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 COVID-19 STRATEGY Amid a record surge in new COVID-19 cases driven by the Omicron variant of concern (VOC), the administration of US President Joe Biden is facing criticism over its handling of the pandemic, particularly surrounding public health guidance and communication. Several top government health officials are testifying today in a US Senate Health Committee hearing, where they will face tough questions regarding the US COVID-19 response. CDC Director Dr. Rochelle Walensky, who will appear before the committee, will face questions regarding the agency’s guidelines on masking, isolation and quarantine, and testing, which have led to several messaging missteps among administration officials and confusion among the public. Dr. Walensky reportedly has undergone media training in recent months and earlier this week held the CDC’s first solo press briefing since heading the agency.

Other questions witnesses could face include how the US is faring during the Omicron wave; how well rapid antigen tests are working and when 500 million free tests will be available; and whether the US needs to reframe its COVID-19 strategy. New daily COVID-19 cases are at a record high and related hospitalizations are on track to soon reach a record high, with some hospitals nearing capacity and facing critical staffing shortages. The Biden administration announced this week that, as of January 15, private health insurers will be required to cover up to 8 at-home rapid antigen tests per month per person on their plans.* The administration also is finalizing plans for 500 million free at-home tests to be available for order through a new website and delivered via the US Postal Service. The administration hopes the strategies to provide easy-to-use, free tests to people at home can help slow the spread of the virus, allow people to gather more safely, and help get kids back to school and people back to work more quickly. It remains unclear how the efforts address the nationwide limited supply of tests, questions surrounding the sensitivity of the tests to detect Omicron, and whether a positive test indicates infectiousness.

Late last week, several former advisors to President Biden’s transition team published a series of articles calling for the administration to revamp its COVID-19 response strategy and set clear goals for a “new normal.” The viewpoint pieces, published in the Journal of the American Medical Association (JAMA), lay out dozens of explicit recommendations on strategies for testing, surveillance, mitigation, vaccines, and therapeutics, including modernizing public health data infrastructure; investing in more tests; providing more high-quality masks free to US residents; implementing more far-reaching vaccine mandates; developing variant-specific and universal coronavirus vaccines; and rebuilding public trust in health institutions. According to The Washington Post, White House officials are pulling together a longer-term funding request to Congress for additional COVID-19-related health spending, including tens of billions more dollars for treatments and vaccine efforts domestically and abroad. 
*Most of the authorized SARS-CoV-2 test kits contain 2 tests. We are interpreting this as insurers will be required to cover 8 test kits per person per month containing a total of 16 tests.

US HOSPITALS US COVID-19 hospitalizations are on track to reach a record high, as early as this week. The current 7-day average is at 109,874 as of January 8, up 34% over the prior week and far surpassing the US CDC’s forecast. Pediatric hospitalizations among children with COVID-19, while still lower than any other age group, also are up, with the rise attributed to hospitalizations of children under the age of five who are not yet eligible for vaccination and driven by the increased transmissibility of Omicron. However, hospitalization data does not always provide an accurate picture of COVID-19 severity and may include incidental infections; for example, in New York, 42% of patients hospitalized with COVID-19 were hospitalized for reasons unrelated to COVID-19 and tested positive during routine testing. 

Even incidental COVID-19 cases place incredible strain on hospitals, as coronavirus patients need to be isolated and require a greater amount of hospital resources than non-infected patients. Around 80% of hospital and ICU beds are occupied nationwide, according to US government data, with about 21% and 31%, respectively, occupied by COVID-19 patients. Hospitals continue to report that patients admitted for COVID-19 who experience poor outcomes are mostly unvaccinated. Additionally, nearly one-quarter of hospitals nationwide report critical staffing shortages. Many healthcare workers are out sick with breakthrough infections—even after changes to CDC guidelines that allow for a shortened period of isolation—and burnout is causing droves of workers to leave their positions or the healthcare profession entirely. In order to compensate for the strain, some hospitals have been forced to cancel or postpone elective procedures and hospitals in several states are implementing crisis standards of care.  

BOOSTER & ADDITIONAL VACCINE DOSES Last week, the US FDA amended the authorization and the US CDC updated recommendations for reducing the interval period between the primary vaccination series and booster doses from 6 months to 5 months for both the Pfizer-BioNTech and Moderna SARS-CoV-2 vaccines. According to the FDA, the change was made in response to the dramatic rise in US cases attributable to the highly transmissible Omicron variant. Third doses of the mRNA vaccines have been shown to increase immune system responses that could help protect against infection with or severe disease from Omicron. In New York, healthcare workers are now required to receive vaccine boosters in addition to the full primary series, with exemptions only allowed for medical reasons. 

Now, discussion among the pharmaceutical and scientific community is turning to whether a fourth dose (ie, second booster) is warranted later this year. Moderna’s CEO publicly voiced that recipients of the company’s vaccine may need an additional fourth dose in the fall to compensate for waning antibody levels. Researchers from Israel recently announced findings from unpublished studies documenting a 5-fold increase in antibodies after a second Pfizer-BioNTech booster. Israel already is offering a fourth dose to certain populations, including healthcare workers and higher-risk older adults. West Virginia Governor Jim Justice has requested permission from US health agencies to follow Israel’s example to provide fourth doses to some residents. The state has the third oldest population of all US states, and many residents have underlying conditions that raise their risk of severe COVID-19. Additionally, the US CDC updated its guidance to allow some moderately or severely immunocompromised individuals to receive 4 doses of COVID-19 vaccine, including a third primary dose and a fourth booster dose. However, the WHO warns that providing continual boosters every few months is not a fiscally or operationally sustainable long-term strategy, and some experts predict continuous boosters could dampen immune responses. Pfizer-BioNTech and Moderna both have plans to roll out vaccine booster doses that target Omicron later this year. 

