Bioethicists Respond: "Now That The Pfizer Vaccine Has Full FDA Approval, What Does This Mean For The Covid-19 Pandemic?"


Vivian V. Altiery De Jesus, MD, MBE and Shika Kalevor, MBE, BSN, RN

Publish date

Tag(s): Legacy post
Topic(s): COVID-19 pandemic Public Health Vaccines

In this series, we ask bioethicists to respond to a question that embodies current challenges for bioethics, medicine, or health care. In this blog, bioethicists were asked to share their thoughts on “Now That The Pfizer Vaccine Has Full FDA Approval, What Does This Mean For The Covid-19 Pandemic?” Here are their responses:

Vivian V. Altiery De Jesus, MD, MBE and Shika Kalevor MBE, BSN, RN

Vivian V. Altiery De Jesus

Approval of Pfizer’s COVID-19 vaccine by the Federal Food Administration (FDA) is without doubt a milestone. But is this enough to gain public trust and hopefully eradicate COVID-19 just as the world eradicated smallpox

The COVID-19 virus is responsible for over 4 million deaths worldwide. In the setting of no cure, prevention is prioritized. Among the preventive measures, vaccines are shown to decrease infection rate, morbidity, and mortality. Despite their benefits, they inherited the controversies surrounding vaccination overall: right to liberty, hesitancy and skepticism

However, unlike its predecessors, COVID-19 vaccines faced unique challenges. First, vaccine development was expedited. It took roughly 11 months from development to distribution due to previous coronavirus research, international cooperation, and substantial funding. Normally new drugs take years from their creation to their full approval.  Not surprisingly, this caused apprehension over the vaccine. Second, the COVID-19 vaccine was administered to the general public under the Emergency Use Authorization (EUA). The authorization allows the use of an unapproved product during a public health emergency. Regardless of the rigorous process involved in EUA, concern for safety deterred three in ten unvaccinated adults until the FDA granted full approval to the Pfizer vaccine. Third, unlike previous pandemics, social media had posed a challenge for experts and government leaders. It only takes one social media platform or communication app to spread misinformation to masses. 

The common denominator in all of these challenges is public distrust. The scientific community and leadership should consider historical trauma (such as racism), mistrust in government, and proactively mitigating misinformation. Public health interventions can improve their success if they have solid communication strategies, such as delivering transparent information. This would allow individuals to know the risks and benefits and reach an informed decision. Although a milestone, full approval of a COVID-19 vaccine is not the antidote to public distrust. Approval does not clarify the reasons behind fast-track development. In fact, FDA full approval, without addressing public trust, can have the contrary effect. Concerns for conflict of interests in FDA officials and financial gain from pharmaceutical companies may cause doubts in the population when deciding how to interpret the meaning of full approval. 

The focus after approval should not be “to mandate or not to mandate”, rather how we can improve public trust with this new information. KKF COVID-19 Monitor Finding Project expects three out of ten of unvaccinated adults to be vaccinated after the FDA vaccine approval. But what about the seven out of ten of the unvaccinated adults? Is the main purpose of a full approval to mandate and/or enforce vaccination efforts? Two prominent ethical concerns are not addressed by the approval status. First, mandating vaccination does not bypass the individual obligation/duty vs public health safety dilemma. Second, mandating vaccination has dire ethical consequences, such has disparities and discrimination against vulnerable populations. From conditioning access to education and jobs to vaccinating people against their will. Therefore, if implementing a vaccination mandate, careful ethical and practical issues should be considered.

Neither full approval nor a mandate will achieve public trust. It is the responsibility of different stakeholders such as healthcare providers, public health officials, politicians, government representatives, community leaders, scientific community, the press, along with other organizational bodies to foster trust in the public. Transparency and effective communication are essential. It is not the time for judgmental and aggressive attitudes, such as name calling, which may alienate individuals and discourage them from even contemplating the benefits and risks of the vaccine. Now that the Pfizer vaccine has a full FDA approval, it means that we have a chance to start building public trust or at least mitigating distrust for the sake of ending this pandemic and learning lessons for future disasters.

Shika Kalevor

Six hundred and thirty-one thousand. The number is so big that it is abstract. Each number represents a life. A story. A human being who died from COVID-19 in the United States. The COVID-19 pandemic has touched the lives of nearly every individual on the planet. In the United States, the pandemic has presented a challenge in which our society’s flaws have been exposed. Wearing a mask became political, the healthcare industry saw a racial reckoning, and countless people lost jobs and homes. Eighteen months ago, we needed PPE for frontline workers and guidance regarding masking and social distancing. Today, the needs of society have shifted as we attempt to transition into a renewed sense of normalcy given the arrival of a safe, efficacious, FDA-approved vaccine. Despite this milestone, the FDA approval of a vaccine against COVID-19 may change very little for BIPOC communities who have been victim to centuries of racial violence, structurally and interpersonally. So, what does the FDA approval mean for the COVID-19 pandemic? For this milestone to mean anything for those most harmed by America’s racialized past and present, we must shift our priorities to a focus on reparative and distributive justice.

Many say that Black Americans are hesitant to get the vaccine because of a history of mistrust. From medical experimentation to the eugenics movement, you could argue that mistrust of a new vaccine is warranted. An FDA approval alone is not a proxy for trust and more trust may require a lens of reparative justice. This approach to justice calls for attention to the inclusion of diverse voices and attention to race and structures of oppression. Prioritizing reparative justice requires a critical look at both the distributors of justice (those in power) and at those on the receiving end of justice (society) to ensure that those in decision-making positions can and will advocate for the needs of the marginalized communities they serve. An FDA approval alone does not change the fact that Black Americans still have to travel farther on average than White Americans in many counties to get a COVID-19 vaccine. We must reckon with injustice in a way that can meet the needs of a society without being ‘colorblind’ to the ways in which racism exists in our day to day lives. If we ignore historical oppression, structural racism, and social determinants of health, then we create environments that are not conducive to repairing the damage of centuries of racial violence. 

Centering mistrust alone in our response to vaccine-hesitant people is inadequate because we must pay attention to how the distribution of resources play a role in how various people gain access to the vaccine. A history of redlining systematically excluded Black Americans from access goods that still affect these communities today. This history is particularly relevant to public health initiatives that attempt to remedy disparities in access to the Covid-19 vaccine. Distribution of the vaccine must include a conception of distributive justice as well.  

We must create conditions that are conducive to ending pandemics, this includes a focus on reparative and distributive justice and the impact of structural racism, equitable access to vaccines, and inclusion of diverse voices affected by these legacies. This can look like including stakeholders of communities of primarily marginalized backgrounds and/or those who have not traditionally held decision-making power in the remediation of public health crises. 

We use cookies to improve your website experience. To learn about our use of cookies and how you can manage your cookie settings, please see our Privacy Policy. By closing this message, you are consenting to our use of cookies.