NEW YORK, Dec. 9, 2020 /PRNewswire/ -- The Michael J. Fox Foundation for Parkinson's Research (MJFF) has received the Advocacy/Policy Award from the Reagan-Udall Foundation for the Food and Drug Administration. MJFF is the second organization ever to receive this award, which honors individuals or groups that have made an impact to improve public health through advocacy and public policy. It was conferred to MJFF at the 2020 Innovations in Regulatory Science Awards Dinner, which was held virtually on Tuesday, December 8, 2020.

Tom Skelton, CEO of Surescripts, recently spoke with Dr. Amy Abernethy of the FDA, about the impact of COVID-19 and the evolving data needs of public health.

ZURICH/LONDON (Reuters) - With COVID-19 vaccine trial results looking positive, governments and pharmaceutical firms face their next daunting challenge: convincing the world to get inoculated.

Public resistance to vaccines has been much discussed this year, but the issue became very real on Monday when Pfizer and BioNTech announced their candidate was more than 90% effective in large trials - hoisting an actual shot onto the horizon.

President Donald Trump has often touted the role of the military in distributing a COVID-19 vaccine, but health officials close to the process who are concerned about public distrust are taking pains to say the federal government won’t actually be handling vaccines. 

The president said at the final presidential debate that the distribution of a vaccine would be swift because he’s “counting on the military.” 

“We have our generals lined up, one in particular that’s the head of logistics. … He’s ready to go,” Trump said Oct. 22.

Black Americans distrust the government so much they're not participating in large numbers in COVID-19 clinical trials, and many say they won't get a COVID-19 vaccine – at least not until many others get it.

Although the first two large clinical trials of candidate vaccines have managed to include about 3,000 Black participants each, it hasn't been easy. And later trials might have even more trouble. 

Extraordinary and unusual measures may be needed to rapidly develop and distribute a vaccine against SARS-CoV-2, but those efforts should not compromise the safety and efficacy of any product that reaches the market, according to the FDA Vaccines and Related Biological Products Advisory Committee.

However, the committee did not make any recommendations for ensuring the products are not compromised.

Concerns raised yesterday by an advisory group to the U.S. Food and Drug Administration (FDA) may once again tap the brakes on Operation Warp Speed, the U.S. government’s $10.8 billion push to rapidly move candidate COVID-19 vaccines from concept to communities.

Executive Summary

CDC officials designing distribution plans worry some eligible for vaccination may wait for a better product to emerge.

Federal officials are now confronting another challenge for the uptake of a potential coronavirus vaccine – patient warehousing – along with waning public confidence in product safety and efficacy.

Vaccine experts on Thursday rigorously debated the Food and Drug Administration’s planned standards for clearing a coronavirus vaccine quickly for broad use, discussing what level of evidence would be sufficient to establish safety and effectiveness.