May 28, 2021

COVID-19 Weekly Newsletter: WHO Sets Global Vaccine Goals for 2021

This week, the World Health Organization (WHO) laid out its goals for boosting vaccination rates worldwide and also asked world leaders to provide additional funding for global vaccination efforts. In other COVID-19 developments, researchers continue to study masking guidance and investigative scientists explain the meticulous, wide-ranging research and analysis necessary to pinpoint the origin of the COVID-19 virus.

FDA Updated Vaccine Guidance

On Tuesday, May 25, the Food and Drug Administration (FDA) issued revised guidance signaling that it will prioritize emergency use authorization (EUA) applications for COVID-19 vaccine manufacturers who have already been engaging with the agency throughout their development process. Therefore, any manufacturers who plan to apply for an EUA but have not been in active communication with the agency may have their application rejected.

WHO Aims for 10% Vaccination Rate in Every Country by September

At the World Health Assembly on Monday, May 24, WHO Director General Tedros Adhanom Ghebreyesus announced the WHO’s goal to have 10% of each country’s population vaccinated by September — and 30% of the same by the end of the year. The COVID-19 Vaccines Global Access (COVAX) — led by WHO, Gavi and the Coalition for Epidemic Preparedness Innovations (CEPI) — is an initiative seeking primarily to provide COVID-19 vaccines to lower income countries. Yesterday, WHO released a statement to boost COVAX by calling for world leaders to provide an additional $2 billion in funding by June 2 to secure supplies, to share excess vaccine doses as vaccination rates increase in higher income countries, and to remove trade barriers to free up the supply chain.

Continued Masking at ‘Points of Service’ Would Help Protect Nurses and Other Essential Workers

The Centers for Disease Control and Prevention (CDC) guidelines relaxing masking requirements for vaccinated individuals were met with relief by some and caution by others. A scientific brief by a nurses association pointed out that the evidence cited by CDC had come from studies that were not peer-reviewed, or whose authors had conflicts of interest, or were conducted in a setting different from the U.S. (e.g., in Israel, where the proportion of fully vaccinated individuals is significantly higher than in the U.S.). Indoors, lack of masking increases pathways for the virus to circulate from person to person, allowing the virus to mutate. Nurses, retailers and other essential workers facing unmasked customers all day long are put at an increased risk.

Guidance on Masking Is a Work in Progress

Globally, mask mandates change from one region to the next and also change over time. In the U.S., CDC continues to study evidence and is regularly updating its guidance on mask wearing. Given the infinite variety of real-world situations, the challenge of coming up with a cut-and-dry, universally applicable guidance is significant. For those interested in understanding current recommendations in all the details, CDC offers several resources:

Vaccine Protection Against Severe COVID-19 May Last Over 8 Months, But Not Protection Against Infection

A new modeling study based on data from convalescent patients as well as vaccine recipients in large-scale clinical trials predicts that with current vaccines, protection against severe COVID-19 will remain strong for as long as 250 days, although protection against infection will drop significantly, necessitating yearly re-vaccinations.

Should Effects of Law Be Studied as Rigorously as Effects of Medicines?

The effects of laws and regulations introduced at local, state and federal level in response to the pandemic have had a direct and tangible impact on people’s health, lives and livelihoods. Several legal scholars therefore argue that “legal epidemiology” is an important scientific discipline that should be given sufficient attention and resources.

Interview With Investigative Scientists

Data-based evidence identifying the precise origin of SARS-CoV-2 is lacking, but active investigations are ongoing. Origins have been established with high certainty for some lethal pathogens and viruses — typically after years of broad-ranging investigations (such as for HIV). The origins of other viruses, such as Ebola, remain mysterious. Pinpointing the original source requires methodical, voluminous sampling of microorganisms present in various species and environments, combined with detailed genomic sequencing and modern bioinformatics. The task is complicated by the lack of sustained global surveillance systems, meaning that the reconstruction of a virus’ emergence is often hampered by geographical and time gaps in the available knowledge. For SARS-CoV-2, the search for the original reservoir will probably expand and continue, as explained by scientists who’d volunteered to join the WHO team. They recently concluded “phase 1” studies and are hoping for “phase 2,” which will be guided by the findings from the first phase. Obtaining and meticulously analyzing real data will be key to revealing the real origin of the virus.

Indirect Result of the Pandemic: Broader Understanding of Microbiomes Around Us

Bread baking became one of the top new skills people acquired during the pandemic. Turns out, understanding what’s going on in the kitchen requires serious science. For example, a recent study of sourdough starters — unprecedented in its thoroughness — revealed that different starters vary in the exact composition of numerous bacteria and fungi, and that their interactions determine the bread’s smell, flavor and other characteristics.

Randomized Controlled Study of Indoor Mass Gathering

How do we know what we know? If people’s health and countries’ economies depend on how reliable our “knowledge” of COVID-19 is, vetting the source of knowledge becomes critical. A randomized controlled study is one of the more rigorous — and trusted — knowledge-generating techniques. A recent study of this type demonstrated that masking, good ventilation and rapid testing led to zero COVID-19 positive tests 8 days after the event.

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.

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