Tuesday, May 17, 2022

May 17, 2022: Johns Hopkins Situation Report

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.

UPCOMING WEBINAR With summer approaching, engaging in sporting events can seem daunting for athletes and spectators alike, especially as the world continues to respond to the pandemic. This webinar will focus on COVID-19 testing strategies and best practices for large sporting events. The panelists, Dr. Brian McCloskey and Ms. Lucia Mullen, served on WHO’s COVID-19 Mass Gatherings Expert Group. They advised Olympic organizers on COVID-19 countermeasures for the Tokyo 2020 Summer and the Beijing 2022 Winter Games. They will discuss developing and implementing masking, testing, and vaccination strategies for the world’s largest international sporting celebrations. Please join us on June 1 at 10:00am ET. Registration is available here.

BA.4/BA.5 SUBVARIANTS On May 12, the European Centre for Disease Prevention and Control (ECDC) reclassified the Omicron BA.4 and BA.5 sublineages from variants of interest to variants of concern (VOC). BA.4 and BA.5 were first identified in South Africa in January and February 2022, respectively. Since their identification, they have spread to other parts of the world, including to Portugal, where BA.4/5 currently account for around 37% of cases. Similar to other Omicron subvariants, such as BA.2, BA.4 and BA.5 appear to be significantly more transmissible than previous variants. BA.5 has an estimated growth advantage of 13% over BA.2 under laboratory conditions. Even individuals previously infected with an Omicron variant do not appear to be well protected against infection from BA.4/BA.5. Notably, BA.4/BA.5 contain enough mutations in key sites to evade both naturally acquired immunity and previous vaccinations. Fortunately, BA.4 and BA.5 do not appear to cause more severe disease than previous variants, although more studies are needed to solidify this observation. In the US, BA.2 and BA.2.12.1 still remain the dominant subvariants at this time, but it is likely that more cases will result from BA.4/BA.5 infection as the summer approaches and as more cases are imported from South Africa and Europe.

VACCINE BOOSTERS FOR CHILDREN The US FDA today authorized a booster dose of the Pfizer-BioNTech SARS-CoV-2 vaccine for children aged 5 to 11 years, administered at least 5 months after completing the 2-dose primary series. In a statement, the FDA said that although COVID-19 is largely less severe in children than in adults, more children have gotten sick and been hospitalized during the Omicron wave, and the agency acknowledged that children also can experience long-term effects of COVID-19, even after mild disease. The US CDC’s Advisory Committee on Immunization Practices is expected to discuss its recommendations for the booster dose at a meeting on May 19. The FDA has authorized the Pfizer-BioNTech vaccine for use in individuals aged 5 years and older and has approved the vaccine, under the brand name Comirnaty, for those aged 16 years and older. Booster, or third, doses are now authorized for anyone aged 5 years and older. Less than one-third of the 28 million 5- to 11-year-old children in the US have received 2 doses of a SARS-CoV-2 vaccine.

In related news, Moderna last week released data showing its 2-dose SARS-CoV-2 vaccine is safe and effective in inducing strong immune responses and preventing COVID-19 in children aged 6 to 11 years. The data, from an ongoing Phase 2/3 clinical trial, were published May 11 in the New England Journal of Medicine (NEJM). Also last week, Moderna submitted a request to the FDA for emergency use authorization (EUA) of its vaccine for children ages 6 to 11 years. The company already has submitted requests for its vaccine to be authorized for children 6 months to 6 years old, as well as adolescents. An FDA advisory committee is expected to discuss updates to the EUAs of both the Moderna and Pfizer-BioNTech vaccines to include younger populations at upcoming meetings in June

SEVERE ACUTE HEPATITIS IN CHILDREN Growing evidence suggests fragments of SARS-CoV-2 can linger in the gastrointestinal tract for months after acute infection. Some researchers believe these viral “ghosts” could be associated with post-acute sequelae of COVID-19 (PASC), often called long COVID, but more research is needed to draw firm conclusions. Additionally, researchers are examining whether these viral reservoirs could be associated with hundreds of cases of severe acute hepatitis cases of unknown origin among young children. At least 450 children in 20 countries have been diagnosed, 11 have died, and more than 2 dozen have received liver transplants. Most of the children with severe acute hepatitis do not show active SARS-CoV-2 infection and are unvaccinated. However, between 75-95% of cases in the US and UK have tested positive for SARS-CoV-2 antibodies and about 60-70% test positive for adenovirus,a family of viruses that is not known to attack the liver but can cause everything from pinkeye to common colds. These results have led some experts to hypothesize that SARS-CoV-2 and a type of adenovirus could both be culprits.

