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December 18, 2020

COVID-19 Weekly Newsletter: 2.9M Vaccines Delivered, Relief Package Update

In observance of the holidays, we will not be preparing a COVID-19 newsletter for the following two weeks. Our next COVID-19 Weekly Newsletter will be sent on January 8, 2021.

While case rates continue to rise, there is some cause for optimism in the COVID-19 response, as the first Pfizer vaccines have been distributed. Meanwhile, lawmakers continue to work towards a potential relief package deal.

Status Update on COVID-19 Relief Package

Congress is positioned to stay in session through the weekend to wrap up end-of-year legislating, including the passage of a $1.4 trillion omnibus government funding measure and COVID-19 relief legislation. This week lawmakers continued to go back-and-forth on priorities for the final COVID-19 package of the year, with Senate Majority Leader Mitch McConnell (R-KY) declaring on Thursday that the Senate would not leave town for the holidays without passing something to assist the American people and businesses. The government is currently operating under a one-week funding extension that passed last Friday, December 11, to avert a government shutdown and buy lawmakers more time to reconcile policy differences. Should lawmakers fail to pass at least the omnibus bill or an additional stop-gap funding measure today, December 18, the federal government will shutdown at midnight tonight.

2.9M Doses of the Pfizer COVID-19 Vaccine Sent This Week

FedEx, UPS, American Airlines and United Airlines assisted in the shipment of the first batch of the recently Food and Drug Administration (FDA)-authorized Pfizer vaccine. Pfizer announced they have successfully shipped all 2.9 million doses to the locations specified by the federal government. In an effort to gain public confidence in the vaccine, many facilities broadcasted the heads and chiefs of their departments getting inoculated throughout the week. This morning, Vice President Mike Pence, Second Lady Karen Pence, and Surgeon General Jerome Adams received the vaccine on national television. President-elect Joe Biden announced plans to receive the vaccine in public on Monday, December 21, and House Speaker Nancy Pelosi (D-CA) and Leader McConnell have signaled plans to do the same in the coming days. The United States joins a number of other nations who have already approved the Pfizer vaccine: the United Kingdom, Bahrain, Canada, Saudi Arabia, Mexico and Chile. Today, Pfizer applied for a fast-track approval in Japan for its vaccine.

  • Allergic Reaction Reported: The Centers for Disease Control and Prevention (CDC) advisory panel endorsed the vaccine for individuals 16 and older but cautioned that those with severe allergic reactions to any vaccine or injectable therapy should be observed for 30 minutes after being vaccinated as a precautionary measure. On Tuesday, a day after the vaccine was deployed, a health care worker in Alaska experienced a serious allergic reaction 10 minutes after getting vaccinated, requiring multiple rounds of epinephrine and a two-day hospital ICU admission. Though this adverse effect was also seen last week in the U.K. after two health care workers were vaccinated, public health experts are not alarmed by this, as similar number of adverse effects were seen in the 44,000 person late-stage Pfizer vaccine clinical trial
  • Extra Doses Found in Vials by Pharmacists: It is common for manufacturers to fill vaccine vials with more than the necessary doses to account for any spills or waste. Since the shipment of the vaccine, pharmacists have noticed one to two extra doses of the vaccine can be pulled from a vial, having the potential to increase the vaccine supply by 40 percent if used.
  • Vaccine Shipment Hiccups: Two trays, holding thousands of doses of the vaccine, were isolated in California and Alabama and returned immediately to Pfizer after they were discovered to be transported in too cold temperatures. Per the CDC, the “vaccine will arrive at a temperature between -80°C and -60°C (-112°F and -76°F) in a thermal shipping container with dry ice,” but these vaccines arrived at -92°C (-134°F). It is unclear what caused these shipments to have such a drop in temperature. Experts already knew Pfizer’s vaccine would present logistical challenges in distribution given its need to be stored in such low temperature.
  • FDA Resource for Providers and Patients: The FDA created a dedicated webpage containing information on the vaccine. The site provides links to information for health care providers and patients as well as proceedings of the vaccines advisory committee meeting. Importantly, the page also includes a link to the FDA’s emergency use authorization (EUA) review memorandum, which describes details of FDA’s review of the CMC, non-clinical and clinical aspects of the submission, and its risk/benefit assessment in context of the indication and proposed use.

