COVID-19: TCTMD’s Dispatch for January Week 2

Since March 2020, TCTMD reporter Todd Neale has been writing up breaking news and peer-reviewed research related to COVID-19 every weekday. In July 2021, we transitioned to Mondays, Wednesdays, and Fridays. If you have something to share, tell us. All of our COVID-19 coverage can be found on our COVID-19 Hub.

January 14, 2022

It was a key question among physicians—and parents—last week when the Advisory Committee on Immunization Practices (ACIP) in the United States started deliberating on the safety and efficacy of expanding COVID-19 booster eligibility to younger kids: would myocarditis cases tick upwards? TCTMD’s Todd Neale put the question to a range of pediatric cardiologists and learned that, in fact, early numbers hint that the already low risk for these rare side effects could be even lower after boosters.

Much has been made of the waning efficacy of COVID-19 vaccines. Now an analysis published in the New England Journal of Medicine looking specifically at hospitalizations and deaths following vaccination with either the Oxford/AstraZeneca or Pfizer/BioNTech jab in the United Kingdom shows “limited waning” of vaccine efficacy for the endpoints of hospitalization and death out to at least 20 weeks after a second dose, although diminishing protection was seen for symptomatic infections. Of note, lessening efficacy was more common in adults over age 65 than in those ages 40 to 64, and the analysis was restricted to individuals infected with the Alpha or Delta variants.

Also in the NEJM, researchers addressed efficacy of the Pfizer/BioNTech vaccine among adolescents (ages 12 to 18) in the United States, concluding that two doses were “highly protective” against COVID-19-related hospitalizations and ICU admissions. Moreover, all seven deaths in the study, conducted across 31 hospitals in 23 states, occurred among the 777 unvaccinated subjects. As the authors bluntly conclude: “Vaccination averted nearly all life-threatening COVID-19 illness in this age group.”

An accompanying editorial by pediatrician Kathryn M. Edwards, MD, points out that COVID-19 vaccinations in younger kids have lagged far behind other common pediatric vaccines—hovering around 15% in early December, as compared with rates in the range of 95% for other established childhood inoculations. “The achievement of similar vaccination rates for protection against COVID-19 would have an enormous effect on the pandemic among children,” she writes. “Vigorous efforts must be expended to improve vaccination coverage among all children and especially among those at highest risk for severe COVID-19.” 

Months after mild-to-moderate COVID-19, there are signs of systemic subclinical effects on the heart, lung, and kidneys, and their long-term impact is unknown, researchers write in the European Heart Journal. As one author told TCTMD’s Caitlin Cox, the findings suggest that at least some level of screening may be appropriate in select patients to guide management. Commenting on the findings, Amanda Verma, MD, observed: “Fifty-plus years ago, we didn’t know that strep throat was going to cause heart problems down the road, and now we’re dealing with a lot of patients who need valve replacements.” 

The World Health Organization (WHO) announced this week that is has backed two new treatments for COVID-19. “Baricitinib is strongly recommended for patients with severe or critical COVID-19. . . . WHO recommends that it is given with corticosteroids.” The second agent, sotrovimab, a monoclonal antibody, is “conditionally recommended” for treating mild or moderate COVID-19 in patients who are at high risk of hospitalization. Both agents are cleared for emergency use in the United States, while only sotrovimab has been cleared in the EU for COVID-19 patients; baricitinib is approved for use in severe rheumatoid arthritis, but is still under review in Europe as a treatment for SARS-CoV-2 infection.

“Part B” results from a randomized, double-blind, placebo-controlled trial of the subcutaneous casirivimab and imdevimab antibody combination (REGEN-COV) showed that the drug prevented disease progression among asymptomatic individuals who tested positive for SARS-CoV-2 and were living with an infected household contact. The findings, published in JAMA, extend those of “Part A,” which found that the antibody combination significantly prevented the development of symptomatic SARS-CoV-2 infection in uninfected close contacts, compared with placebo.

