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April 02, 2021

COVID-19 Vaccine Development and Distribution

This Bulletin is brought to you by AHLA’s Life Sciences Practice Group.
  • April 02, 2021
  • Lindsay P. Holmes , BakerHostetler

As Joe Biden enters the third month of his presidency, it is an opportune time to review the progress of COVID-19 vaccine development and distribution. Because new information is made available every day, this is a summary of some of the recent interesting developments related to COVID-19 vaccines.

The theme and tone of the Biden administration related to the vaccine rollout have been that we are making progress and there is hope, but still more work to do. Within days of the inauguration, the Biden administration published the “National Strategy for the COVID-19 Response and Pandemic Preparedness.”[1] In 200 pages, the administration outlined its action plan to address the pandemic, including ensuring “the availability of safe, effective vaccines for the American public.”[2] The administration announced that it would use the Defense Production Act (DPA) to expand manufacturing[3] and issued a flurry of executive orders focused on vaccine development and distribution.

The Food and Drug Administration (FDA) has now authorized three COVID-19 vaccines through the emergency use authorization (EUA) process, most recently the Janssen vaccine, authorized by the FDA on February 27, 2021.[4] Janssen is unique in that it is a single-dose regime.[5] The Pfizer, Moderna, and Janssen (Johnson & Johnson) vaccines are now in wide distribution in the United States. The White House estimates that roughly 81 million vaccinations have been delivered.[6]

Biden credited the DPA for enabling the expansion of the safe manufacturing of vaccines to accelerate vaccine production.[7] He also noted that the DPA will continue to be used to ensure that materials needed to produce the vaccines remain available.[8]

On March 11, the administration announced that all Americans will be eligible for vaccinations by May 1, 2021.[9] As it stands currently, states are phasing eligibility criteria at different rates, making the current phase of eligibility different based on the state where you live or work. Biden’s announcement is aimed at correcting this disorganized state-by-state approach. However, Biden's announcement does not mean that as of May 1 every American will have access to the vaccine. There is also a plan to make sure that access is addressed, including increasing vaccination sites and vaccinators and making it easier for people to find a place to get vaccinated.[10] The access piece will likely prove to be a bigger hurdle than the eligibility piece of the national vaccine rollout. The administration is also paying particular attention to variants, as are the FDA and the Centers for Disease Control and Prevention (CDC). The administration hopes to limit the spread of newly developing variants through increased testing.[11]

FDA Vaccine Updates

In late February, the FDA issued two guidance documents related to vaccine development, one of which was updated guidance related to EUAs for COVID-19 vaccines.[12] This guidance supersedes the guidance issued on October 22 and is aimed at assisting sponsors in determining the data and information required to support an EUA request. The guidance also outlines the FDA’s planned strategy for evaluating vaccines to address COVID-19 variants, which have become a growing concern as they spread around the globe. During a recent hearing before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, the FDA stated, “The emergence of the virus variants raises new concerns about the performance of these authorized vaccines, as well as therapeutics and diagnostics that FDA has authorized for COVID-19. … We want the American public to know that we are using every tool in our medical toolbox to fight this pandemic, including pivoting as the virus adapts.”[13]

In addition to efforts to authorize vaccines to combat COVID-19, the FDA has been hard at work, along with the Federal Trade Commission, Department of Justice, and other agencies, tackling a new category of fraudsters looking to take advantage of consumers’ desire to protect themselves against COVID-19. The FDA recently stated, “While vaccine distribution is underway throughout the country, schemes and unsavory efforts to mislead and scam the American public are plentiful” and noted the agency is seeing injectables and herbal inoculations popping up in the market as well as websites purporting to sell COVID-19 vaccines.[14] The FDA continually reminds consumers that “[u]nproven products purporting to prevent or treat COVID-19, made from unknown substances under unknown conditions, present significant health risks in and of themselves. They can also lead consumers to make lifestyle choices that increase their risk of infection with COVID-19, or to delay or stop appropriate medical treatment.”[15]

With respect to the currently authorized vaccines, the FDA recently announced the launch of an FDA adverse event reporting system (FAERS) dashboard for drugs and therapeutic biological products authorized under an EUA. This dashboard is available to the public and “provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under an EUA during the COVID-19 public health emergency.”[16] With this dashboard, the FDA hopes to increase transparency and provide the public with easier access to safety information.

