OSHA Vaccine/Testing Standards Published

• In today’s Recommendations for Industry, we include TAG’s weekly matrix information, and discuss the Occupational Safety and Health Administration (OSHA) issuance of the emergency temporary standard (ETS) establishing the requirements for the COVID-19 vaccine/testing mandate for employers with 100 or more employees. Read more below.
• The CDC has recommended the Pfizer COVID-19 vaccine for children aged 5 – 11 years old.
• A large multi-state study has found that the mRNA COVID-19 vaccines (Pfizer and Moderna) are less effective with immunocompromised individuals. The findings of this have been published in CDC’s MMWR.
• Starting next week on November 08, 2021, the U.S. “will allow vaccinated foreign tourists to enter” the country. This essentially replaces the travel ban from various countries and instead allows for “provid[ing] proof of vaccination status.” Additionally, S.A. Today reports that “International visitors who cross land borders with Canada and Mexico or by passenger ferry for non-essential reasons will also be required to be vaccinated and show vaccination proof, the White House official continued.”
• The ETS on Vaccination and Testing has come out. We will discuss this further this week and next.

OSHA Vaccine/Testing Standards Published

As noted in Key Points, OSHA has issued the ETS establishing requirements for the COVID-19 vaccine/testing mandate for large employers (100 or more employees). With the document being nearly 500 pages, TAG’s medical and public health experts are delving deeply into the ETS to provide our clients with details and perspectives in our next newsletters on what businesses will need to do. TAG also will be updating the COVID-19 Toolkit to include information on the requirements.

Meanwhile, there are a few major points that we have dug out and are passing along at this point. These include:

• According to the OSHA Fact Sheet, employers must comply with most provisions by 30 days after its publication in the Federal Register (December 5), but have 60 days (January 5) to comply with testing mandates.
• The ETS does not apply to employees who do not report to a workplace where other individuals such as coworkers or customers are present, employees while they are working from home, or employees who work exclusively outdoors.
• Regarding testing, the ETS also defines an authorized COVID-19 test as being one that is:
  • cleared, approved, or authorized (including by EUA) by FDA to detect a current COVID-19 infection (e.g., a viral test)
  • administered in accordance with the authorized instructions
  • not both self-administered and self-read unless observed by the employer or an authorized telehealth proctor.

Examples OSHA gave are tests with specimens that are processed by a laboratory (including home or on-site collected specimens which are processed either individually or as pooled specimens), proctored over-the-counter tests, point of care tests, and tests where specimen collection and processing is either done or observed by an employer.

• Tests can therefore be either antigen tests, PCR, or other molecular based tests.
• The ETS also states that employers do not need to cover the cost of testing or masks for employees who choose not to be vaccinated and can require employees to bear these costs.
• The ETS defines “Fully Vaccinated” in significant detail, although the definition is currently limited to the primary dose series of CDC or WHO authorized or approved vaccines and doesn’t require booster doses to be considered fully vaccinated.
• Additionally, as we’ve previously discussed, there may be some differences between states due to variation in OSHA state regulation: as 22 states operate under OSHA State Plans covering both private sector and state and local government workers, six have State Plans that cover only state and local government workers, while the others operate directly under OSHA. State plans are monitored by OSHA to ensure they are at least as effective. And in all cases, OSHA standards preempting state standards for any issues addressed by the Federal standards.

Risk Matrix:

This week’s COVID-19 matrix is showing that trends are continuing with some states having increased case rates, but most holding steady. Risk factors of areas of colder weather also are continuing to climb, as people and groups move indoors. TAG recommends businesses continue to be prudent and maintain protections to control risk.

Table 1.

Figure 1.

Table 2.

Table 3.

