`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`
`MONROE COUNTY EMPLOYEES’
`RETIREMENT SYSTEM, Individually and on
`Behalf of All Others Similarly Situated,
`
`Plaintiff,
`
`vs.
`
`ASTRAZENECA PLC, PASCAL SORIOT,
`MARC DUNOYER and MENELAS
`PANGALOS,
`
`Defendants.
`
`x
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`:
`x
`
`Civil Action No. 1:21-cv-722
`CLASS ACTION
`
`COMPLAINT FOR VIOLATIONS OF THE
`FEDERAL SECURITIES LAW
`
`DEMAND FOR JURY TRIAL
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 2 of 32
`
`
`
`Plaintiff Monroe County Employees’ Retirement System, individually and on behalf of all
`
`others similarly situated, by plaintiff’s undersigned attorneys, for plaintiff’s complaint against
`
`defendants, alleges the following based upon personal knowledge as to plaintiff and plaintiff’s own
`
`acts and upon information and belief as to all other matters based on the investigation conducted by
`
`and through plaintiff’s attorneys, which included, among other things, a review of the U.S. Securities
`
`and Exchange Commission (“SEC”) filings of AstraZeneca plc (“AstraZeneca” or the “Company”),
`
`Company releases, and analyst reports, media reports and other publicly disclosed reports and
`
`information about the Company. Plaintiff believes that substantial additional evidentiary support
`
`will exist for the allegations set forth herein after a reasonable opportunity for discovery.
`
`NATURE OF THE ACTION
`
`1.
`
`This is a securities class action on behalf of all purchasers of AstraZeneca American
`
`Depositary Shares (“ADSs”) between May 21, 2020 and November 20, 2020, inclusive (the “Class
`
`Period”), against AstraZeneca and certain of the Company’s executive officers seeking to pursue
`
`remedies under the Securities Exchange Act of 1934 (the “Exchange Act”).
`
`JURISDICTION AND VENUE
`
`2.
`
`The claims asserted herein arise under §§10(b) and 20(a) of the Exchange Act, 15
`
`U.S.C. §§78j(b) and 78t(a), and Rule 10b-5, 17 C.F.R. §240.10b-5. Jurisdiction is conferred by §27
`
`of the Exchange Act, 15 U.S.C. §78aa.
`
`3.
`
`Venue is proper in this District pursuant to §27 of the Exchange Act. The acts and
`
`transactions giving rise to the violations of law complained of occurred in part in this District,
`
`including the dissemination of false and misleading statements into this District. AstraZeneca’s
`
`sponsored ADSs traded in this District on the New York Stock Exchange (“NYSE”), as well as on
`
`the Nasdaq Global Select Market (“NASDAQ”) after the Company transferred the U.S.-listing of its
`
`ADSs on September 24, 2020.
`
`- 1 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 3 of 32
`
`
`
`4.
`
`In connection with the acts and conduct alleged in this complaint, defendants, directly
`
`or indirectly, used the means and instrumentalities of interstate commerce, including, but not limited
`
`to, the mails and interstate wire and telephone communications.
`
`PARTIES
`
`5.
`
`Plaintiff Monroe County Employees’ Retirement System purchased AstraZeneca
`
`ADSs during the Class Period as described in the Certification attached hereto and incorporated
`
`herein by reference and suffered damages.
`
`6.
`
`Defendant AstraZeneca is a multinational biopharmaceutical company. AstraZeneca
`
`shares traded on the NYSE and the NASDAQ under ticker symbol “AZN” during the Class Period,
`
`and each AstraZeneca ADS represents one half of an ordinary share.
`
`7.
`
`Defendant Pascal Soriot was Chief Executive Officer (“CEO”) and a director of
`
`AstraZeneca at all relevant times.
`
`8.
`
`Defendant Marc Dunoyer was Chief Financial Officer (“CFO”) and a director of
`
`AstraZeneca at all relevant times.
`
`9.
`
`Defendant Menelas Pangalos was Executive Vice President of Biopharmaceuticals
`
`Research & Development at AstraZeneca at all relevant times.
`
`10.
