November 19, 2021

COVID-19 Weekly Newsletter: Booster Shots Get FDA, CDC Greenlight

Major developments in vaccine authorizations and mandates continue in the U.S., while the surge in Europe has prompted one country to implement a lockdown — and also declare a national vaccine mandate.

mRNA COVID-19 Boosters Approved for All

The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have expanded the eligibility for COVID-19 vaccine boosters. FDA amended the emergency use authorizations (EUA) for both the mRNA vaccines for a single booster dose for all individuals 18 years of age and older.

10 Million Courses of COVID-19 Treatment Pill

The Biden administration has purchased 10 million courses of an anti-covid pill for $5.29 billion. The first courses will be delivered by the end of 2021, pending FDA emergency use authorization. The drug was developed to treat non-hospitalized, symptomatic adults diagnosed with COVID-19 who are at increased risk of progressing to severe illness that could lead to hospitalization or death.

OSHA Suspends Enforcement of Vaccine Mandate

On Thursday, November 4, OSHA released their emergency temporary standard (ETS) rule that requires employers with 100 or more employees to ensure that their employees who report to a workplace are vaccinated against COVID-19 or submit to weekly COVID-19 testing. The Fifth Circuit issued an order that bars OSHA from taking any steps to implement or enforce the ETS, and OSHA has in fact suspended its activities related to the implementation and enforcement of the ETS, stating: “While OSHA remains confident in its authority to protect workers in emergencies, OSHA has suspended activities related to the implementation and enforcement of the ETS pending future developments in the litigation.” Businesses now face an uncertain future with OSHA conceding that it will abide by the court’s order while pursuing its reversal. Learn more from Faegre Drinker professionals on this rule’s impact on employers.

Austria Will Mandate COVID-19 Vaccinations

In response to a surge of new COVID-19 cases and deaths and hospital intensive care units reaching capacity, Austria is set to implement a 10-day lockdown starting Monday, which could be extended to 20 days if needed. Possessing one of the lowest vaccination rates in western Europe, the Austrian government is also preparing to declare a vaccine mandate to come into effect in February 1. The mandate will allow for medical exemptions, and those refusing vaccination will be subject to fines. Details (such as age requirements) are still being determined by the government. While Italy and France require vaccinations for health workers, Austria would be the first country in Europe to require vaccination for the entire vaccine-eligible population.

Promising Candidates for Future COVID-19 Treatment

A retrospective analysis of Electronic Health Records identified several medical interventions that were associated with lower mortality in COVID-19 patients. Among these candidates for re-purposing as COVID-19 treatments are several vaccines against other diseases, some herbals with anti-inflammatory properties, and some common prescription and over-the counter medicines approved and used for other indications. More work is needed to elucidate their mechanism of action contributing to their “anti-COVID” potential. That understanding could lead to the development of new products and strengthen physicians’ arsenal of COVID-19 treatments.

Infants Get Antibodies With Mother’s Milk

A relatively small study compared SARS-CoV-2 antibodies in human milk of mothers who had been vaccinated or had had an infection. In both cases, antibodies were neutralizing the virus. Post-infection, the milk had variable levels of mainly IgA type antibodies, while post-vaccination, the levels were robust and IgG-dominated.

COVID-19 Associated With Complications in Pregnancy

A review of global data indicates that while earlier in the pandemic, COVID-19 outcomes in pregnant and non-pregnant individuals were similar, the later virus strains were associated with worse COVID-19 in pregnancy and with complications for the pregnancy and birth. The trimester in which the mother contracts COVID-19 may also play a role for the severity of outcomes. By contrast, in several large studies, vaccination was found to carry no additional risks for pregnant individuals. Moreover, recent research and experts’ comments underscore the importance of completing the full course of vaccination to ensure a safer pregnancy.

Socioeconomic Determinants of COVID-19 Outcomes

In a very large study of COVID-19 cases, racial and ethnic minorities were more likely to experience more severe disease and death. More studies would be needed to understand specific causative factors, which would in turn enable targeted policy interventions to improve public health outcomes in all populations.

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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