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?

2. Why does the FDA seem surprised by the recent reports of life-threatening anaphylactic reactions after the agency approved emergency use of two mRNA COVID-19 vaccines that contain polyethylene glycol?

3. Why did FDA officials not acknowledge the valid and scientifically supported concerns regarding the use of PEG in COVID-19 vaccines when CHD first notified them in September? 

4. Why did the FDA abandon its regulatory authority to the pharmaceutical companies developing COVID-19 vaccines?

5. Will FDA and NIAID now require mRNA vaccine manufacturers to conduct assessments of the immunogenicity of the pegylated lipid nanoparticles used in their COVID-19 vaccines, and will they also consider pre-screening of all mRNA vaccine recipients for the presence and titers of anti-PEG antibodies?