COVID-19 Situation Report
Editor: Alyson Browett, MPH

Contributors: Clint Haines, MS; Natasha Kaushal, MSPH; Amanda Kobokovich, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS.
US VACCINATION REQUIREMENTS The administration of US President Joe Biden on November 5 released an interim final rule regarding SARS-CoV-2 vaccination for private employers with 100 or more workers in an effort to increase vaccination rates among the US population. The next day, the US Court of Appeals for the Fifth Circuit in New Orleans granted an emergency stay of the federal Occupational Safety and Health Administration (OSHA) temporary emergency rule that employees of those companies be fully vaccinated by January 4 or be required to undergo weekly testing, although it is unclear whether the stay is applicable nationwide or only in those states under the court’s jurisdiction.* According to the 3-judge panel, the petitioners bringing the request—including 5 states, all led by Republican governors, and various companies—"give cause to believe there are grave statutory and constitutional issues with the Mandate." 

The court—considered to be one of the nation’s most conservative appeals courts—gave the federal government a deadline of 5 pm on November 8 to respond. Late that day, the US Department of Justice requested the court lift its stay, stating that the petitioners’ claims of harm are “premature,” given the rule’s first deadline—for large businesses to require masking of unvaccinated employees in the workplace—does not go into effect until December. The Biden administration said employers should move forward with efforts to get their employees vaccinated, saying the rule “will save thousands of lives and prevent hundreds of thousands of hospitalizations.” OSHA rules apply to private workplaces in 29 states, while the remaining states have their own state-run OSHA agencies that are required to adopt any federal rules. In October, OSHA threatened to take over the operations of the state-run OSHA agencies in Arizona, South Carolina, and Utah for failing to adopt a similar SARS-CoV-2 vaccination rule for healthcare workers; Arizona and South Carolina have begun the process to adopt that standard. Several other lawsuits challenging the vaccine rule have been filed in federal courts, including by at least 21 other Republican-led states. The Fifth Circuit must now decide whether to lift the stay or make it permanent. If the latter, OSHA could appeal to the US Supreme Court. So far, courts have largely upheld vaccination mandates issued by local and state governments and private companies, but the federal rule is more far-reaching. Despite opposition to the OSHA standard and other vaccine requirements, data show they are working to increase vaccination rates, with some companies reporting nearly 100% of their workers have received at least one dose of vaccine.
*Those states include Texas, Louisiana, and Mississippi.

PFIZER ANTIVIRAL CANDIDATE Pfizer announced last week that its investigational antiviral pill to treat COVID-19 reduced the risk of COVID-19-related hospitalization or death from any cause by 89% when compared to a placebo among patients treated within 3 days of symptom onset. The planned interim results come from a Phase 2/3 clinical trial examining the pill—which is called Paxlovid and is taken in combination with an older antiviral named ritonavir—among COVID-19 patients recovering at home who are at high risk of developing severe disease. The company said it plans to submit the data to the US FDA as soon as possible to request emergency use authorization (EUA) for the antiviral. This is the second oral pill that has shown positive results in clinical trials for treating people with COVID-19 at home and could help alleviate the strain of the pandemic on hospitals. The other antiviral, molnupiravir, being developed by Merck and Ridgeback Biotherapeutics, reduced the risk of hospitalization and death by about half, and UK regulators granted conditional authorization to the pill last week. Clinical trial data for both drugs have not yet been peer-reviewed or published in a journal.

Access to any new therapy is a global concern, and Pfizer said it will institute a tiered-pricing approach to promote equitable access if the drug receives regulatory clearance. Merck also has taken steps to facilitate manufacturing and distribution of its antiviral, including entering into advance purchase agreements with individual nations, implementing tiered pricing, and granting voluntary licenses to generic manufacturers and the Medicines Patent Pool. Notably, wealthy nations are already contracting with both companies for supplies of the antivirals, raising questions about when low- and middle-income countries (LMICs) might be able to access the treatments, with limited supply expected to be produced through the end of the year.

