November 05, 2021

COVID-19 Weekly Newsletter: Vaccine Approved for Children, OSHA Vaccination Mandate

Efforts to continue to promote and expand access to COVID-19 vaccines reached major milestones this week, as the holiday season draws near.

OSHA Vaccination Mandate

In early September, President Biden released a 6-pronged plan to get the country back to normalcy. The plan mandated that employers provide paid time off for vaccination and that the Department of Labor’s Occupational Safety and Health Administration (OSHA) develop a rule to require employers with 100+ employees to mandate vaccination or weekly testing. On Thursday, November 4, OSHA released its emergency temporary standard rule that will require workers who work at a 100+ employee company to be fully vaccinated in order to enter the workplace, no later than January 4, 2022. OSHA clarified that these rules preempt any inconsistent state or local laws, including laws that ban or limit an employer’s authority to require vaccination, masks or testing. Both rules are effective November 5, 2021. Businesses that don't comply could be fined $14,000 per infraction. Learn more from Faegre Drinker Professionals on this rule’s impact on employers.

COVID-19 Pill Approved in the U.K.

The U.K. became the first country to approve a COVID-19 antiviral drug. It will be given following a positive COVID-19 test and within five days of the onset of symptoms. The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) recommended the drug for use for individuals with mild to moderate COVID-19 symptoms and at least one risk factor — such as diabetes, obesity or age — for developing severe illness. The drug manufacturer had submitted its Food and Drug Administration (FDA) emergency use authorization (EUA) request last month, and FDA's Antimicrobial Drugs Advisory Committee (AMDAC) will meet November 30 to review the company’ data and potentially hold a vote on its recommendation for its use.

Second COVID-19 Pill Option Shows Promise

Another pharmaceutical company reported that its COVID-19 pill, when used in combination with a common HIV treatment, reduced risk of hospitalization or death by 89% of high-risk adults exposed to the SARS-CoV-2 virus. The COVID-19 pill inhibits a key enzyme required for viral replication in human cells, and the HIV drug slows down the breakdown of the COVID-19 drug so it remains effective longer in the body. The company plans to submit their data to the FDA later this month and hopes to have the treatment available by the end of the year.

CDC Endorses COVID-19 Vaccine for Children

This week, Centers for Disease Control and Prevention (CDC) Director Walensky endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation to approve use of one of the mRNA COVID-19 vaccines for children ages 5-11. The vaccine began to be distributed nationwide this week, with anticipated scale-up efforts to include availability at pediatric offices, pharmacies, federally qualified health centers (FQHCs) and more. Some states and cities are expanding existing vaccination incentives to encourage kids to get vaccinated.

CDC Releases Report on Cruise Ship COVID-19 Infections

After a long hiatus, cruises from the U.S. resumed sailing with passengers this past summer under restrictions set by the CDC’s “Conditional Sail Order” (CSO). Looking over the past four months, of the estimated 600,000 people that sailed on cruise ships from the U.S., there were 1,359 laboratory-confirmed COVID-19 cases reported on cruise ships (0.23%) from both passengers and crew. Of these cases, 49 required hospitalization and 38 required medical evacuation. Due to concerns around the Delta variant, the CDC extended the CSO with the expectation it will become a voluntary guidance starting in January 2022.

‘When To Test’ Tool

A coalition of academic centers, medical research institutions, and government research institutions have developed a tool called “When to Test” for individual use. Originally developed for companies, the tool provides a means to assess what kinds of SARS CoV2 testing should be applied at companies and how often they should be applied, depending on factors such as location, vaccination rate, and the application of mitigation protocols, such as mask-wearing. The tool can provide individuals with recommendations on whether the user should be tested based on, for example, location, vaccination, mask-wearing behavior, number of regular close contacts and recent or planned contact with crowds.  This test is taken anonymously — it does not ask for any id information other than general location.

Data Is Key to Knowledge

The U.K. Health Security Agency (UKHSA) was established in April 2021 in order to coordinate the U.K. response to threats from infectious diseases. Since then, the agency has been publishing technical reports on the SARS-CoV-2 variants circulating in the U.K., with a wealth of information about the virus’ genotypes, their geographic distribution, changes over time and other details. 

Genetic Resistance to COVID-19

Researchers have launched a search for genetic clues about people who have proven to be resistant to SARS-CoV-2 infection. Of particular interest are those who remained SARS-CoV-2 negative despite being exposed to the virus without protection, such as close partners of those who did become ill with COVID-19.

What Childhood Vaccination Could Mean for the Pandemic’s Trajectory

Now that vaccines for 5-12 year-olds are available, modelers built projections for the course of the pandemic under various assumptions about the emergence of new variants. In all cases, childhood vaccinations reduce the number of projected cases, hospitalizations and deaths. The graphs provided in the article also show the observational data collected since the previous modeling exercise, showing that current models had somewhat overestimated the number of weekly cases and hospitalizations, while underestimating the number of weekly deaths. All graphs and details are regularly updated at the COVID-19 Scenario Modeling Hub.

WHO Guideline for COVID-19 Treatment

The BMJ and the World Health Organization maintain a “living guideline” for treating COVID-19 patients. The guideline gets regularly updated based on the evolving evidence about efficacy of various approaches.

Frequent Tests Coupled With Other Measures Keep Students Safe in Schools and Camps 

A prospective study in one school district demonstrated that a multi-layered mitigation approach including weekly at-home self-tests by staff and students minimized school-based COVID-19 transmission while enabling the in-person schooling. These findings align with experience in overnight camps where a multipronged approach including pre-arrival and subsequent frequent testing prevented transmission of SARS-CoV-2 among the campers.

The U.K. Experiment

Latest data show that cases of SARS-CoV-2 infections in the U.K. are now much higher than in similar — probably due to the lifting of all restrictions on social distancing and masking. Nevertheless, thanks to the high proportion of fully vaccinated individuals there, the number of hospitalizations is lower than could have been expected. The number of deaths per 100,000 people in the U.K. is lower than in the U.S. — but higher than in France or Germany.  Furthermore, the vaccines-induced protection against severe COVID-19 disease and death might be waning with time, so some in the U.K. are now counting on the “booster” dose to curb the increasing rate of infections. These ongoing and still unfolding challenges have prompted a serious self-reflection – as illustrated, for example, by a recent parliamentary report on “lessons learned” and recommendations for the future.  

Potential Animal Reservoir of SARS-CoV-2

A study of wild white-tailed deer in the U.S. found that 40% of these animals have antibodies to SARS-CoV-2, meaning they had been infected at some point. This finding is worrisome, not least because the transmission from animals to humans cannot be ruled out, although our current knowledge about cross-species jumps is incomplete and pertinent data are still scarce.

Holiday Gift Recommendations: Fun, Exciting and Relevant

With so many wonderful holidays to be celebrated in the next couple of months, you might enjoy browsing through the following book-gift ideas. Entertaining and educational, these books would never go out of style and will prove useful well beyond the holiday season! 

If you plan to deliver your gifts in person, remember the CDC recommendations for safer — and, thus, more enjoyable — holidays.

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.

The material contained in this communication is informational, general in nature and does not constitute legal advice. The material contained in this communication should not be relied upon or used without consulting a lawyer to consider your specific circumstances. This communication was published on the date specified and may not include any changes in the topics, laws, rules or regulations covered. Receipt of this communication does not establish an attorney-client relationship. In some jurisdictions, this communication may be considered attorney advertising.

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