Will more or less time save or cost lives?
Shortcuts On Regulations For The Coronavirus/Covid-19 Vaccine Research
According to Dr. Steven Goldstein, founder of the Houston Healthcare Initiative, it usually takes years for any vaccine to be developed, tested on humans and finally introduced to the public. What of the Shortcuts On Regulations For The Coronavirus/Covid-19 Vaccine Research? The much-anticipated vaccine for the Coronavirus/Covid-19 pandemic is progressing at unprecedented speed. But why is this the case and should the public be concerned? On his regular podcast Dr. Goldstein provides explanations. The listen to the Houston Healthcare Initiative podcast visit: Soundcloud, Libsyn, iHeartRadio, Apple Podcasts, Spotify, Stitcher, and Radio.com,
Timing
Dr. Goldstein described to his audience some of the reasons these vaccine trials were progressing so quickly. “Given the urgent need for a vaccine to help end this global pandemic, some vaccine developers are compressing the clinical process by running trial phases simultaneously,” Dr. Goldstein said. “Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), said that independent Data and Safety Monitoring Boards can end trials early if their interim results are overwhelmingly positive or negative, so that is another time saver.”
Caution Takes Time
The Food and Drug Administration (FDA) promised to fast track the approval process for a Covid-19 vaccine. But they have also said that there are far more rigorous standards in place than is typical for the Emergency Use Authorization (EUA) process for this vaccine. So while the NIAID made a way for the work on the vaccine to proceed more quickly than normal, the FDA says that its work will be ‘a careful evaluation with no rushing.’
The FDA Speaks
In an article published in the October 27, 2020 issue of USA Today, Dr. Peter Marks states that “this process will not be rushed. There will be no shortcuts in developing the relevant phase 3 efficacy results.” Dr. Marks also said that the public’s trust is important for the Covid-19 vaccine so it gets taken by the public. “Trust means everything. Trust in vaccines facilitated the incredible positive impact that vaccination had on public health in reducing illness and death over the past century.”
Not Predicting The Future But
Dr. Goldstein admitted that he was not very good at predicting the future, but he believed that the Coronavirus/Covid-19 vaccine could be available as early as January 2021. “There are currently dozens of vaccines under development and in the advanced stages of approval,” Dr. Goldstein said. “That the government has streamlined some of the requirements without compromising safety to help advance development is remarkable. But nothing in the world of medicine is without risk and the ultimate introduction of the Coronavirus vaccine is no exception. The laws and regulations, at least for now, seem to strike a balance that protects the public and aids in the fast delivery of a vaccine.”
About The Houston Healthcare Initiative
Dr. Steven Goldstein is a Houston based neurologist. He founded the Houston Healthcare Initiative and is an advocate for common sense solutions to the healthcare crisis that confronts the citizens and residents of the United States of America.