• In Thursday’s Recommendations for Industry, we discussed the fluctuation in case rates. Read more here.
• At least 5 million people worldwide have died from Covid – though experts believe the total number is undoubtedly far higher. COVID-19 is responsible for more than five million confirmed deaths around the world –a loss that would wipe out almost the entire population of Melbourne, Australia, or most of the nation of Singapore. But experts say the real number could be as high as twice the reported figure, as many countries are unable to accurately record the number of people who have died from COVID-19, like India and African nations, and experts have questioned the veracity of data from other countries, like Russia.
• At the G20 leaders meeting in Rome this weekend, the group agreed on a goal of vaccinating at least 70% of the world’s population by the middle of next year and at least 40% of the world’s population by the end of this year. In its Rome Declaration, the group agreed to take steps to boost the global vaccine supply such as easing export rules, strengthening supply chains, and boosting global production capacity, calling on the private sector and multilateral groups to contribute to the efforts, and establishing a joint finance-health task force to improve global coordination and funding of pandemic preparedness measures.
• Oramed Pharmaceuticals won approval to run an initial clinical trial for its orally delivered COVID-19 vaccine candidate in South Africa, enrolling patients in Phase 1 of tests. A similar trial is planned in Israel and a Phase 2 trial in the US. While South Africa has hosted a number of COVID-19 vaccine trials, this would be the first oral treatment, surmounting some hurdles confronting Africa, such as the need for refrigeration, and help improve inoculation in the least-vaccinated continent.
• Fewer than 10% of African countries to hit key COVID-19 vaccination goal. Just five African countries, less than 10% of Africa’s 54 nations, are projected to hit the year-end target of fully vaccinating 40% of their people, unless efforts to accelerate the pace take off.
• After receiving its first emergency use authorization (EUA) from Indonesia, Novavax Inc expects regulators in India, the Philippines and elsewhere to decide on the vaccine within “weeks,” its chief executive said. The company also filed EUA applications to Canada and the European Medicines Agency, and the World Health Organization (WHO) is reviewing Novavax’s regulatory filing.
• Cognitive impairment occurred relatively often within several months of patients having had COVID-19, according to results of a cross-sectional study published in JAMA Network Open. Examining data of 740 patients (mean age, 49 years; 63% women; mean time from COVID-19 diagnosis, 7.6 months) who survived COVID-19 and were treated in outpatient, ED, or inpatient hospital settings, results showed the most significant deficits occurred in processing speed (18%), executive functioning (16%), phonemic fluency (15%) and category fluency (20%), memory encoding (24%) and memory recall (23%). Findings suggest that a substantial proportion of patients may experience cognitive problems several months after COVID-19, which can contribute to significant functional disability.
• Thousands were gathered Sunday for Shanghai Disneyland’s Halloween party when suddenly the gates closed and health-care workers fully dressed in white protective suits descended on the site. The site had been ordered to shut its doors after a woman who visited Disneyland over the weekend tested positive Sunday for the coronavirus. Visitors were told they couldn’t leave until they got tested. Officials tested more than 30,000 people – all were negative.

Flu Status:

• According to the CDC, as of this week, “seasonal influenza activity in the United States remains low,” with only 0.1% of clinical lab tests showing positive for influenza and only 1.8% of visits leading to influenza activity. This week, New Mexico was the only state to have higher flu rates than other jurisdictions.
• According to the WHO, globally, “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.” As we discussed last week, it seems that “Worldwide, influenza B/Victoria lineage viruses” is currently dominant.
• On Monday, CDC reported two new U.S. human infections with influenza viruses that usually spread in pigs and not people. One of these variant influenza virus infections is the first to occur during the 2021-2022 flu reporting season, the other reported infection is the 11th infection that occurred during the 2020-2021 season. Variant virus infections occur rarely, and usually in the context of exposure to pigs when they happen. However, there have been a small proportion where the original source of exposure to a pig cannot be readily identified, meaning the possibility of limited human-to-human spread of a variant influenza virus cannot be ruled out. The virus may have passed from a pig to an intermediary person who then spread the virus to the patient in whom the virus was detected.