On May 14, a team led by researchers from Case Western Reserve University Medical School posted a study to medRxiv (preprint) showing that children infected with SARS-CoV-2 were at significantly increased risk of elevated liver enzymes and bilirubin than children who had non-COVID other respiratory infections (ORIs). They theorize that children with severe hepatitis of unknown origin could have recovered from mild or asymptomatic COVID-19, causing SARS-CoV-2 particles to linger in their gastrointestinal tracts. If the children were subsequently infected with an adenovirus or a different virus, the lingering SARS-CoV-2 particles could prompt immune system overreaction leading to high amounts of inflammatory proteins that could then cause liver damage. The researchers suggested that children with severe acute hepatitis be evaluated for SARS-CoV-2 particles in their stool, as more data need to be collected to test the theory.

US EMERGENCY DECLARATION The number of new US COVID-19 cases is at its highest level since November, when the initial Omicron surge began. Experts say the true size of the wave is unknown, but people can expect the number of new cases in their communities to be 5 to 10 times the official counts. Cases—which are being driven by the BA.2 and BA.2.12.1 subvariants—are rising across the nation, but the Northeast and Midwest regions are experiencing surges that are now higher than during last summer’s peak caused by Delta. Most of New York state, including New York City, has moved to or is close to a “high alert” level, under which people are urged to wear masks indoors and take other precautions. Hospitalizations are up nationwide as well, and while the average number of new daily deaths are falling, an average of 260 people continue to die of COVID-19 each day. The US CDC released data showing that more than 1 million people have died with COVID-19 since the beginning of the pandemic.

The administration of US President Joe Biden is expected to extend the COVID-19 public health emergency declaration past mid-July. The declaration allows the US to grant emergency use authorization (EUA) of therapeutics, diagnostics, vaccines, and other medical tools, as well as provide those products at no cost to millions of residents and extend Medicaid benefits to allow millions to receive health coverage. However, the US Congress has stalled on negotiations over new funding to address the virus. While the nation is in a different place in the pandemic than in earlier periods, the government has run out of money to purchase additional vaccine doses, oral antiviral courses, and other treatments, as well as to develop next-generation vaccines and therapies. Without new funding, the government will have to limit access to no-cost vaccines and treatments, and funding for pandemic-era Medicaid coverage already has expired. And soon, those countermeasures will be bought and sold through regular healthcare systems, meaning the costs will be passed on to consumers and the potential for inequitable access widens.

US & AUSTRALIA RESPONSES More than 1 million people have died of COVID-19 in the US since the beginning of the pandemic, more than any other country. For every 100,000 US residents, about 303 people have died of the novel disease, according to the Johns Hopkins University Coronavirus Resource Center. But the death toll did not have to be so high. Many public health experts attribute the pandemic’s impact in the US to underinvestment in public health departments, primary healthcare, and long-term care, making people more vulnerable to the virus. Marginalization made some communities more vulnerable to the virus and its impacts. Political polarization of the pandemic also contributed, as did misinformation regarding vaccines, which is partly to blame for the nation’s relatively low vaccination rate among wealthy countries. According to a new estimate from Brown University and Microsoft AI Health, nearly 319,000 deaths could have been prevented if 100% of US adults were fully vaccinated.

Around the globe, Australia’s death rate is about one-tenth of the rate in the US. In other words, if the US had the same death rate as Australia, 900,000 people might have been saved. One important trait differentiates the US and Australian responses: trust. At the beginning of the epidemic, 76% of Australians said they trusted the healthcare system, compared with about 34% of Americans, and 93% of Australians said they felt supported by their friends, colleagues, or communities. Australia’s leadership worked quickly to translate much higher levels of public trust in science and institutions, as well as interpersonal trust, into action, urging individuals to take steps that would prove vital to protecting themselves and their communities. Early in the pandemic, Australia’s politicians and public health officials—who adopted a “one voice” cooperative approach—moved to close borders; quarantine international travelers; implement isolation, surveillance, and contact tracing tactics; and enforce long-term lockdowns. Unlike the US, Australia’s non-partisan response to the pandemic, national health insurance program, smaller gaps in income inequality, and a concept of “mateship”—of not wanting to let down one’s neighbor—helped the nation comply with public health guidance and vaccination requirements. All of these measures helped Australia weather the pandemic and reach a vaccination rate of more than 95% among people aged 16 years and older, which is proving vital during its latest surge of cases due to the Omicron variant.

