COVID-19 Situation Report |
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Editor: Alyson Browett, MPH
Contributors: Clint Haines, MS; Noelle Huhn, MSPH; Amanda Kobokovich, MPH; Aishwarya Nagar, MPH; Christina Potter, MSPH; Matthew Shearer, MPH; Marc Trotochaud, MSPH; and, Rachel A. Vahey, MHS
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UK APPROVAL OF BIVALENT VACCINE BOOSTER The UK became the first country to approve a bivalent COVID-19 vaccine for use as a booster among adults, as many countries plan late-2022 booster drives to hopefully broaden population immunity to SARS-CoV-2 before winter. The adapted bivalent vaccine is an updated version of Moderna’s original monovalent mRNA vaccine, known as “Spikevax bivalent Original/Omicron.” The vaccine targets the original SARS-CoV-2 strain and the Omicron BA.1 variant, a combination which produces significantly more Omicron BA.1-specific neutralizing antibodies than the original monovalent vaccine and may generate BA.4 and BA.5 neutralizing antibodies at a rate 1.69 times higher than the original vaccine, according to trial data from Moderna. The UK Joint Committee on Vaccination and Immunisation (JCVI) published guidance this week for which vaccines should be used during the UK’s fall COVID-19 booster campaign. For adults, the JCVI recommends using either the newly approved Spikevax bivalent Original/Omicron vaccine, one of the original Moderna or Pfizer-BioNTech booster shots, or, in exceptional circumstances, the Novavax Matrix-M adjuvanted wild-type vaccine (Nuvaxovid). The JCVI also offered advice that a single type of booster be used where possible to facilitate deployment and mobilization.
Drug regulators in the EU may meet as soon as September 1 to consider approving a bivalent vaccine that targets the original SARS-CoV-2 strain and BA.1 and could meet later in the month to review a bivalent vaccine using the original strain and BA.5. Meanwhile, US government health officials have indicated they plan to wait for bivalent vaccines capable of targeting the original SARS-CoV-2 strain and the newer BA.4 and BA.5 Omicron subvariants. The Biden administration is aiming to begin a COVID-19 booster shot campaign for all adults in September, but there remain many considerations for regulators to work through before recommending a booster. One of these considerations is that vaccine-induced immunity can wane over time, so the timing of a booster campaign is important. However, many experts agree that getting a booster too early is better than not getting one at all.
NOVAVAX BOOSTER EUA APPLICATION Novavax announced August 15 that it has submitted an application to the US FDA for emergency use authorization (EUA) of its recently authorized SARS-CoV-2 vaccine as a booster dose. If authorized, the booster dose could be administered to qualifying adults who previously received full courses of Novavax or other SARS-CoV-2 vaccines. The Novavax vaccine is an adjuvanted protein-based vaccine, a more traditional vaccine technology than the platform used in mRNA vaccines. Experts have hoped that this tried-and-true formulation may convince more unvaccinated people to receive their primary courses, although uptake in the US has been slow. Based on clinical trial results, the Novavax vaccine appears to remain relatively effective against SARS-CoV-2 variants, including the Omicron and Delta variants of concern. It is less clear how effective this formulation is against BA.5 specifically, but vaccine experts have been looking forward to Novavax’s EUA booster submission to provide another tool in the fight against the wide variety of Omicron subvariants.
BCG VACCINE The Bacillus Calmette-Guérin (BCG) vaccine continues to offer protection from tuberculosis infection into adulthood when given at birth. The vaccine, which has been in use for nearly 100 years, is routinely given to newborns worldwide but is not part of the standard childhood immunization program in the US. Research has shown that neonatal BCG vaccination confers off-target, nonspecific protection against unrelated infectious diseases in early childhood, and the vaccine has been used in clinical trials to examine its effectiveness to reduce the impact of COVID-19, but with little positive outcome. Now, a small, double-blind, placebo-controlled study published in Cell Reports Medicine by researchers from Massachusetts General Hospital suggests the BCG vaccine is highly effective in protecting patients with type 1 diabetes from COVID-19. The researchers found that 12.5% of the group that received placebo shots and 1% of the group that received 3 BCG doses met the criteria for confirmed COVID-19, yielding an efficacy of 92%. Additionally, the BCG group had fewer infectious disease symptoms and lesser severity, and fewer infectious disease events per patient, including COVID-19. The study provides a basis for additional research into the BCG vaccine’s broad-based infection protection, including against SARS-CoV-2 variants.