REGEN-COV Regeneron Pharmaceuticals on November 8 announced positive results from a Phase 3 clinical trial of its combination monoclonal antibody REGEN-COV for SARS-CoV-2 prevention. The trial—jointly run with the US National Institute of Allergy and Infectious Diseases (NIAID)—enrolled SARS-CoV-2-negative individuals who lived in the same household as someone who tested positive for SARS-CoV-2 within the prior 4 days. Participants received either one 1,200mg dose of REGEN-COV, administered via 4 subcutaneous injections, or a placebo. The trial found that REGEN-COV reduced the risk of developing COVID-19 by 81.5% during an 8-month timeframe. Notably, by the end of the follow-up period, about 35% of participants had also received at least 1 dose of a SARS-CoV-2 vaccine. REGEN-COV also reduced the risk of COVID-19-related hospitalization by 100%, with 0 individuals hospitalized in the REGEN-COV group and 6 individuals hospitalized in the placebo group. There were no deaths during the trial, and the trial did not record any new safety concerns for the treatment. REGEN-COV is currently authorized for the treatment of individuals with mild-to-moderate COVID-19 who are not hospitalized and to prevent infection in individuals exposed to COVID-19. The new data provide some indication that REGEN-COV could provide long-lasting immunity for immunocompromised individuals and others who are unresponsive to vaccines. Regeneron said it plans to submit the data, which is not yet published or peer-reviewed, to the US FDA as soon as possible in hopes of gaining authorization for the drug to be used as pre-exposure prophylaxis.

CHILDHOOD VACCINATION Now that a SARS-CoV-2 vaccine is authorized for children ages 5 to 11 years in the US, state regulators—along with parents, pediatricians, and public health officials—are contemplating when and if the shots should become mandatory for children. All 50 US states have requirements for school-age children to be immunized against other diseases such as polio, chickenpox, and measles. The nation’s second-largest school district, Los Angeles Unified School District in California, already has said children aged 12 and older must be vaccinated by mid-December to continue in-person learning, and several other jurisdictions and states have plans to make SARS-CoV-2 vaccination mandatory for children and adolescents to attend school as soon as the US FDA grants a vaccine full approval for those age groups.

Costa Rica will require SARS-CoV-2 vaccination for all children aged 5 and older beginning in March 2022, making it one of the first countries to implement such a policy for youth. So far, nearly 75% of the country’s adolescents ages 12 to 19 years have received at least one dose of vaccine. In the UK, the number of breakthrough infections among vaccinated individuals is increasing, and health officials say children—who remain largely unvaccinated—are partly to blame, with unvaccinated kids passing the virus to their vaccinated parents. A recent study published in The Lancet Infectious Diseases showed that fully vaccinated individuals who were exposed to a household contact infected with the Delta variant had an appreciable risk of becoming infected in the home, although the risk was lower than for unvaccinated individuals (25% vs 38%). Another study published in The Lancet Regional Health Europe highlights the role the Delta variant plays, showing increased transmissibility among household contacts when compared with the Alpha variant. While no vaccine is 100% effective in preventing COVID-19, evidence shows vaccination can help reduce the risk of infection and transmission to others, as well as significantly reduce the risk of hospitalization and death.

INTERNATIONAL TRAVEL TO US The US on November 8 reopened its borders to fully vaccinated travelers from 33 countries that were subject to previous restrictions implemented in early 2020. The countries—including Mexico, Canada, the UK and most European nations, China, India, South Africa, Iran, and Brazil—accounted for more than half of international visitors to the US in 2019, prior to the pandemic. Travelers entering the US by air will be required to show proof of vaccination status and a negative SARS-CoV-2 test, while those entering through land borders with Canada and Mexico will only need to show proof of vaccination. Notably, the loosening of restrictions comes just as Europe is experiencing a new surge of COVID-19 cases, with the WHO last week warning the region is again “at the epicenter” of the pandemic. Notably, Germany this week recorded its highest 7-day incidence since the beginning of the pandemic. Additionally, several countries, including Austria and Iceland, have implemented new or reinstated previous restrictions, and vaccination rates have plateaued across the region. A WHO official urged the US to pay close attention to Europe’s current situation and to not delay in reinstating public health measures, especially prior to the upcoming holidays.

