COVID-19 Weekly Newsletter: U.S. Vaccination Effort Goes International

While actively launching new initiatives and incentives to boost the vaccination rate within its own population, the U.S. government this week announced its plans to share portions of its vaccine stockpile internationally.

COVID-19 Vaccine Manufacturer Seeks Full FDA Approval

This week, one of the mRNA-based COVID-19 vaccine producers asked for full approval from the Food and Drug Administration (FDA) for its vaccine that has been in circulation under an emergency use authorization (EUA). This is the second vaccine manufacturer to seek such an approval from FDA. The United States has already bought 150 million doses of the vaccine.

The U.S. Will Send 25 Million Vaccines Abroad

As domestic vaccination rates dwindle, President Biden announced plans to distribute the first 25 million vaccine doses out of the 80 million doses the White House has committed to share globally by the end of June. As White House Coronavirus Response Coordinator Jeff Zients noted, “these 80 million doses represent 13% of the total vaccines produced by the United States by the end of this month and we will continue to donate additional doses across the summer months as supply becomes available.” The vaccines will come from the U.S. stockpile, comprised of the three vaccines that have been approved for use in the U.S. Approximately 75% of the doses will be sent through the World Health Organization’s (WHO) COVID-19 Vaccines Global Access (COVAX) program. The rest will be sent directly to countries.

Defense Production Act Priority Ratings Removed

The U.S. removed the priority ratings tied to the Defense Production Act (DPA), which will allow three vaccine manufacturing companies to no longer have to give preference to U.S. orders.

Increased Interest in COVID-19 Origin Investigation

In recent weeks, policymakers and scientists alike have increasingly expressed interest in further investigating the origins of the novel coronavirus. Last week, the U.S. Senate passed a bipartisan measure requiring the Biden administration to declassify intelligence related to any potential links between the Wuhan Institute of Virology and the origins of the COVID-19 pandemic. Other congressional inquiries into the origins of the virus have been partisan in nature, but some members of Congress continue to push for independent investigations. One new strategy this week, led by Energy and Commerce Committee Ranking Member Cathy McMorris Rodgers (R-WA), calls for an independent investigation by the nonpartisan Government Accountability Office into identifying technology that could be used to determine the source of the virus and potentially help prevent future pandemics. This recent interest on Capitol Hill follows the May publication in Science of a letter signed by 18 prominent scientists making the case for further investigation.

New Efforts To Help Meet U.S. Vaccination Goal by Independence Day

As of June 4, 63% of adults in the U.S. have received one dose of a COVID-19 vaccine; an average of about 371,000 adults were added to that total each day last week. Closer to 564,000 adults would need to initiate vaccination each day to reach President Biden's goal of 70% by July 4. In an effort to increase vaccinations, the administration and partners have announced new initiatives and incentives — including free childcare for people getting shots, extended pharmacy hours, vaccination sites at Black-owned barbershops, sweepstakes and even free beer. President Biden also announced the launch of a new vaccine confidence website: WeCanDoThis.hhs.gov.

COVID-19 Trackers Highlight Health Inequities

COVID-19 continues to highlight existing and emerging health inequities in the U.S., some of which can be seen in the Centers for Disease Control and Prevention’s (CDC) improved demographics-tracking resources featured in the agency's COVID Data Tracker. A recently launched health equity tracker also provides an additional, advanced tool that integrates a number of data sources and visualizes health outcomes related to COVID-19, as well as other diseases and their relationship to COVID-19 outcomes. Information can be visualized on a national, state and local level for a variety of demographics. Additional determinants of health will be added in future. Data sources include longitudinal survey results in addition to CDC information. The Department of Health and Human Services (HHS) Office of Minority Health recently launched a vaccines information resource page for racial and ethnic minority communities, addressing immigration concerns, providing links to vaccine finders, and information about post-vaccine symptoms. Further, FDA announced the Enhance Equity Initiative, which focuses on increasing clinical trial diversity and data available on diverse populations, and improving FDA’s communications with diverse communities.

Rare Cases of Heart Inflammation Linked to Vaccination in Young Men

Researchers in Israel have reported about 1 out of 50,000 vaccine recipients developed myocarditis, or heart muscle inflammation, after receiving their second dose of the mRNA-based COVID-19 vaccine. When compared to the background rate of myocarditis in the general population, this rate is not concerning. However, when you look at the incidence of these cases in young men — a population where myocarditis is more common — the chances increase to approximately 1 in 3,000-6,000. In the U.S., the CDC advisory group stated at a recent meeting that the data from Vaccine Adverse Event Reporting System (VAERS) supported the observation with a higher-than-expected number of heart inflammation cases in 16- to 24-year-olds. However another database — Vaccine Safety Datalink (VSD) showed no increase over what was expected. And the European Medicines Agency they have received reports of myocarditis as well. If a link between the mRNA-based vaccines and an increased chance of myocarditis is proven, the benefits of the vaccine in protecting against COVID-19 would still outweigh the myocarditis risks — especially when you consider that 95% of the myocarditis cases were reported to be mild and treatable with anti-inflammatory drugs.

Emotional Appeal Is Important for Communications That ‘Stick’

A research paper examining how facts and data become effective communications emphasizes that communicators should engage emotion and values in order for their messages to “stick” — in other words, for the audience to both remember the information conveyed and act on it when making decisions.

Basic Research Lays Foundation for Life-Saving Applications

The spectacular success of COVID-19 vaccines developed and delivered in under a year was built on many years of “basic” research in numerous disciplines. Reflecting on such “pre-requisites” is particularly important now, as governments and funding agencies consider how to be better prepared for future calamities.

Stats by the State

Becker’s Hospital Review has assembled a handful of resources that may be useful for those planning to travel or to receive guests from out-of-state this summer. These resources are updated daily:

• New COVID-19 cases and test positivity rates
• Percent fully vaccinated
• Percent of population having received at least one dose of the vaccine

Data Gathering and Sharing Will Be Key to Combating Next Pandemic

The COVID-19 pandemic brought the importance of timely, detailed and comprehensive data into stark relief. Moreover, deep insights and practical recommendations were enabled when data were shared widely, freely, and rapidly, while mainlining highest quality of data gathering, analysis, and interpretation. To help curb or to prevent the next pandemic, many leading institutions are actively discussing whether and how the global data-sharing could be established and governed, and some countries are forging ahead with plans to establish global surveillance systems.

Protecting Pets

COVID-19 has unfortunately affected animals in zoos, on farms, and in people’s homes. The good news is that some countries have developed and are starting to administer veterinary vaccines against SARS-CoV-2. SARS-CoV-2 has been known to jump back and forth between humans and animals. In addition to protecting our pets, vaccinating animals would further limit biological pools in which the virus could replicate and mutate.

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.