COVID-19 Weekly Newsletter: Pandemic Restrictions Are Disappearing

Restrictions put in place to halt the spread of COVID-19 are disappearing across the U.S. as states reach vaccination goals, while the search for effective COVID-19 therapeutics to treat the disease and prevent future outbreaks continues.

States Lifting Restrictions

Many state governors this week have announced lifting pandemic-related restrictions — social distancing and masking practices and business capacity limitations — that have been in place for the past 15 months since the start of the pandemic. Many governors had set to open their states once 70% of their population was vaccinated, a goal many states are approaching. Just this week, New York met that goal, triggering Gov. Andrew Cuomo to call for the state to go back to normal. Similarly, Gov. Gavin Newsom of California on Tuesday did the same, while Gov. Larry Hogan of Maryland announced he will end most of the pandemic restrictions on July 1.

Phase 3 Clinical Trial Results for COVID-19 Vaccine

In December, Novavax, a Maryland-based biotech company, started late-stage clinical trials of its COVID-19 vaccine in the United States and Mexico, making them, at that time, the fifth company to get to this stage in the U.S. On Monday, June 14, 2021, the biotech company announced the final data from their U.S./Mexico COVID-19 phase 3 trial. The vaccine demonstrated 100% efficacy against prototype-like virus and 93% efficacy against variants of concern and interest.

New mRNA Vaccine Candidate Shown not To Be Effective

A mRNA-based vaccine candidate from a German-based company was shown only to have 47% efficacy against COVID-19, which is below the globally accepted threshold of 50%, and did not meet the statistical criteria to demonstrate success in the late-stage trial. Since the mRNA technology is similar to the other two highly effective mRNA-based vaccines currently available, this outcome came as a surprise. It was noted that the new COVID-19 variants now in circulation may have created additional challenges in the clinical trials.

U.S. To Commit $3 Billion To Develop COVID-19 Antiviral Pill

On Thursday, June 17, 2021, the White House said the United States will spend $3 billion, a portion of the $1.9 trillion COVID-19 relief bill passed in March 2021, to advance the development of antiviral pills for COVID-19. The head of the National Institute of Allergy and Infectious Diseases, Dr. Anthony Fauci, said, “New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives.” The National Institutes of Health (NIH) and the Biomedical Advanced Research Development Authority (BARDA) will be the primary recipients of the funding to do the work and the Department of Health and Human Services (HHS) will overlook the operations. 

G-7 Leaders Make Vaccine Pledge

The G-7 summit concluded last Sunday, June 13, 2021, with the seven international leaders sharing that they collectively have promised to deliver 2.3 billion COVID-19 vaccine doses to the rest of the world. This total includes 1 billion pledged over the weekend, 500 million of which will come from the United States. The countries are also factoring in funding for the global vaccine equity effort COVAX and production partnerships with other countries.

COVID-19 Likely Entered U.S. Earlier Than Initially Reported

A recent study using blood samples collected from a little over 24,000 people from a variety of demographics and locations throughout the United States, conducted from early January to mid-March 2020, has indicated that the SARS-CoV-2 virus may have been present in the U.S. in December 2019, much earlier than the typically noted February timeframe. The study investigated the presence of antibodies to SARS-CoV-2 from samples collected through the NIH All of Us health data initiative and evaluated via two different serological testing systems to minimize false positives. Results indicated that the virus was present in five states weeks earlier than previously thought and in one state likely in late December 2019.The results note the likelihood of low-level community transmission during a timeframe where main mitigations were focused on testing of travelers from overseas hotspots. The study thus highlights the importance and necessity of nonrestricted testing within communities in epidemic or pandemic situations when possible.

CORONA Registry May Help Find Effective Treatments

COVID-19 cases may be going down in vaccinated areas, yet the challenge of effectively treating patients who do contract the disease remains formidable. Current clinical guidelines are better informed than a year ago, but effective treatments are very few and must be administered within narrow time windows to be of any help. Many organizations, therefore, are continuing to look for more reliable and more broadly applicable medical interventions. In this race for a cure, an online registry called CORONA (COvid19 Registry of Off-label & New Agents) offers researchers hints of where to look. This registry, started in early 2020, has been aggregating information about all published reports where old or new agents were tried as a COVID-19 treatment — both failed and somewhat promising. Most of these reports are small studies not powered to deliver conclusive proof but they do help to generate ideas and inspire larger trials, as well as to flag potential “dead ends.”

Travel Accelerates Spread of New Variants

A new study demonstrates that last summer, travel combined with inconsistent virus containment policies led to the opportunistic spread of new SARS-CoV-2 variants across regions.

Previous Infection Only Partially Protective

After more than a year of the pandemic, more types of longer-term data can be queried for insights. For example, a recently released study found that a natural infection with SARS-CoV-2 confers some immunity against re-infection, but the effect depends on the patient’s age. In those under 65 years old, the protection averages at 80%. For older adults, protection is only 47%, meaning that without vaccination, one is more likely to get re-infected than not.

Keeping Track of PCR Test Results Can Help Spot and Prevent Emerging Outbreaks

Before vaccines became available, genome-based PCR testing was one of the more rigorous tools to identify COVID-19 cases and thereby manage its spread. Such testing still has an important role to play, at least until a vast majority of the world population acquires and maintains long-lasting immunity. A report published in Science explains how accumulating and monitoring PCR test results can help identify emerging “hot spots” of potential SARS-CoV-2 transmission, providing an early warning system that would trigger public health measures to prevent a full-blown outbreak.

Rapid Testing of Incoming Travelers Can Significantly Limit Viral Transmission

A new modeling study found that rapid testing of incoming travelers resulted in an approximately five-fold reduction of infection’s spread compared to unrestricted entry. Most significant risk reduction was shown with isolation of infected individuals for about two weeks after symptom onset.

In the Future, Nanomedicines Could Treat and Prevent COVID-19

Scientists have engineered antibodies that are much smaller than typical ones, and therefore could fit into hard-to-reach areas of a SARS-CoV-2 virion particle. Furthermore, by targeting the most stable areas of the virus, these “nanobodies” can be effective against multiple strains of SARS-CoV-2. Another group of researchers created and studied “nanotraps” made up of particles displaying the ACE-2 receptor, which is the main entry point for SARS-CoV-2. When delivered to the lungs, these nanotraps could fight off a SARS-CoV-2 infection and prevent COVID-19 disease.

Arts to the Rescue!

The global crisis stimulated unprecedented levels of innovation, collaboration, open research and free educational opportunities. It has also resulted in amazing creative productions such as a catchy song explaining antibodies, a theatrical production about a renowned virologist and an online streaming docudrama about frontline medical workers.

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.