It’s hard to keep up with the pace of research and regulatory clearance of therapies intended to stop progression of COVID-19 in nonhospitalized patients, and what their track record might be against subsequent strains of the virus. A viewpoint in JAMA summarizes the “currently available therapeutics for nonhospitalized patients in the setting of the Omicron variant including principles for equitable allocation.”

Many of the world’s poorest nations have only managed to vaccinate a fraction of their populations, but the short shelf-life of the vaccines being donated by wealthier countries means that even these are going to waste. According to Reuters, more than 100 million doses of COVID-19 vaccines distributed by the global COVAX program were destroyed in December alone because of their expiry dates. A lack of storage and transportation for vaccines that need refrigeration or freezers has also posed major problems.

The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended a labeling change to the Oxford/AstraZeneca and Janssen (Johnson & Johnson) vaccines to warn of very rare cases of transverse myelitis reported following vaccination. The rare neurological condition can cause limb weakness, tingling, numbness, or pain, as well as bladder or bowel dysfunction. “The PRAC has concluded that a causal relationship between these two vaccines and transverse myelitis is at least a reasonable possibility,” a summary of meeting highlights reads. “The benefit-risk profile of both vaccines remains unchanged.”

On a rosier note, PRAC has also determined that there are fewer cases of thrombosis with thrombocytopenia following the second dose of the Oxford/AstraZeneca vaccine than after the first dose, and is updating product information accordingly.

Australian immigration officials have revoked tennis star Novak Djokovic’s visa for the second time, mere days ahead of the start of the Australian Open. In a statement, a government official, Alex Hawke, said he had exercised his power to cancel the visa “on health and good order grounds, on the basis that it was in the public interest to do so.” As the New York Times explains, “A federal investigation led by Hawke had revealed that Djokovic provided false information on the documents he gave to border officials when he tried to enter Australia last week. Those documents failed to state that Djokovic, who lives in Monte Carlo, had traveled between Serbia and Spain during the 14 days ahead of his arrival in Australia.”

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January 12, 2022

COVID-19 deaths in the United States are up by approximately 40% this week compared with last, while hospitalizations are up 33%, the US Centers for Disease Control and Prevention (CDC) said today. But the recent increase in deaths is likely a lagging effect of the Delta variant, which was surging before Omicron took hold in the United States in December, Reuters reports. “We may see deaths from Omicron but I suspect that the deaths that we’re seeing now are still from Delta,” said CDC Director Rochelle Walensky, MD, during a media briefing.

Also speaking during a news briefing, World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus, PhD, agreed with other health leaders that the Omicron variant “causes less-severe disease than the Delta strain but it remains a ‘dangerous virus,’ particularly for those who are unvaccinated,” Reuters reports. More than 90 countries have not yet managed to vaccinate 40% of their populations, while over 85% of people in Africa have not yet received a first dose, he noted.

Counting cases is just not going to cut it in the Omicron era, the Associated Press has told its reporters and editors. “The Omicron wave is making a mess of the usual statistics, forcing news organizations to rethink the way they report such figures,” AP reports. “That means, for example, no more stories focused solely on a particular country or state setting a 1-day record for number of cases, because that claim has become unreliable.” Other media outlets are also moving away from reporting case counts, relying instead on other metrics such as hospitalizations, a number also fraught by the inclusion of incidental infections, deaths, or increased employee sick days.

Much has been made about distinguishing between hospitalizations due to COVID-19 versus incidental infections detected among patients hospitalized for other reasons since the latter may inflate the sense of COVID-19’s severity. For healthcare workers, however, the distinction is less important, as both types of patients require isolation strategies and both types put workers at risk. Becker’s Hospital Review probes the issue.

