New Research Paper: mRNA COVID-19 Vaccines Are Gene Therapy Products

The Epoch Times Header

Now that the pandemic has ended, researchers are urging regulatory agencies to consider the safety issues associated with the rapid approval of COVID-19 vaccinesโ€”and to correctly classify messenger RNA (mRNA) vaccines as gene therapy products (GTPs) to prevent pharmaceutical companies from bypassing regulatory standards.

According to a paper published in Nature on June 22, COVID-19 mRNA vaccines, by mode and action, are gene therapy products and should adhere to different regulatory standards. Yet U.S. and European regulatory agencies have not classified COVID-19 mRNA vaccines as gene therapy products, which has allowed them to be regulated as vaccines against infectious diseases instead of being subjected to the more stringent regulation of GTPs.

Because current regulatory guidelines either do not apply, do not mention RNA therapeutics, or do not have a widely accepted definition for these products, regulatory agencies adopted a modified and accelerated approval process for COVID-19 vaccines in the form of a โ€œrolling review.โ€

A rolling review is a regulatory tool typically used during a public health emergency to speed up the assessment of data for medicines or vaccines. It allows data to be reviewed as it becomes availableโ€”without the complete data package or specific controls.

This process led to broad and continuous biodistribution of mRNA COVID-19 vaccines that were not thoroughly studied and yielded tests with noncompliant results regarding purity, quality, and batch homogeneity. Manufacturers are now planning to replace classic vaccines with mRNA vaccines using the same processโ€”starting with influenza vaccines.

Vaccines With mRNA Technology Are Gene Therapies

The Centers for Disease Control and Prevention currently defines a โ€œvaccineโ€ as a preparation used to stimulate the bodyโ€™s immune response against diseases. However, the agencyโ€™sย definitionย was changed in 2021 out of concern it didnโ€™t apply to COVID-19 vaccines.

A vaccine must contain an antigenย to trigger the bodyโ€™s natural immune response. Pfizer and Modernaโ€™s mRNA vaccines doย not contain antigens. The active substance usedย to elicit an immune responseย in these vaccines is the mRNAโ€”aย form of nucleic acidย and theย genetic material of the SARS-CoV-2 virusย that provides instructions to the body for producing antigensโ€”spike proteins.

By Megan Redshaw, J.D.

Read Full Article on TheEpochTimes.com

The Epoch Times
The Epoch Timeshttps://www.theepochtimes.com/
Tired of biased news? The Epoch Times is truthful, factual news that other media outlets don't report. No spin. No agenda. Just honest journalism like it used to be.

Columns

Trans-wormal

No worm ever said "I am anthropomorphizing, I am a butterfly" to a toad or flock of geese and expected acknowledgement and support.

In Greenlandโ€™s Icy Capital, Past Troubles Haunt Hopes for the Future

As geopolitical realities and ongoing economic growth raise the stakes, U.S. interest in Greenland and the dream of independence may change things in a big way.

How a Chinese Government Statistician Was Forced to Report Fake Data

Chinese local govt employee produced a non-authorized report on bees and was visited by police and threatened with being sent to a mental hospital.

โ€˜This One Time, at Groomer Campโ€™

All Camp Brave Trails programs focus on helping LGBTQ+ youth find what they need most to thrive: their people, their place, and their passion.

Why Recognizing a Palestinian State Now Undermines U.S. Interestsย 

A recent American Conservativeย article suggests President Trump recognize a Palestinian state, but this would undermine the interests of the United States.

News

Trump Administration Asks Supreme Court to Allow Dismantling of Education Department

Trump admin asked Supreme Court to allow it to resume dismantling U.S. Dept of Education, following a lower courtโ€™s previous order halting process.

FTC Warns of Rising Student Loan Scams, Says Fraudsters Took Millions From Borrowers

FTC is warning borrowers to steer clear of student loan debt-relief scams, after shutting down group of companies that allegedly charged millions in illegal fees and left customers worse off.

Court Orders Trump Administration to Restore AmeriCorps Funding to States

Federal court ordered Trump admin to restore AmeriCorps funding to states. The ruling comes as part of a lawsuit filed by 24 states and DC.

Tax Deductions You Can Take Without Itemizing

Itโ€™s not always beneficial to itemize. With IRSโ€™s current standard deduction for 2025 most Americans who canโ€™t itemize go with standard deduction.

US Economy Adds 139,000 New Jobs in May, Topping Market Forecasts

U.S. economy added 139,000 new jobs last month, surpassing economistsโ€™ expectations and indicating U.S. labor market remains in a robust position.

Guatemalan Deportee Arrives in US After Judge Orders Trump Admin to Facilitate Return

โ€œAmericaโ€™s asylum system was never intended to be used as a de facto amnesty program or a catch-all, get-out-of-deportation-free card,โ€ McLaughlin said.

Trump-Musk Feud Escalates Over Spending Bill: 5 Things to Know

A public feud between Musk and Trump took a turn for the worse. Musk claimed president wouldnโ€™t have won without him and president suggested Muskโ€™s subsidies could be pulled.

Supreme Court Rules 9-0 Wisconsin Violated First Amendment by Denying Tax Exemption to Catholic Charity

Supreme Court ruled unanimously that WI violated the First Amendment by not granting Catholic charity an exemption from paying unemployment tax.
spot_img

Related Articles