5 Questions Fauci and FDA Need to Answer on Pfizer and Moderna COVID Vaccines • Children’s Health Defense

26-12-20 08:25:00,

Another day, another story about a healthcare worker suffering a “severe allergic reaction” after receiving Pfizer’s COVID vaccine — this time, in New York. The report follows the news Children’s Health Defense (CHD) has been covering about similar severe reactions, first in the UK, then in Alaska and Illinois.

In light of these events, and because CHD previously warned the U.S. Food and Drug Administration (FDA) officials and Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases (NIAID), about the potential for the Pfizer and Moderna vaccines to cause anaphylactic reactions, we have some questions we’d like Fauci and the FDA to answer.

They are:

1. Why didn’t the FDA’s Center for Biological Evaluation and Research require Moderna and Pfizer-BioNTech to conduct immunogenicity testing on their COVID-19 vaccines for anti-drug antibodies as recommended in the agencies’ own guidelines for drug development during clinical trials?

In January 2019, the U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research issued a document, “Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody (ADA) Detection: Guidance for Industry.”

The document, described as providing “recommendations to facilitate industry’s development and validation of essays for the assessment of the immunogenicity of therapeutic protein products during clinical trials,” clearly acknowledges the existence of anti-drug antibodies, such as polyethylene glycol (PEG), in humans. The document states:

  • Immune responses to therapeutic protein products have the potential to affect product pharmacokinetics, pharmacodynamics, safety and efficacy.
  • The clinical effects of immune responses in subjects are highly variable, ranging from no measurable effect to extremely harmful.
  • Detection and analysis of ADA formation is a helpful tool in understanding potential immune responses.
  • Information on immune responses observed during clinical trials, particularly the incidence of ADA induction or any implications of ADA responses affecting pharmacokinetics, pharmacodynamics, safet, or efficacy is crucial for any therapeutic protein product development program.
  • Accordingly, such information, if applicable, should be included in the prescribing information as a subsection of the ADVERSE REACTIONS section entitled Immunogenicity.

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Six Questions We Should Be Asking About Covid-19

11-03-20 09:14:00,

Authored by Sharyl Attkisson, op-ed via TheHill.com,

One death is too many – and with careful management and a lot of luck, the coronavirus sweeping the globe will be curbed, in terms of illness and loss of life.

But in the heat of the moment, difficult questions have been raised that will persist beyond the current crisis. Here are six of them:

1. Is self-quarantining good enough?

Everyone would like to believe that anyone possibly exposed to a serious contagious disease would comply with self-quarantine requirements. But history teaches a different lesson. We need only look at TV personality Nancy Snyderman, a medical doctor who violated her Ebola self-quarantine in 2014. She had agreed to observe a voluntary 21-day quarantine in her New Jersey home after reporting in Liberia, where a photographer on her team contracted Ebola. Yet, Snyderman was spotted getting takeout soup from a local restaurant.

There are plenty of examples of lesser-known patients violating quarantines. In 2003, a San Mateo County, Calif., man came down with symptoms of Severe Acute Respiratory Syndrome (SARS) and got caught violating a voluntary agreement to stay in his home.

Others who are quarantined during public health emergencies might be ill-informed, noncompliant, or even willfully spread the disease.

2. Do quarantines work well anyway?

Maybe not. A quarantine after the 2003 outbreak of SARS in Toronto was deemed “both inefficient and ineffective,” according to an article published by The Canadian Journal of Infectious Diseases & Medical Microbiology. A subsequent public health analysis concluded that at least 25 times more people were quarantined than was appropriate, the quarantine was “clearly ineffective” in identifying potential SARS patients, and only 57 percent of people quarantined were “compliant.”

3. How would a large quarantine be implemented and enforced?

During the 2003 SARS outbreak, police in China arrested a doctor infected with SARS for allegedly breaking quarantine and starting a further outbreak that infected more than 100 people. China then threatened to impose the death penalty on anyone who knowingly spread the disease.

If self-quarantining is not deemed effective enough, how would one reasonably enforce a quarantine of large numbers of people in a free society such as the U.S.?

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