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.
GLOBAL VACCINE & TREATMENT ACCESS The COVID-19 pandemic is at a critical stage, and it is dangerous for the world to assume “we are in the endgame,” WHO Director-General Dr. Tedros Adhanom Ghebreyesus warned at the opening of a WHO Executive Board meeting on January 24. The conditions are ideal for new variants to emerge, but the world can end the acute phase of the pandemic this year by achieving the target of vaccinating 70% of each nation’s population and improving testing and surveillance, Dr. Tedros encouraged. Globally, at least 5.6 million people have died of COVID-19 as the pandemic enters its third year, but only about 10% of people in low-income countries have received at least 1 dose of vaccine. 

The global vaccine sharing scheme COVAX announced last week that it has delivered 1 billion SARS-CoV-2 vaccine doses to 144 countries, only half of its goal to deliver 2 billion doses by the end of 2021. The scheme was hampered by wealthier nations’ hoarding of the shots, export restrictions, and numerous changes within the organization. Gavi, the Vaccine Alliance and other partners in the initiative last week warned that COVAX is “basically out of money” and needs at least US$5.2 billion in new funding over the next 3 months to support the quick rollout of already-donated doses and to purchase more vaccines. Leading African public health authorities recently called for donated shots to have a shelf life of at least 3 to 6 months to allow countries time to plan distribution and avoid situations where the doses expire. According to the Africa Centres for Disease Control and Prevention (Africa CDC), approximately 0.5% of the 572 million doses delivered to the continent so far have expired before being administered. Efforts continue to increase vaccine manufacturing in Africa. Last week, South African-American businessman Dr. Patrick Soon-Shiong opened a new vaccine plant in Cape Town to address the lack of capacity. 

The Africa CDC said it also is in talks with pharmaceutical companies to increase supplies of COVID-19 treatments. Merck and Ridgeback Biotherapeutics, which make the antiviral molnupiravir, last week said they will provide 3 million courses of the drug to UNICEF for use in low- and middle-income countries (LMICs) throughout the first half of this year. In another development, the Medicines Patent Pool announced agreements with 27 generic drug manufacturers in Africa, Asia, and the Middle East to produce low-cost versions of molnupiravir for use by LMICs. The consumer advocacy group Public Citizen sent a letter to Pfizer on January 24, asking the company to commit to reserve at least two-thirds of its annual supply of the COVID-19 treatment Paxlovid for LMICs, to be purchased at lower prices. Public Citizen said it is trying to discourage a repeat of vaccine inequity as newer treatments become available.

The Center for Health Security is hosting a webinar on Thursday, January 27 at 1pm on this topic. Please join us for Protecting U.S. National Security by Increasing Vaccination Globally. 

BOOSTER DOSES Several new peer-reviewed studies provide additional evidence that SARS-CoV-2 vaccine booster doses elicit antibody responses that help protect against severe disease from the Omicron variant. Two of the studies were published in the US CDC’s Morbidity and Mortality Weekly Report (MMWR). The first study examined data on hospitalizations and emergency room and urgent care center visits in 10 states from August 2021 to January 2022, spanning both Delta- and Omicron-predominant periods. In that study, researchers found that vaccine effectiveness (VE) of the 2-dose mRNA vaccine regimens dropped around 6 months after the second dose, during both periods. However, VE increased following a third dose of mRNA vaccine during both waves and was highly protective against emergency room and urgent care encounters (94% during Delta and 82% during Omicron) and hospitalization (94% and 90%, respectively). A second study examined incidence and death rates between April and December 2021, again across both Delta- and Omicron-predominant periods, among unvaccinated and fully vaccinated adults with and without booster doses. In 25 US states, individuals who had received a booster dose of mRNA vaccine had the highest protection against SARS-CoV-2 infection across both periods when compared to unvaccinated and vaccinated but unboosted individuals. 

Another study, published in the Journal of the American Medical Association (JAMA) and led by CDC researchers, examined data collected from 4,666 COVID-19 testing sites across 49 US states between December 10, 2021, and January 1, 2022. The findings show that individuals who had 3 doses of vaccine were better protected against both Omicron and Delta variants when compared with those who were unvaccinated and with those who received only 2 vaccine doses, although higher odds ratios for Omicron suggest less protection for Omicron than for Delta. Yet another study, published online in The Lancet, funded by the Brazil Ministry of Health, and conducted by researchers from Brazil and the University of Oxford, shows that a third booster dose of the Oxford-AstraZeneca, Pfizer-BioNTech, J&J-Janssen, or Sinovac (CoronaVac) SARS-CoV-2 vaccines induces a significant increase in antibody levels among individuals who previously received 2 doses of the Sinovac vaccine. The researchers note that the most robust responses were seen in those who received heterologous (mixed) boosters, a finding that could be most relevant to older populations.  

