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COVID-19 Weekly Newsletter: Vaccine Progress Report

As countries in the Western Hemisphere prepare for the first shipments of vaccines, researchers continue to release new COVID-19 findings.

Vaccine News Galore!

  • U.K. Approves COVID-19 Vaccine, Ahead in the Western World: On December 2, the United Kingdom became the first country in the Western Hemisphere to approve a COVID-19 vaccine. Within days of the approval, 40 million doses of BioNTech/Pfizer’s two-dose vaccine were secured and will be distributed within days. Home care residents, health care workers, the elderly, and the medically vulnerable will be prioritized and get the two doses three weeks apart. The rest of the countries in the European Union (EU) could approve a vaccine for emergency use before the EU’s drug regulator, the European Medicines Agency (EMA), makes a decision, which is anticipated by December 29, but the European Commission has discouraged countries from doing so.

  • First Delivery of Pfizer Vaccine in the U.S. (Possibly) on December 15: The first shipment of the COVID-19 Pfizer vaccine for December 15 is contingent on the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) decision to recommend FDA to issue an EUA for the vaccine. The group will meet December 10 to review Pfizer’s data and a week later, on December 17, will review Moderna’s vaccine data. The first shipment of Moderna’s vaccine, also contingent on the VRBPAC’s decision, could be on December 22. The United States could vaccinate 100 million people against the coronavirus by the end of February, according to Moncef Slaoui, chief scientific adviser to the Trump administration's vaccine program, Operation Warp Speed.

  • Top Priority Groups for Vaccine Allocation Identified: Health Care Workers, Long-term Care Facility Residents: The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) held an emergency meeting on Tuesday to determine who should be prioritized for the first doses of the COVID-19 vaccine. Though the Advisory Committee voted 13-1 to recommend health care workers and long-term care residents as the first group of people to get vaccinated, ACIP will refine and finalize its full recommendations for vaccine distribution after FDA authorizes a vaccine. In order to address vaccine skepticism, the American Medical Association (AMA), American Hospital Association (AHA) and the Americans Nurses Association (ANA), the same day as the ACIP meeting, released an open letter asking the American public to trust the vaccine development process and to understand the importance of herd immunity.

COVID-19 Relief Package Talks Again

On December 1, a bipartisan group of lawmakers released a $908 billion proposal that included aid to states and localities, unemployment insurance, small businesses, the transportation industry, schools and colleges. On the same day, Federal Reserve Chair Jerome Powell and Treasury Secretary Steven Mnuchin testified at the Senate Banking Committee hearing. Powell warned against being guarded in the next relief package, because when Congress has not done enough during past recessions, the economy and people suffered. Last month, Mnuchin was under fire when he decided to terminate several federal emergency lending programs — a decision which is explicitly within the Treasury secretary’s authority, and which he argued was in adherence to the requirements of the Coronavirus Aid, Relief and Economic Security (CARES) Act passed in March — at the start of the pandemic. Senate Democrats also introduced a COVID-19 relief package this week, offering additional unemployment benefits and aid to the Pandemic Unemployment Assistance (PUA) Program of the CARES Act. The bill would ensure workers who have run out of regular state benefits or are receiving them under the federal PUA program would get an additional 26 weeks of aid. Today, House Speaker Nancy Pelosi (D-CA) indicated she and Senate Majority Leader Mitch McConnell (R-KY) are hopeful to pass a legislative vehicle that includes COVID relief and federal government funding, which is set to run out next Friday.

CDC Shortens COVID-19 Quarantine

The CDC issued new guidance that cuts quarantine time for people exposed to COVID-19 from 14 days to 10 days without a COVID-19 test and seven days if the person tested negative. Public health authorities have identified this as a harm reduction move that factors in the public’s resistance to restrictions and pandemic fatigue. Though CDC officials encourage the 14-day quarantine, they have given some flexibility considering occupational and financial pressures that play into someone’s ability to comply to restrictions. It also reflects the CDC’s desire that people quarantine for a shorter period of time rather than foregoing quarantine altogether.

