September 03, 2021

COVID-19 Weekly Newsletter: EU Restricts Travel, U.S. Boosts Vaccine Supply Chain

The European Union removed the U.S. from its safe travel list earlier this week, as the Biden administration took measures to bolster the vaccine supply chain to meet the anticipated rise in demand.

Children Account for One in Five COVID-19 Cases

Last week, according to the American Academy of Pediatrics, children accounted for 22.4% of reported weekly COVID-19 cases, a substantial increase since the beginning of summer and well above the average seen since the beginning of the pandemic. Experts anticipate these numbers to increase as schools are reopening. The Centers for Disease Control and Prevention (CDC) recommends indoor masking in schools for all students, staff, teachers and visitors, irrespective of vaccine status. Children under the age of 12 are unvaccinated, as no vaccine has been approved for use for under the age of 12 — but this week Dr. Anthony Fauci, chief medical adviser to President Biden, said there is a chance vaccines may be available for these children by the winter holidays. This week, CDC director Rochelle Walensky spoke about new data set to be released Friday that indicates more children are contracting COVID-19 because of increased disease in their communities — but that there is no increased disease severity, and that community-level vaccination is protecting children.

Restrictions on American Travelers Headed to Europe

This week the United States was removed from the European Union’s safe list for travel; however, the travel restrictions are not uniform throughout the continent. Only two countries have entirely blocked U.S. travelers from visiting — Bulgaria and Norway — while two others have only closed their border to unvaccinated Americans. Nine countries have quarantine requirements for unvaccinated travelers, and the remaining countries are open to American travelers but with certain pre-qualifying requirements, includingproof of vaccination, a EU Digital COVID certificate or a negative test results within a certain timeframe prior to arrival.

$3B To Improve COVID-19 Vaccine Supply Chain

White House Coronavirus Response Coordinator Jeff Zients announced the Biden administration will spend $3 billion in expanding the domestic vaccine manufacturing supply chain by supporting the purchase of equipment, inputs, supplies and other necessities. This is intended to increase manufacturers’ capacity and capability to keep up with anticipated increase in demand, as eligible vaccinated Americans in the coming weeks will be heading to get their booster shot. The funds will be available to vaccine manufacturers as well as producers of personal protective equipment. During a news briefing, Zients said the funding will allow manufacturers to add new production lines and facilities and fulfill President Biden’s pledge to be the “arsenal of vaccines for the world.”

FDA Considers Booster Shots

The Biden administration recently announced the United States will begin rolling out booster shots of the mRNA vaccines in September, pending Food and Drug Administration (FDA) and CDC recommendations. Some public health authorities raised concerns that the White House's announcement will pressure FDA and the CDC to endorse the extra shot, even if the data are insufficient. In a press release Wednesday, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research said FDA's independent evaluation and determination of the safety and effectiveness of additional vaccine doses is key to the Biden administration's booster plan. He added that FDA will review Pfizer's application as fast as possible. The FDA’s vaccine advisory group, the Vaccine and Related Biological Products Advisory Committee, announced this week they will convene on September 17 to discuss the application of one mRNA vaccine manufacturer’s application for authorization of booster shots. Another mRNA vaccine manufacturer this week asked FDA for authorization for their separate booster dose.

Mu Variant Raising Concerns

While the COVID-19 Delta Variant accounts for almost all new COVID-19 cases in the U.S., a new variant “Mu” has been designated by the World Health Organization (WHO) as a “variant of interest.” Mu has spread to 43 countries after first being detected in Columbia in January 2021. While there is little clinical data on Mu, laboratory data implies that the mutations found in Mu allow the virus to partially evade the current vaccines, convalescent serum and monoclonal antibodies. More studies are needed to further evaluate the impact of Mu on the current therapies and vaccines.

Patients’ Genetics Play a Role in Severe COVID-19

Two different studies published in Science found that certain genetic characteristics related to specifics of our immune system are associated with a higher risk of the COVID-19 disease’s progressing to severe stages. There is a wide variety of factors that may contribute to our immune responses, and many external as well as internal factors that determine the course of the disease in infected individuals. These latest studies identify the genetic signatures that are likely responsible for the disease severity in some patients.

Unmasking Plus Delta Tied to Rise in COVID-19 Cases

A study of COVID-19 cases among health care workers in California showed some troubling trends. During the period that coincided with the removal of mask mandates there, as well as the spread of the Delta variant in the general population, a rise in symptomatic disease in health care staff was observed, although the vast majority of them (around 80%) were fully vaccinated.

Stopping Misinformation at the Source

The Federation of State Medical Boards (FSMB) issued a statement in late July about measures intended to dissuade physicians from spreading misinformation about COVID-19. Recently, the American Board of Emergency Medicine (ABEM) followed suit. Unfortunately, such steps are necessary to help make everyone safer.

Laws Need to Support Public Health

An article in the New England Journal of Medicine examined legal cases that have impacted public health measures during the COVID-19 pandemic, influencing its course. The authors conclude that Congress should clarify CDC’s powers in order to ensure that the health of the American public is adequately protected during the current and future pandemics.

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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