COVID-19: TCTMD’s Daily Dispatch for June 18
We’re curating a list of COVID-19 research and other useful content, and updating it daily.
TCTMD reporter Todd Neale is keeping up on breaking news and peer-reviewed research related to COVID-19 and will update daily. If you have something to share, tell us. All of our COVID-19 coverage can be found on our COVID-19 Hub.
June 18, 2021
As concern about infection falls, most Americans are resuming their pre-pandemic habits when it comes to eating out, traveling, and attending events like movies or sports, according to an Associated Press-NORC Center for Public Affairs Research poll. Only 21% of respondents said they were very or extremely worried about COVID-19 in their inner circle, which is the lowest level of the pandemic, and only 25% are highly concerned that the easing of restrictions will lead to more people getting infected in the community. However, another 34% think the restrictions were lifted too quickly.
On Friday, the chief scientist of the World Health Organization (WHO) said the Delta variant of SARS-CoV-2, which first emerged in India, is approaching world dominance, Reuters reports. “The Delta variant is well on its way to becoming the dominant variant globally because of its increased transmissibility,” the official said at a press conference.
Hundreds of doctors and healthcare workers in the Kudus region of Indonesia have gotten COVID-19, with dozens hospitalized, despite receiving China’s Sinovac vaccine, Reuters reports. Most of those affected have remained asymptomatic. “The data shows they have the Delta variant (in Kudus) so it is no surprise that the breakthrough infection is higher than before, because, as we know, the majority of healthcare workers in Indonesia got Sinovac, and we still don’t know yet how effective it is in the real world against the Delta variant,” one epidemiologist said.
More than 300 cases of myocarditis after COVID-19 vaccination have been reported in young people, US Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, said Thursday, according to NBC News. In the context of more than 20 million vaccinations in adolescents and young adults, that’s rare, but it’s still higher than expected. The CDC’s Advisory Committee on Immunization Practices (ACIP) was set to discuss the issue on Friday, but the meeting was pushed to next week due to observance of the newly created Juneteenth National Independence Day holiday celebrating the end of slavery in the United States. A story by TCTMD’s Michael O’Riordan delves into new data on the potential myocarditis-vaccine link published this week.
Addressing one potential factor underlying a hesitancy to get vaccinated against COVID-19, researchers report in JAMA that receiving two doses of an mRNA vaccine was not associated with a detrimental impact on any sperm parameters in a small cohort of healthy young men, which may ease concerns about any negative effects on fertility. The study was limited, however, by the lack of a control group and the fact that it didn’t look at fertility per se.
Loss of smell and taste has been a frequently reported symptom of COVID-19 infection. Now a preprint study using before-and-after imaging data from the UK Biobank suggests that COVID-19 leads to loss of brain tissue related to those senses. The findings “consistently relate to loss of grey matter in limbic cortical areas directly linked to the primary olfactory and gustatory system,” the researchers write. Scott Gottlieb, MD, former US Food and Drug Administration (FDA) Commissioner and current member of the Pfizer board of directors, told CNBC, “You could compensate for that over time, so the symptoms of that may go away, but you’re never going to regain the tissue if, in fact, it’s being destroyed as a result of the virus.”
The number of diagnostic tests for cardiovascular disease in the United States fell by 68% in the first month of COVID-19 lockdowns, similar to the drop seen globally in the INCAPS-COVID registry, researchers report in JACC: Cardiovascular Imaging. And while the sharp drop in cardiac admissions and procedures amid COVID-19 has been well documented, the new study shines a light on the decline in cardiovascular diagnostic tests and what this may portend for the future. “If these don't get made up, at a certain point, it's going to catch up with us in terms of cardiovascular outcomes,” the senior author told TCTMD Managing Editor Shelley Wood.
Taking advantage of subtle changes caused by acute SARS-CoV-2 infection, artificial intelligence (AI)-enhanced ECG may prove useful as a way to screen for—and exclude—COVID-19, a study published in Mayo Clinic Proceedings suggests. The high negative predictive value achieved using this approach “may permit the development of ECG-based tools to rapidly screen individuals for pandemic control especially in a clinic or hospital setting. Development of mobile technology enabled AI-ECGs may have broader implications that may enable resumption of normal operations across society,” the authors say. TCTMD has the story.
