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New Vaccine Lawsuit
INSIDE JW
Judicial Watch Sues HHS for Records of Communication from Top FDA Officials Who Resigned Reportedly over COVID Booster Shots


Two of our nation’s top vaccine scientists –  called giants in the field – are no longer at their posts in the FDA, and it appears that the Biden White House’s politicization of the COVID vaccines is the reason.

To get to the bottom of it, we filed a Freedom of Information Act (FOIA) lawsuit against the Department of Health and Human Services for records of communication from Dr. Marion Gruber and Dr. Philip Krause, the former director and deputy director of the Food and Drug Administration’s Office of Vaccines Research and Review, who reportedly resigned during the White House’s push to approve the COVID-19 “booster shot” (Judicial Watch v. U.S. Department of Health and Human Services (No. 1:22-cv-00292)).

We sued in the United States District Court of the District of Columbia after HHS failed to respond to a September 3, 2021, FOIA request for:
  • All emails sent to and from Center for Biologics Evaluation and Research Director Marion Gruber regarding the Centers for Disease Control and Prevention/CDC, the Advisory Committee on Immunization (ACIP), and/or “booster vaccines” for the prevention and/or treatment of SARS-CoV-2 and/or COVID-19.
  • All emails sent to and from Center for Biologics Evaluation and Research Deputy Director Phil Krause regarding the Centers for Disease Control and Prevention/CDC, the Advisory Committee on Immunization (ACIP), and/or “booster vaccines” for the prevention and/or treatment of SARS-CoV-2 and/or COVID-19.
On September 22, 2021, the FDA approved the use of a booster dose of the Pfizer drug. According to the organization’s news release, the FDA “amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series” for people at “high risk” of “severe COVID-19.”

On September 13, 2021, Gruber and Krause were among a group of resigning doctors who agreed that, “Available evidence doesn’t yet indicate a need for COVID-19 vaccine booster shots among the general population …” 

Also, on September 13, 2021, The Lancet published a paper to which Gruber and Krause contributed that noted:

Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics.… Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.
 
This booster shot cover-up shows the FDA is politicized and corrupt. The American people have a right to know about the safety and efficacy of the COVID-19 vaccines – especially given that officials in the FDA seem to have objected to the agency’s recommendations about the vaccines.


Judicial Watch and CatholicVote Sue for Biden Border Crisis

President Biden has a lot of explaining to do about his administration’s spurious actions along the border. Now we learn that federal bureaucrats are shoveling your tax dollars to charities to do their dirty work.

Joining with CatholicVote Civic Action, we filed a Freedom of Information Act (FOIA) lawsuit for communications between the Department of Homeland Security and the Department of Health and Human Services with Catholic organizations that were aiding illegal immigrants near the Texas border (CatholicVote Civic Action and Judicial Watch v. U.S. Department of Homeland Security and U.S. Department of Health and Human Services (No. 1:22-cv-00290)).

CatholicVote.org is a community of patriotic Americans who believe that the timeless truths of the Catholic faith are good for America. It makes its mission “to inspire every Catholic in America to live out the truths of our faith in public life.”
We sued in the United States District Court for the District of Columbia after both the U.S. Customs and Border Patrol and HHS failed to respond to FOIA requests on September 1, 2021.
The first FOIA request is for:

All communications between the U.S. Customs and Border Patrol and any of the following:
  1. The Diocese of Brownsville (San Juan, Texas);
  2. Bishop Daniel E. Flores in his capacity as Bishop of the Diocese of Brownsville, Texas;
  3. Catholic Charities of the Rio Grande Valley (“CCRGV”);
  4. Sister Norma Pimentel in her capacity as the Executive Director of CCRGV; or
  5. The Humanitarian Respite Center in McAllen, Texas.
The second FOIA request is for:

All communications between the U.S. Customs and Border Patrol and the U.S. Conference of Catholic Bishops regarding any of the following:
  1. Catholic Charities of the Rio Grande Valley (“CCRGV”);
  2. Sister Norma Pimentel in her capacity as the Executive Director of CCRGV; or
  3. the Humanitarian Respite Center in McAllen, Texas.
In a February 3 interview, Sister Pimentel acknowledged that her charity is reimbursed with tax dollars to buy “very few” plane and bus tickets for illegal aliens to move throughout the United States.

In July 2021, a Texas Police Officer encountered a COVID-positive illegal immigrant family at a fast food restaurant near the border who had been released by Border Patrol. The family told the officer that Catholic Charities of the Rio Grande Valley “had booked all the rooms in the hotel to house undocumented immigrants detained by Border Patrol.”