`
`Defendants Soriot, Dunoyer and Pangalos are referred to herein as the “Individual
`
`Defendants.” During the Class Period, the Individual Defendants ran the Company as hands-on
`
`managers overseeing AstraZeneca’s operations and finances and made the materially false and
`
`misleading statements described herein. The Individual Defendants had intimate knowledge about
`
`core aspects of AstraZeneca’s financial and business operations, including the development of the
`
`Company’s COVID-19 vaccine as detailed herein. They were also intimately involved in deciding
`
`which disclosures would be made by AstraZeneca regarding the vaccine’s ongoing clinical trials.
`
`- 2 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 4 of 32
`
`
`
`SUBSTANTIVE ALLEGATIONS
`
`11.
`
`Defendant AstraZeneca is one of the largest biopharmaceutical companies in the
`
`world. The Company is headquartered in Cambridge, England, and it maintains its North American
`
`headquarters in Wilmington, Delaware, a global research and development center in Gaithersburg,
`
`Maryland, and a primary commercial and manufacturing hub in Boston, Massachusetts.
`
`AstraZeneca is primarily known for its development of drugs to treat cancer, asthma and other
`
`chronic conditions, and has not historically specialized in vaccine development.
`
`12.
`
`In early January 2020, the World Health Organization (“WHO”) announced the
`
`discovery of a new coronavirus strain in China, later dubbed COVID-19. The virus causes a variety
`
`of adverse symptoms in victims, including in some cases a severe acute respiratory illness that can
`
`be life threatening. The disease is highly contagious and has caused hundreds of thousands of deaths
`
`around the world, as well as debilitating symptoms in millions more people afflicted with the virus.
`
`13.
`
`On January 23, 2020, Chinese authorities placed the 11 million person city of Wuhan
`
`under quarantine in an effort to contain the rapid spread of the virus. A week later, the WHO
`
`declared COVID-19 a global public health emergency, and the next day the United States banned
`
`foreign nationals from entering the country if they had travelled to China within the prior two weeks.
`
`Shortly thereafter, the United States declared COVID-19 a public health emergency.
`
`14.
`
`By February 2020, COVID-19 had begun to have a significant impact on global
`
`markets, as consumer demand plummeted and governments began to impose lockdowns and other
`
`restrictions. By February 9, 2020, the death toll in China had surpassed that of the SARS epidemic
`
`in the early 2000s. Between February 12 and 21, 2020, the international expansion of COVID-19
`
`accelerated, with South Korea, Iran and Italy suffering outbreaks. On February 25, 2020, San
`
`Francisco declared a local emergency, with several California counties following suit over the
`
`ensuing week. The United States reported its first death from COVID-19 on February 29, 2020
`- 3 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 5 of 32
`
`
`
`(though later reports would confirm that earlier deaths had in fact occurred. Shortly thereafter, U.S.
`
`state and local governments began imposing limitations on business and social activities in an effort
`
`to stop the spread of the virus, contributing to a severe economic downturn.
`
`15.
`
`The human and economic devastation wrought by COVID-19 spurred an
`
`unprecedented campaign by governments and biopharmaceutical companies to develop treatments
`
`and vaccines for the virus. The U.S. Food and Drug Administration (“FDA”) slashed regulatory
`
`hurdles and employed its emergency use authorization powers to speed up drug development,
`
`dramatically shortening the timeframe in which new drugs for COVID-19 could be brought to
`
`market. The U.S. government also launched Operation Warp Speed, a public-private partnership to
`
`facilitate and accelerate the development, manufacturing, and distribution of COVID-19 vaccines,
`
`therapeutics, and diagnostics. This valiant effort resulted in rapid breakthroughs in drug
`
`development, including novel technologies such as vaccines based on synthetic mRNA.
`
`16.
`
`However, the loosening of regulatory restrictions also increased the material
`
`importance for biopharmaceutical companies developing COVID-19 drug candidates to maintain
`
`high quality in the conduct of clinical trials, adhere to industry standards, and communicate honestly
`
`and transparently with government authorities, investors and the general public. COVID-19
`
`vaccines will be administered to tens of millions of people, and it is imperative that the drugs are
`
`both safe and effective and accepted as such by target populations who may be skeptical, especially
`
`in light of the regulatory shortcuts that may have been taken to bring the vaccines quickly to market.
