The COVID-19 pandemic has spurred scientists to move at a faster clip than ever before to deliver an inoculation to the public, “but the need for safety and efficacy must remain our priority,” AMA President Susan R. Bailey, MD, recently said in a speech she gave to a virtual gathering of the City Club of Cleveland.
“Politics should have no place in a public health crisis. … We must ensure that policy decisions are driven by facts and evidence and not ideology and politics,” she said. “That’s why the AMA continues to call on elected officials and major intuitions to affirm science and evidence in their words and actions.”
Dr. Bailey said the government’s name for the push to compress a usually lengthy process to produce a vaccine—Operation Warp Speed—is “unfortunate.”
“Safety and efficacy are always the No. 1 priority when it comes to vaccine development. So, whether it’s accurate or not, this title sends a bit of a mixed message. Yes, we’re all incredibly eager for a vaccine to fight COVID-19, but if it’s not safe and it’s not effective then it’s going to create more problems than it will solve,” she said in her speech.
Dr. Bailey also addressed:
- Accelerated vaccine development.
- What the AMA has been doing to help physicians and patients during the COVID-19 pandemic.
- How the AMA is working to bring greater equity across medicine, something that has become even more urgent during the pandemic.
Dr. Bailey believes the institutions, procedures and policies the nation has in place to guide vaccine development will ensure that any vaccine administered would be safe and effective, even though the timeline is compressed.
The Food and Drug Administration (FDA) provided guidance on the development and licensure of a COVID-19 vaccine, she wrote in an opinion piece, “Evidence, Science Must Guide COVID-19 Vaccine Development,” that ran shortly before her speech.
Also, the Advisory Committee on Immunization Practices—recognizing that safety is paramount—will review evidence and weigh the risks and benefits of a vaccine so the committee can make a recommendation on a its use.
Certain things will remain the same during vaccine development. As with all potential vaccines, the clinical development of a COVID-19 vaccine is occurring in three distinct phases.
In phase I, fewer than 100 people receive the vaccine so scientists can determine its safety and the response it produces. For phase II, hundreds of people receive the vaccine so scientists can gather more detailed information on safety, immunogenicity, as well as the timing and amount of dose size.
And in phase III, thousands or tens of thousands of people are inoculated to detect potential side effects and further determine the vaccine’s effectiveness. She said the AMA is aware of more than 160 experimental vaccines in the preclinical trial stage of development worldwide; at least 19 are in Phase I trials, about a dozen have entered Phase II and five are in Phase III.
“I have faith that the scientists and medical professionals at the CDC [Centers for Disease Control and Prevention] and FDA will not cut corners in the race to develop a safe and effective vaccine,” said Dr. Bailey, an allergist and immunologist in Fort Worth, Texas.
Sound science is important because it will help combat vaccine hesitancy and bolster the public’s confidence and willingness to be inoculated once a COVID-19 vaccine is available.
“It is crucial that physicians and patients have total confidence in the vaccine and the process that led to its development” and that “this is something the AMA is going to continue to monitor very closely … that means analyzing the peer-reviewed research and data and not just taking information sent out in press releases and through news articles,” Dr. Bailey said in her speech.
A recent Pew Research Center survey found that 27% of American adults said they would not opt for a COVID-19 vaccine if it were available.
During her speech, Dr. Bailey emphasized that it is critical that those who participate in the trials for the experimental vaccines come from diverse backgrounds. She said that will help ensure more people get vaccinated, which is especially important in communities of color that have seen African Americans and Hispanics three times as likely as whites to become infected with COVID-19 and about twice as likely to die.
“It’s important that drugmakers make inroads into communities they have historically ignored for clinical trials of disease—communities where there is, rightfully, a lot of mistrust after decades and decades of mistreatment, exploitation and injustice,” she said and noted that Black, Hispanic and Indigenous Americans have higher infection and death rates than white Americans. “Historically, African Americans make up only about 5% of clinical trial participants. Hispanics, far less. We need your help in encouraging people to participate in the trials that started enrolling volunteers.”
She also said that it will be important that all who need the vaccine can get it, noting that the National Academy of Medicine recently announced a committee that will create an overarching framework to help policymakers plan for equitable allocation of vaccines. The committee will consider what criteria should be used to set priorities for equitable distribution among groups of potential vaccine recipients, including those at high risk because of health status, occupation or living conditions and those in communities of color. The committee is also expected to recommend strategies to ease concerns for those hesitant to receive a vaccine.
You can stay up to speed on the AMA’s COVID-19 advocacy efforts and track the fast-moving pandemic with the AMA’s COVID-19 resource center, which offers a library of the most up-to-date resources from JAMA Network™, the CDC, and the World Health Organization.
Find out what the AMA is doing to promote health equity for all Americans at the AMA Center for Health Equity.