Grace Ketron

COVID-19 has created a new world filled with cloth masks and hand sanitizer. In March, conversations began revolving around the availability of hospital beds, respirators, and toilet paper. As researchers persistently combated this new strain of coronavirus, the world held its breath, waiting on the edge of its seat for the release of an accessible and affordable COVID-19 vaccine. Now, the moment the world has waited for is here: potential vaccines are ready for FDA approval, with a vaccine created by Pfizer leading the charge.

Typically, American vaccines take years or even decades to effectively develop. With COVID-19 cases still rising, the FDA has recognized the importance of developing a vaccine as quickly and safely as possible. The FDA Commissioner and the Director of the Center for Biologics Evaluation and Research explained, “We are committed to expediting the development of COVID-19 vaccines, but not at the expense of sound science and decision making. We will not jeopardize the public’s trust in our science-based, independent review of these or any vaccines. There’s too much at stake.”[1] To that end, federal agencies, like the CDC and HHS, created Operation Warp Speed“to produce and deliver 300 million doses of safe and effective” COVID-19 vaccines to Americans by January 2021.[2] In order for Pfizer’s vaccine to become widely accessible, three thingsmust happen in the next few weeks: (1) the FDA must grant an Emergency Use Authorization; (2) state governments must determine who will receive the vaccine first; and (3) the federal government must determine whether the public will pay for the vaccines.

First, the FDA must grant Emergency Use Authorization for Pfizer’s vaccine. The federal government began regulating American drugs in 1902 with the Biologics Control Act.[3] By establishing what later became the National Institutes of Health, the federal government gave itself the power to control how vaccines were created. In 1972, the FDA assumed responsibility for controlling vaccine testing in the United States. Today, Section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) grants the FDA Commissioner the authority to enact Emergency Use Authorizations that “allow unapproved medical products or unapproved uses of approved medical products” during national health emergencies.[4] In October, the FDA Commissioner determined that Emergency Use Authorizations should apply during the COVID-19 pandemic. Now, if and when the FDA Commissioner initiates an Emergency Use Authorization in the next few weeks, Pfizer can begin sending a small number of doses to hospitals and pharmacies around the country. The FDA plans to release its decision about Pfizer’s vaccine on December 10.[5]

Second, although approving vaccines during emergency health crises is an issue for federal agencies, state governments decide which Americans will receive these vaccinations first.[6] Pfizer estimated that it would make 50 million doses of its vaccine during 2020, but Pfizer has locations in both Michigan and Belgium.[7] Because Pfizer plans to split vaccines between countries, Americans likely have access to 25 million vaccine doses. While this initially sounds like quite an impressive number, one full vaccination requires two doses per person, so that leaves 12.5 million vaccines available for Americans during the remainder of 2020. To help states decide who to vaccinate first, the National Academies of Science, Engineering, and Medicine guides the Advisory Committee on Immunization Practices.[8]  In turn, the Advisory Committee speaks with the CDC, who then discusses options with state officials. Hospital workers and immunocompromised individuals will likely be the first to receive the COVID-19 vaccine.[9]

Third, the federal government must determine whether the public will pay to be vaccinated. While Americans are often required to pay for vaccines not covered by insurance, such as flu shots, the current national pandemic has altered cost analyses for COVID-19 vaccines. According to the CDC’s website, COVID-19 vaccines will be free for all Americans, although vaccine providers retain the ability to charge administration fees.[10] Essentially, the vaccines themselves are free to the public, but individual vaccine providers may charge additional fees that will be paid by insurance companies or the Health Resources and Services Administration’s Provider Relief Fund. By predominantly using taxes to fund vaccine dispersal, the federal government can ensure that everyone has access to the vaccine over the next few years. Otherwise, many Americans affected by COVID-19 would be unable to pay for an expensive vaccine.

In sum, federal agencies like the CDC and HHS are facing unprecedented challenges. They constantly engage in precarious balancing acts that simultaneously aim to save lives, reduce healthcare costs, and develop effective vaccines as quickly as possible. As specific COVID-19 vaccines receive Emergency Use Authorization from the FDA, federal agencies must offer widespread vaccinations without compromising drug testing mechanisms in place since 1902. New testing challenges will arise as federal agencies work with other countries that have developed vaccines. As we continue fighting COVID-19, federal agencies must determine whether foreign companies will be held to the same testing standards as American companies. Although Pfizer’s request for Emergency Use Authorization is a step in the right direction, stringent vaccine protocols will ultimately help Americans combat COVID-19.

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[1] COVID-19 Vaccines, FDA (last updated Nov. 20, 2020), https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines.

[2] Fact Sheet: Explaining Operation Warp Speed, HHS (last updated Nov. 20, 2020),  https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html#:~:text=Operation%20Warp%20Speed’s%20goal%20is,and%20diagnostics%20(collectively%20known%20as.

[3] Linda Bren, The Road to the Biotech Revolution: Highlights of 100 Years of Biologics Regulation, FDA Consumer Magazine, Centennial Edition (Jan.-Feb. 2006), https://www.fda.gov/files/about%20fda/published/The-Road-to-the-Biotech-Revolution–Highlights-of-100-Years-of-Biologics-Regulation.pdf.

[4] Emergency Use Authorization, FDA (last updated Nov. 23, 2020), https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

[5] Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate, FDA (last updated Nov. 20, 2020), https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccine.

[6] Rebecca Robbins and David Gelles, How Pfizer Plans to Distribute Its Vaccine (It’s Complicated), New York Times (last updated Nov. 20, 2020), https://www.nytimes.com/2020/11/12/business/pfizer-covid-vaccine-coronavirus.html.

[7] Id.

[8] 8 Things to Know about Vaccine Planning, CDC (last updated Nov. 20, 2020), https://www.cdc.gov/coronavirus/2019-ncov/vaccines/8-things.html.

[9] Robbins & Gelles, supra note 6.  

[10] 8 Things to Know about Vaccine Planning, supra note 8.