Timeline of U.S. Army & Sanofi Zika Vaccine Collaboration

For quite a more detail on this issue, see http://keionline.org/zika.

2016 January: Walter Reed Army Institute of Research (WRAIR) begins development of a vaccine candidate for Zika virus, based on its work in developing vaccines “against other flaviviruses, such as yellow fever, dengue and Japanese encephalitis.”

2016 March 2: Health and Human Services Secretary Sylvia Mathews Burwell declares a public health emergency and authorizes emergency use of Zika virus diagnostic tests.

2016 May 6: The U.S. Trade Representative informs the Army that it has no objections, based on analysis required under Executive Order 12591 (Apr. 10, 1987) sec. 4(a), to the proposed Cooperative Research and Development Agreement (CRADA) between the Army and Sanofi on Zika research.

2016 May 31: The U.S. Army files U.S. provisional patent application no. 62/343,315, entitled, “Zika Virus Vaccine and Methods of Production.”

2016 June 24: Sanofi and U.S. Army sign a CRADA related to the development of the WRAIR Zika purified inactivited virus (ZPIV). The Army agrees to transfer the ZPIV vaccine technology to Sanofi and conduct phase 1 clinical trials with technical assistance from NIAID and the Biomedical Advanced Research and Development Authority (BARDA).

2016 August 3: The U.S. Army files U.S. provisional patent application no. 62/370,260, entitled, “Zika Vaccine and Methods of Preparation”

2016 September 26: Sanofi announces receipt of $43.2 million in funding from BARDA to support phase 2 clinical trials and manufacturing for the WRAIR ZPIV vaccine candidate. Sanofi has the option of eventually renewing its grant for an additional $130 million. Le Progrès reports that Sanofi will manufacture phase 2 vaccine doses near Lyon, France.

2016 October 27: Sanofi announces an agreement on Principles of Collaboration with the Oswaldo Cruz Foundation (Fiocruz) and WRAIR on the development of WRAIR's ZPIV technology.

2016 November 8: The U.S. Army begins a phase 1 clinical trial with 75 healthy enrollees to test the “safety and immunogenicity” of the ZPIV vaccine.

2016 December 9: U.S. Army announces its intent to grant an exclusive patent license to Sanofi on the vaccine in a Federal Register notice. KEI requests information on the details of the proposed license.

2016 December 21: KEI files comments with the U.S. Army asking them to include, amongst other provisions, a requirement that Sanofi charge a reasonable price on the ZPIV vaccine in the United States and lower income countries.

2017 January 11: The U.S. Army extends the initial comment period on the notice of the intent to grant an exclusive license through January 23, 2017.

2017 January 12: KEI, the American Federation of State, County and Municipal Employees (AFSCME), People of Faith for Access to Medicines (PFAM), Public Citizen, Social Security Works, Universities Allied for Essential Medicines (UAEM), and Dean Baker of the Center for Economic and Policy Research file comments with the U.S. Army on the Army’s failure to satisfy requirements in the Bayh-Dole Act (35 U.S.C. § 209(a)(1)) that an exclusive license may be granted “only if” the exclusivity is “a reasonable and necessary incentive to call forth the investment capital needed to bring the invention to practical application; or otherwise promote the invention’s utilization by the public.”

2017 January 23: Doctors Without Borders/Médecins Sans Frontières (MSF) files comments opposing the proposed exclusive license and asking the Army to grant an “open non-exclusive patent license.”

2017 January 27: The U.S. Army extends the comment period on the notice of the intent to grant an exclusive license through March 10, 2017.

2017 February 15: Rep. Jan Schakowsky, D-Ill., and 10 other House Democrats send a letter to the Acting Secretary of the U.S. Army opposing the proposed exclusive patent license.

2017 February 16: Dr. Diane Singhroy from KEI prepares a memorandum on the capacity for Zika vaccine manufacture.

2017 March 10: KEI files its final set of comments on the proposed exclusive license, addressing reasonable pricing requirements in the Bayh-Dole Act. Sen. Bernie Sanders, I-Vt., publishes an op-ed in the New York Times opposing the proposed exclusive licensing deal.

2017 March 21: Dr. Elias Zerhouni, former Director of the National Institutes of Health and now president of global research and development for Sanofi, criticizes Sen. Sanders’ op-ed in a letter to the editor in the New York Times (KEI response here).

2017 April 3: Sanofi pays $19.8 million to the Department of Veterans Affairs to resolve overcharges between 2002 and 2011.

2017 April 24: Both KEI and MSF receive letters from the U.S. Army dated April 21, 2017, rejecting the pricing concerns raised by KEI, MSF, and other public interest groups and members of Congress.

2017 April 28: The Centers for Disease Control announces that there will be a shortage of Sanofi's yellow fever vaccine due to manufacturing problems, and that the FDA has approved importation of an alternative Sanofi-manufactured vaccine.

2017 May 17: Louisiana Governor John Bel Edwards sends a letter to the U.S. Army on including a reasonable pricing provision in the Zika vaccine license.

2017 May 19: KEI, AFSCME, PFAM, Public Citizen, Social Security Works, and Dean Baker appeal Army response to comments. MSF files a separate appeal, available here.