November 13, 2020

COVID-19 Weekly Newsletter: Positive Developments in the Race for a COVID-19 Vaccine

Positive news is emerging on the vaccine front in the fight against COVID-19, as one vaccine candidate is reported to have prevented more than 90% of symptomatic infections in clinical trials, and another was granted a Fast Track Designation from the Food and Drug Administration (FDA). While the FDA is highlighting the effectiveness of face coverings and working with other federal agencies to combat fraudulent activity resulting from the public health emergency, President-elect Joe Biden is putting together a 10-member COVID-19 Task Force, and the Department of Health and Human Services launched a crowdsourcing initiative to capture and standardize diagnostic test data. A new variant of COVID-19 found in minks has led to the culling of mink farms in Denmark and a new study reconfirms key findings about the disease.

COVID-19 Fraud

Fraudulent activities are common during emergencies; however, the volume of fake online products that have been flagged by the Food and Drug Administration (FDA) during the pandemic has exceeded norms, with more than 1,000 products being flagged, 120 warning letters sent to sellers, 230 reports to online marketplaces and more than 270 complaints to domain registrars. As a result, the FDA created a task force with the Centers for Disease Control and Prevention (CDC), the Department of Justice (DOJ) and the Federal Trade Commission (FTC) in March called “Quack Hack” to promote consumer safety and combat phony products. Keep updated of fraud related to the COVID-19 pandemic via Faegre Drinker’s tracker.

New COVID-19 Mutation Found in Mink Farms

Recently, another mutated variant of COVID-19, which is now being called “cluster 5,” has been found in Danish mink farms. Currently, the implications of these changes in the cluster 5 variant are not yet known but of the five clusters identified to date this one raised concern since the mutations found in this variant result in less sensitivity to neutralizing antibodies. The first noted cases of COVID-19 in mink farms occurred in mid-July in the Netherlands and Spain. At that time, stricter hygiene rules were enforced in lieu of the culling of animals. However, that has proven to be ineffective. In mid-October, the Danish Veterinary and Food Administration reversed their decision and culling of farms began at all infected farms along with surrounding areas. As of November 6, six countries report having infected mink farms: Sweden, Italy, Spain, Denmark, the Netherlands and the United States. Minks are known to be susceptible to the virus and it can spread rapidly between humans and animals.

Vaccine Development Efforts

  • Pfizer Vaccine: Pfizer announced promising results that its COVID-19 vaccine candidate prevented more than 90% of symptomatic infections in clinical trials. If it passes key safety hurdles, the vaccine may be made available later this month. Multiple news outlets have raised concerns about the extreme cold (-80°C/-112°F) storage conditions for the vaccine, requiring specialized freezers or dry ice (-78°C/108°F). But it is noted that once shipments of vaccine packed in dry ice are delivered, they can be stored under refrigeration for five days or more dry ice can be added for an additional 15 days of storage.
  • Novavax Vaccine: This week the FDA granted Novavax a Fast Track Designation for their late-phase clinical development COVID-19 vaccine. Fast Track Designation by the FDA is a process to expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the intent of getting important new drugs to the patient earlier. A Phase 3 trial of Novavax’s COVID-19 vaccine candidate is ongoing in the United Kingdom, and Phase 3 trials could start in the United States and Mexico by the end of November.

President-Elect Biden’s COVID-19 Task Force and Plan

Three chairs — former Surgeon General Vivek Murthy, public health care expert Marcella Nunez-Smith and former FDA Commissioner David Kessler — have been appointed to serve on the newly elected Biden administration’s 10-member COVID-19 Task Force. In the Biden-Harris transition document, a seven-point plan has been outlined to combat the pandemic that includes creating a Pandemic Testing Board, increasing testing capacity, supporting another federal COVID-19 funding package, improving the supply and demand for personal protective equipment (PPE), creating the Nationwide Pandemic Dashboard and more. In the meantime, President-elect Joe Biden continues to urge Americans to wear masks.

FDA Grand Rounds Highlight Effectiveness of Face Coverings

The FDA discussed its ongoing research on facial coverings during the COVID-19 pandemic in a recent Grand Rounds presentation. FDA researchers discussed their studies on various materials, including denim and cotton sheets, to reduce risk of exposure to aerosols and larger droplets; current studies on modeling effectivity of 3D-printed respirators, and efforts to improve face fit; and the development of risk assessment models to design countermeasures. Their research on materials suggests that face coverings using commonly available materials are most effective in managing sources of droplets (e.g., sneezing and coughing), although it shows a high variability in efficacy for blocking exposure to aerosols (depending on the thread counts or material type). Risk assessment modeling using data from materials research and computational fluid dynamics was used to examine, for example, the impact on infection rate based on filtration efficiencies of certain materials or based on percentage adoption of mask wearing.

This work adds to the significant body of evidence pointing to the efficacy of nonpharmaceutical interventions to reduce COVID-19 infections, including the use of face coverings. A recent study has used data and modeling to project that 95% mask use among the public could prevent the loss of about 130,000 lives. Current context regarding virus transmission, and assessment of case studies that show data-based positive impacts of face coverings in reducing SARS CoV-2 positivity rates are noted in a recent commentary.

Crowdsourcing COVID-19 Data Standardization

The Department of Health and Human Services (HHS) has launched a COVID-19 At-Anywhere Diagnostics Design-a-thon, soliciting proposals to develop digital solutions for capturing and standardizing data from COVID-19 diagnostic tests. Solutions would provide a device/systems-agnostic interface between reporting systems and the HHS Protect system. Solutions would seek to address challenges related to COVID-19 diagnostic tests administered outside of traditional laboratories that do not capture and report data in standardized ways for reporting to health care providers and public health agencies, which can hinder the public health response.

Key “Knowns” About COVID-19 Reconfirmed in a Unique Setting

Clinical observations from a COVID-19 outbreak among almost 5,000 predominantly young and initially healthy adults naturally isolated on an aircraft carrier have just been published. The new data reconfirm key findings about this disease that had been suggested by numerous other studies, such as:

  • Nearly half of those testing positive had no symptoms.
  • People confined to smaller spaces were at a higher risk of getting infected.
  • Reported symptoms ranged from gastrointestinal upsets to dizziness, altered sense of smell, fatigue, fever and headaches.
  • A small but noticeable number of virus-carriers required hospitalization and some, intensive care. In this population, over the course of this clinical observation, one person died.

The outbreak on the ship began in March 2020. The clinical observations lasted throughout the spring of 2020. 

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.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.

The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.

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