In an otherwise troubling week, there are some positive developments in the COVID-19 response, including progress in the development of a new vaccine.
The Pandemic Is Far from Over: 4000 Lives Gone in One Day
Thursday, January 7, was the deadliest day for COVID-19 in the United States with 4000 lives lost, exceeding the previous record of 3915 from the previous day. The rate of COVID-19 deaths is projected to reach roughly one out of every 1000 people, with an infection rate of 62 for every 1000. States are scrambling for resources, staffing and assistance. Arizona has become the new surge spot, claiming the “hot spot of the world” title as diagnosis rates soar. On January 7, the testing positivity rate in Arizona was 23.9%. One in every 119 people in Arizona tested positive for the virus in the past week.
Federal Public Health Emergency Extended
On Thursday, January 7, Health and Human Services (HHS) Secretary Alex Azar announced he signed an extension of the current Public Health Emergency declaration, effective January 21. The previous declaration was set to expire this month, and this new extension will ensure federal resources and flexibilities can continue throughout the Biden transition through at least April 21.
End-of-Year COVID-19 Relief Package
Over the holidays, after months of negotiating and political stalemate, Congress passed, and President Trump signed into law, an additional $900 billion COVID-19 relief package coupled with end-of-year policy riders and government funding. The bill includes $600 stimulus check for qualifying individuals, state and local funding, and protections around surprise medical billing.
Tracking COVID-19 Variation
A new, more transmissible variant of COVID-19 has been identified in the U.K., which has prompted the Centers for Disease Control and Prevention (CDC) to expand genomic sequencing of strain by enlisting private laboratories to do so. LabCorp signed a contract with CDC this week in an effort to double the number of samples sequenced.
Novavax Starts Phase 3 Clinical Trials in the United States
On December 28, Novavax, a Maryland-based biotech company, started late-stage clinical trials of its COVID-19 vaccine in the United States and Mexico, making them the fifth company to get to this stage in the U.S. The randomized placebo trial is enrolling 30,000 individuals at over 100 sites. Participants will get the two-dose vaccine 21 days apart. The vaccine can be stored at above freezing temperatures which, if approved, will be helpful for vaccine distribution, as states are finding keeping Pfizer’s vaccine at extreme temperatures to be challenging.
Did You Know There Are Nine Approved Vaccines Worldwide?
As of this newsletter, nine COVID-19 vaccines have been approved for use in various countries around the world. Only two of these have been approved for use in the U.S. under emergency use authorization (EUA) by the Food and Drug Administration (FDA) — the two most widely known mRNA-based vaccines from Pfizer and Moderna. AstraZeneca’s adenovirus-based vaccine was recently approved in the United Kingdom and several other countries as well. There are additional vaccines on the horizon from multiple sources including three in Phase 3 clinical trials worldwide from Novavax (see above), Johnson and Johnson, and CanSino Biologics with Johnson and Johnson reporting they hope to seek EUA by the FDA soon. If the Johnson and Johnson vaccine is approved, it would be the first single-dose COVID-19 vaccine in the US.
Vaccination Schedules Are Part of What Makes a Vaccine Effective
In rolling out the approved vaccines to its population, Britain plans to deviate from the schedule that had been used to demonstrate those vaccines’ safety and efficacy. The U.K.-proposed regimen had not been studied previously, and could either prove to be an efficient alternative, or could lead to the rise of vaccine-resistant strains of SARS-CoV-2. At the moment, there is hope that the vaccines will remain effective even in the face of the mutations identified so far.
The uncertainty in predicting the impact of current vaccination efforts on the course of the pandemic is compounded by the fact that for the vaccines approved to date, the clinical studies were designed to answer the question of whether those vaccinated would avoid getting sick themselves and not whether the vaccinated individuals would be able to “silently” transmit the virus to other people. Concerns about deviations in vaccination schedules are being discussed, with theoretical speculations abounding but evidence so far lacking, although NIH plans to study the “half-dose” vaccine’s efficacy. In the meantime, FDA recommends adhering to the approved protocols.
Individual Hygiene Habits and Lapses Have Sizable Economic Impact
While the world is looking forward to safe, efficacious, and accessible vaccines against SARS-CoV-2, the spread of the virus could be quelled by behavioral modifications, such as sanitizing hands after touching common-use surfaces, wearing face coverings, and avoiding indoor gatherings. Unfortunately, as the latest studies show, even simple protective measures such as wearing masks while inside public spaces and appropriate hand-washing are applied inconsistently by the adult U.S. population. Individual decisions have far-reaching consequences. A recent CDC analysis concluded that “increasing universal masking by 15% could prevent the need for lockdowns and reduce associated losses of up to $1 trillion or about 5% of gross domestic product.” In addition, allowing the virus to circulate freely exacerbates its rapid mutation, which heightens the risk that current vaccines are rendered ineffective.
COVID-19 Infection Fatality Ratio
The percentage of people infected with SARS-CoV-2 who eventually die from the disease (the so-called “infection fatality ratio,” or IFR), has been difficult to determine precisely, and the reported numbers have varied widely. One of the biggest challenges is counting the number of all infected people — which is impossible to establish with any accuracy in the absence of universal testing. Iceland, which is a relatively small, island country and a centralized, well-funded health care system, has been able to test more than half of its population, providing a sound basis for calculating IFR. For Iceland, whose population is relatively young (median age 36.5 years) and enjoys universal health care, the IFR is 0.3%. This number is lower than some have feared — but on-par, or higher, compared to the seasonal flu (for which IFR is estimated to be around 0.1%. IFR does depend on the population’s overall health and the quality of accessible health care, so this number may be different in other countries.
Cellphone Camera, Paper Tests Can Detect SARS-CoV-2 Genetic Material in Academic Labs
Researchers published a proof-of-concept demonstration of a method to detect viral RNA of SARS-CoV-2 using CRISPR-Cas technology and a cellphone’s camera. The complete measuring device also includes a low-cost laser for illuminating the sample and an optical assembly to capture the fluorescence signal. Data can be processed on the same cellphone unit. A cartoon representation illustrating the method is available on YouTube. This technique provides results in as little as half an hour.
Another academic study demonstrated the possibility of an even faster test — under five minutes — based on paper impregnated with nanoparticles of gold metal decorated with so-called antisense oligonucleotides (ssDNA) which target SARS-CoV-2 nucleocapsid phosphoprotein (N-gene). These rapid and simple-to-use tests — if and when commercialized — could provide convenient point-of-care options for diagnosing SARS-CoV-2 infections. In the meantime, several rapid “antigen” tests — which detect SARS-CoV-2 proteins rather than the more consequential genetic material — are already authorized for use in the U.S. either with a physician’s prescription or even as an over-the-counter test kit for home use. More rapid tests might be coming to the market in the future, based on the just-concluded “Design-a-thon” hosted by the HHS.
More COVID-19 Insights
Additional ResourcesGlobal 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.