With people across America seeking any ray of hope amid this pandemic, news reports can sometimes make it seem like a COVID-19 vaccine is right around the corner. But the reality is that developing, testing, manufacturing, and distributing a vaccine is a complicated and expensive process.
Given the urgency of the pandemic, normal vaccine development timelines are being compressed, and public-private partnerships have been formed to provide funding — but the need for safety and efficacy must remain a priority.
The Food and Drug Administration (FDA) has issued industry guidance for the development and licensure of a vaccine to combat the novel coronavirus.
The Advisory Committee on Immunization Practices will review the evidence, and weigh the risks and benefits, to make a recommendation on use of vaccines — with recognition that safety is paramount.
In the race for such a vaccine, it’s crucial that medical researchers here and worldwide are guided by sound, evidence-based science.
We cannot allow political considerations, or any factor or procedure that lies outside evidence-based science, to compromise vaccine development.
Today, it’s easy for us to take vaccines for granted. But the fact is vaccines are one of the greatest advances in modern medicine the world has yet witnessed, responsible for saving countless lives and vastly reducing the incidence of diseases such as tetanus and diphtheria.
The effort to develop a COVID-19 vaccine is global in scale, with unprecedented resources devoted to work that’s proceeding at a rapid pace, given what is at stake.
As with any vaccine, the object is to imitate an infection as closely as possible without inducing illness in an otherwise healthy person.
Clinical development of vaccines occurs in three distinct phases. Each phase involves testing the vaccine on a larger group of participants.
In phase I, the vaccine is administered to a small group, typically fewer than 100 people, to determine if it’s safe and to learn about the response it produces.
In phase II, the test pool is expanded to hundreds of people to gain detailed information on safety, immunogenicity, and the timing and amount of dose size.
In phase III, the testing pool is expanded to include thousands or even tens of thousands of participants to detect potential side effects that didn’t appear in smaller groups, and to further evaluate the effectiveness of the vaccine.
Ensuring that groups of individuals of varying levels of risk for COVID-19 are included in clinical trials for vaccines should be a priority.
The speed at which the vaccine development process is proceeding reflects the urgency of this public health emergency and a commitment by producers in the United States and elsewhere to “manufacture at risk.”
This means producing enormous volumes of one or more promising vaccine formulations before testing is completed, with the goal of having millions of doses on hand once FDA approval is secured.
The risk is financial, of course. If the selected vaccine fails in a clinical trial, that supply must be discarded at a tremendous financial loss.
Of additional concern is the fact that misinformation about vaccines, primarily spread by the repetition of disproved theories and false claims, has led some individuals to avoid immunizing themselves or their children.
The tragic result has been outbreaks of measles, whooping cough (pertussis), mumps, and other vaccine-preventable diseases in some communities in recent years.
The pandemic and stay-at-home orders have also affected routine childhood immunizations, which have dropped sharply since mid-March.
A Centers for Disease Control and Prevention (CDC)
I encourage parents to contact their pediatricians or other healthcare providers and resume the recommended schedule of childhood immunizations, which are considered essential medical care.
It is my hope that the government and manufacturers take necessary steps to bolster public confidence when COVID-19 vaccines are brought forward.
I have faith that the scientists and medical professionals at the CDC and FDA will not cut corners in the race to develop a safe and effective vaccine.
When that milestone is achieved, I also have faith that our nation will accept the vaccine(s) and make COVID-19 a distant, if painful, memory.
Susan R. Bailey, MD, is an allergist/immunologist and the 175th president of the American Medical Association. You can learn more about Dr. Bailey by reading her full bio here.