House lawmakers call for transparency, independent review for COVID-19 vaccine program
Democrats on Oversight Committee ask FDA how it plans to evaluate, deploy vaccines
A trio of Democrats on the House Oversight Committee are asking FDA for more information on how the agency plans to evaluate and deploy COVID-19 vaccines, in an effort to ensure the process is transparent, and involves independent review and interagency cooperation.
The demands for vaccine transparency come as Sichuan Clover Biopharmaceuticals Inc. dosed the first volunteers in a Phase I trial of its COVID-19 vaccine. According to BioCentury’s COVID-19 Resource Center, it is the eighteenth vaccine to enter the clinic.
“If we wait until a vaccine candidate is in hand before announcing the rules by which it will be judged, people will not have faith in the process,” the lawmakers wrote in a letter to FDA Commissioner Stephen Hahn. “We want the American public to be confident in the fact that FDA will not allow vaccine developers to cut corners, and that FDA will not approve coronavirus vaccines unless they are safe and effective.”
The letter’s co-signers are Rep. Carolyn Maloney (D-N.Y.), chairwoman of the Committee on Oversight and Reform; Raja Krishnamoorthi (D-Ill.), chairman of the subcommittee on economic and consumer policy; and James Clyburn (D-S.C.), chairman of the select subcommittee on the coronavirus crisis.
The Oversight Committee members requested a briefing with FDA on July 2 and requested information on the “decision-making process, the decision-makers and their roles, and the evaluation criteria that will be employed for vaccines applying for Emergency Use Authorization.” They also asked for the policies and procedures regarding deploying and monitoring a vaccine.
The legislators also urged Hahn to commit to several transparency initiates, including guaranteeing that any vaccine candidate will have to be proven safe and effective in a Phase III trial of 30,000 volunteers.
Safety and efficacy data should also be available to independent scientists, such as those on the Vaccine and Related Biological Products Advisory Committee (VRBPAC). The lawmakers emphasized that “interagency cooperation must be built into the process from the beginning” to ensure all groups are contributing to the vaccine programs’ success.
Once a vaccine is authorized, the National Vaccine Advisory Committee could help prioritize groups to be vaccinated.
Clover’s randomized, double-blind, placebo-controlled study will enroll about 90 healthy adults and 60 healthy elderly volunteers in Australia to receive SCB-2019, a trimeric spike protein subunit vaccine. The trial will also evaluate separate adjuvants from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Dynavax Technologies Corp. (NASDAQ:DVAX).
Clover has received $3.5 million from the Coalition for Epidemic Preparedness Innovations (see “Clover: Trimerizing Fusion Proteins”).