The higher likelihood of 30-day inpatient mortality or discharge to hospice among Black versus white COVID-19 patients in the United States “is associated with the hospitals at which Black patients disproportionately received care,” which had higher mortality rates than other centers for patients of all races, according to a study in JAMA Network Open. David Baker, MD, writes in an accompanying editorial: “To achieve large gains rather than marginal improvements, we must understand the full set of root causes for disparities in COVID-19 incidence and mortality and use a broad combination of policies and programs to mitigate them and move our country toward equity. But we must dig deep. We must trace these roots to their origin, for there we find the legacy of structural racism, the most difficult and lasting cause that we must finally address if we are to succeed.”
US President Joe Biden’s administration is investing more than $3 billion from the American Rescue Plan to develop the next generation of antivirals to treat COVID-19, the US Department of Health and Human Services (HHS) announced yesterday. “Vaccines remain the centerpiece of our arsenal against COVID-19, but antivirals are an important complement to existing vaccines,” Anthony Fauci, MD, chief medical adviser to the President and director of the National Institute of Allergy and Infectious Diseases (NIAID), said at a White House press briefing, as reported by CIDRAP News.
June 17, 2021
Three new papers in Circulation provide insights into cases of myocarditis occurring after COVID-19 vaccination, usually with one of the mRNA-based vaccines. In a case series of seven men younger than 40—six who received an mRNA vaccine and one who received the adenovirus vaccine from Johnson & Johnson (Janssen)—symptoms resolved in all patients. A case report details what happened with a 52-year-old man who presented with presumed myocarditis following a second dose of mRNA vaccine; his chest discomfort had fully resolved within 3 hours of onset and didn’t recur throughout the rest of his 4-day hospital stay. And another study of eight men ages 21 to 56 diagnosed with myocarditis 2 to 4 days after mRNA vaccination shows that all had resolution of their chest pain and were discharged in stable condition. In a press release, the American Heart Association (AHA) continued to urge people to get vaccinated, saying the benefits of doing “far exceed the very unusual risks.”
The Advisory Committee on Immunization Practices (ACIP), which provides guidance to the US Centers for Disease Control and Prevention (CDC), will meet Friday to discuss reports of myocarditis in young people receiving the mRNA vaccines. The issue is sowing doubts in the minds of some experts about vaccinating children, according to a KHN story.
Pfizer’s rheumatoid arthritis drug tofacitinib (Xeljanz) reduces the risk of death or respiratory failure through day 28 in patients hospitalized with COVID-19 pneumonia, according to results of the placebo-controlled STOP-COVID trial published in the New England Journal of Medicine. In the trial, conducted at 15 Brazilian sites, the rate of that composite primary endpoint was 18.1% in those treated with tofacitinib and 29.0% of those treated with placebo.
Two other NEJM studies delve into the treatment of the multisystem inflammatory syndrome in children (MIS-C) associated with SARS-CoV-2 infection. A propensity-matched analysis demonstrated that CV dysfunction was reduced by initial treatment with IV immune globulin (IVIG) plus glucocorticoids compared with IVIG alone. An analysis of data from 32 countries did not, however, show a difference in outcomes when patients were treated with IVIG plus glucocorticoids or glucocorticoids alone, when compared with IVIG alone. An editorialist points to a couple of factors that can explain the “apparently disparate” results, citing differences in patient populations, study periods, and limitations of observational studies. “Although it is becoming increasingly clear that swift and decisive institution of immunomodulatory therapy can be lifesaving in patients with MIS-C, neither of these studies definitively answered the question about the most effective single or combination treatment,” he writes.
On Wednesday, CureVac reported underwhelming results from a phase IIb/III trial of its COVID-19 vaccine candidate. “In the unprecedented context of at least 13 variants circulating within the study population subset assessed at this interim analysis, CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria,” the company said.
While COVID-19 is waning in other parts of the world, numbers are spiking in Africa, with the World Health Organization (WHO) reporting a 44% jump in weekly cases and a 20% increase in deaths, according to CNBC. A WHO official said Wednesday: “While the numbers in Africa themselves . . . don’t represent a massive proportion of global cases, we know that diagnosis in Africa is not at the same level of intensity. So when you see the shift in trend, the trend is concerning.”
Spread of the Delta variant has driven a 50% increase in infections in England since May, according to a preprint study from Imperial College London investigators. The R number was 1.44, which “means 10 infected people would pass the virus on to 14 others on average, resulting in fast growth of the epidemic,” an accompanying news story notes.