Even as hospitals around the world and throughout the United States are straining under the latest wave of COVID-19 caused by the Omicron variant, a large study conducted in the Kaiser Permanente health system in California and published to the medRxiv preprint server echoes what’s also been seen in Europe and South Africa—that patients testing positive for COVID-19 face significantly less-severe illness with this variant. The nearly 70,000-patient study, not yet peer-reviewed, indicates that hospital admissions, ICU admissions, and mortality were all lower with Omicron than with Delta; no Omicron patients needed mechanical ventilation as compared with 11 Delta-infected patients. Hospital stays were also significantly shorter. The New York Times has the story.

COVID-19 was the number one cause of death among law enforcement officers in the United States in 2021, according to preliminary data released by the National Law Enforcement Officers Memorial Fund. According to the report, “these officers have died due to direct exposure to the virus during the commission of their official duties.”

In Nature, an in-depth feature explores the effects of the pandemic on fetal and child development, concluding that “research on pandemic babies presents a mixed picture, and scientists say it’s too early to draw meaningful interpretations. . . . Overall, researchers maintain that most children will probably be OK—but more than usual might currently be struggling. And if we want to support those who are falling behind, we should ideally intervene soon.”

A viewpoint in JAMA Surgery asks whether cardiovascular complications of COVID-19 warrant consideration beyond the acute phase of illness, particularly for patients undergoing elective noncardiac surgery after recovering from COVID-19. The authors provide a series of recommendations but conclude that, ultimately, “prospective trials evaluating the optimal approach to preoperative cardiovascular risk stratification after COVID-19 are necessary.”

A Canadian study of more than 24,000 middle-aged and older adults who recovered from mild or moderate COVID-19 indicates that many still face worsened mobility and physical function, despite having never been hospitalized. “In view of the large number of adults diagnosed with COVID-19 worldwide, there is a need to further understand the longer-term impacts of the illness and to consider the development and implementation of effective intervention and management approaches to address any persistent deficits in mobility and functioning among those living in the community,” the authors write in JAMA Network Open.

Novak Djokovic has now acknowledged that he broke with quarantine protocols when he appeared in public the day after testing positive for COVID-19. The tennis number one, who is unvaccinated, has been embroiled in a visa dispute in Australia where he traveled to compete in the Australian Open next week, but had his visa revoked on the grounds that a prior COVID-19 infection did not count as a medical exemption to the country’s vaccination rules. A judicial ruling saw Djokovic released from detention, but as BBC News reports, his visa could still be revoked again on “character grounds” amid concerns that he made a “false declaration” in his application related to recent travel.

Also published as a preprint, a French study indicates that sniffer dogs can be trained to distinguish between sweat samples from people with long COVID and those who have not had COVID-19. “This study suggests the persistence of a viral infection in some long COVID patients and the possibility of providing a simple, highly sensitive, noninvasive test to detect viral presence, during acute and extended phases of COVID-19,” they conclude.

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January 10, 2022

Omicron is causing a massive spike in hospitalizations in the parts of the world where infection rates are exploding. Becker’s Hospital Review is tracking the crisis in the United States, noting that, as of last Friday, three states had declared states of emergency to manage the surge, while Reuters has the story of European healthcare systems currently “groaning” under the weight of Omicron.

Meanwhile Pfizer CEO Albert Bourla told CNBC today that a version of its vaccine specifically targeted to Omicron will be ready in March. Manufacturing, he added, has already commenced.

Children under age 5, not eligible for vaccination, are seeing a sharp spike in infections, according to new data from the US Centers for Disease Control and Prevention (CDC). The rate of pediatric infections among hospitalized 0- to 4-year-olds was 4.3 per 100,000 in the week ending January 1, which is four times higher than the rate seen in 5- to 17-year-olds, although of note, case counts include children hospitalized for reasons other than COVID-19. “We are still learning more about the severity of Omicron in children, and whether these increases we are seeing in hospitalization reflect a greater burden of disease in the community or the lower rates of vaccination for these children under age 18,” CDC Director Rochelle Walensky, MD, said in a press briefing. “Please, for our youngest children, those who are not yet eligible for vaccination, it’s critically important that we surround them with people who are vaccinated to provide them protection.” 