More Than Half of COVID-19 Transmissions Are Caused by Asymptomatic or Pre-symptomatic Individuals

The latest CDC analysis indicates that the majority of COVID-19 transmissions are due to pre-symptomatic or asymptomatic individuals who “shed” the virus, e.g., in their breath, without even realizing that they are already infected — and infectious — and therefore dangerous to others around them. Earlier studies had already shown that people are contagious well before (three or more days before), as well as after the onset of symptoms, and that most symptoms usually develop 5-6 days after the infection. All these findings underscore the importance of masking and social distancing in minimizing risk of infection. They also reinforce the need to (self)-isolate after contact with individuals whose health status is uncertain, such as during travel.

Mechanical Ventilation Has Higher Risk of Complications if Patient Has COVID-19

Our bodies need oxygen to sustain life. When breathing is impaired and the oxygen level in the blood fall dangerously low — as could happen due to pneumonia, drug overdose or other problems — the situation further becomes life-threatening or even fatal if not addressed immediately. As a life-saving measure, mechanical ventilation can be used while the underlying root-cause problem is getting resolved (e.g., a bacterial pneumonia gets treated with antibiotics). To connect a mechanical ventilator to the patient’s respiratory tract, a plastic tube is inserted into patient’s airways through the trachea (windpipe). As with any procedure, mechanical ventilation carries some risk of complications, ranging from the effects of anesthesia to unintentional damage to the trachea. COVID-19 patients often do require mechanical ventilation, and unfortunately, the COVID-19 condition increases the incidence of long-term tracheal complications more than 20 times compared to matched controls (i.e., similar patients without COVID-19 who needed mechanical ventilation for other reasons). Some of the reasons behind this dramatic increase in the rate of complications have to do with the disturbances in natural blood coagulation processes, as well as the weakening of the normally-protective mucosal layers in the respiratory tract — which, in turn, is a consequence of the viral infection and high-dose long-term steroids often used as part of the COVID-19 treatment.

Timeline of a COVID-19 Illness

The CDC researchers, building on the growing accumulated knowledge about COVID-19 manifestations and treatments, are laying down the groundwork for characterizing and monitoring the various stages of a COVID-19 illness. Broadly speaking, three main phases can be identified: acute COVID-19 (lasting about a week), post-acute hyperinflammatory illness (lasting a couple of weeks), and late inflammatory and virological sequelae (beyond 3-4 weeks). Each phase has distinct clinical presentations and corresponding medical response. Overall, such a higher-level understanding of the COVID-19 picture is a pre-requisite for an optimal management of the disease in each individual patient as well as for the development of most effective public health measures.

COVID-19 Related Mortality Is Higher in the U.S. Than in 18 Other Countries

Per capita deaths from COVD-19 itself and excess deaths during the pandemic (relative to similar pre-pandemic periods) were lower in the U.S. compared to other countries in the first few months of 2020, but since June 2020, that index has been rising and now surpasses that of other countries’ multiple fold. Among reasons for this high toll could be inconsistent and de-centralized public health messaging and interventions.

SARS-CoV-2 Was Present in the U.S. by Mid-December 2019

CDC researchers analyzed blood donated to the American Red Cross between December 13, 2019 and January 17, 2020, and found evidence of SARS-CoV-2 antibodies in 84 samples. Those infections may have been missed at the time because — as is known by now — the SARS-CoV-2 infection causes only mild or no symptoms in about half the cases; and when symptoms do occur (e.g., headache, muscle ache, cough), they are easily mistaken for other illnesses unless a specific test for SARS-CoV-2 is performed. Previously, the first reported case of COVID-19 in the U.S. was dated January 20, 2020. New evidence suggests that the virus was present in the U.S. before that time.

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© 2021 Faegre Drinker Biddle & Reath LLP. All Rights Reserved.National Law Review, Volume X, Number 339
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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,...

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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...

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