December 4, 2020
A new informational resource concerning COVID-19 vaccine development, covidvaccinestatus.info, was recently launched to provide accurate and up-to-date information about ongoing, late-stage clinical trials of vaccines to prevent COVID-19.
The website was developed by Susan Blalock, Ph.D., Professor Emeritus at the UNC Eshelman School of Pharmacy, a leading behavioral scientist with over 30 years of experience in patient and public health education.
“The U.S Food and Drug Administration (FDA) review of vaccines to prevent COVID-19 is being fast tracked to make a safe and effective vaccine available to people in the United States as soon as possible,” Blalock said. “It is important for people in the general public, as well as health care providers, to have access to accurate, timely and unbiased information about the leading COVID-19 vaccine candidates in clinical trials, including findings concerning safety and effectiveness when available.”
Blalock is collaborating on this project with Linda Distlerath, Ph.D., JD, a health care industry leader who brings over three decades of experience in the global biopharmaceutical sector, with deep expertise in public policy, public affairs, and strategic alliances, especially in China, India and other the emerging markets.
Covidvaccinestatus.info has four major sections:
- Phase 3 Clinical Trials provides detailed information concerning 31 late-stage clinical trials of COVID-19 vaccines (as of Nov. 5, 2020) in the U.S. and other countries around the world. The trials are identified using ClinicalTrials.gov, a web-based resource maintained by the United States National Library of Medicine at the National Institutes of Health. This section will include links to authoritative sources of information about clinical trial findings and FDA announcements when available.
- Traditional Drug/Vaccine Development describes the phases of drug and vaccine development, including the FDA review and approval process.
- Operation Warp Speed explains the elements of the U.S. plan to develop and deliver 300 million doses of a COVID-19 vaccine by early 2021, including the collaborating government agencies such as the U.S. FDA, Centers for Disease Control (CDC) and the National Institutes of Health (NIH) and the financial support of several companies that will manufacture the vaccines, syringes and glass vials.
- FDA at Warp Speed outlines the criteria the FDA and its body of experts will use to evaluate the safety and efficacy of COVID-19 vaccines, covering the design of Phase 3 clinical trials, the clinical trial participants, emergency use authorization, and ongoing safety monitoring after approval of COVID-19 vaccines.
“A growing number of scientists, medical doctors and patient advocates are concerned that decisions to approve COVID-19 vaccines may be influenced by political pressure and emphasize that the regulatory review and approval process must be guided entirely by the evidence,” Blalock said. “I hope that the information provided by covidvaccinestatus.info will better equip patients and their families to talk with their doctors about immunization with COVID-19 vaccines once they are approved and available in the U.S.”
Questions about the covidvaccinestatus.info website can be directed to firstname.lastname@example.org.