`
`To illustrate the potential skepticism vaccine manufacturers may need to overcome, a December
`
`2020 Associated Press-NORC poll found that only about half of Americans were willing to take a
`
`COVID-19 vaccine at the time of the survey. A COVID-19 vaccine can only work if target
`
`populations are willing to take it, and the failure of a biopharmaceutical company to operate openly
`
`- 4 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 6 of 32
`
`
`
`and truthfully in the development of a COVID-19 vaccine could undermine public confidence in the
`
`vaccination process generally.
`
`17.
`
`AstraZeneca was one of the early front-runners in the race to develop a COVID-19
`
`vaccine. In April 2020, the Company partnered with Oxford University to develop a potential
`
`recombinant adenovirus vaccine for the virus, later dubbed AZD1222. Oxford University’s work on
`
`developing a COVID-19 vaccine began in January 2020, almost as soon as the virus was recognized
`
`globally. Volunteers for the first clinical trial were recruited and screened in March 2020, and a
`
`Phase 1 clinical trial was launched the following month.
`
`18.
`
`On April 30, 2020, AstraZeneca announced its partnership with Oxford University,
`
`with defendant Soriot hailing the agreement: “‘This collaboration brings together the University of
`
`Oxford’s world-class expertise in vaccinology and AstraZeneca’s global development,
`
`manufacturing and distribution capabilities.’” Notably, at the time, AstraZeneca did not release a
`
`full breakdown of the trial protocols to be employed at the outset of these clinical trials, as had its
`
`competitors, such as Pfizer and Moderna.
`
`19.
`
`AstraZeneca’s vaccine candidate was met with great optimism by investors and
`
`governments around the world. Unlike certain other leading vaccine candidates, AZD1222 is not
`
`based on novel mRNA technology, but rather on more tried and tested vaccine approaches.
`
`AZD1222 is also relatively cheap and easy to store and distribute as compared to mRNA vaccine
`
`candidates, as it does not require extremely cold temperatures to maintain vaccine integrity. In May
`
`2020, the United States made what was at the time its biggest investment in COVID-19 vaccine
`
`development, awarding AstraZeneca up to $1.2 billion for the development and manufacturing of the
`
`vaccine in exchange for 300 million doses.
`
`- 5 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 7 of 32
`
`
`
`DEFENDANTS’ MATERIALLY FALSE AND MISLEADING STATEMENTS
`AND OMISSIONS DURING THE CLASS PERIOD
`
`20.
`
`The Class Period starts on May 21, 2020. On that date, AstraZeneca issued a release
`
`announcing that it had received substantial government commitments for the development of
`
`AZD1222. The release stated in pertinent part as follows:
`
`AstraZeneca advances response to global COVID-19 challenge as it receives first
`commitments for Oxford’s potential new vaccine
`
`Company working on a number of agreements in parallel to ensure broad and
`equitable supply of the vaccine throughout the world at no profit during the
`pandemic
`
`First agreements to supply at least 400 million doses; Company has total
`capacity sourced for one billion doses through 2020 and into 2021; continues to
`increase capacity further
`
`More than $1bn US BARDA investment to support development and
`production of the vaccine
`
`AstraZeneca is advancing its ongoing response to address the unprecedented
`challenges of COVID-19, collaborating with a number of countries and multilateral
`organisations to make the University of Oxford’s vaccine widely accessible around
`the world in an equitable manner.
`
`The Company has concluded the first agreements for at least 400 million
`doses and has secured total manufacturing capacity for one billion doses so far and
`will begin first deliveries in September 2020. AstraZeneca aims to conclude further
`agreements supported by several parallel supply chains, which will expand capacity
`further over the next months to ensure the delivery of a globally accessible vaccine.
`
`AstraZeneca today received support of more than $1bn from the US
`Biomedical Advanced Research and Development Authority (BARDA) for the
`development, production and delivery of the vaccine, starting in the fall. The
`development programme includes a Phase III clinical trial with 30,000 participants
`and a paediatric trial.
`
`In addition, the Company is engaging with international organisations such as
`the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi the Vaccine
`Alliance and the World Health Organisation (WHO), for the fair allocation and
`distribution of the vaccine around the world. AstraZeneca is also in discussions with
`governments around the world to increase access. Furthermore, AstraZeneca is in
`discussions with the Serum Institute of India and other potential partners to increase
`production and distribution.
