COVID-19 Weekly Newsletter: A Fourth Vaccine Dose?

Two prominent vaccine manufacturers submitted requests for authorization of an additional COVID-19 booster dose this week. Meanwhile, as case rates rise in Europe and China, U.S. public health officials take stock of what to expect in the coming warm-weather months.

Fourth COVID-19 Vaccine Dose?

On Tuesday, March, 15, one of the mRNA vaccine manufacturers submitted an emergency use authorization (EUA) to the Food and Drug Administration (FDA) for an additional booster dose of its COVID-19 vaccine for adults over 65. On Thursday, March 17, another mRNA vaccine manufacturer submitted a similar but broader request to the agency for an additional booster of its vaccine to be given to all adults. Both vaccines are currently authorized as a single booster dose administered after completion of a primary series.

New White House COVID-19 Response Coordinator Announced

The Biden administration named Dr. Ashish Jha as the new White House COVID-19 Response Coordinator. Dr. Jha, recognized as an authority on pandemic preparedness and response, replaces Jeff Zients, the Response Coordinator since President Biden took office and a former economic adviser to President Barack Obama. Zients is set to leave in April.

Ivermectin Shown Ineffective Against COVID in Large Study

The Wall Street Journal reported the results of a large clinical trial in Brazil in which researchers have concluded that the anti-parasitic drug ivermectin provided no clinical benefit to high-risk COVID-19 patients. The findings will be presented at a National Institutes of Health event on March 18, 2022, and have been accepted for publication in a major peer-reviewed medical journal.

COVID-19 Trajectory Abroad and Seasonal Trends

In the past couple of weeks, COVID-19 cases have sharply increased in Europe and China, making U.S. public health experts consider what may be in store for the United States. In the U.S., the number of COVID-19 hospitalizations and deaths has been slowly but steadily declining just as the proportion of vaccinations and boosters are slowly climbing up. The number of daily deaths per million of people, however, remains higher in the U.S. than in many other countries. Moreover, among the infected, the proportion of Omicron’s sublineage BA.2 accounts for 23% of infections in the U.S. — and that number is growing. Nevertheless, if SARS-CoV-2 infections become largely seasonal (as some experts expect), the coming summer, in combination with vaccinations and boosters, should bring further decline in COVID-19 mortality and severe disease, at least in the Northern Hemisphere. And just in time for summer travel, the Centers for Disease Control and Prevention (CDC) downgraded the risk of cruise-ship travel from high to moderate while encouraging all travelers to vaccinate.

SARS-CoV-2 Effects on Endothelium

A recent review described the various ways in which a SARS-CoV-2 infection leads to pathologies of the membranes lining the heart and blood vessels. This thin layer, called endothelium, is normally releasing substances that regulate blood clotting, constriction or dilation of blood vessels, and certain immune functions. A viral infection interferes with these mechanisms. The published review could be helpful in selecting effective medical treatments and in identifying new molecular targets for drug development.

Viruses Are Not Mutually Exclusive

With the COVID-19-related protections against respiratory infections (such as masking and distancing) going away, CDC has noted a steady rise in the hospitalizations and deaths from influenza in the U.S. Co-infections of COVID-19 and flu complicate the diagnosis, treatment and prognosis of both viruses. Completing vaccinations against both remains a priority.

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.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.