Alert: Washington State Senate Passes Bill Redefining Vaccines Amidst mRNA Technology Controversy: The Legal and Ethical Conundrum
Despite the passage of Washington State Senate Bill 5982, which redefines the term "vaccine" to encompass all FDA-approved immunizations, including mRNA vaccines, critical discrepancies persist in understanding the legal and historical context surrounding these products.
The legislation overlooks the crucial distinction between 'immunization' and 'vaccination,' leading to a misalignment with the definition outlined in the 1986 Act. Furthermore, the mRNA technology employed in COVID-19 vaccines challenges traditional vaccine paradigms, as it neither prevents infection nor disrupts transmission, as typically required for vaccines.
This divergence from established norms underscores a pressing need for clarity in public health discourse and regulatory oversight. Moreover, the agenda of lobbyists advocating for the alteration of the definition of gene therapy coincides with the passage of this legislation in Washington State.
This concerted effort to redefine terms raises concerns about the influence of special interests on public health policy. It's essential to note that the so-called Covid-19 vaccines do not confer immunity but are purported to only reduce the symptoms of the disease. Consequently, they should be categorized as treatments rather than vaccines.
Even the FDA has classified them as 'CBER-Regulated Biologics' or 'therapeutics' under the 'Coronavirus Treatment Acceleration Program. In a filing with the Securities and Exchange Commission on November 9, 2018, Moderna stated, "Currently, mRNA is considered a gene therapy product by the FDA."
Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed not to irreversibly change cell DNA. However, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite differences in mechanism. Additionally, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain.
This SEC filing also indicates Moderna's concern with the use of the term 'gene therapy'. Some of their investigational medicines are classified as gene therapies by the FDA and the EMA, and the FDA has indicated that their investigational medicines will be reviewed within its Center for Biologics Evaluation and Research (CBER).
Despite the differences in mechanism, the association of their investigational medicines with gene therapies could result in increased regulatory burdens, impair the reputation of their investigational medicines, or negatively impact their platform or business. Again -- the crucial distinction lies in the focus on the word and meaning of 'immunize,' which pertains to providing immunity against a disease.
This definition conflicts with the criteria outlined in the 1986 Act, which focuses solely on immunity. In 1986, Congress passed the National Childhood Vaccine Injury Act (42 U.S.C. ยง 300aa-1), establishing 'a National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization.'
From both a public health and legal standpoint, immunization is the intended essence of vaccination. It's crucial to differentiate between a product being deemed "safe and effective" by the CDC and a medical product/medication/gene therapy technology actually conferring immunity.
Here are the sponsors and co-sponsors:
@Sen_ACleveland @gruberobinson @KarenKeiser1
@Dhingrama Senator Kevin Van De Wege [D]; Senator Steven Conway [D] ;
@SenNoelFrame
Senator Patty Kuderer [D];
@SenMarkoLiias
Senator Mark Mullet [D];
@GovInslee
Senator T'wina Nobles [D]; Senator Jesse Salomon [D];
@SenatorTrudeau Senator Javier Valdez [D]; @lisawellman44