Lawsuits

ICAN v. NIH

ICAN V. NIH: ICAN SUBMITS THIRTEEN FOIAS TO THE NATIONAL INSTITUTES OF HEALTH REGARDING ITS RESPONSE TO COVID-19 AND SUES THE AGENCY TO OBTAIN THE DOCUMENTS IT SOUGHT

ICAN made a number of FOIA requests to NIH for documents regarding COVID-19 and a potential COVID-19 vaccine, including a request for “all safety and efficacy data and information regarding mRNA-1273, including from the Phase I clinical trial of this experimental vaccine.”  NIH failed to respond to this and all the other related requests submitted by ICAN as required under FOIA.  Therefore, ICAN sued NIH on June 29, 2020.

The National Institute of Allergy and Infectious Diseases (“NIAID”) is at the center of the federal government’s response to COVID-19. NIAID is an institute within the National Institutes of Health (“NIH”). Dr. Anthony S. Fauci serves as NIAID’s Director.  NIAID funded and lead the development of mRNA-1273, the first vaccine for COVID-19 that entered into clinical trials.

The first vaccine for COVID-19 to begin trials in the U.S., Moderna’s mRNA-1273, is an experimental vaccine developed by NIAID, the NIH institute directed by Dr. Fauci, along with Moderna Inc.  NIAID used taxpayer dollars to sponsor, assume responsibility for, and perform the first clinical trial for the mRNA-1273 vaccine.  Likewise, NIAID’s parent department, the Department of Health and Human Services (“HHS”), awarded $483 million to accelerate development of mRNA-1273.  HHS has also granted those developing and those who will sell this product broad immunity from liability for injuries. Furthermore, a number of NIAID employees are listed as inventors on two patents relating to the development of mRNA-1273.  NIAID employees listed on these patents include Barney GrahamMasaru KanekiyoHadi YassineKizzmekia CorbettMichael Joyce, and Olubukola Abiona.

Given the public interest in this product and the potential for mandates to administer this product, which is antithetical to informed consent, ICAN submitted a number of FOIA requests to NIH.

On March 27, 2020, ICAN made the following requests to NIH related to mRNA-

1273:

i. “Copies of any and all Employee Invention Report related to any vaccine or therapeutic for COVID-19.”

ii. “Copies of any and all royalty or licensing agreements related to any vaccine or therapeutic for COVID-19.”

iii. “A copy of the page of any patent application filed with regard to the mRNA-1273 vaccine which lists the inventors.”

On April 10, 2020, ICAN also made the following requests to NIH:

i. “All emails sent or received by Anthony Fauci between November 1, 2019 and the present that include the term Moderna or mRNA-1273 in any portion of the email, including the body, subject, metadata, sender line, or recipient line of the email, or any attachment to the email.”

ii. The same request was made regarding Barney GrahamKizzmekia CorbettMichael Gordon JoyceMasaru KanekiyoOlubukola Mary Abisola Abiona, and Hadi Yassine.

Thereafter, on May 5, 2020, ICAN made the following additional requests to NIH:

i. “All emails sent or received by Anthony Fauci between November 1, 2019 and the present that include the terms SARS-CoV, COVID, COVID-19, or coronavirus in any portion of the email, including the body, subject, metadata, sender line, or recipient line of the email, or any attachment to the email;” and

ii. the same request as to Barney Graham.

On May 22, 2020, ICAN submitted a FOIA request to NIH for: “All safety and efficacy data and information regarding mRNA-1273, including from the Phase I clinical trial of this experimental vaccine conducted by the National Institute of Allergy and Infectious Diseases.”  Given the critical nature of this specific data, ICAN also requested that NIH grant expedited processing for this request.

NIH withheld in full the safety and efficacy data regarding Moderna’s vaccine and failed to respond to any of the other FOIAs.  ICAN therefore sued the NIH for its withholding of the Moderna vaccine data and for its lack of response to the other requests and the NIH responded.  ICAN and the agency subsequently came to an agreement regarding production of responsive documents and NIH agreed to produce the Moderna data.  However, ICAN challenged the adequacy of the search for the Moderna data as well as redactions that were made.  Both parties moved for summary judgment and await the Court’s decision.

In the meantime, NIH has been producing responsive documents in an order prioritized by ICAN. The first documents being produced are emails from Dr. Fauci regarding SARS-CoV-2 and COVID-19.  To date, more than 2,000 pages of Dr. Fauci’s emails have been produced with more to follow.  The other individuals’ emails will then be produced on a rolling basis.