More COVID-19 Vaccines May Be Available Soon

An advisory panel to the FDA met December 17 to consider the Moderna vaccine for EUA. Following the meeting, the FDA informed Moderna the agency would work toward finalizing and issuing an EUA, which is expected to come as early as December 18. This vaccine is also an mRNA-based, two-dose vaccine like the Pfizer vaccine but does not require storage at ultra-cold temperatures. When approved, Moderna plans to ship the vaccine to McKesson, a Texas-based distributor company that was instrumental in the distribution of the H1N1 vaccine in 2009 and 2010. Johnson & Johnson’s COVID-19 vaccine may be ready to submit an application for an EUA as early as late January as it will enter the late stages of U.S. clinical trials in early January. It has already secured 42,000 enrollees in its study and will stop recruiting by December 18. The previously halted AstraZeneca vaccine could have its first efficacy readout by the end of January, with a possible FDA EUA submission sometime in February.

FDA Authorized an Over-the-Counter, At-Home COVID Test

Australian manufacturer Ellume developed — with the help of $30 million of National Institutes of Health (NIH) funding — a COVID-19 nasal swab test that got FDA EUA this week. This is the first test FDA has authorized that does not require a prescription and can result within one’s home, without samples having to be sent to a laboratory. Nearly 200 million tests are planned to be shipped within the first half of 2021, and it is expected to be priced at $30. The test results are delivered through a smartphone app within 20 minutes and are also sent to health departments based on the patient’s zip code entry. To date, 304 tests and sample collection devices are authorized by FDA under EUAs; these include 232 molecular tests and sample collection devices, 62 antibody tests, and 10 antigen tests.

SARS-CoV-2 Protein Mutations Closely Watched

Of the four types of structural proteins in SARS-CoV-2 (Spike/S, Envelope/E, Membrane/M and Nucleocapsid/N), the S protein seems to mutate more than the others (with N not far behind), and its variant (now spread globally) seems to exacerbate the viral infectivity. Unfortunately, this S protein is also the target of several current vaccines or vaccine candidates. Whether and how the observed mutations may affect the effectiveness of the available vaccines remains to be seen. Researchers have also speculated that mutational variants of the S and other SARS-CoV-2 proteins may account for the difference in symptomology of COVID-19. Besides the four structural proteins, the SARS-CoV-2 genome encodes 16 nonstructural and 6 accessory proteins, some of which also show mutations leading to changes in the virion’s properties and host’s (patient’s) responses.

Subsequent Hospitalizations After COVID-19 Discharge

In the U.S. Veteran Affairs system, the health of COVID-19 patients was tracked for up to two months after initial discharge. Data from 132 VA hospitals was included in this study; with over two thousand COVID-19 patients (of which 81.5% survived to their initial discharge). Within 60 days of the discharge, close to 20% were readmitted and close to 10% died. The most frequent reasons for readmission were COVID-19 (in over 30% of readmission cases), followed by sepsis, pneumonia and heart failure.

Lungs Weakened by COVID-19 Are Vulnerable to Fungal Infection

Evidence is emerging that COVID-19 patients’ lungs may succumb to a fungal infection known as aspergillosis. The type of fungus (“mold”) causing aspergillosis can be found in human airways without producing a disease. When the immune system is weakened, however — e.g., due to other health conditions or immune-suppressing drugs (such as steroids, which are often administered to stem inflammation in severe COVID-19 cases) — the fungus can colonize the lungs unchecked.

Human Genetic Variations Partially Responsible for Differences in Responses to SARS-CoV-2

Results from the U.K.-based GenOMICC (Genetics Of Mortality In Critical Care) study in over two thousand COVID-19 patients have shown that certain genetic variants found in critically ill patients are associated with lung-damaging immune response to SARS-CoV-2, while other variants interfere with the body’s launching an early immune response that might have protected the patient from a full-blown infection.

Enrollment of Children in Observational Study

The NIH has begun enrollment of children and young adults 20 years or younger for an observational study to monitor the health effects of SARS-CoV-2 on children, including multisystem inflammatory syndrome in children (MIS-C). The study seeks at least 250 participants from diverse racial and ethnic backgrounds. The study is designed to improve understanding of the short- and long-term health outcomes of the virus in children and young adults, and the immunologic mechanisms and characteristics of MIS-C and COVID-19 in children.

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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