08.04.20

CNN: 3 senators introduce legislation aimed at increasing transparency in vaccine approval process

Three US senators released bipartisan legislation Tuesday aimed at increasing safety and transparency around the approval of a coronavirus vaccine for emergency use in the US.

Sens. Maggie Hassan, a Democrat from New Hampshire, Mike Braun, a Republican from Indiana) and Lisa Murkowski, a Republican from Alaska, said they introduced the Safe Authorization for Vaccines during Emergencies (SAVE) Act in part to improve public confidence in a potential vaccine amid some concerns that safety is being sacrificed in the race for a Covid-19 vaccine.

The bill would codify the role of the Centers for Disease Control and Prevention and Food and Drug Administration in reviewing a potential vaccine, ensuring that recommendations on vaccine safety and efficacy be made public. The bill aims to hold the Health and Human Services Department accountable for ensuring vaccine advisory committee meetings are transparent.

“Academic institutions, researchers, and industry have all stepped up during this crisis to move towards a successful vaccine — regulators need to as well,” Braun said in a statement.

The senators plan to push for the bill to be included in an upcoming Covid-19 relief package.

The FDA has issued guidance requiring a vaccine to be at least 50% effective in preventing infection or serious disease before it receives emergency use authorization (EUA). An EUA would greenlight a coronavirus vaccine for use on an expedited basis.


By:  Lauren Mascarenhas
Source: CNN