US CDC COVID-19 GUIDANCE Late last week, the US CDC updated its guidance on COVID-19 vaccination, quarantine, isolation, and testing. The new “streamlined” guidance is in response to broader levels of immunity among the population, from previous infection or vaccination or both, and the availability of effective COVID-19 prevention and management tools that can reduce the risk for medically significant illness and death. The guidance places significant onus on individuals to assess their personal risk and take steps to prevent infection, transmission, or serious outcomes for themselves or others. One of the most significant changes is that persons who are exposed to SARS-CoV-2 and not up to date on their vaccinations no longer need to quarantine. Instead, the CDC recommends they wear a mask in indoor settings for 10 days after exposure and take a test on day 5. The CDC also removed its recommendations for social distancing, test-to-stay programs, and cohorting of students in schools.
These changes have been met with varied reactions, from acceptance to outrage. Expressing concern over the relaxed guidance, many public health experts cite continuing risk from the predominant BA.5 subvariant; the risk of future, possibly more virulent, variants; and declining adherence to personal protective measures that might inhibit their reinstatement if a new wave of infections begins. On the other hand, many members of the general public and institutional decision makers welcomed the simplified guidance as a sign that COVID-19 should not continue to overburden daily routines, particularly as we move closer to the fourth year of the pandemic. Though 3 years of heightened precautions is a long time to expect a global population to remain vigilant against disease, many public health experts believe the CDC is sending the wrong signal at the wrong time. Of particular controversy is CDC’s “Community Levels” metric that is being used to influence its decision making. Because this indicator is influenced more by hospitalizations than transmission, certain areas can appear as if there is less circulating virus than there actually is. Some argue that community transmission* should be more heavily weighted in decision making, especially while highly transmissible variants are circulating.
*To see community transmission levels, change the “Data Type” dropdown menu to “Community Transmission.”
SERIAL TESTING The US FDA this week recommended that people use serial testing—taking multiple COVID-19 tests over several days—to reduce the risk of a false-negative result and to help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. People who test negative on an at-home antigen test should take a second or third test to confirm their result, even if they do not have symptoms. Specifically, the FDA recommends the second test be taken 48 hours after the first test. For those without symptoms but with a known exposure, the agency goes further to say that a third test should be taken another 48 hours after the second test to be even more confident of a negative result. Repeated testing is not a new concept, but this updated recommendation demonstrates the need for continued vigilance in driving down SARS-CoV-2 transmission. While not at odds with the US CDC’s new COVID-19 guidance on quarantine and isolation, the FDA’s recommendation does appear to place more emphasis on assuring lower likelihood of person-to-person transmission following exposure.
US SCHOOLS On August 11, the US CDC released new operational guidance for K-12 schools, early education programs, and daycares to support safe in-person learning during the ongoing COVID-19 pandemic. The new guidelines largely loosen protocols and leave more of the decision-making responsibility in the hands of local officials. Notably, several states—including California, Colorado, Washington, and West Virginia—have issued their own guidance or taken steps to facilitate testing and vaccinations at schools. Few districts are implementing vaccination mandates for students, as Americans are divided over whether such requirements are needed.
The CDC’s guidance recommends that school staff and students stay up-to-date on vaccinations, stay home when sick, practice proper hand hygiene and respiratory etiquette, and that schools optimize and improve ventilation and clean surfaces at least once a day. The guidance also discusses masking, testing, quarantine, and other mitigation strategies, particularly in relation to local community levels or outbreaks. Though the CDC notes that wearing well-fitting masks reduces the risk of spreading SARS-CoV-2 in schools—with a recent preprint study providing additional supporting evidence—the agency only recommends masking in schools located in localities where SARS-CoV-2 “Community Levels” are high. Additionally, most students no longer are advised to quarantine if they have been exposed to someone with COVID-19 but they should wear a mask for 10 days and get tested. The new guidelines also drop the recommendations for routine testing in K-12 schools, although schools located in areas where COVID-19 Community Levels are high may consider implementing screening testing programs. Approximately 40% of counties in the US are currently experiencing high COVID-19 Community Levels, while “Community Transmission” is high in nearly 94% of the country, according to CDC data.
The CDC’s more relaxed guidelines coincide with increased concern about the social, economic, and mental welfare of students who have had limited social interactions over the last few years. Some of the social concerns expressed by parents include students experiencing depression due to extended isolation, students experiencing distress due to missing key social milestones and events, and suicidal ideation in student populations. Economic concerns stem from the pandemic-related disruption in education. Experts estimate that each year of education can add 10% to an individual’s expected lifetime earnings. As a result, disruptions in education due to the pandemic could mean that the current generation of students might be less competitive when they enter the workforce. Concerns about the mental welfare of students have increased due to reports of more emergency room visits linked to mental health among young people, more reports of eating disorders among adolescent girls, and emotional disturbances that can last for years or decades after a traumatic event.