EMERGENT BIOSOLUTIONS The US government has ended its contract with Emergent BioSolutions, a Baltimore, Maryland-based SARS-CoV-2 manufacturer that had to pause production earlier this year after an inspection revealed a batch of J&J-Janssen vaccine doses had been contaminated. The more than US$650 million contract—which only involved production of the AstraZeneca-Oxford vaccine that is not authorized for use in the US but is widely used in Canada, the EU, and South Africa—originally was awarded in May 2020, and Emergent will not receive about US$180 million after the government stopped making payments following the contamination discovery. Notably, J&J-Janssen will continue to use Emergent to produce its vaccine under a separate agreement even though the facility continues to lack federal regulatory approval to manufacture vaccine doses for use in the US. 

VACCINE MISINFORMATION Tackling COVID-19 misinformation is far from simple. Sources and believers of misinformation range from high-profile NFL players to religious institutions, and efforts to combat vaccine hesitancy are often hodgepodge with unclear or mixed efficacy. According to new findings from the KFF COVID-19 Vaccine Monitor, 78% of adults have heard at least 1 of 8 different false statements about COVID-19 and believe it to be true or are uncertain if the statement is true or false. Only 22% did not believe any of the 8 false statements, the survey found. Belief in misinformation was associated with unvaccinated status, identification as Republican, rural residency, lack of a college degree, and age under 50 years. Belief in misinformation also was correlated with individuals who listed One America News, Fox News, or Newsmax as their trusted news source. In an effort “to understand, identify, and stop misinformation, and help others do the same,” US Surgeon General Dr. Vivek Murthy released a community toolkit for the general public this morning. Dr. Murthy previously identified COVID-19 misinformation as a threat to public health, and he hopes health professionals, faith leaders, teachers, parents, and others will use the new toolkit to engage in in-person conversations to dispel myths and rumors, especially regarding vaccination.

In a new analysis from the Center for Health Security, its estimated that COVID-19 vaccine misinformation and disinformation costs an estimated $50 to $300 million each day.

LOSS OF BENEFITS ​​The US military has implemented SARS-CoV-2 vaccine mandates as a matter of readiness, a US Department of Defense official recently told the Senate Veterans' Affairs Committee. If service members refuse to get vaccinated, discharge decisions will be left to individual commanders, and those personnel that receive other-than-honorable discharges might lose certain US Department of Veterans Affairs (VA) benefits, including GI Bill funding, home loans, transition assistance, and some healthcare services. The military’s first vaccine mandate deadline passed on November 2, when active-duty members of the US Air Force and US Space Force (USAF/USSF) were to be fully vaccinated against COVID-19. As of last week, about 3% of the USAF/USSF active-duty members were not vaccinated and face possible expulsion. Deadlines for the other branches are looming. According to the Pentagon, 97% of the nation’s 1.3 million active-duty service personnel have had at least one vaccine dose, with 99% of the Navy with at least one shot, 93% of Marines, and 90% of the Army. Notably, the US Department of Defense has issued only a handful of exemptions, although none for religious reasons. 
Outside of the military, other workers who remain unvaccinated may face financial repercussions, including increases in health insurance premiums, costs of weekly testing to comply with mandates, or even job loss. Now, some employers are rescinding death benefits for unvaccinated workers who die of COVID-19. New York’s Metropolitan Transportation Authority (MTA) is one of the highest-profile employers to do so, no longer paying a $500,000 death benefit to the families of subway, bus, and commuter rail employees who are unvaccinated and die of COVID-19. Other employers also are considering limiting benefits, such as short-term disability, to unvaccinated workers. Insurers—including MetLife, Hartford Financial Services Group, and Prudential Financial—have reported increases in the number of death-benefit claims for COVID-19 deaths among working-age people amid the Delta variant surge, causing them to payout higher-than-normal amounts through their employer-sponsored life insurance and international life insurance businesses. 

SINGAPORE Currently, the government of Singapore fully covers medical costs for COVID-19 treatment for all nationals, permanent residents, and long-term visa holders. However, because unvaccinated individuals are causing a disproportionate strain on the healthcare system, the Ministry of Health announced this week that individuals who are “unvaccinated by choice” will be ineligible to receive full government coverage for COVID-19 medical bills beginning December 8. These unvaccinated individuals will still have access to normal healthcare financing options where applicable, such as private insurance or government subsidies. As of November 8, 85% of Singapore’s population is fully vaccinated, and vaccination is free to all nationals and long-term residents.