• In today’s Recommendations for Industry, we respond to employer questions on the OSHA ETS. Read more below.
• The Sixth Circuit Court of Appeals, based out of Cincinnati, was selected via lottery by the Judicial Panel on Multidistrict Litigation to hear legal challenges to the OSHA ETS issued on November 5. A three-judge panel from the Sixth Circuit will now be randomly assigned to hear the legal challenges to the OSHA ETS. It is almost assured that the Biden Administration and OSHA will ask the Sixth Circuit Panel to review and repeal the Fifth Circuit Court of Appeals’ stay of the OSHA ETS.
• New global study shows mask-wearing is the single most effective public health measure at tackling COVID-19, reducing incidence by 53%, the first global study of its kind shows. (Study published in BMJ). Researchers said results highlight the need to continue with face coverings, social distancing, and handwashing alongside vaccine programs
• As temperatures drop and coronavirus infections spike across Europe, some countries are introducing increasingly targeted restrictions against the unvaccinated. The World Health Organization warned that Europe was once again the epicenter of the pandemic and that half a million people on the continent could die from COVID-19 in the next few months. Facing a 134 percent increase in cases in the last two weeks, the Austrian government cracked down on its unvaccinated population over the age of 12, restricting their movement to traveling for work, school, buying groceries, and medical care.
• Health and Human Services withdrew a policy that directed FDA not to enforce premarket review requirements for laboratory-developed tests (LDTs). FDA also updated its policies regarding tests, including LDTs, currently being offered prior to or without authorization, and policies regarding the types of tests on which the FDA intends to focus its review. Moving forward, the FDA generally intends to focus its review on EUA requests for at-home and point-of-care (POC) diagnostic tests; certain high-volume, lab-based molecular diagnostic tests and home collection kits; certain lab-based and POC high volume antibody tests; and tests for which the request is from, or supported by, a U.S. government stakeholder. FDA also took several actions aimed at further increasing access to accurate and reliable tests that can be performed at home or in places like doctor’s offices, hospitals, urgent care centers, and emergency rooms without having to be sent to a central lab for testing.
• 6 million American children ages 5 to 11 have gotten their first shot of the Pfizer-BioNTech COVID-19 vaccine, meaning 10% of that age group will have started the two-dose series in the first 10 days the vaccines have been available.
• New research from the Mayo Clinic shows monoclonal antibodies reduce the risk of hospitalization by 77% in 1,395 patients who had breakthrough COVID-19 infections. The research was published yesterday in the Journal of Infectious Diseases. More than two-thirds of the breakthrough infections—71.8%—occurred after June 2021, when the Delta (B1617. 2) variant was the dominant strain in the Midwest, where the study was conducted. The rate of hospitalization was 2.7% among patients treated with monoclonal antibodies, compared with 10.7% among those who did not receive therapy.

TAG Responds to Employer’s Questions on the ETS

TAG has been receiving a number of questions related to the OSHA ETS along with the current legal challenges it is facing. Following are some of those along with TAG’s take and recommendations.

Q. Should businesses expect to have to comply with the original compliance dates of the ETS?

As noted in the first key point above, the Sixth Circuit Court has been selected by lottery to hear the legal challenges to the OSHA ETS, and we foresee a strong likelihood that it will end up moving forward to the Supreme Court. Due to the challenges, OSHA has stated that it “has suspended activities related to the implementation and enforcement of the ETS pending future developments in the litigation.” Based on all this, TAG’s Take is that businesses should keep thinking and planning to determine how you will enforce the mandate – but don’t make any significant investments (e.g., purchasing tests, software tracking systems, etc.). As we see it as almost inevitable that OSHA will need to push out the compliance dates.

Q. If ETS is reinstated, will prior infection count in the ETS?

The short, and complete, answer is No.

Q. Will we need to validate the authenticity of vaccine cards?

No, OSHA does not put the burden on the employer to have proof of validity. But you should make it clear to employees that they are held responsible for any fraudulent statements of vaccination, and it is breaking the law.

