’t Up to Snuff” which cited several red flags that raised concerns about the Company’s clinical data, including that it did not result from “a single, large-scale, Phase 3 clinical trial,” but instead came from “two studies [that] were substantially different from one another: They didn’t have standardized dosing schemes across the trials, for one thing, nor did they provide the same “control” injections to volunteers.”

On this news, AstraZeneca’s share price fell a further $0.97 per share, or 1.8%, to close at $52.60 per share on November 25, 2020.