A large retrospective analysis published in the Journal of Women’s Health affirms that women fared better than men in the early days of the pandemic. Among patients hospitalized between March 1 and April 27, 2020, women had lower odds of in-hospital mortality, ICU admission, mechanical ventilation, vasopressor requirement, acute cardiac injury, acute kidney injury, and venous thromboembolism. These differences “may be due to protective factors inherent to female sex and protective behaviors typically associated with female gender,” the authors say, adding, however, that “these findings should not lead to the assumption that women require less clinical concern or attention when presenting with COVID-19.”
The European Union is set to start lifting restrictions on American tourists following a meeting of representatives from its 27 countries, the Associated Press reports. “The recommendation is nonbinding, and national governments have authority to require test results or vaccination records and to set other entry conditions,” the story notes. “The EU has no unified COVID-19 tourism or border policy, but has been working for months on a joint digital travel certificate for those vaccinated, freshly tested, or recently recovered from the virus. EU lawmakers endorsed the plan last week.”
June 16, 2021
Regeneron’s monoclonal antibody combination of casirivimab and imdevimab, called REGEN-COV, reduced mortality in patients hospitalized with severe COVID-19 who didn’t have an immune response to the infection in the UK RECOVERY trial, as reported both by the company and the trial investigators. Mortality at 28 days was 24% in patients treated with the combo and 30% in those who received usual care (rate ratio 0.80; 95% CI 0.70-0.91). “It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own,” Peter Horby, MD, PhD, joint chief investigator for RECOVERY, said in a press release.
Surging COVID-19 case numbers in Haiti, which was relatively unscathed during much of the pandemic, have the US government looking at ways to get much-needed vaccines to the country quickly, the Miami Herald reports. “A White House official said the administration is in ‘active’ conversations with the Haitian government on the complexities of delivering a significant number of US vaccine doses to the country, including Haiti’s storage capacity and the logistics of shipping the vaccines in proper conditions.”
More than one in every five patients who recover from COVID-19 (23.2%) have a least one post-COVID condition 30 days or more after their initial diagnosis, according to a study conducted by the nonprofit organization FAIR Health based on more than 34 billion private healthcare claim records. Long-haul symptoms were more common after severe COVID-19, found in half of patients who were hospitalized, 27.5% of those who were symptomatic but not hospitalized, and 19% of those who had asymptomatic infections. The most common symptoms were pain, breathing difficulties, hyperlipidemia, malaise/fatigue, and hypertension. The New York Times has more.
On Monday, the US Centers for Disease Control and Prevention (CDC) released initial guidance on how to manage patients with these long-haul symptoms, with the agency noting that “understanding of post-COVID conditions remains incomplete and guidance for healthcare professionals will likely change over time as the evidence evolves.” Roll Call provides details.
The Delta variant of SARS-CoV-2, first identified in India and now causing spikes in cases and growing concern in other parts of the world, has been declared a “variant of concern” by the CDC, following a similar move by the World Health Organization (WHO) last month, CNN reports. US Surgeon General Vivek Murthy, MD, told CNN the strain is rapidly increasing in the country. A Scottish study published earlier this week shows that the variant carries a higher risk of hospitalization compared with the Alpha variant that first emerged in England. The good news is that available vaccines reportedly provide strong protection against the Delta variant.
The vast majority of patients currently getting hospitalized with COVID-19 in the United States are not vaccinated, according a story from USA Today. “We're all seeing the same thing—when someone does get sick and comes to the hospital, they're much more likely to be young and unvaccinated,” one expert told the paper. The message, another expert said, is that “vaccination works in preventing severe COVID illness.”
Awareness about COVID-19’s prothrombotic qualities that emerged early in the pandemic soon translated into broad use of anticoagulation to prevent venous thromboembolism, according to a Michigan registry study published recently in JAMA Network Open, which also showed that that prophylactic—but not treatment-level—dosing was associated with better survival at 60 days. One expert stressed to TCTMD’s Caitlin Cox, however, that observational data like these cannot establish causality. The appropriate anticoagulation strategy in patients with COVID-19 remains an area of active research.
