BMN Blog

MAR 16
Vaccine Hesitancy

Currently, Alabama ranks toward the bottom in the country in regard to the number of citizens receiving the vaccine on a per capita basis. Why does Alabama seem to be trailing behind the rest of the country in vaccination rates?

“Alabama physicians are no stranger to patient education and how it can ease hesitancy regarding vaccines. However, the public’s uncertainty surrounding the COVID-19 vaccine is unparalleled,” says Dr. John S. Meigs, who is President of the State of Alabama Medical Association.

Around 39 percent of Americans say they probably or definitely would not get a coronavirus vaccine, though half of this group says they might consider getting vaccinated once more information is available. Yet, 21 percent of American adults do not intend to get vaccinated and are “pretty certain” more information will not change their mind.[1]

“Physicians throughout Alabama must be prepared to not only administer COVID-19 vaccines but to also explain why people should receive them,” Meigs says. “Health care providers must maintain a balance between educating their patients about the necessity for the vaccine while avoiding any implication of coercion. You are essential in helping to rebuild trust and could be a catalyst for a more successful uptake of the vaccine.”

While most physicians don’t have the background to determine a vaccines’ safety and effectiveness on their own, they can follow the recommendations of the Advisory Committee on Immunization Practices (ACIP) while simultaneously educating their patients on ACIP’s processes, clinical trials, and Emergency Use Authorizations.

Consistent and clear communication from physicians and other health care providers is critical while attempting to build public confidence in vaccine programs. This includes explaining how vaccines work and how they are developed, from recruitment to regulatory approval based on safety and efficacy.

A leading concern among those who are hesitant to get vaccinated seems to be how quickly the COVID-19 vaccines are being developed and distributed to the public. Usually, vaccines can take anywhere from 10 to 15 years to reach the public. When patients voice these concerns, take the opportunity to educate them on the following topics:

Clinical Trials

  • Clinical trials evaluate COVID-19 vaccine responses in a large group of participants to generate scientific data and other information needed by the FDA to determine safety and effectiveness.
  • The FDA sets rigorous standards regarding how the clinical trials are being conducted.
  • During phase 1, the vaccine is given to a small number of generally healthy people to assess its safety at increasing doses and to gain early information about how well the vaccine works to induce an immune response.
  • If no safety concerns are raised during the phase 1 studies, the phase 2 studies will include more people. Various dosages are tested with typically varying health statuses and from different demographic groups in randomized-controlled studies.
  • The studies provide additional safety information on common short-term side effects and risks, examine the relationship between the dose administered and the immune response, and may provide initial information regarding the effectiveness of the vaccine. controlled studies involving broad demographic groups (i.e., the population intended for
  • In phase 3, the vaccine is generally administered to thousands of people in randomized, use of the vaccine) and generates critical information on effectiveness and additional important safety data.[2]
  • This final phase provides additional information about the vaccinated participant’s immune response compared to those who receive a placebo.

Emergency Use Authorization

  • The definition of an Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.
  • Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives.[3]
  • The FDA evaluates the information submitted by the manufacturer and must determine that the potential and known benefits outweigh the potential and known risks of the vaccine in order for an EUA to be issued for a vaccine.

Advisory Committee on Immunization Practices

  • The Advisory Committee on Immunization Practices (ACIP) is composed of public health and medical experts who establish recommendations on vaccine use in the general population of America.
  • The resulting recommendations stand as public health guidance for safe use of vaccines and related biological products.
  • ACIP consists of 15 authorities who are responsible for developing vaccine recommendations. The Secretary of the U.S. Department of Health and Human Services (DHHS) selects these members after an application and nomination process.
  • 14 of these members have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, or preventive medicine.
  • One member is a consumer representative who provides perspectives on the social and community aspects of vaccination.[4]
  • There are also 30 additional non-voting representatives from other highly-regarded professional organizations.

Safety and Efficacy of Pfizer and Moderna Vaccines

  • According to a safety and efficacy abstract on the Pfizer vaccine, the two-dose Pfizer regimen was found to be safe and 95 percent effective against Covid-19.[5]
  • The Moderna abstract shows that the vaccine showed 94.1 percent efficacy at preventing Covid-19 illness.
  • Side effects for both vaccines seem to be more prevalent after the second dose and include redness at the injection site, swelling, fatigue, headache, and muscle and joint pain. There have been a few reports of fever after vaccination.
  • These side effects are typical of many vaccines and is a sign of the patient’s immune system kicking into gear, which is the response you want.
  • The Pfizer vaccine has seen a few cases of anaphylaxis and lesser allergic reactions. No allergic reactions showed up during the clinical trials but it remains to be seen how common this is and if the Moderna vaccine will cause the same effect.

Information regarding the Coronavirus has been riddled with partisanship and conspiracy theories. The Medical Association continues to work with public health officials, state leadership and more to clarify some of the mixed messages received by the general public. We pledge to help our member physicians by demonstrating a unified front while working with state leaders at all levels about the need for the COVID-19 vaccine.

Physicians also have the opportunity to share the necessity of vaccinations with their patients. You can use time in the exam room, social media, and email to notify their patients about how you feel about COVID-19 vaccines. It’s best to offer neutral, scientific information just to keep the subject in people’s minds.

We can start to renew the trust in our health care system now by shutting down divisive rhetoric and focusing on science. The vaccine may not be widely available until later this year but start having these conversations with your patients now. The road to recovery is long but will be possible thanks to the dedicated health care workers throughout Alabama.

 

 

[1]Funk, C., & Tyson, A. (2021). Intent to Get a COVID-19 Vaccine Rises to 60% as Confidence in Research and Development Process Increases. Retrieved 19 January 2021, from https://www.pewresearch.org/science/2020/12/03/intent-to-get-a-covid-19-vaccine-rises-to-60-as-confidence-in-research-and-development-process-increases/

[2] Emergency Use Authorization for Vaccines Explained. (2021). Retrieved 19 January 2021, from https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

[3] Emergency Use Authorization for Vaccines Explained. (2021). Retrieved 19 January 2021, from https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained

[4] Role of the Advisory Committee on Immunization Practices in CDC’s Vaccine Recommendations | CDC. (2021). Retrieved 19 January 2021, from https://www.cdc.gov/vaccines/acip/committee/role-vaccine-recommendations.html

[5] Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine | NEJM. (2021). Retrieved 19 January 2021, from https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

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