Regulation of COVID-19 Vaccines; Who is in Control?

by | Jun 23, 2021 |

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Two important regulatory developments are converging in the United States and the United Kingdom at the same time for the ill-fated COVID-19 investigational vaccines. The Centers for Disease Control has logged some more grim milestones in America as of June 4, 2021, with 329,021 certified serious safety reports, including 5,888 deaths and 19,597 hospitalizations.  

Sadly if Americans just said “no” to the elective vaccination program, 5,888 lives would have been spared, and possibly tens of thousands more not yet reported or still backlogged at the CDC. 

In this issue of The McCullough Report, we have Dr. Hamid Merchant, an academic pharmacologist in the UK who gives us the rationale why the COVID-19 vaccines are not sufficiently safe for full FDA approval. If the vaccines are not fully approved, this would be a blow to the propagandized mass vaccination program. However, if the vaccines win approval, the full prescribing information and the televised advertisements must contain fair, balanced information on safety which is not good for these products. An unfair package insert can be the basis for a lawsuit and removal of the product(s) from the market. Under the current EUA, no such mechanism exists. 

We also have Dr. Tess Lawrie, who is also based in the UK and is a well-recognized contract analyst to the WHO. She has submitted a report this week to the UK Medicines and Healthcare products Regulatory Agency with the conclusion that the COVID-19 vaccines are not safe for human use. Her analyses are unassailable, and the MHRA has a problem on its hands. So strap in, headphones on, and let’s cycle our way through this next edition of The McCullough Report.

The McCullough Report: Sat/Sun 2 PM ET Encore 7 PM – Internationally recognized Dr. Peter A. McCullough, known for his iconic views on the state of medical truth in America and around the globe, pierces through the thin veil of mainstream media stories that skirt the major issues and provide no tractable basis for durable insight. Listen on iHeart Radio, our world-class media player, or our free apps on AppleAndroid, or Alexa. Each episode goes to major podcast networks and can be heard on-demand anywhere in the world.

 https://www.openvaers.com/covid-data (accessed June 15, 2021)
 https://joppp.biomedcentral.com/articles/10.1186/s40545-021-00315-w
 https://blogs.bmj.com/bmj/2021/06/08/why-we-petitioned-the-fda-to-refrain-from-fully-approving-any-covid-19-vaccine-this-year/
 https://freedomalliance.co.uk/2021/06/10/open-letter-from-dr-tess-lawrie-to-chief-exec-mhra-dr-raine-urgent-report-covid-19-vaccines-unsafe-for-use-in-humans/

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Dr. Peter McCullough

Dr. McCullough is an internist, cardiologist, and epidemiologist managing the cardiovascular complications of both the viral infection and the injuries developing after the COVID-19 vaccine in Dallas, TX, USA.

Since the outset of the pandemic, Dr. McCullough has been a leader in the medical response to the COVID-19 disaster and has published “Pathophysiological Basis and Rationale for Early Outpatient Treatment of SARS-CoV-2 (COVID-19) Infection,” the first synthesis of sequenced multidrug treatment of ambulatory patients infected with SARS-CoV-2 in the American Journal of Medicine and subsequently updated in Reviews in Cardiovascular Medicine. He has dozens of peer-reviewed publications on the infection and has extensively commented on the medical response to the COVID-19 crisis in TheHill, America Out Loud, NewsMax, One America News, Victory Channel, NTD, and FOX NEWS Channel.

On November 19, 2020, Dr. McCullough testified in the US Senate Committee on Homeland Security and Governmental Affairs, in 2021-2022, the Texas Senate Committee on Health and Human Services, Colorado General Assembly, New Hampshire Senate, Pennsylvania Senate, and South Carolina Senate concerning many aspects of the pandemic response. On January 24, 2022, Dr. McCullough co-moderated and testified in the US Senate Panel “COVID-19: A Second Opinion” chaired by Senator Ron Johnson. Dr. McCullough has reviewed thousands of reports, participated in scientific congresses, group discussions, and press releases, and has been considered among the world's top experts on COVID-19.

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