COVID-19 Evidence and Vaccines
It is imperative for clinicians to base their practice on evidence to ensure optimal outcomes for our patients and the public. That focus on evidence-based practice has been extraordinarily challenged over the past months of the COVID-19 pandemic. We have witnessed the rapid evolution of evidence regarding COVID-19 and the ongoing challenges that evolution creates in living with uncertainty, struggling to interpret new evidence, and determining what to do in a crisis when there is no solid evidence.
We have made remarkable progress in caring for COVID-19 patients based on evidence generated in a short period of time: new therapies, new medications, new care processes. At the same time, we have seen the struggle people have understanding and believing basic facts such as those surrounding the safety precautions we know work in limiting the spread of the disease: wearing masks, social distancing, and washing our hands. The evidence has often been distorted, misrepresented, and politicized for purposes other than the promotion of public health.
Now we are facing a similar situation with the COVID-19 vaccine. There are varying opinions of the safety and efficacy of the vaccine across the United States. Yes, the vaccines have been developed and tested rapidly, more rapidly than any other vaccine in our history. And yes, it is understandable why minorities and others may distrust vaccine safety and the US health care system on the basis of historic and ongoing health inequities. But we have also never had thousands of brilliant scientists and researchers using novel techniques based on previous research all focused at the same time on achieving a singular purpose: finding a vaccine to end an ongoing pandemic.
Consider the following facts. The US Food and Drug Administration (FDA) has developed rigorous guidelines to ensure the safety and effectiveness of COVID-19 vaccines and determine emergency use authorization.1 The FDA will provide fact sheets for both health care providers and vaccine recipients/caregivers on each vaccine as it becomes available.2,3 An African-American scientist is being lauded as a leader in the development of one of the first and most successful vaccines.4 And more than 40% of global participants and 30% of US participants for the Pfizer-BioNTech vaccine trials were from racially and ethnically diverse backgrounds.5 Therefore, it is imperative that as health professionals we model making sound decisions related to the vaccine—relying on science6 rather than emotions, politics, or fear. We need to take the lead in having discussions with those who have concerns about receiving the vaccine. What does the evidence state regarding specific questions people have related to their individual situations?
We will continue to be confronted with the need to generate and understand the resulting evidence regarding COVID-19. Vaccines need to be tested in other populations such as pregnant women and children. How do we best care for and support patients who have long-term comorbidities and consequences in recovering from COVID-19? How can what we learn be applied to other diseases, populations, and situations? Now, more than ever, we need to follow and rely on the evidence.
Mary Fran Tracy, PhD, RN, CCNS
- US Food and Drug Administration (FDA). COVID-19 vaccines. Accessed December 14, 2020. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
- US Food and Drug Administration (FDA). Fact sheet for healthcare providers administering vaccinee (vaccine providers). Emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). December 2020. Accessed December 23, 2020. https://selfservehosteu.pfizer.com/pfrrdownload/file/fid/77056
- US Food and Drug Administration (FDA). Fact sheet for recipients and caregivers. Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19) in individuals 16 years of age and older. December 2020. Accessed December 23, 2020. https://selfservehosteu.pfizer.com/pfrrdownload/file/fid/77051
- Romero L, Salzman S, Folmer K. Kizzmekia Corbett, an African American woman, is praised as key scientist behind COVID-19 vaccine. December 13, 2020. Accessed December 23, 2020. https://abcnews.go.com/Health/kizzmekia-corbett-african-american-woman-praised-key-scientist/story?id=74679965
- Pfizer. Our progress in developing an investigational COVID-19 vaccine. December 14, 2020. https://www.pfizer.com/science/coronavirus/vaccine
- Gavi. The COVID-19 vaccine race. Accessed December 2, 2020. https://www.gavi.org/vaccineswork/covid-19-vaccine-race