March 2, 2021

Volume XI, Number 61

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March 02, 2021

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March 01, 2021

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COVID-19 Weekly Newsletter: Biden Announces Ambitious Vaccination Plan

With Inauguration Day rapidly approaching, President-elect Biden has announced an ambitious vaccination plan, and the federal government has signaled a change to its vaccine distribution process, among other COVID-19 developments from the past week.

COVID-19 Hospitalizations

For the first time in weeks, the number of hospitalized COVID-19 patients has stayed flat, which is thought to be due to the end of the holiday incubation period. However, experts do not expect this to remain true for long with at least 10 states already reporting cases of a new, highly contagious variant. In another troubling trend, the hospitalization rates for children — which vary by state — have nearly tripled over the course of six months, according to a recently published JAMA Pediatrics research letter that analyzed data from 22 states. Similar findings were also noted in the recent Centers for Disease Control and Prevention (CDC) Morbidity and Mortality Weekly Report (MMWR).

COVID-19 Vaccination News

  • Biden’s 100 Million Vaccinations in First 100 Days: President-elect Joe Biden’s promise of 100 million vaccinations in the first 100 days appears, to some, to be a heavy lift given the sluggish start of vaccine distribution efforts that started three weeks ago. On Thursday, January 14, President-elect Biden proposed a roughly $1.9 trillion COVID-19 response plan which includes $350 billion to help state and local governments, including to support first responders, expand testing and reopen schools. The proposal would create a national vaccination program, provide funding to expand the health workforce by 100,000 people to conduct outreach and contact tracing, offer $50 billion to expand national testing, and provide $40 billion for supplies. On Friday, January 15, Biden has planned to name former Food and Drug Administration Commissioner David Kessler as the top scientist of Operation Warp speed, the U.S. government initiative to invest in the development and disbursement of the COVID-19 vaccine. Also on Friday, President-elect Biden announced his administration will retire the “Warp Speed” name.

  • Vaccine Syringes Problem: Previously, pharmacists were applauded for discovering extra doses of the Pfizer vaccine able to be drawn from a given vial. The efficient, low-dead volume syringes are designed to maximize vaccine extraction; however, the supply kits sent from Operation Warp Speed to states include a mixture of syringe types, making it difficult for the sixth, extra dose to be extracted. Providers and hospitals have alerted state officials on this issue.

  • Leaked Pfizer and Moderna Data: The European Medicines Agency (EMS) in December had a cyberattack and earlier this week confirmed that some of its data related to Moderna’s and Pfizer’s vaccines had been leaked on the internet by hackers. An Italian cybersecurity firm, Yarix, found Pfizer’s vaccine’s authorization and commercial processes on the dark web which prompted the agency to look further. Fortunately, the agency has been able to proceed with no interruptions in evaluating and approving COVID-19 medications and vaccines.

  • States to Get Shipments From the Feds Based on 65-and-Over Population: States were originally sent shipments of the COVID-19 vaccine based on their adult population, but now it will depend on the size of the state’s over 65 population and how quickly they can be administered. The new strategy will take effect in two weeks, after the new administration has taken office. As of Thursday, 11.9 million COVID-19 vaccine doses have been given. At least 1.46 million Americans have received their second dose.

  • Educational Videos and Online Events for the General Public: There are numerous educational sources for the public to go to regarding COVID-19 and vaccines. Last week, the Black Coalition Against COVID held another installment of “Making It Plain,” its town hall-style virtual public education series, providing information on COVID-19 and vaccines. Leaders from the National Institutes of Health (NIH), FDA, CDC, the Department of Health and Human Services (HHS), historically black colleges and universities (HBCUs), and medical, faith and social organizations participated and answered audience questions. These online town halls are primarily hoping to reach the Black community; the intent is to convey information in clear, straightforward terms to increase engagement and decrease health inequalities. Topics addressed include explanations about the current state of the pandemic and impacts on the Black community, viruses and virus mutations, descriptions of the currently authorized vaccines in the U.S. and their efficacy, special populations, side-effects, the vaccine roll-out, and public communication and engagement. Watch the recording of the town hall here. A Yale University physician and professor, Dr. Howard Forman, also produced a video explaining how herd immunity is achieved through vaccines.

More Than Half of SARS-CoV-2 Transmissions Occur From Asymptomatic Individuals

A recent analysis of available data from epidemiological studies indicates that more than half of all SARS-CoV-2 transmissions have been passed on by individuals who themselves were asymptomatic at the time, meaning they were either in the early pre-symptomatic stage of COVID-19 or never had any noticeable symptoms despite being infected and infectious to others. This finding underscores the critical importance of social distancing and face masking as long as the population-wide immunization levels remain below the herd-immunity threshold. It also raises questions about potential “silent” transmissions from vaccinated individuals who may be harboring the virus without necessarily becoming ill. 

Additional Resources

Global COVID-19-Related Patent Office Status and Deadline Extension Updates

Information regarding the status of each foreign patent office and the availability of extensions of time in each jurisdiction.

Government Actions: COVID-19

Tracking executive orders, legislation, and other government actions related to COVID-19 by state and major locality across the U.S.

Tracking Fraud Related to the COVID-19 Pandemic

Tracking federal and state law enforcement and regulatory actions taken against bad actors who have exploited the COVID-19 emergency to defraud consumers and payers.

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© 2020 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume XI, Number 15
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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,...

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Sarah Lloyd Stevenson Life Sciences Policy Advisor
Director

A former policy advisor to federal government agencies and elected officials, Sarah-Lloyd Stevenson helps health and life sciences stakeholders advance policy goals before Congress and federal agencies. Having worked to draft, enact and gain support for health laws and policies at the highest levels of federal government, Sarah-Lloyd delivers policy advocacy strategies informed by firsthand experience getting results in Washington, D.C.

White House Policy Advisor

Prior to joining Faegre Drinker Consulting, Sarah-Lloyd served as policy advisor to the White House’s Domestic...

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

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...

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Svetlana Lyapustina Ph.D. a pharmaceutical scientist with Drinker Biddle
Senior Director, Science, Regulation, & Policy

Svetlana Lyapustina, Ph.D. counsels individual companies and consortia comprised of industry, government and academia representatives on a wide range of topics related to medical product development (pharmaceuticals, medical devices, biologics, and combination products), quality control, manufacturing, regulatory compliance, patient adherence, and regulatory submissions.

Svetlana has represented clients in interactions with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Health Canada, the Medicines...

(202) 230-5179
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...

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