CSPI urges vaccination of placebo groups in vaccine trials

Dr. Peter G. Lurie will testify at FDA advisory committee meeting

No volunteer who puts his or her body on the line in a COVID-19 vaccine trial should be at a disadvantage in terms of vaccine access, according to Dr. Peter G. Lurie, president of the nonprofit Center for Science in the Public Interest. Lurie will urge the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee today to offer access to an authorized vaccine as soon as it is offered to others in their clinical or demographic group, and in accordance with federal or state guidelines.

“Some observers appear to be advocating for extended periods of blinded follow-up even after authorization,” Lurie will testify. “This position is hard to justify ethically, if it is inconsistent with public health recommendations, particularly with rapidly rising case rates and the reported levels of effectiveness for the Pfizer/BioNTech and Moderna vaccines.”

Lurie will argue that individuals for whom a vaccine is not yet recommended can be followed in blinded fashion for up to six months, as in the case of the Pfizer trial. But when a vaccine is recommended for an individual by federal or state authorities, Lurie says that the groups could be vaccinated in a blinded crossover manner, where the placebo group gets the vaccine and the vaccinated group gets the placebo.

“I believe that this will facilitate the collection of essential data while honoring the contributions of the tens of thousands of people whose altruistic efforts have brought us to where we are today,” Lurie plans to tell the committee.

Lurie also praised the FDA for the extraordinary effort involved in making so much progress so quickly, but cautioned the agency to be candid with the public about the side effects associated with the Pfizer vaccine, which include pain at the injection site, fatigue, headache, muscle ache, and other symptoms.

CSPI maintains a COVID-19 evidence hub for journalists, clinicians, researchers, and others who are seeking the most credible sources of trial information related to testing, therapeutics, and vaccines for the disease. Dr. Lurie also writes a blog that comments primarily on medical and regulatory aspects of COVID-19.