The studies released by the CDC represent the most comprehensive data to date on the impact of booster doses in the US during the pandemic. The data from these reports also indicate that booster doses of the mRNA vaccines provide the most benefit to adults older than 50 years. However, uptake of booster doses has started to slow since the initial days of the Omicron wave despite advice from public health officials to stay “up to date” on vaccinations and recent evidence showing the boosters help prevent severe disease caused by Omicron. In updated data on breakthrough cases, the CDC notes that in November 2021, unvaccinated adults had 13 times the risk of testing positive for SARS-CoV-2 and 68 times the risk of dying from COVID-19 compared with fully vaccinated adults with booster doses.

VACCINE FOR UNDER-5 CHILDREN Many in the US continue to eagerly wait for the authorization of a SARS-CoV-2 vaccine for children under age 5. White House Chief Medical Advisor Dr. Anthony Fauci said last week he hopes the US FDA will soon authorize a vaccine for the youngest children, perhaps within the next month. More than 250 physicians recently sent a letter to the FDA concerning the issue and suggesting 2 options to expedite the process, such as joint decision making for parents and physicians to immunize children with off-label use of the Pfizer-BioNTech 10 μg dose vaccine formulation or removing the age de-escalation barrier to vaccine approval. The letter also urges the FDA to review and authorize the Moderna vaccine for children aged 6 months to 5 years as soon as data become available showing the vaccine is safe and effective, arguing the Moderna vaccine offers better protection against the Omicron variant and severe disease than other vaccines. Pfizer-BioNTech in December announced their plans to submit data to the FDA on a 3-dose study in the first half of 2022, after initial trials of the 3 μg 2-dose regimen given to 2- to 4-year olds did not produce as much of an immune response as it did in other age groups. 

The American Academy of Pediatrics reports that, based on state-level data, the number of pediatric cases during the Omicron surge has drastically risen to nearly 5 times the rate of the peak of last winter’s surge. Parents continue to struggle with efforts to keep their children safe, stuck in limbo between daycare closures and child care crises. According to an analysis from the Center for the Study of Child Care Employment, 110,00 fewer people are working in childcare now than in February 2020. Outside of COVID-19 fears, some parents might take solace knowing that the rates of pediatric hospitalizations for other types of infections fell dramatically during the pandemic in England, including a 94% reduction in influenza-related hospitalizations, 90% reduction in measles-related hospitalizations, and an 82% drop in bronchitis-related hospitalizations in children under 14 years of age from March 1, 2020 to June 30, 2021 compared to March 1, 2017 to February 20, 2020. The researchers at the University of Oxford attribute the decreases to a range of behavioral and societal changes implemented to reduce transmission of SARS-CoV-2 and urge continued monitoring of other infections as COVID-19 mitigation strategies evolve. It is not clear whether similar reductions occurred in the US.

OMICRON-SPECIFIC VACCINES Though current SARS-CoV-2 vaccines continue to offer protection against severe COVID-19 disease and death, vaccine manufacturers are working to update the shots to hopefully provide better protection against the Omicron variant. Pfizer and BioNTech announced today they have begun a study to evaluate a SARS-CoV-2 vaccine based on the Omicron variant among adults aged 18 to 55 years. The study will enroll up to 1,420 healthy adults to test the Omicron-based shot as an initial (third shot) or secondary (fourth shot) booster dose or as primary vaccinations in previously unvaccinated individuals. 