NORTH KOREA The Democratic People's Republic of Korea (DPRK), commonly known as North Korea, continues to experience what it says is an “explosive” outbreak of SARS-CoV-2 reporting nearly 1.5 million people have become ill with fever, believed to be COVID-19, and 56 have died since late April. The nation lacks test kits to confirm whether the fevers are due to SARS-CoV-2 infections, and its 26 million people remain unvaccinated. As of today, the nation said at least 663,910 people were in quarantine. North Korea Leader Kim Jong Un, who has berated officials for delays in pandemic responses, this week mobilized the nation’s military to help distribute medications and support healthcare workers to trace potential patients. Experts feel the death toll likely is underreported and will surge over time. The WHO expressed concern over the North Korean outbreak on May 16, saying it is ready to support the country’s pandemic response.

SECOND GLOBAL COVID-19 SUMMIT The second Global COVID-19 Summit—co-hosted by the US, Belize, Germany, Indonesia, and Senegal and held on May 12—garnered new financial commitments totaling US$3.2 billion, including US$2.5 billion for COVID-19 response efforts and US$712 million in new pledges for the pandemic preparedness and global health security financial intermediary fund (FIF) at the World Bank. Leaders from more than 35 nations and representatives of the private sector, philanthropy, and civil society made commitments, both financial and non-financial. Many public health experts praised the meeting’s outcomes for being better than expected, but others expressed concern that complacency played a role in preventing the summit from reaching its goal of raising US$10 billion to support vaccination access and US$3 billion to improve access to treatments and oxygen.

Without new funding from the US Congress, US President Joe Biden only announced relatively small commitments at the meeting. The US pledged an additional US$200 million for the FIF, bringing its total commitment to total US$450 million, as well as US$20 million for pilot projects to bring testing and treatment to low-income countries. Additionally, the US NIH announced it finalized an agreement to share 11 COVID-19-related technologies to the WHO’s COVID-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) to help improve access to tools needed to manufacture and develop vaccines, treatments, and tests. However, it is unclear how quickly the deal will result in improved access to existing or new products.

In related news, the G7 Foreign Ministers of Canada, France, Germany, Italy, Japan, the UK, and the US, and the High Representative of the European Union on May 13 endorsed an action plan on COVID-19, with a focus on improving access to, delivery, and production of vaccines, particularly in low-income countries.

US MEAT INDUSTRY In the early stages of the COVID-19 pandemic, the largest meatpackers in the US successfully lobbied members of then-US President Donald Trump’s administration and pushed “baseless” claims of meat shortages to keep their processing plants operating, prioritizing profits over the health of thousands of workers, according to a report based on an investigation conducted by the US House Select Subcommittee on the Coronavirus Crisis. The report alleges meatpacking executives knew the acute risks of COVID-19 to workers in their plants but worked with the Trump administration to force workers to remain on the job. An estimated 334,000 COVID-19 cases nationwide have been tied to meatpacking plants, and at least 269 meatpacking workers died of COVID-19. The investigation, based on a review of 151,000 pages of documents, showed that although meat production slowed to about 60% of normal levels during spring 2020, 4 of the nation’s largest meat processors collectively increased their profits 120% compared with before the pandemic and at least 2 companies significantly increased their pork exports to China during the first 3 quarters of 2020, belying claims of shortages. Meatpacking corporations and trade groups said the report “distorts the truth” of their efforts to protect employees during the pandemic.

AT-HOME VIRAL RESPIRATORY INFECTION TEST The US FDA granted Emergency Use Authorization (EUA) to the first non-prescription, at-home test that can detect various respiratory viral infections. The test—which requires nasal swabs to be collected at home and sent by mail to Labcorp, the test’s manufacturer—can detect influenza A and B (flu), respiratory syncytial virus (RSV), and SARS-CoV-2. Once processed, the user can access their test results via an online portal. This is the first of what many public health experts hope is an expansion of at-home diagnostics.