`
`- 6 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 8 of 32
`
`
`
`AstraZeneca recently joined forces with the UK Government to support
`Oxford University’s vaccine and has progressed rapidly in its efforts to expand
`access around the world. The Company will supply the UK starting in September
`and is thankful for the Government’s commitment and overall work on vaccines.
`
`Pascal Soriot, Chief Executive Officer, said: “This pandemic is a global
`tragedy and it is a challenge for all of humanity. We need to defeat the virus together
`or it will continue to inflict huge personal suffering and leave long-lasting economic
`and social scars in every country around the world. We are so proud to be
`collaborating with Oxford University to turn their ground-breaking work into a
`medicine that can be produced on a global scale. We would like to thank the US and
`UK governments for their substantial support to accelerate the development and
`production of the vaccine. We will do everything in our power to make this vaccine
`quickly and widely available.”
`
`AstraZeneca has now finalised its licence agreement with Oxford University
`for the recombinant adenovirus vaccine. The licensing of the vaccine, formerly
`ChAdOx1 nCoV-19 and now known as AZD1222, follows the recent global
`development and distribution agreement with the University’s Jenner Institute and
`the Oxford Vaccine Group. AstraZeneca has also agreed to support the
`establishment of a joint research centre at Oxford University for pandemic
`preparedness research.
`
`A Phase I/II clinical trial of AZD1222 began last month to assess safety,
`immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 years
`across several trial centres in southern England. Data from the trial is expected
`shortly which, if positive, would lead to late-stage trials in a number of countries.
`AstraZeneca recognises that the vaccine may not work but is committed to
`progressing the clinical program with speed and scaling up manufacturing at risk.
`
`The Company’s comprehensive pandemic response also includes rapid
`mobilisation of AstraZeneca’s global research efforts to discover novel coronavirus-
`neutralising antibodies to prevent and treat progression of the COVID-19 disease,
`with the aim of reaching clinical trials in the next three to five months. Additionally,
`the Company has quickly moved into testing of new and existing medicines to treat
`the infection, including CALAVI and ACCORD trials underway for Calquence
`(acalabrutinib) and DARE-19 trial for Farxiga (dapagliflozin) in COVID-19 patients.
`
`21.
`
`On June 4, 2020, AstraZeneca issued a release announcing a $750 million agreement
`
`with the Coalition for Epidemic Preparedness Innovations and the Gavi Vaccine Alliance for 300
`
`million doses of AZD1222, as well as a licensing agreement with the Serum Institute of India to
`
`supply one billion doses for low and middle-income countries. The release claimed that clinical
`
`trials for AZD1222 (at the time known as ChAdOx1) had been preceding without any significant
`
`- 7 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 9 of 32
`
`
`
`issues, stating that “[v]accines made from the ChAdOx1 virus have been given to more than 320
`
`people to date and have been shown to be safe and well tolerated, although they can cause temporary
`
`side effects such as a temperature, influenza-like symptoms, headache or a sore arm.”
`
`22.
`
`On June 13, 2020, AstraZeneca issued a release announcing an agreement with
`
`Europe’s Inclusive Vaccines Alliance to supply up to 400 million doses of AZD1222. The release
`
`also highlighted a “Phase II/III UK trial of AZD1222 in about 10,000 adult volunteers” launched by
`
`Oxford University in May 2020.
`
`23.
`
`On July 20, 2020, AstraZeneca issued a release providing interim results for ongoing
`
`AZD1222 clinical trials. The release stated that AZD1222 had exhibited a promising immune
`
`system response in patients with no notable adverse reactions. The release stated in pertinent part as
`
`follows:
`
`Interim data showed strong antibody and T-cell responses
`
`Interim results from the ongoing Phase I/II COV001 trial, led by Oxford
`University, showed AZD1222 was tolerated and generated robust immune responses
`against the SARS-CoV-2 virus in all evaluated participants.
`
`COV001 is a blinded, multi-centre, randomised controlled Phase I/II trial
`with 1,077 healthy adult participants, aged 18-55 years. It assessed a single dose of
`AZD1222 against a comparator meningococcal conjugate vaccine, MenACWY. Ten
`participants also received two doses of AZD1222 one month apart.
`
`The results published in The Lancet confirmed a single dose of AZD1222
`resulted in a four-fold increase in antibodies to the SARS-CoV-2 virus spike protein
`in 95% of participants one month after injection. In all participants, a T-cell response
`was induced, peaking by day 14, and maintained two months after injection.
