October 01, 2021

COVID-19 Weekly Newsletter: A Pill To Treat COVID-19?

A promising new COVID-19 treatment grabbed headlines this week, along with new updates on one mRNA vaccine manufacturer’s path to potentially seeking Food and Drug Administration (FDA) approval on vaccines for children between the ages of 5 and 11.

A Pill To Treat COVID-19?

One pharmaceutical company claims its pill cuts the risk of COVID-19-related hospitalization and death by half. If approved by the FDA for an emergency use authorization (EUA), it would be the first COVID-19 oral medication available, as currently authorized therapies require an IV or injection. It is unclear when the company plans to file its EUA, but the company is hoping to do it “as soon as possible.” Early results, released today, showed patients who received the pill within five days of having COVID-19 symptoms were less likely to be hospitalized or die from the virus. Patients from across Latin America, Europe, Africa and the U.S. were enrolled in the study. The U.S. government has committed to purchase 1.7 million doses of the drug if authorized by FDA.

Vaccine Data From 5- to 11-Year-Olds Submitted to FDA

Last week, it was reported that trials on one of the mRNA vaccines has been shown to be safe and elicit a robust antibody response in children aged 5 to 11 years old.  This week those initial data were submitted to the FDA — but the company has not officially sought an EUA. The company has stated they expect to request an EUA in the next few weeks, with similar requests to the European Medicines Agency and other regulatory authorities around the world planned as well. No official timeline has been provided, but estimates have a decision being made by the FDA sometime between Halloween and Thanksgiving.

Supreme Court Justice Brett Kavanaugh Tests Positive for COVID-19

As part of the Supreme Court’s regular testing protocols, Justice Kavanaugh was found to be positive for COVID-19. He is fully vaccinated and is currently experiencing no symptoms. The Court is scheduled to start its new term on Monday, in person for the first time since the pandemic. It is unknown if Justice Kavanaugh will join the other Justices in the courtroom.

CDC Releases Guidance for Pregnant Woman

On Wednesday, September 29, the Centers for Disease Control and Prevention (CDC) issued guidance strongly urging pregnant women to get vaccinated against COVID-19. This comes as a response to the recent reports that 22,000 pregnant women have been hospitalized and 161 have died because of COVID-19, yet less than a third of pregnant women are vaccinated.

YouTube Expands Policy to Block Anti-Vaccine Misinformation Content

YouTube announced Wednesday it will ramp up its efforts to stamp out anti-vaccine misinformation and content, including banning the accounts of prominent vaccine opponents.

Vaccine Effectiveness in the Real World

A recent CDC report counted the number of COVID-19 cases among the hospitalized patients in 21 hospitals in 18 U.S. states. The report indicates that in the control group of unvaccinated individuals, almost two-thirds had COVID-19. Among those who were vaccinated, less than one-third of hospitalizations were for COVID-19 during March-August 2021.

Pandemic Is Global, Ending It Requires a Global Effort

A modeling study using the data available to date indicates that equitable vaccination of as much of the world population as possible, and as soon as possible, would be the optimal strategy for clamping down on the SARS-CoV-2 continued mutations and transmissions.

Recognizing Trailblazers

A prestigious scientific award for clinical research has been given to the researchers whose work enabled the development of mRNA vaccines.

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.

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