January 11, 2021

COVID-19 Vaccines: Development, Distribution and Dosing

Holland & Knight Alert
Michael J. Werner


  • The Centers for Disease Control and Prevention (CDC) reports that as of Jan. 8, 2021, about 6.7 million people have received at least one dose of a COVID-19 vaccine, far short of the prediction by the Trump Administration of 20 million by the end of December 2020.
  • It is likely that the incoming Biden Administration's recently named COVID-19 response staff will recommend new policies based on its evaluation of distribution plans and the balance between federal and state response to maximize the vaccine distribution nationwide, especially to underserved populations and those most affected by the virus. Congress will likely legislate additional funding and policies as well.
  • This Holland & Knight alert takes a further look at challenges with vaccine distribution both nationally and at the state and local levels, as well as questions about flexibility in doses and a small number of allergic reactions associated with the vaccine.

The Centers for Disease Control and Prevention (CDC) reports that as of Jan. 8, 2021, about 6.7 million people have received at least one dose of a COVID-19 vaccine, far short of the prediction by the Trump Administration of 20 million by the end of December 2020.

Vaccine Administration Updates and Background

On Jan. 8, the transition team for President-Elect Joe Biden announced that instead of keeping half the doses in reserve to make sure people who received their first dose can receive their second dose, it would release the vast majority of available doses of authorized vaccines at the same time. This is a reversal of the Trump Administration's current plan.

Biden is expected to announce more details about his administration's plans for vaccine distribution this week. They are expected to include establishing federally run vaccination sites, as well as mobile units that can travel to rural and underserved areas, as well as the launch of a national public awareness campaign focused on vaccine safety and guidelines.

On Dec. 11, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for use of the Pfizer-BioNTech COVID-19 vaccine in persons ages 16 years and older, followed a week later by the FDA issuing an EUA for the use of the Moderna COVID-19 vaccine for use in individuals 18 years and older. Other vaccines are expected to be reviewed by FDA in the coming weeks and months. (See Holland & Knight's previous alert, "Operation Warp Speed and Vaccine Distribution Policies," Nov. 23, 2020.)

In addition to the age of recipient, the two currently available vaccines have slightly different dosages. For the Pfizer-BioNTech COVID-19 vaccine, the second dose is provided 21 days after the first dose. For the Moderna COVID-19 vaccine, the interval is 28 days between the first and second doses.

Recent reports have argued for reduced doses, changing the dose (providing only one vaccine), or mixing and matching vaccines in order to immunize more people against COVID-19. FDA has explicitly rejected all of these approaches, saying:

"At this time, suggesting changes to the FDA-authorized dosing or schedules of these vaccines is premature and not rooted solidly in the available evidence … we run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19."

Other countries, including the United Kingdom, the Netherlands, Belgium and Germany, are also looking at ways to make vaccine dosing more flexible. However, at this time, any changes to dosing are not anticipated unless new clinical data is presented. Prompted by a proposal by Operation Warp Speed (OWS) leadership, the government program overseeing the accelerated COVID-19 vaccine development program, the National Institutes of Health (NIH) is currently studying the effects of utilizing a half-dose in the second-dose administration for the Moderna vaccine. The results of those studies are pending.

Regulators have also called for more data in pregnant women and for certain risk factors such as heart disease, diabetes and other illnesses that could affect the immune system.

Recent reports also identify that a small number of vaccine recipients have experienced allergic reactions, including anaphylaxis. According to CDC, the rate of anaphylaxis cases is about 5.5 per 1 million vaccine doses given. Anaphylaxis is a known but rare side effect of vaccination, though the rate at which it occurs following COVID-19 vaccination appears to be higher than it is for some vaccines, such as flu shots. Most of the people who developed the reaction were treated with epinephrine. There was no geographic clustering of cases, and people who developed anaphylaxis were not all vaccinated from the same batch of vaccine, suggesting that whatever is causing the reaction was not limited to a single batch of product.

CDC has stated explicitly that the small number of allergic reactions do not change its recommendations for who ought to be vaccinated, the agency said, emphasizing that the positive effects of vaccination still outweigh the negative risks.

CDC is urging all sites where COVID-19 vaccines are being administered to be ready to handle anaphylaxis cases, including by having epinephrine available.

State, Local Vaccine Rollout Still Problematic

As mentioned previously, vaccine rollout has been significantly subdued compared to the original goals and projections set by the Trump Administration. The Coronavirus Response and Relief Supplemental Appropriations Act, 2021 (H.R. 133) included much-needed funding to combat the COVID-19 pandemic. However, only $3 billion of the $22 billion allocated for such efforts went specifically to state and local efforts on the COVID-19 vaccine distribution. States and localities have commented extensively on the lack of resources, both financial and otherwise, for administering the vaccine at the pace that the Trump Administration and public health officials have urged. The Biden Administration has stated that funding included in the bill for these efforts should be considered a "down payment." Expect for Congress to provide additional funding for these efforts in legislation early this year.

Issues still remain related to cold-chain storage and transport, which is required for the Pfizer vaccine, which must be kept at -70 C, and the Moderna vaccine, which must be kept at -20 C. Operation Warp Speed officials have estimated that 3,000-6,000 pharmacies may begin administering COVID-19 vaccines with the next two weeks. However, this figure is small compared with the approximately 40,000 pharmacies, including pharmacies within national pharmacy chains, which have been part of the OWS plans. This situation is exacerbated not only by a lack of capacity and medical personnel who are able to administer the vaccine but also by the presence of "pharmacy deserts," a lack of pharmacy access typically affecting underserved populations, based on the closure of less profitable pharmacies.

While the CDC has developed overall recommendations for how to prioritize vaccine distribution based on the perceived risk of COVID-19 adverse events for certain populations, the level of increased exposure to potential COVID-19 patients and other similar considerations, the states remain the primary entities administering the vaccine and designing distribution protocols. This has resulted in significantly different distribution plans among states prioritizing different populations at different times. Further, many states and localities are having IT difficulties with scheduling vaccines and are turning to the use of online platforms typically used to book entertainment and other events. Hospitals and other facilities are receiving uneven amounts of vaccine, and in some cases are not able to distribute enough vaccine doses after they are thawed and must dispose of additional, unused vaccine.

These challenges have further confounded distribution efforts. It is likely that the Biden transition team's recently named COVID-19 response staff will continue to evaluate distribution plans and the balance between federal and state response to maximize the vaccine distribution nationwide, especially to underserved populations and those most affected by the virus.

For further information or specific vaccine questions as they relate to your organization, please contact Michael Werner or Ethan Jorgensen-Earp.

DISCLAIMER: Please note that the situation surrounding COVID-19 is evolving and that the subject matter discussed in these publications may change on a daily basis. Please contact your responsible Holland & Knight lawyer or the authors of this alert for timely advice.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.

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