On December 8, Children’s Health Defense submitted a petition to U.S. Food and Drug Administration (FDA) Commissioner Marty Makary. The petition requests that the Commissioner “deem Moderna’s SPIKEVAX and all its currently marketed Biologics License Application (“BLA”) versions (including MNEXSPIKE) and Pfizer/BioNTech’s Comirnaty, and all its BLA versions, misbranded.” Additionally, it requests that the BLA licenses for these vaccines should be revoked “due to a lack of compliance with FDA regulations.”
During the Covid-19 pandemic, the Health and Human Services Secretary approved an Emergency Use Authorization (EUA) for the Pfizer and Moderna Covid vaccines. An EUA serves to expedite the authorization of a vaccine considered reasonably effective during a declared public health emergency.
An EUA differs substantially from BLA licensure: “EUA products are deployed on the market based on only a ‘may be effective’ opinion of the HHS Secretary and are not subject to formal product recall procedures, applicable to regular pharmaceutical products.” On the other hand, BLA requires the submission of applicant information, product/ manufacturing information, pre-clinical studies, clinical studies, and labeling. A product may be granted BLA licensure if it meets the purity, potency, safety, efficacy, manufacturing compliance, labeling disclosure/ marketing compliance standards.
According to the petition, the vaccines in question were granted BLA licensure despite not undergoing legally compliant clinical investigations. Not only were the investigations sidestepped, but also “ample evidence points to the FDA’s continual waiver of most (if not all) normally applicable BLA standards, such as cGMP/cGLP compliance in R&D and manufacture of these products.”
A letter from Director of Alaskans 4 Personal Freedom Linda Boyle, DM, MSN, RN urges families to sign the petition and comment:
“Children’s Health Defense has filed an official petition with the FDA requesting that the agency revoke all licenses for the Pfizer-BioNTech and Moderna COVID-19 vaccines. It is very easy to comment. It takes little time to protect your family and children! Go here to sign the petition: Tell the FDA to Revoke Licenses on COVID Vaccines. We all have worked very hard to inform our friends, neighbors, and co-workers. Let’s not give up now. Thank you for helping keep our nation free.”