CDC Vaccine Updates

There are many questions about what it means for a return to normal once vaccinations are widely administered. The CDC has been clear that there are still things it does not know about the functioning of these vaccines. The CDC’s website states, “Although COVID-19 vaccines are effective at keeping you from getting sick, scientists are still learning how well vaccines prevent you from spreading the virus that causes COVID-19 to others, even if you do not have symptoms. Early data show the vaccines do help keep people with no symptoms from spreading COVID-19, but we are learning more as more people get vaccinated.”[17] Further, the CDC notes that it is still learning about variants and how the vaccines defend against them.[18]

For this reason, the CDC recently published “Interim Public Health Recommendations for Fully Vaccinated People.”[19] The recommendations, which will continue to evolve, encourage fully vaccinated people, among other things, to continue to wear masks and to keep physical distance in public and when visiting unvaccinated people, avoid medium/large gatherings, and get tested if experiencing COVID-19 symptoms. The recommendations do also offer some reprieve. The recommendations state that fully vaccinated people can visit other fully vaccinated people indoors without wearing masks and can visit unvaccinated people from a single household who are at low risk indoors without masks or distancing.[20]

 

[1] See National Strategy for the COVID-19 Response and Pandemic Preparedness (Jan. 21, 2021), https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-Pandemic-Preparedness.pdf.

[2] Id. at 8.

[3] Id.

[4] See U.S. Food & Drug Admin., Emergency Use Authorization to Janssen Biotech, Inc. (Feb. 27, 2021), https://www.fda.gov/media/146303/download.

[5] Id. at 4.

[6] See Presidential Fact Sheet: President Biden to Announce All Americans to be Eligible for Vaccinations by May 1, Puts the Nation on a Path to Get Closer to Normal by July 4th (Mar. 11, 2021),

https://www.whitehouse.gov/briefing-room/statements-releases/2021/03/11/fact-sheet-president-biden-to-announce-all-americans-to-be-eligible-for-vaccinations-by-may-1-puts-the-nation-on-a-path-to-get-closer-to-normal-by-july-4th/.

[7] See Remarks by President Biden on the Administration’s COVID-19 Vaccination Efforts (Mar. 2, 2021), https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/03/02/remarks-by-president-biden-on-the-administrations-covid-19-vaccination-efforts/.

[8] Id.

[9] See supra note 6.

[10] Id.

[11] Id.

[12] See U.S. Food & Drug Admin., Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry (Feb. 22, 2021), https://www.fda.gov/media/142749/download.

[13] Leading the Way Forward: Biden Administration Actions to Increase COVID-19 Vaccinations: Hearing Before the Subcomm. on Oversight and Investigations Comm. on Energy and Com., 117th Cong. 13 (2021)(statement of Peter Marks, M.D., PhD, Director, Ctr. for Biologics and Research, U.S. Food & Drug Admin.), https://energycommerce.house.gov/sites/democrats.energycommerce.house.gov/files/documents/Witness%20Testimony_Marks_OI_2021.03.17.pdf.

[14] U.S. Food & Drug Admin., FDA Voices, National Consumer Protection Week: FDA is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams (Mar. 2, 2021), https://www.fda.gov/news-events/fda-voices/national-consumer-protection-week-fda-vigilant-protecting-consumers-against-covid-19-vaccine-scams (last visited Mar. 22, 2021).

[15] Id.

[16] U.S. Food & Drug Admin., Questions and Answers on FDA’s Adverse Event Reporting System (FAERS), https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/fda-adverse-event-reporting-system-faers-public-dashboard (last visited Mar. 22, 2021).

[17] Ctr. For Disease Control & Prevention, Key Things to Know, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html (last visited Mar. 22, 2021).

[18] Ctr. For Disease Control & Prevention, About Variants of the Virus that Causes COVID-19, https://www.cdc.gov/coronavirus/2019-ncov/transmission/variant.html (last visited Mar. 22, 2021).

[19] Ctr. For Disease Control & Prevention, Interim Public Health Recommendations for Fully Vaccinated People (Mar. 8, 2021), https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated-guidance.html.

[20] Id.