COVID-19 Weekly Newsletter: Variants and Vaccine Hesitancy

As the delta variant becomes more prominent in the U.S., public health authorities look for ways to address vaccine hesitancy, and the scientific community seeks to better understand viruses — as our list of identified viruses continues to grow exponentially.

Vaccine Protects Against the Delta Variant

The single dose COVID-19 vaccine approved for use in the U.S. has been found to protect against the delta variant. First identified in India, the delta variant now accounts for 10% of new infections in the United States.

Overcoming Vaccine Hesitancy in U.S. Through Full Approval

There are currently three vaccines available in the U.S. providing at least one vaccine choice for individuals 12 and older through emergency use authorization (EUA) by the Food and Drug Administration (FDA). The “emergency use” designation has fueled the misguided assumption that these vaccines are “experimental,” a narrative that has led to vaccine hesitancy among a percentage of adults in the U.S. While it is true these vaccines were approved for use much quicker than past vaccines, the integrity of the clinical trials used to evaluate the safety and efficacy of the vaccines was not compromised or accelerated beyond conducting some phases in parallel and overlapping with animal trials. A survey conducted by the Kaiser Family Foundation has shown that approximately one-third of unvaccinated adults in the U.S. (~10% of the U.S. adults) would be more likely to get vaccinated if the vaccine was approved by the FDA. While health authorities are encouraging the FDA to approve the vaccines in order to remove this barrier to vaccination, the full approval process takes many months and may not occur until the end of the year.

European Guidance for Vaccines and Therapeutics Developers

The European Medicines Agency (EMA) published a regulatory guidance document for COVID-19 vaccine developers that explains how SARS-CoV-2 variants should be addressed. The guidance addresses traceability and naming of the variants, evaluation steps and post-authorization amendments, among other topics. Also this week, the European Commission published a COVID-19 Therapeutics Portfolio to facilitate development of drugs to treat COVID-19 patients.

Explosion of Virus Types

Viruses are considered one of the oldest, if not the oldest, lifeforms on Earth, and in fact are on the borderline of “life” and “not-life.” They are inert particles when on their own, but come to life and multiply when they get inside a host cell. Researchers estimate that only a small portion of all viruses is known to science, but in recent years — and especially in the past year and a half — the number of virus types that have been identified and characterized has risen exponentially.

Viruses vary widely in their shape, structure, preferred host environments, biochemical processes, pathogenicity and other attributes, and they can be difficult to sort out into neat and useful categories. The newest cataloguing system is therefore based on their genetic information — which allows establishing connections and “pedigrees.”  Today, over 9,000 virus species are known, and this is just the beginning of the era of broad genomics studies of viruses.  

Evidence of Ancient Coronavirus Epidemics in Today’s Human Genes

A study of a human genome database called “1000 Genomes” has shown that coronaviruses caused epidemics in East Asia as early as 25 000 years ago. Genetic adaptations caused by ancient infections were found in modern-day human DNAs — presumably passed on by the survivors of those epidemics.

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.