In an opinion paper published in Cardiovascular Research, the European Society of Cardiology’s (ESC) Working Group on Cellular Biology of the Heart explores the potential mechanisms underlying the cardiac damage seen in the setting of COVID-19. “Although the main cause of cardiac damage in COVID-19 remains coagulopathy with micro- (and to a lesser extent macro-) vascular occlusion, open questions remain about other possible modalities of cardiac dysfunction, such as direct infection of myocardial cells, effects of cytokines storm, and mechanisms related to enhanced coagulopathy,” the authors write.
Approval of Russia’s Sputnik V COVID-19 vaccine in Europe has been delayed after a June 10 deadline to submit data was missed, Reuters reports. A German government official said the issue will postpone any authorization of the vaccine in Europe until at least September. The European Medicines Agency (EMA) was initially expected to conclude its review and issue a decision about the vaccine in May or June.
June 15, 2021
SARS-CoV-2 may have been in the US several weeks earlier than initially believed, according to an analysis of blood samples from the US government’s All of Us research program published in Clinical Infectious Diseases. The samples were taken between January 2 and March 18, 2020, with antibodies against the virus found in samples taken as early as January 7. “The results expand on findings from a Centers for Disease Control and Prevention study that suggested SARS-CoV-2, the virus that causes COVID-19, was present in the US as far back as December 2019,” according to a press release from the US National Institutes of Health (NIH). The AP’s Mike Stobbe has more on the findings.
As expected, British Prime Minister Boris Johnson postponed “freedom day”—June 21, the day pandemic-related restrictions were set to be lifted—by 4 weeks in response to a recent spike in COVID-19 cases driven by the Delta variant first detected in India, the New York Times reports. “The decision, which will be reviewed in 2 weeks, sent a warning to the world that even well-vaccinated nations remain at risk and angered a noisy caucus of libertarian lawmakers within Mr. Johnson’s own party.”
A Scottish analysis published in the Lancet indicates that the risk of COVID-19 hospitalization is nearly twice as high when infection is caused by the Delta variant rather than the Alpha variant that first emerged in the UK. Though the Oxford/AstraZeneca and Pfizer-BioNTech vaccines provided protection against the Delta variant, the effects were weaker than the protection against the Alpha variant.
The COVID-19 death toll in the US has exceeded 600,000, with about 33.4 million confirmed cases so far, according to the Johns Hopkins COVID-19 Dashboard. The number of people who have died is greater than the populations of Baltimore or Milwaukee and is roughly the same as the number of Americans who died of cancer in 2019, according to the Associated Press. The worldwide death total comes in at more than 3.8 million.
That grim milestone was reached as many parts of the US continue to reopen and lift many virus-related restrictions. California, the first state to lock down in the early days of the pandemic, eased most limits Tuesday, “meaning no more state rules on social distancing or capacity limits at restaurants, bars, supermarkets, gyms, stadiums, or anywhere else,” the Associated Press reports. Masks are no longer required for vaccinated people in most settings.
AstraZeneca reported Monday that its long-acting antibody combination dubbed AZD7442 failed to prevent symptomatic COVID-19 in people recently exposed to SARS-CoV-2. It was studied in the placebo-controlled STORM CHASER trial. A post hoc analysis suggested that the treatment might be useful in people who are not already infected, and the ongoing PROVENT trial will provide insights into that question. Reuters provides some context.
Novavax announced the first data from a trial evaluating the co-administration of vaccines against influenza and COVID-19, which showed that the efficacy of its COVID-19 vaccine candidate was preserved in that scenario. The data were published on the medRxiv preprint server.
A third booster dose of COVID-19 vaccine may enhance protection against SARS-CoV-2 in solid organ transplant recipients, who have a reduced response to vaccination, according to a case series published in the Annals of Internal Medicine. “It is encouraging that antibody titers increased after the third dose in one-third of patients who had negative antibody titers and in all patients who had low-positive antibody titers,” the authors write. “In addition, the vaccine reactions seem acceptable, given the benefits that these vaccines can confer. Antibody responses, however, appear to vary, and potential risks, such as organ rejection, should be evaluated on an individual basis.”
COVID-19 vaccination rates are lagging behind in Hispanic and Black Americans, according to an analysis by researchers from Stanford University and the Kaiser Family Foundation. At the current rate of vaccination, 65% of those 12 and older will receive at least one dose by July 4, the date by which President Joe Biden aims to have at least 70% of US adults at least partially vaccinated (a goal that appears increasingly unlikely due to a slowdown in vaccinations). In this new analysis, Asian individuals are the only ones expected to hit that 70% figure, with lower rates in white (66%), Hispanic (63%), and Black (51%) individuals.
