June 28, 2022

Volume XII, Number 179


June 27, 2022

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Vaccine News, New Findings on Long-Term Effects of COVID-19

A planned phase 3 vaccine clinical trial is now enrolling volunteers at multiple sites in the U.S., in the same week that the Centers for Disease Control and Prevention (CDC) asked states to prepare for a vaccine to be ready for distribution as early as November 1. The vaccine developments coincided with the release of a new survey of COVID-19 patients that revealed a litany of recurring, longer-term symptoms.

Long-Lasting COVID-19 Effects

Those who were hospitalized early on in the year and survived COVID-19 have reported life-changing, long-lasting effects on their health even months after discharge. There unfortunately is little known as to how to treat and what the future holds for these patients. There is a wide spectrum of recurring symptoms patients report, including shortness of breath, memory loss, fatigue, headaches, muscle pains and much more. The sudden lifestyle changes in these individuals has caused uncertainty and anxiety in patients who feel they are alone in this battle as medical professionals are unable to provide any further guidance as our understanding of how to effectively treat the pandemic is in its infancy.

Individuals who have or are experiencing long recovery times from COVID-19 symptoms developed and have released results from an initial patient survey of this post-COVID syndrome. The survey examined topics such as typical symptoms, time of initial testing, and impacts on exercise.  Another survey will be done looking at additional disease aspects, and importantly will seek to increase geographic and demographic diversity in response. 

CDC Signaled to States to Prepare to Distribute a COVID-19 Vaccine as Early as November 1

In a letter dated August 27, CDC Director Dr. Robert Redfield asked governors to begin preparing to distribute a COVID-19 vaccine by November 1. Many hospitals have been asked by their state health department to start to operationalize a plan that would be activated once the vaccine is ready to be distributed. In CDC’s COVID-19 vaccine guidance, there is a tiered approach to distribution with prioritized populations (such as health care workers, national security personnel and other essential workers) being part of the first round of vaccinations. The CDC guidance does note that, given the evolving and uncertain nature of vaccine development, the timeline is subject to change.

More Vaccine Trials

A planned phase 3 SARS-CoV-2 vaccine clinical trial at multiple sites in the U.S. is now enrolling volunteers. The vaccine candidate is the adenovirus vector product being developed by AstraZeneca and the University of Oxford, with trial support from the National Institutes of Health (NIH), Biomedical Advanced Research and Development Authority (BARDA) and other organizations. The trials are seeking about 30,000 adult volunteers. Phase 1/2 trials are being conducted in South Africa and Phase 2/3 trials in the U.K. and Brazil. 

As noted in past newsletters, there are a number of different types of candidate SARS-CoV-2 vaccines, including RNA, DNA, and inactivated virus vaccine types. Adenoviral vector applications in therapies and preventative medicines have a noteworthy background.

COVID-19 Impact on Racial and Ethnic Minority Communities Virtual Symposium

The Department of Health and Human Services (HHS) Office of Minority Health is holding a half-day virtual symposium entitled Advancing the Response to COVID-19: Sharing Promising Programs and Practices for Racial and Ethnic Minority Communities on September 17, 2020. This symposium will seek to support sharing of practices, programs and strategies for combating COVID-19, especially in racial and ethnic minority communities. 

Vitamin D and COVID-19 Infection

A study published in JAMA Network Open has provided preliminary evidence from a study of 500 patients that individuals with vitamin D deficiency may have an increased risk of COVID-19 infection compared to individuals with sufficient vitamin D levels. This finding coupled to previous studies showing that vitamin D treatment decreases other viral infections suggests that further study on vitamin D treatment for COVID-19 is warranted. 

© 2022 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 248

About this Author

James M. Vergis, Ph.D. Director of Science & Technology Faegre Drinker Biddle & Reath Washington, D.C.
Director, Science & Technology

James Vergis is a multidisciplinary Ph.D. scientist who provides scientific and management support to pharmaceutical, biotechnology and medical device industry consortia. He is particularly adept at helping clients streamline the development of new technology and data-sharing processes. A researcher whose work has touched on various fields of study, Jamie is passionate about helping clients cultivate new scientific knowledge and drive public policy changes that enhance the drug-development process.

Scientific Background

Jamie is an experienced biochemistry, biophysics,...

Nisha K. Quasba Public Health Policy Advisor Faegre Drinker Biddle & Reath Washington, D.C.

Nisha Quasba serves as a strategic advisor in complex matters regarding public health policy. Staying nimble in an evolving legislative and policy environment is her greatest strength. Through effective advocacy, stakeholder, and coalition engagement, Nisha is able to address client needs and pinch-points. Translating complex policy and scientific jargon into understandable language is her strong suit.

Public Health Experience

Prior to her time with Faegre Drinker, Nisha served as a public policy specialist with the Association of Public Health Laboratories, liaising...

Lee Mia Nagao Ph.D. Senior Director Science, Regulation, & Policy Faegre Drinker Biddle & Reath Washington, D.C.
Senior Director Science, Regulation & Policy

Lee Mia Nagao partners with pharmaceutical innovators to identify and overcome regulatory and product-development obstacles as they shepherd their products from the lab to the marketplace. Driven by her own background as a scientist, Lee is passionate about helping clients maximize efficiency in the product development lifecycle so that high-quality, life-saving products reach patients quickly and clients have more time to focus on new innovations.

Advising Pharmaceutical and Biopharmaceutical Companies

Lee advises domestic and international clients on current and emerging...