`
`Neutralising activity against SARS-CoV-2 (as assessed by the MNA80 assay)
`was seen in 91% of participants one month after vaccination and in 100% of
`participants who received a second dose. The levels of neutralising antibodies seen
`in participants receiving either one or two doses were in a similar range to those seen
`in convalescent COVID-19 patients. Strong correlations were observed across
`neutralisation assays.
`
`The early safety responses confirmed that transient local and systemic
`reactions were common in the AZD1222 group and were comparable to previous
`
`- 8 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 10 of 32
`
`
`
`trials and other adenoviral vector vaccines. They included temporary injection site
`pain and tenderness, mild-to-moderate headache, fatigue, chills, feverishness,
`malaise and muscle ache. No serious adverse events were reported with AZD1222,
`and reactions were lessened with the use of prophylactic paracetamol, a pain killer,
`and occurred less frequently after a second dose.
`
`Professor Andrew Pollard, Chief investigator of the Oxford Vaccine Trial at
`Oxford University and co-author of the trial, said: “The interim Phase I/II data for
`our coronavirus vaccine shows that the vaccine did not lead to any unexpected
`reactions and had a similar safety profile to previous vaccines of this type. The
`immune responses observed following vaccination are in line with what we expect
`will be associated with protection against the SARS-CoV-2 virus, although we must
`continue with our rigorous clinical trial programme to confirm this. We saw the
`strongest immune response in participants who received two doses of the vaccine,
`indicating that this might be a good strategy for vaccination.”
`
`Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:
`“We are encouraged by the Phase I/II interim data showing AZD1222 was capable of
`generating a rapid antibody and T-cell response against SARS-CoV-2. While there
`is more work to be done, today’s data increases our confidence that the vaccine will
`work and allows us to continue our plans to manufacture the vaccine at scale for
`broad and equitable access around the world.”
`
`Late-stage Phase II/III trials are currently underway in the UK, Brazil and
`South Africa and are due to start in the US. Trials will determine how well the
`vaccine will protect from the COVID-19 disease and measure safety and immune
`responses in different age ranges and at various doses.
`
`(Footnotes omitted.)
`
`24.
`
`On July 30, 2020, AstraZeneca filed its financial report for the six months ended June
`
`30, 2020 on Form 6-K with the SEC. The Form 6-K highlighted AstraZeneca’s development of
`
`AZD1222, stating in pertinent part as follows:
`
`AZD1222 (SARS-CoV-2 vaccine)
`
`During the period, AstraZeneca advanced its ongoing response to address
`COVID-19 including licence, development and distribution agreements with the
`University of Oxford for the recombinant adenovirus vaccine, AZD1222.
`
`The Phase I/II COV001 trial, launched in April 2020 in the UK with more
`than 1,000 participants, is ongoing. Initial data was reviewed in May 2020 by a Data
`Safety Monitoring Board and the UK Medicines and Healthcare products Regulatory
`Agency, resulting in the advancement to the COV002 Phase II/III trial in the UK,
`with over 10,000 participants.
`
`- 9 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 11 of 32
`
`
`
`In July 2020, results from the COV001 trial were published in The Lancet,
`showing that AZD1222 was tolerated and generated robust immune responses
`against the SARS-CoV-2 virus in evaluated participants. Neutralising activity
`against SARS-CoV-2 (as assessed by the MNA80 assay) was seen in 91% of
`participants (32/35) one month after vaccination and in 100% (10/10) of participants
`who received a second dose. In all evaluated participants, a T-cell response was
`induced, peaking by day 14, and maintained two months after injection. The levels
`of neutralising antibodies seen in participants receiving either one or two doses were
`in a similar range to those seen in convalescent COVID-19 patients. Data from these
`assays correlated positively with antibody levels to the SARS-CoV-2 spike protein,
`as measured by Enzyme-Linked Immunosorbent Assays data on the other
`participants.
`
`COV002 has launched and has recruited almost 9,000 participants in the UK;
`late-stage development has begun in Brazil and South Africa. As part of the
`announced agreement with BARDA, the Company anticipates the launch of a Phase
`III clinical trial with c.30,000 participants in the US in the third quarter of this year.
`
`25.