June 14, 2021
India continues to emerge from what was a terrible COVID-19 situation, with many states easing virus-related restrictions on Monday, Reuters reports. The number of new infections is the lowest it’s been in more than 2 months. Still, “experts have cautioned against a full reopening as India has vaccinated only about 5% of its estimated 950 million adults with the necessary two doses, leaving millions vulnerable.”
In a phase III trial conducted in the United States and Mexico, the COVID-19 vaccine candidate from Novavax had 90% overall effectiveness, providing complete protection against moderate and severe disease, the company announced Monday. Of note, vaccine efficacy was 93% against variants of concerns or interest. All COVID-19 hospitalizations or deaths occurred in the placebo group, and all COVID-19 cases observed in the vaccine group were classified as mild. Novavax said it plans to apply for regulatory authorizations in the third quarter of the year.
Celltrion, a Korean company, announced Monday that its monoclonal antibody treatment regdanvimab reduced COVID-19-related hospitalization or death by 72% for patients at high risk of progressing to severe COVID-19, and by 70% for all patients with mild-to-moderate symptoms of COVID-19 in a phase III trial. The therapy also shortened the time to clinical recovery. Infusion-related reactions were mild and transient, the company said.
Responding to some news stories suggesting that the Oxford/AstraZeneca vaccine should not be used in certain groups, the European Medicines Agency (EMA) affirmed Monday that the shot “remains authorized for all populations” and that the balance between benefit and risk is positive. “The source of the misinformation was an article published in an Italian newspaper, which misquoted one of our experts. The article has been revised since and we have also asked for a formal correction,” the agency said in a statement.
The American Heart Association/American Stroke Association (AHA/ASA) has come out with a new statement in response to reports that the US Centers for Disease Control and Prevention (CDC) is investigating rare cases of myocarditis in teens and young adults who have received one of the mRNA-based COVID-19 vaccines, as TCTMD’s Michael O’Riordan reported last week. The group “continues to urge all adults and children ages 12 and older in the US to receive a COVID vaccine as soon as they can, as recommended by the CDC,” noting that a causal connection between myocarditis and the vaccines has not been established.
Governors across the United States are considering whether to end pandemic-related emergency orders as numbers of new COVID-19 cases and deaths remain far lower than previous highs, the Associated Press reports: “In many states, those emergency declarations have been routinely extended by governors every few weeks or months since the pandemic began. But those decisions are getting harder to make—and the extensions harder to justify—as circumstances improve and state lawmakers press to restore a balance of power.” Another story notes, however, that areas of the US with low vaccine uptake have seen increases in case numbers in recent weeks.
There are cautionary notes from other parts of the world, too. British Prime Minister Boris Johnson is expected to delay the next phase of reopening—which was scheduled for “no earlier” than June 21—by up to several weeks due to a surge in COVID-19 cases in the UK driven by the more-infectious Delta variant first detected in India, Reuters reports. “We're continuing to look at the data. No final decision has been taken and the right time to fill everybody in on what we're going to do with . . . June the 21st is tomorrow,” Johnson said Sunday.
The Delta variant is also spreading in southeastern China, where “doctors say they are finding that the symptoms are different and more dangerous than those they saw when the initial version of the virus started spreading in late 2019 in the central city of Wuhan,” according to a New York Times story. Patients are reportedly getting sicker and their conditions are worsening more quickly.
In Canada, two outbreaks of the Delta variant at a Calgary hospital, affecting 22 people, are making national news because 11 of the people infected (including five healthcare workers) had already received two doses of an mRNA vaccine more than 2 weeks previously. Most cases have been mild, but one patient has required ICU care, CBC News reports.
New restrictions have been implemented in Moscow in response to rising COVID-19 numbers, the Associated Press reports: “After several weeks of lockdown as the pandemic spread in the spring of 2020, the Russian capital eased restrictions and did not reimpose any during subsequent case increases. But because of the recent sharp rise, ‘it is impossible not to react to such a situation,’ Moscow Mayor Sergei Sobyanin said.”
