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Dr. Stephen Thomas, Chief of Infectious Diseases at SUNY Upstate Medical University, who has been involved in multiple vaccine trials and is conducting a Pfizer Covid-19 trial at his University, he explains that while concerns about a Covid-19 vaccine are understandable, the development process is robust.
Clinical trials are underway for multiple Covid-19 vaccines.
My university in Syracuse, New York, is one of many places testing an experimental Covid-19 vaccine being developed by Pfizer and its partner BioNTech. In just a few weeks, my team enrolled hundreds of volunteers. Our participants include men and women from our community who are at increased risk of SARS-CoV-2 infection or at increased risk of a poor clinical outcome if they develop Covid-19. Many of our volunteers are healthcare providers, essential public-facing employees, or seniors with underlying medical problems. The vast majority of these people had never participated in a research trial before, but enthusiastically rolled up their sleeves for two injections of the candidate vaccine or a placebo.
I always ask volunteers why they are considering participating in a research trial. In the past, the motivations that people shared with me ranged from personal concerns to pure altruism. With this trial of the Covid-19 vaccine, the responses are much more consistent: People volunteer to make a difference. They want to end this pandemic, they see a vaccine as a tool that can help us get there, and if volunteering speeds up the vaccine development process, everyone is there.
Another common sentiment among our Covid-19 vaccine volunteers is that they expect others to take the vaccine if the FDA finally approves its use. I share my volunteers’ concern that vaccine acceptance will be low as more and more information indicates that a significant percentage of Americans may choose not to get vaccinated.
It doesn’t take 10 years to develop a vaccine.
Some trends can help explain why people are considering not getting vaccinated. The first is an increase in the activity of the anti-vaccine movement. I am referring to the movement that combines the vaccination recommendations and requirements of the United States with broader agendas based on personal rights. These groups represent a small minority, but they are well organized and communicate effectively. Their messages have sparked the resurgence of diseases like measles that were once thought to be virtually eradicated. Anti-vaccine messengers are exploiting the Covid-19 pandemic, promulgating feelings of mistrust about the Covid-19 vaccine development process, and people are listening.
The second trend is that people are concerned about the rapid development speed of Covid-19 vaccine candidates. People wonder how a development process that has historically lasted up to 10 years can now be carried out in a single year; they wonder which safety corners are being cut to travel at “warp speed.”
At this point, people must realize that no need take 10 years to develop a vaccine. Extended vaccine development schedules are, in part, the byproduct of efforts to mitigate financial risk. With development prices often exceeding US $ 1 billion per vaccine, it makes sense for developers to move slowly and iteratively rather than embarking on expensive and high-risk parallel paths.
For example, you would never invest hundreds of millions of dollars into large-scale manufacturing of a vaccine before you know that the vaccine is safe and effective. For companies participating in the US government’s “Operation Warp Speed”, much of this financial risk is being borne by the US taxpayer. Almost $ 10 billion USD will support the development and manufacture of the most promising Covid-19 vaccine candidates. If a vaccine is shown to be safe and effective, the doses will be ready.
The vaccine review and approval process is also known to extend development timelines. The FDA used to take more than 2 years to review a vaccine license application. Since the early 1980s, various acts of Congress, such as the Prescription Drug User Fees Act, have reduced review times to 10 months or less. A highly responsive and engaged FDA demonstrated even more efficiency during the recent Ebola and Zika epidemics, and we’re seeing the same thing during the Covid-19 pandemic.
It is also important for people to understand that the technologies supporting the leading Covid-19 vaccine candidates are not new. Developers are using vaccine platform technologies that were previously designed to support HIV, influenza, Ebola, Zika, and other experimental vaccines. A platform technology is a common vaccine design that allows developers to connect and use new components for specific diseases, such as Covid-19. Many Covid-19 vaccines are based on platforms that have previously been administered to thousands of people.
A third trend is growing concern over the FDA’s Covid-19 vaccine review process. The alleged White House influence on hydroxychloroquine and convalescent plasma regulatory reviews has people wondering whether the policy will undermine the objective review of any Covid-19 vaccine seeking an emergency use authorization or license. Public concern is so palpable that some developers posted their clinical trial protocols for all to see, and many signed a pledge reaffirming their commitments to public safety.
These concerns are understandable, but it is important to understand that there are numerous procedures that are routinely used during large-scale vaccine trials aimed at protecting public safety, reducing bias, and ensuring that data reviews are objective. Before a trial can even begin, external ethical review committees and institutional review boards determine whether a vaccine trial study plan has scientific merit and protects people from unnecessary risk.
The gold standard for ensuring that vaccine results are unbiased is the use of randomized, double-blind methods. Randomization means that chance determines which volunteer will receive placebo and which will receive the vaccine. “Double blind” means that neither the volunteer nor those administering the vaccine know who was randomly assigned to which group.
“My biggest concern is the possibility that millions of Americans will refuse to receive a safe and effective Covid-19 vaccine.”
Another step to ensure robust studies is periodic data reviews by independent data and security monitoring boards. These groups of external subject matter experts review the data at various times during the test and advise developers on whether the test should continue or stop.
A trial can be stopped if there are safety concerns, efficacy has been clearly demonstrated (so that things can move to the next step), or if the performance of the vaccine is so poor that continuing is pointless. Once the trial data finally reaches the FDA, additional committees will review the data and advise the FDA on whether the data supports approval of the vaccine to go to market and, if so, how the vaccine should ultimately be distributed. .
Every day, there is new information (and inevitable feedback) about the ongoing Covid-19 vaccine development efforts. Much of the information is confusing and some is misleading on purpose. As a result, many people are unsure whether they will choose to get vaccinated if a vaccine is available.
From my perspective of conducting multiple vaccine trials over the years, I see efficiencies being introduced into the Covid-19 vaccine development process that are long overdue, financial risks being taken without the associated security risks, and a redundant external review and oversight system that should be immune to even the most aggressive attempts to influence the process.
My biggest concern is the possibility that millions of Americans will refuse to receive a safe and effective Covid-19 vaccine. If this happens, the pandemic will undoubtedly continue, overwhelming hospitals, shortening the lives of patients and taking an unfathomable toll on the fabric of society.
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