The police added, “Border Patrol was quarantining other undocumented individuals who were COVID positive, or showed symptoms of illness, then handing them over to the non-profit. Catholic Charities would in turn place the undocumented individuals in hotels …”

On July 28, 2021, Texas Governor Greg Abbott issued an executive order halting the transportation of illegal immigrants by any person other than, “a federal, state or local law-enforcement official.”

“The Biden administration has refused to provide copies of communications between Catholic-affiliated charities and organizations at the border,” said Brian Burch, president of CatholicVote. “Their lack of transparency and obstruction forced us to file these federal lawsuits. American Catholics deserve to know the full extent of the U.S. government's role in funding and coordinating with Catholic church affiliated agencies at the border, and what role these agencies played in the record surge of illegal immigrants over the past year. We will do whatever is necessary to uncover the truth.”

Americans have the right to know how the Biden administration is using tax dollars to conspire with “charities” and release illegal immigrants into their communities.


U.S. Taxpayer Funded Korean COVID Test Turns Out to Be Flawed

The federal government continues to demonstrate its ineptitude in dealing with COVID-19. The latest: It shelled out millions for a test that doesn’t work. And, as our Corruption Chronicles reports, we had to learn this from the Philippines:

A COVID-19 test developed by a Korean company with a $10.3 million infusion from the U.S. government is so flawed at least one state stopped using it after just a few weeks and a third-world country flagged it as defective months ago. In late September, the rapid antigen tests received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) to test individuals suspected by healthcare providers of being infected and by the end of December the authorization was expanded to include asymptomatic individuals. The test is made by South Korean manufacturer GenBody and is being promoted by a “minority-owned, female-led” public relations agency based in southern California.

Utah began using GenBody in late December at state-run testing sites. This week the Utah Department of Health (UDOH) announced it will temporarily pause the use of the on-site rapid antigen tests at all state-operated facilities after data revealed more than half of the tests resulted in a false negative. “The UDOH analyzed test results from nearly 18,000 Utah residents who received both GenBody rapid antigen and PCR tests on the same day,” the UDOH statement says. “Among people who tested positive by PCR, more than half of them tested negative by GenBody rapid antigen test; this was true even for people who reported COVID-like symptoms.” State epidemiologists raised questions about the performance of the GenBody rapid tests, the agency further writes.

In a local newspaper article Utah state epidemiologist Leisha Nolen says concerns were raised last week when mobile testing partners “noticed that they were getting a lot more negatives that would come up later as positives.” The health official reveals that for every 100 people who tested positive on a PCR test, only 38% tested positive on the GenBody rapid antigen test. “Even for those who displayed clear symptoms of COVID-19, only 41% out of every 100 who tested positive on a PCR test also tested positive on a GenBody rapid test,” the news story says, adding that Nolan and her colleagues “were really concerned by those numbers.” The UDOH announcement acknowledges that rapid antigen tests are known to be less likely to identify a positive individual, but the difference identified in the state analysis was higher than expected.

Back in October, officials in the Philippines—an impoverished third-world country—issued a warning against 10 COVID-19 antigen and rapid tests that failed to meet its health department standards. GenBody appears at the top of the list. A director at the Philippine FDA explains in a local media report that all of the tests were manufactured abroad and failed to comply with the standard for sensitivity and specificity set by the southeast Asian country’s Research Institute for Tropical Medicine (RITM), the agency charged with protecting Filipinos against infectious disease. “Those test kits published with failed performance validation were not able to comply with the standard set for sensitivity, specificity or both,” according to the Filipino FDA director who is identified in the news article as Maria Cecilia Matienzo.

GenBody received $10.3 million from the U.S. Department of Health and Human Services (HHS) to develop the COVID-19 test kits. The money was doled out under a program called Rapid Acceleration of Diagnostics (RADx) launched by the National Institutes of Health (NIH), a division of HHS, to speed innovation in the development, commercialization and implantation of technologies for COVID-19 testing. “Accurate, fast, easy-to-use, and widely accessible testing is required before the nation can safely return to normal life,” the NIH writes in its overview of RADx. The initiative is described as a national call for scientists and organizations to bring their innovative ideas for new COVID-19 testing approaches and strategies. “Funded projects include new applications of existing technologies that make tests easier to use, easier to access, and more accurate,” according to the NIH. “At the same time, NIH is seeking opportunities to move more advanced diagnostic technologies swiftly through the development pipeline toward commercialization and broad availability — with the goal of making millions of tests per week available to Americans, particularly those most vulnerable to and/or disproportionately impacted by COVID-19, and having even more tests available in time for the 2020–2021 flu season.”
 
Until next week …
 
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