Among children ages 5 to 11, only 16% are fully vaccinated, and only half of those ages 12 to 17 have received two doses, Walensky noted. “While children still have the lowest rate of hospitalization of any group, pediatric hospitalizations are at the highest rate compared to any prior point in the pandemic,” she said. CIDRAP News has more details.

There’s emerging evidence that full vaccination in kids ages 12 to 18 years also helps reduce the risk of multisystem inflammatory syndrome in children (MIS-C), researchers report in Morbidity and Mortality Weekly Report. Between July and December 2021, 24 pediatric hospitals admitted 117 MIS-C patients in this age range (younger patients were excluded because vaccines had not been approved for use in children at the time). After excluding patients who had received only one vaccine dose, or had received their second within 28 days of admission, researchers found that just five out of 102 MIS-C patients had been fully vaccinated. Of note, 89% of MIS-C patients had cardiovascular involvement, and 61% were admitted to the ICU. “The current findings contribute to the growing body of evidence that vaccination is likely effective in preventing severe COVID-19–related complications in children, including MIS-C,” the authors conclude.

A study of 1,928 healthcare workers in Israel (mean age 44; 72% women) indicates that a booster dose of the Pfizer/BioNTech vaccine was associated with a significantly reduced risk of SARS-CoV-2 infection over the next 4 to 6 weeks. Of 44 cases (70.5% asymptomatic), five were in the 1,650 “boosted” workers, while 39 were in fully vaccinated workers who had not had a booster dose. “In a time-dependent Cox regression analysis, the adjusted hazard ratio of SARS-CoV-2 infection for booster-immunized versus booster-nonimmunized participants was 0.07 (95% CI, 0.02-0.20),” the authors conclude in JAMA today. An accompanying editorial offers some context, including the tantalizingly perspective that “the additional dose of mRNA vaccines that is currently being distributed may result in more-robust and long-lasting immune responses, obviating the need for further boosters.” 

As COVID-19 case counts skyrocket in many parts of the world along with demand for rapid tests, so too has misinformation about the tests themselves. As Davey Alba reports for the New York Times, a range of different false “themes” related to testing—for example, that PCR tests don’t work or are vaccines “in disguise,” or that at-home tests can test positive with tap water—have “jumped into the thousands of mentions in the last 3 months of 2021, compared with just a few dozen in the same time period in 2020, according to Zignal Labs, which tracks mentions on social media, on cable television, and in print and online outlets.”

Can you catch the flu and COVID-19 simultaneously, and what might happen if you did? The New York Times explores the possibility and implications of coinfection.

Novartis and Molecular Partners say their investigational antiviral drug, ensovibep, is effective in reducing SARS-CoV-2 viral load over an 8-day period. Announcing top-line results from their phase II EMPATHY Part A trial in a joint statement, the companies say deaths or hospitalizations and ER visits, a secondary endpoint, were down by 78% with the intravenous drug, a “multispecific DARPin (Designed Ankyrin Repeat Protein), specifically designed to block the receptor binding domains of SARS-CoV-2 spike protein.”

Tennis fans have been transfixed by the fracas over Novak Djokovic’s efforts to compete in the Australian Open despite not being fully vaccinated—a requirement of visitors and residents returning to the country. Djokovic had received a visa to enter the country using a medical exemption after testing positive for COVID-19 on December 16, 2021, but this was revoked by Australian Border Force officials who said this was not sufficient grounds. According to the Sydney Morning Herald, the world number one had quit his quarantine hotel for a late-night training session at Melbourne’s Rod Laver Arena on Monday after the Federal Circuit Court overturned the visa cancellation. At issue now is why, a day after testing positive, a maskless Djokovic was photographed shaking hands at a ceremony awarding him his own postage stamp in Serbia on December 17. He could still face deportation, the Herald notes.