`
`Also on July 30, 2020, AstraZeneca hosted a conference call with analysts and
`
`investors led by defendants Soriot, Dunoyer and Pangalos to discuss the Company’s second quarter
`
`2020 earnings results. In his prepared remarks, defendant Pangalos praised AstraZeneca’s efforts to
`
`develop AZD1222 to date, stating in pertinent part as follows:
`
`We’re really proud to be at the forefront and highly active in the pursuit of tackling
`the COVID-19 global health crisis.
`
`Last week, as many of you know, we published data in Lancet for our Phase
`I/II COV001 trial as part of our collaboration with Oxford University showing that
`the vaccine AZD1222 was tolerated and generated robust immune response in terms
`of both neutralizing antibodies and T cells. Late-stage trials are currently ongoing in
`the U.K., in Brazil, in South Africa and are about to start in the United States.
`
`26.
`
`On August 14, 2020, AstraZeneca issued a release stating that the Company had
`
`finalized an agreement with the European Commission to supply 400 million doses of AZD1222.
`
`The release continued in pertinent part as follows:
`
`Pascal Soriot, Chief Executive Officer, said: “This first vaccine agreement
`with the European Commission will ensure that millions of Europeans have access to
`the AZD1222 vaccine following its approval. With production in our European
`supply chain soon to be started, we hope to make the vaccine available widely and
`rapidly, with the first doses to be delivered by the end of 2020. I would like to thank
`the entire European Commission, and especially the Commissioner for Health and
`
`- 10 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 12 of 32
`
`
`
`Food Safety, Stella Kyriakides, for their swift response in ensuring Europeans may
`soon be protected with a vaccine against this deadly virus, enabling our global
`society and economy to rebuild.”
`
`In July 2020, interim results from the ongoing Phase I/II COV001 trial were
`published in The Lancet and showed AZD1222 was tolerated and generated robust
`immune responses against the SARS-CoV-2 virus in all evaluated participants.
`Clinical development of AZD1222 is progressing globally with late-stage Phase II/III
`trials ongoing in the UK and Brazil, a Phase I/II trial in South Africa, and trials
`planned in the US, Japan and Russia. Results from the late-stage trials are
`anticipated later this year, depending on the rate of infection within the clinical trial
`communities.
`
`27.
`
`On August 31, 2020, AstraZeneca issued a release claiming that the Company was
`
`committed to “the highest safety standards” and adherence to “the highest scientific and clinical
`
`standards” in its development of AZD1222. The release quoted defendant Soriot, who claimed that
`
`AstraZeneca was developing AZD1222 “without cutting corners” and was following the “clear and
`
`stringent efficacy and safety standards” set by regulators. The release stated in pertinent part as
`
`follows:
`
`Company reiterates core values to “follow the science” and “put patients first”
`
`AstraZeneca is today issuing a commitment to the highest safety standards
`and to broad and equitable access around the world for its COVID-19 vaccine
`AZD1222.
`
`At the heart of AstraZeneca’s core values is to “follow the science” and
`adhere to the highest scientific and clinical standards, making the safety and efficacy
`of the vaccine of paramount importance. The Company’s submissions for market
`authorisation will meet the stringent requirements established by regulators
`everywhere around the world.
`
`To this end, AstraZeneca is implementing a clinical development program
`that will enroll in excess of 50,000 volunteers, including 30,000 in the US, in Latin
`America, Asia, Europe, Russia and Africa that will provide data for ethnically
`diverse populations.
`
`The Company also has a core value to “put patients first” and will continue to
`work with governments and other organisations towards broad and equitable global
`access to the vaccine, scaling up manufacturing with independent parallel supply
`chains around the world to produce billions of doses to a consistent and high standard
`of safety and efficacy.
`
`- 11 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 13 of 32
`
`
`
`Pascal Soriot, Chief Executive Officer, said: “In recent weeks we have seen
`an increasing number of questions around the safety and availability of vaccines to
`fight this terrible COVID-19 pandemic and I want to reiterate my commitment that
`we are putting science and the interest of society at the heart of our work. We are
`moving quickly but without cutting corners, and regulators have clear and stringent
`efficacy and safety standards for the approval of any new medicine, and that includes
`this potential COVID-19 vaccine. We will remain true to our values as we continue
`our efforts to bring this vaccine broadly and equitably to billions of people around
`world.”
