OSHA ETS Temporarily Stayed…and Other COVID News

• In today’s Recommendations for Industry, we discuss the stay of the OSHA ETS, the Pfizer antiviral, and a Science vaccine efficacy study. Read more below.
• On Saturday, a federal appeals court issued a stay of the Biden administration’s vaccine mandate for private companies. In the brief order temporarily blocking the new vaccine rules and OSHA ETS, a three-judge panel on the Fifth Circuit Court of Appeals said that the petitioners in the case — Republican-led states and private businesses — “give cause to believe there are grave statutory and constitutional issues with the Mandate.” The court said it would expedite the case.
• According to a Pfizer press release, its investigational novel COVID-19 oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to the placebo in non-hospitalized high-risk adults with COVID-19. In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo. Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible.
• As detailed in CIDRAP, a study published in Science evaluating the effectiveness of the Pfizer, Moderna, and J&J vaccines showed that from February to October 2021, overall vaccine effectiveness fell from 87.9% to 48.1%, with the steepest decline in recipients of the J&J vaccine, which dropped from 86.4% to 13.1%, followed by Moderna (89.2% to 58.0%), and Pfizer (86.9% to 43.3%). While breakthrough infection increased the risk of COVID-19 death, vaccination still protected against death in patients infected amid the Delta surge.
• Global cases of COVID-19 now exceed 250 million infections. In this time, there is a resurgence surge of the Delta variant in Europe. WHO’s COVID-19 technical lead, Dr. Maria Van Kerkhove has said that the “virus activity is rising in places where it shouldn’t be—in countries with ample vaccine and tools to fight the pandemic.”
• Yesterday (Monday, November 08) was the first day that the U.S. lifted its COVID-19 travel ban. The U.S. will now allow nonessential travel through air and land if the individual can “prove they are vaccinated against COVID-19 and can demonstrate a recent negative test for the virus. The United States will recognize full vaccination with any of the vaccines approved for use by the World Health Organization. Negative tests will need to have been procured within 72 hours of a flight or crossing into the United States.”
• Evictions are rising in the U.S., in “communities across the country, especially those where the distribution of federal rental assistance has been slow, and where tenants have few protections.” It is likely that evictions will be underrepresented and the numbers will be undercounted.
• China continues to drive for “zero COVID”; in this case, while it has over 900 current cases around the country, China will continue to push for zero cases completely. It has been postulated that China will continue to push for zero cases (unlike many other countries that are hoping to ‘live with it’). Although they have a high vaccination rate, their vaccines may not be as effective as new mRNA vaccines.
• Researchers at UC San Diego have developed a rapid diagnostic test for SARS-COV-2 using CRISPR-technologies called SENSR (sensitive enzymatic nucleic acid sequence reporter).

Flu Vaccine Update

• The H5N1 avian flu outbreak continues to spread across Europe, and now into South Korea. It is possible that the outbreak will continue as migration routes expand (CIDRAP).
• The CDC is reporting that although “seasonal influenza activity […] remains low”, detection of influenza has increased slightly in the last few weeks with 0.2% of clinical labs coming back positive. Two CDC jurisdictions, specifically New Mexico and D.C. (District of Columbia) are seeing moderate flu activity (higher than the remainder of the country).
• The WHO is reporting that although influenza activity remains low, globally, it is starting to increase slightly, too. Indeed, Influenza B/Victoria lineage is dominant (as reported last week).

OSHA ETS Temporarily Stayed … and Other COVID News

On Saturday, a federal appeals court issued a stay on the OSHA ETS for the vaccine/testing mandate for private companies. In the brief order temporarily blocking the new vaccine rules, a three-judge panel on the Fifth Circuit Court of Appeals said that the petitioners in the case — Republican-led states and private businesses — “give cause to believe there are grave statutory and constitutional issues with the Mandate.” With challenges also being posed by others, we don’t know how this will proceed.

However, this does not mean to stop planning for compliance with the rule. If the hold gets lifted, compliance dates may – or may not – be pushed out. So, we need to assume that the ETS will go through as written until we know something more specific.

There also has been other interesting news on the COVID front in recent days:

• Pfizer has developed a COVID-19 oral antiviral medication, PAXLOVID, which according to the company was found to reduce the risk of hospitalization or death in non-hospitalized high-risk adults with COVID-19 – by 89% compared to the placebo. Additionally, only 0.8% of patients who received PAXLOVID were hospitalized through Day 28 compared to 7.0% of patients who received placebo and were hospitalized or died. In the overall study population of 1,219 adults, no deaths were reported through Day 28 in patients who received PAXLOVID as compared to 10 deaths in patients who received placebo. Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible.
• A study published in Science evaluating the effectiveness of the Pfizer, Moderna, and J&J vaccines showed that from February to October 2021, vaccine effectiveness against infection fell from 87.9% to 48.1%, with the steepest decline in recipients of the J&J vaccine, which dropped from 86.4% to 13.1%, followed by Moderna (89.2% to 58.0%), and Pfizer (86.9% to 43.3%). In relation to death, however, vaccination remained protective, with effectiveness against death staying at 73.0% for Janssen, 81.5% for Moderna, and 84.3% for Pfizer-BioNTech for those up to age 65, with some decline for those 65 and older.

While the findings support continued vaccination efforts and other protection against infection, these findings could explain why we are starting to see a rise in the diminished rate of slowing in areas with high vaccination rates. While the vaccines may not be stopping case counts, they are protecting again serious outcomes.

• 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.