According to reporting from STAT News, a senior US FDA official said that if the agency moves to update vaccines to better confront Omicron or other variants, it will likely participate in an internationally coordinated program with other regulatory agencies and the WHO to decide if, when, or how to update the shots. The program could operate in a similar way to the one already in place to decide which strains to include in influenza vaccines, the unnamed official said. Even with Pfizer-BioNTech expecting to apply for authorization of an Omicron-specific vaccine by the end of March, the current surge in cases is already waning in Africa, Europe, and the US, suggesting it could end within or close to that timeframe. And while Omicron might remain the globally predominant strain, it is possible future variants will emerge with potentially very different mutations. Already, scientists are tracking an Omicron subvariant called BA.2, which has some new mutations, including several on the spike protein. The variant is not viewed as a “gamechanger,” but it already accounts for most new cases in India, Sweden, and Denmark and has been detected in the US

COVID-19 THERAPIES On January 24, the US FDA revised the emergency use authorizations (EUAs) for 2 monoclonal antibody treatments—bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab)—to restrict their use to only when a patient is likely to have been infected with or exposed to a variant that is susceptible to these therapies. The treatments have been shown to be highly unlikely to be effective against the Omicron variant of concern (VOC), and because that VOC is currently responsible for more than 99% of COVID-19 cases in the US, “these treatments are not authorized for use in any US states, territories, and jurisdictions at this time,” the FDA said in a statement. As a result, the US Department of Health and Human Services (HHS) has halted distribution of the therapies. However, the therapies could be useful in certain geographic regions or against new variants in the future. The FDA noted other therapies are available and expected to work against Omicron, including the monoclonal antibody sotrovimab, and the antivirals Paxlovid, remdesivir (Veklury), and molnupiravir.

Late last week, the FDA expanded the EUA for the COVID-19 treatment remdesivir to include certain non-hospitalized adults and pediatric patients ages 12 and older with mild-to-moderate disease. Previously, the use of the intravenous antiviral was limited to hospitalized patients. Additionally, the FDA authorized the drug’s use for pediatric patients younger than 12 years of age who weigh at least 3.5 kg but under 40 kg who are at high risk for progression to severe COVID-19, including hospitalization or death. A 3-day course of the drug is recommended as a third option behind the oral antiviral Paxlovid and sotrovimab. A 5-day course of remdesivir is recommended for hospitalized patients who are not on mechanical ventilation or extracorporeal membrane oxygenation (ECMO), while critically ill hospitalized patients should receive a 10-day course.

US VACCINE REQUIREMENTS On January 21, a federal judge in Texas issued a nationwide injunction against US President Joe Biden’s SARS-CoV-2 vaccine requirements for federal government employees, saying the president had exceeded his executive authority in issuing the rule. US District Judge Jeffrey Vincent Brown cited a recent US Supreme Court opinion blocking a different federal rule that would have required employees of companies with 100 or more workers to be vaccinated or submit weekly testing. Notably, the Supreme Court allowed a separate vaccine rule pertaining to workers at medical facilities that receive Medicare or Medicaid funding to remain in force. The US Department of Justice immediately filed notice that it plans to appeal the decision to the US Court of Appeals for the 5th Circuit. The case likely will go to the Supreme Court. At the beginning of December 2021, the Office of Management and Budget said 97.2% of the federal workforce was compliant with the rule, including those who had pending or approved exemptions. The plaintiff in the case, a Nevada-based group called Feds for Medical Freedom, also asked the judge to enjoin the rule applying to federal contractors, but that executive order is already subject to a nationwide injunction. Over the weekend, thousands of anti-vaccination protestors gathered in Washington, DC, for a rally against vaccine mandates.

VACCINE HESITANCY The results of a survey of 1,200 US adults led by researchers from the Ohio State University and published in JAMA Network Open found that vaccine hesitancy has decreased more rapidly among Black individuals than White individuals since December 2020. Hesitancy rates were comparable at the start of the survey, but Black individuals experienced larger increases in intention to vaccinate than White individuals relative to baseline. The belief that vaccines were necessary for protection also increased more among Black individuals than White individuals. The new survey data showing declines in hesitancy among Black individuals suggest there may be other factors to consider, including barriers to access. The study’s discussion notes Kaiser Family Foundation surveys that document the substantial portion of Black individuals who worry about access barriers. For example, 55% of Black individuals (vs 41% of White individuals) are very or somewhat concerned about missing work if the vaccine makes them sick; 37% of Black individuals (vs 24% of White individuals) worry they will have to pay for the vaccine; 23% of Black individuals (vs 16% of White individuals) are concerned about taking time off of work to get vaccinated; and 17% of Black individuals (vs 9% of White individuals) worry about finding transportation to vaccination sites. Though the administration of US President Joe Biden has taken some steps to alleviate such barriers—including paid sick leave and free Uber and Lyft rides to vaccination sites—some people remain unaware of these programs.