`
`In July 2020, interim results from the ongoing Phase I/II COV001 trial were
`published in The Lancet and showed AZD1222 was tolerated and generated robust
`immune responses against the SARS-CoV-2 virus in all evaluated participants.
`
`to engage with governments, multilateral
`AstraZeneca continues
`organisations and partners around the world to ensure broad and equitable access to
`the vaccine, should clinical trials prove successful. Recent supply announcements
`with Russia, South Korea, Japan, China, Latin America and Brazil take the global
`supply capacity towards three billion doses of the vaccine.
`
`28.
`
`Also on August 31, 2020, AstraZeneca issued a release announcing that the Company
`
`was expanding U.S. clinical trials for AZD1222 into Phase III. The release noted that AstraZeneca
`
`“today issued a commitment to the highest safety standards and to broad and equitable access,
`
`reiterating its core values to ‘follow the science’ and ‘put patients first.’”
`
`29.
`
`On September 8, 2020, AstraZeneca CEO defendant Soriot signed a “pledge”
`
`together with eight other biopharmaceutical CEOs. According to this pledge, AstraZeneca and
`
`defendant Soriot promised that the Company’s COVID-19 vaccine development would adhere to the
`
`highest manufacturing and clinical standards and “uphold the integrity of the scientific process.”
`
`The widely publicized pledge stated in pertinent part as follows:
`
`Biopharma leaders unite to stand with science
`
`Nine CEOs sign historic pledge to continue to make the safety and well-being of
`vaccinated individuals the top priority in development of the first COVID-19
`vaccines
`
`The CEOs of AstraZeneca (LSE/STO/NYSE: AZN), BioNTech (NASDAQ:
`BNTX), GlaxoSmithKline plc (LSE/NYSE: GSK), Johnson & Johnson (NYSE:
`JNJ), Merck (NYSE: MRK), known as MSD outside the United States and Canada ,
`
`- 12 -
`
`
`
`Case 1:21-cv-00722-JPO Document 1 Filed 01/26/21 Page 14 of 32
`
`
`
`Moderna, Inc. (Nasdaq: MRNA), Novavax, Inc. (Nasdaq: NVAX), Pfizer Inc.
`(NYSE: PFE), and Sanofi (NASDAQ: SNY), today announced a historic pledge,
`outlining a united commitment to uphold the integrity of the scientific process as
`they work towards potential global regulatory filings and approvals of the first
`COVID-19 vaccines.
`
`All nine CEOs signed the following pledge:
`
`We, the undersigned biopharmaceutical companies, want to make clear our
`on-going commitment to developing and testing potential vaccines for COVID-19 in
`accordance with high ethical standards and sound scientific principles.
`
`The safety and efficacy of vaccines, including any potential vaccine for
`COVID-19, is reviewed and determined by expert regulatory agencies around the
`world, such as the United States Food and Drug Administration (FDA). FDA has
`established clear guidance for the development of COVID-19 vaccines and clear
`criteria for their potential authorization or approval in the US. FDA’s guidance and
`criteria are based on the scientific and medical principles necessary to clearly
`demonstrate the safety and efficacy of potential COVID-19 vaccines. More
`specifically, the agency requires that scientific evidence for regulatory approval must
`come from large, high quality clinical trials that are randomized and observer-
`blinded, with an expectation of appropriately designed studies with significant
`numbers of participants across diverse populations.
`
`Following guidance from expert regulatory authorities such as FDA
`regarding the development of COVID-19 vaccines, consistent with existing standards
`and practices, and in the interest of public health, we pledge to:
`
`
`
`
`
`
`
`
`
`Always make the safety and well-being of vaccinated individuals our top
`priority.
`
`Continue to adhere to high scientific and ethical standards regarding the
`conduct of clinical trials and the rigor of manufacturing processes.
`
`for approval or emergency use authorization after
`Only submit
`demonstrating safety and efficacy through a Phase 3 clinical study that is
`designed and conducted to meet requirements of expert regulatory
`authorities such as FDA.
`
`Work to ensure a sufficient supply and range of vaccine options, including
`those suitable for global access.
`
`We believe this pledge will help ensure public confidence in the rigorous
`scientific and regulatory process by which COVID-19 vaccines are evaluated and
`may ultimately be approved.
`
`Together, these nine companies have collec