PREGNANCY COVID-19 directly affects people’s health, but the early pandemic also impacted how and when people accessed health care, with lockdowns, workforce shortages, and supply chain issues forcing many to skip or delay routine medical appointments. A retrospective cohort study published August 12 in JAMA Network Open that included more than 1.6 million pregnant patients in 463 hospitals found that the number of live births decreased by 5.2% during the first 14 months of the pandemic compared with the previous 14 months. Additionally, there were increased odds of maternal death during delivery hospitalization (from 5.17 to 8.69 deaths per 100,000 pregnant patients; OR, 1.75; 95% CI, 1.19-2.58), as well as small but significant increased odds of certain pregnancy complications, including gestational hypertension (OR, 1.08; 95% CI, 1.06-1.11), obstetric hemorrhage (OR, 1.07; 95% CI, 1.04-1.10), preeclampsia (OR, 1.04; 95% CI, 1.02-1.06), and preexisting chronic hypertension (OR, 1.06; 95% CI, 1.03-1.09). While it is unclear whether COVID-19 infection directly caused any of the complications, the study’s authors suggested that missed or delayed prenatal visits may have led to some pregnancy complications going undetected or unmanaged and that increased societal stress could have contributed to the increase in hypertension issues.
Prior to vaccines becoming available in late 2020, mis- and disinformation campaigns to discredit the vaccines had already taken hold and especially created uncertainty among pregnant people. Part of what allowed disinformation to flourish was that pregnant people were not included in the initial clinical trials of SARS-CoV-2 vaccines, creating a dearth of safety data that led to pregnant people having some of the lowest vaccination rates among adults when the vaccines were first authorized. Subsequently, many pregnant people, or those looking to become pregnant, chose to delay or forego vaccination, sometimes with dire outcomes. Unvaccinated pregnant women with COVID-19 have a higher risk of stillbirth and other pregnancy complications, including maternal death, than those who are vaccinated. Multiple studies have shown that the vaccines are safe before and during pregnancy and that SARS-CoV-2 infection can have deleterious impacts on pregnant individuals, including heart complications.
INCARCERATED POPULATIONS Several large California (US) counties are ending initiatives meant to keep more nonviolent offenders out of jail to lower incarcerated populations during the COVID-19 pandemic amid rising crime. Los Angeles, San Diego, and Santa Clara counties are among those that recently stopped issuing zero bail for people who committed certain nonviolent felony offenses. Similar public health measures instituted nationwide, meant to depopulate jails to avoid COVID-19 outbreaks, brought the US jail population to its lowest level in nearly a decade, according to federal statistics. But rising crime rates are forcing more progressive district attorneys to end such practices, leading to rising jail populations, which remained below their pre-pandemic levels as of the end of 2021. Incarcerated populations have been disproportionately impacted by COVID-19. In California, nearly half of state prisons had 3 to 4 times more COVID-19 cases than the general population.
WESTERN PACIFIC Officials in the Marshall Islands have declared a national health disaster due to the arrival of the highly transmissible Omicron SARS-CoV-2 variant, shifting from a prevention to mitigation strategy. More than 4,000 people have tested positive in a population of about 60,000 in the past week, and the test positivity rate is about 75% in the capital city, Majuro. The Marshall Islands, with a population of about 59,000, was one of the last countries to claim to be COVID-free because of its strict quarantine rules, and until about one week ago, the nation had not recorded a single case of community transmission. About 70% of the nation’s residents are vaccinated. The health disaster declaration provides the government access to emergency funding and the ability to institute several public health measures, including closing schools. While officials have not instituted lockdowns, many people are choosing to stay at home to prevent further community transmission.
Further south in the Pacific Ocean, the number of new COVID-19 cases in New Zealand dropped to its lowest level in 6 months and the average number of hospitalizations is down, showing hopeful signs the winter wave of infections is subsiding. Cases there spiked in mid-July, when deaths from COVID-19 were essentially on par with those from heart disease, the country’s leading killer. About 90% of people aged 12 years and older have completed a primary vaccination series, according to the New Zealand government. In neighboring Australia, there are signs the recent Omicron surge is in decline there as well. However, the number of hospitalizations and the 7-day average of COVID-19-related deaths remain high, and an unknown number of people are suffering long-term impacts of COVID-19 infection. Wait lists for specialized long COVID rehabilitation clinics are now more than 5 months, and experts in Australia are calling for a nationally coordinated approach to address the condition. Infectious disease experts cautioned that while the worst of the winter surge might have passed, there will be future surges and people should continue to wear masks to help mitigate disease transmission. According to the Australian government, 96% of people aged 16 years and older have received at least 2 doses of vaccine.
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