Q. Are AstraZeneca vaccines accepted?

Yes. Any vaccine that has been authorized by the WHO or FDA is acceptable.

Q. In general, would you have any guidelines about what I should do when an employee calls in sick with COVID-like symptoms?

TAG does not provide medical advice, but logic says that employees should be recommended to see their doctor/healthcare provider and ask for treatment – even if they are vaccinated. Early diagnosis followed by use of available treatments (e.g., monoclonals) will help to reduce severity and hospitalization. It will likely be expensive, but relative to even one day in hospital it is still a massive savings. Of importance is that one seeks care early enough. We have heard that some healthcare providers are responding that the person seeking care “is not yet sick enough for a monoclonal,” but the reality is that the sicker one is, the less likely a monoclonal will work, as it is intended to be an early treatment.

 

RISK MATRIX:

TAG’s weekly COVID-19 matrix is showing that a little over half of the states in the U.S. have high case rates, with the numbers in many states increasing. It seems that every state has to go through the Delta phase of increase – if your state hasn’t yet, expect that it will. Additionally, if the U.S. continues to follow the European trend of about a two-month delay, as we have throughout the pandemic, we can expect to see a significant increase in cases toward the end of 2021/beginning of 2022.

Table 1.

Figure 1.

Table 2.

Table 3.

• In Tuesday’s Recommendations for Industry, we discussed the legal opinion from the Littler law firm that businesses will likely not be held to the current OSHA ETS deadlines. Read more here.
• Pfizer will begin producing its COVID-19 antiviral pill, “to be made and sold inexpensively in 95 poorer nations that are home to more than half of the world’s population.” They join agreements similar to that of Merck. (NYT)
• Reuters explores the impacts of the Delta variant and the potentiality for other Delta offshoots.
• Fauci encourages that all “eligible Americans should ‘by all means’ get their COVID booster shots.”
• Due to rising COVID-19 cases, Austria and Germany have imposed restrictions on unvaccinated individuals. In Austria, those who are unvaccinated will only be allowed to leave home for “work, food shopping or emergencies,” while in Germany, those unvaccinated will not be allowed to go to “restaurants, cinemas [or] sports facilities” (NPR). Also with the rise in COVID-19 cases, the CDC has added the Czech Republic, Guernsey, Hungary, and Iceland to the “very high” risk travel destinations (CNN). 
• On the other hand, India drops COVID-19 travel restrictions for unvaccinated tourists (Fortune). Despite this, Delhi is considering a new lockdown – but due to pollution and not COVID-19 (Washington Post).

 

Influenza:

With influenza rising in certain areas, and the similarities between COVID-19 and influenza symptoms, TAG continues to recommend that anyone with symptoms stay home so as not to transmit the illness. Following are some statistics on the current spread of the flu:

• According to the CDC, while “Seasonal influenza activity in the United States remains low […] the number of influenza virus detections reported by public health laboratories has increased in recent weeks.” This week, New Mexico has jumped from moderate influenza activity to high/very high influenza activity. Rhode Island also has moderate influenza activity. Around the country, other states are at low or minimal influenza activity.
• According to the WHO, “despite continued or even increased testing for influenza in some countries, influenza activity remained at lower levels than expected for this time of the year.” Globally, the influenza B viruses are predominant.
• Other countries are reporting more H5N1 poultry-sourced avian flu in Norway, UK, and Japan (CIDRAP).

 

Public Health/Food Safety:

• FSIS has extended its comment period for the labeling of lab-grown meat and poultry products.
• The US FBI, in September 2021, warned of cybercriminals targeting the food and agriculture sector, listing a string of incidences in a Private Industry Notification, as discussed further by the Global Seafood Alliance which explores seafood companies’ vulnerabilities in cybersecurity.
• EFSA will be providing “scientific advice on the nutrients and non-nutrient food components of public health importance for Europeans, food groups with important roles in European diets, and scientific criteria to guide the choice of nutrients for nutrient profiling. The Commission intends to propose new legislation at the end of 2022.”