You Too Can See How COVID-19 Vaccines Are Approved
As of September 3, 2020, the US's Operation Warp Speed (OWS) is reported to have invested more than $10 billion in SARS-CoV-2 vaccine candidates.
Much of that investment is “at-risk” for the purchasing of experimental vaccines, which means the pharmaceutical companies are producing hundreds of millions of doses that may end up unusable if those coronavirus vaccine candidates fail to prove they are safe and effective during clinical trials.
The good news is there are vaccine candidates in late-stage efficacy trials in the USA, and around the world.
These studies could publish revealing insights as early as October 2020. If that happens, a vaccine candidate could become available through what’s known as a U.S. FDA Emergency Use Authorization.
The FDA has already scheduled an open session meeting on October 22, 2020, at 10 a.m. EST.
The 161th meeting of the Center for Biologics Evaluation and Research’s, Vaccines and Related Biological Products Advisory Committee, will discuss, in general, the development, authorization, and/or licensure of vaccines to prevent COVID-19.
“The FDA has scheduled a meeting and is also prepared to rapidly schedule additional meetings of this committee upon submission of any applications as appropriate,” said FDA Commissioner Stephen M. Hahn, M.D. “I want to assure the American people that the process and review for vaccine development will be as open and transparent as possible.”
“A discussion with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding regarding clinical development of these vaccines indicated to prevent COVID-19 and the data needed to facilitate their authorization or licensure.”
“It is critical for people to see FDA’s expectations for data to support safety and effectiveness,” concluded Dr. Hahn’s press comments on September 2, 2020.
Anyone can virtually attend this FDA meeting by enrolling at this link.
Operation Warp Speed is a partnership of the Department of Health and Human Services (HHS), the Department of Defense (DOD), and the private sector — aims to accelerate control of the Covid-19 pandemic by advancing the development, manufacturing, and distribution of vaccines, therapeutics, and diagnostics.
Announced on May 15, 2020, OWS set ambitious objectives: to deliver tens of millions of doses of a SARS-CoV-2 vaccine, with demonstrated safety and efficacy, and approved or authorized by the FDA for use in the U.S. population… beginning at the end of 2020.
And to have as many as 300 million doses of such vaccines available and deployed by mid-2021.
An updated list of SARS-CoV-2 preventive vaccine candidates can be found at this CoronavirusToday’s link.
PrecisionVaccinations publishes research-based vaccine development news.