US VACCINE REQUIREMENTS The US Supreme Court on January 7 heard nearly 4 hours of oral arguments in 2 sets of cases involving federal SARS-CoV-2 vaccine requirements. At issue are 2 federal regulations: the Occupational Safety and Health Administration’s (OSHA) Emergency Temporary Standard (ETS) that requires all workers at firms with 100 or more employees either get vaccinated or be tested weekly and wear a mask to work (National Federation of Independent Business v. Department of Labor, No. 21A244) and a Centers for Medicare and Medicaid Services (CMS) regulation issued by the US Department of Health and Human Services (HHS) requiring vaccination for nearly all workers at hospitals, nursing homes, and other medical facilities that receive federal funds through Medicare and Medicaid (Biden v. Missouri, No. 21A240). Both cases came to the court last month on an emergency basis, and the justices elected to fast-track the cases for oral arguments to determine whether the Biden administration can continue enforcement of the rules while litigation continues.

The court’s conservative majority signaled it is unlikely to permit the Biden administration to enforce the OSHA rule, with several justices questioning the agency’s authority to issue such a wide-ranging emergency regulation without explicit congressional authorization. The court’s 3 liberal justices, on the other hand, indicated the regulation clearly meets OSHA’s authority to take actions to protect workers from “grave danger.” The rule is currently being enforced after the US Court of Appeals for the Sixth Circuit dissolved a stay of the ETS issued by the Fifth Circuit. If the court allows the rule, OSHA expects to begin issuing citations for noncompliance no sooner than February 9. 

In the CMS case, more justices appeared to support the Biden administration’s authority to require certain healthcare workers to be vaccinated, unless they qualify for a medical or religious exemption. Notably, Chief Justice John Roberts suggested a clear association between healthcare workers and the safety of patients. Additionally, Associate Justice Brett Kavanaugh noted that none of the facilities or workers covered under the mandate are challenging the requirement and questioned whether the Republican-led states behind the challenge had the legal authority to do so because they operate only some of the facilities affected by the mandate. The CMS requirement is currently blocked in 25 states due to a lower court injunction. The federal government is asking the Supreme Court to lift that injunction. CMS said on December 28 it plans to begin phased enforcement for facilities located in states not covered under the stay, and those facilities’ employees will need to be fully vaccinated by February 28. 

NOVAVAX Novavax expects its SARS-CoV-2 vaccine to receive regulatory approval in multiple countries, including the US, over the next several months, the company’s CEO, Stanley Erck, said on January 10. As expected, Novavax completed its data submission on its protein-based vaccine to the US FDA on December 31, a prerequisite for emergency use authorization (EUA) application. The company expects to file a request for an FDA EUA at the end of this month, and it has recently applied for authorization in other nations, including Japan, the United Arab Emirates, Singapore, New Zealand, Australia, South Africa, and the UK. Shipments of the vaccine have begun to the European Union, which authorized the vaccine last month. The WHO has issued emergency use listings for 2 versions of the vaccine (NVX-CoV2373): Nuvaxovid, which will be manufactured in Europe and is authorized for use by the European Medicines Agency; and Covovax, which will be manufactured by the Serum Institute of India and is authorized for use by the Drugs Controller General of India. Some experts feel the vaccine’s 6-month stability under simple refrigeration storage will make it particularly useful in low-income countries.

INDIA Several states in India are imposing COVID-19 restrictions amid a sharp increase in the number of new cases due to the Omicron variant of concern (VOC). The country experienced an 8-fold rise in new cases in the 10 days since January 1, reporting the most daily COVID-19 cases since early June. More than 1 million healthcare and frontline workers and high-risk older adults received a third dose of SARS-CoV-2 vaccine on January 10, the first day of the country’s “precaution” dose rollout. The government reported an additional 277 deaths on January 11, bringing the official total to 484,213. Notably, an analysis published last week in Science questions the official count, suggesting instead that close to 3 million people have died of COVID-19 in the country. The analysis—which several outside experts praised for its robust design—shines a light on the potential for undercounting COVID-19 mortality in other countries with anomalously low death rates, including Russia, Tajikistan, Nicaragua, Uzbekistan, Belarus, and Egypt.

CORBEVAX & PAN-SARS VACCINES Researchers in Texas (US) are celebrating India’s recent regulatory authorization of CORBEVAX, a SARS-CoV-2 vaccine designed using traditional technology specifically for use in resource-poor settings. Researchers from Texas Children’s Hospital Center for Vaccine Development (Texas Children’s CVD) and Baylor College of Medicine developed the protein subunit vaccine and licensed it, without patents, to Biological E. Limited (BioE) for manufacturing. India already has ordered 300 million doses, and BioE plans to deliver more than 1 billion doses to other countries. While some questions remain about CORBEVAX’s effectiveness against Omicron and a lack of publicly available data, the vaccine’s development—funded by private philanthropies with no strings attached—represents a model for future vaccine development and vaccine equity. Unlike vaccines using newer technology, CORBEVAX’s intellectual property is available to manufacturers worldwide. 

Similarly, scientists with the US Department of Defense’s Walter Reed Army Institute of Research are developing a pan-SARS vaccine aimed at providing broad protection against SARS-CoV-2 variants and other coronaviruses that could be useful in low- and middle-income countries because it does not require ultra-cold freezer storage. The investigational Spike Ferritin Nanoparticle (SpFN) vaccine completed phase 1 clinical trials in December with positive results that are currently under analysis. The vaccine uses a ball-shaped ferritin nanoparticle that allows scientists to attach up to 24 spike proteins of various coronaviruses, which they hypothesize will induce potent and broad immune responses. The SpFN vaccine has not yet been tested against Omicron and needs to undergo phase 2 and phase 3 clinical trials.