Between April and June 2020, the multisystem inflammatory syndrome in children (MIS-C) was rare among people younger than 21, with an incidence of 316 per million SARS-CoV-2 infections, according to a study in JAMA Network Open. However, the condition was more likely to be seen in the Black, Hispanic/Latino, and Asian/Pacific Islander communities than in white individuals, and in younger age groups.
Another analysis in JAMA Network Open indicates that international medical graduates (IMGs) were disproportionately affected in terms of physician deaths during the first wave of the COVID-19 pandemic in the United States. IMGs account for an average of 25% of practicing physicians, but they made up 45% of physician deaths due to COVID-19, with most of the IMG deaths occurring in New York, New Jersey, and Florida. Primary care specialists were hardest hit.
June 11, 2021
On Friday, Group of 7 leaders—from the Canada, France, Germany, Italy, Japan, the United Kingdom, and the United States—who met in England pledged to donate at least 1 billion COVID-19 vaccine doses to struggling countries, the Associated Press reports. That includes the previously announced promise of 500 million doses by US President Joe Biden, as well as another 100 million pledged by British Prime Minister Boris Johnson.
High COVID-19 vaccine uptake appears to protect the unvaccinated, according to a study in Nature Medicine. Based in Israel, which rolled out the Pfizer/BioNTech vaccine, the analysis showed that “on average, for each 20 percentage points of individuals who are vaccinated in a given population, the positive test fraction for the unvaccinated population decreased approximately twofold.” CIDRAP News has more.
Cerebral venous sinus thrombosis (CVST), a manifestation of vaccine-induced immune thrombotic thrombocytopenia (VITT), is much more likely to be observed in patients hospitalized with COVID-19 than in people who have received one of the adenovirus-based COVID-19 vaccines, according to new estimates published in the Journal of the American College of Cardiology. The analysis lacks details on key subgroups and doesn’t address the phenomenon of VITT, “but at least having some information would be better than making an entirely arbitrary decision without objective information,” Behnood Bikdeli, MD, told TCTMD.
Italy has decided to stop using the Oxford/AstraZeneca vaccine in people younger than 60 after a teenager who received the shot died from a rare blood clotting condition more than 2 weeks later, Reuters reports.
The safety committee of the European Medicines Agency (EMA) has recommended adding information to the label for remdesivir (Veklury) to indicate that sinus bradycardia is an adverse reaction of unknown frequency. They “concluded that a causal relationship between the use of the medicine and this adverse event is at least a reasonable possibility and recommended a change in the product information to raise awareness among healthcare professionals.”
The EMA has also advised against using the Oxford/AstraZeneca vaccine in patients with a history of the very rare, but serious, capillary leak syndrome following a review of six cases in people who received the shot—three had a prior history of the condition and one died. Most of the cases involved women and occurred within 4 days of vaccination.
The US Centers for Disease Control and Prevention (CDC) will hold an emergency meeting of its Advisory Committee on Immunization Practices (ACIP) to discuss the higher-than-expect occurrence of myocarditis in young people following vaccination with one of the mRNA-based shots. The issue was discussed at a US Food and Drug Administration (FDA) advisory committee meeting yesterday, CBS News reports. The EMA said its review of the risk of myocarditis and pericarditis is ongoing in relation to use of both the mRNA-based and adenovirus-based vaccines.
Patients hospitalized with COVID-19 fare worse when they stop taking their antihypertensive medication, a study in Hypertension indicates. Discontinuation of ARBs, ACE inhibitors, and beta-blockers was associated with greater odds of dying compared with continuing treatment. “The observational study design prevents us from concluding causality,” the authors write. “However, this study provide association in the protective roles of ARBs, ACE inhibitors, and beta-blockers in hospitalized patients with SARS-CoV-2.”
Suicide attempts among US adolescents remained higher in February/March 2021 than during the same period in 2019, according to data in Morbidity and Mortality Weekly Report. Suspected suicide emergency department visits were 50.6% higher among girls ages 12 to 17 and 3.7% higher among boys the same age. “Suicide prevention requires a comprehensive approach that is adapted during times of infrastructure disruption, involves multisectoral partnerships, and implements evidence-based strategies to address the range of factors influencing suicide risk,” the authors write.
Two people on a cruise billed as the first one to include only fully vaccinated passengers tested positive for SARS-CoV-2 shortly before the ship was set to return to St. Maarten, the New York Times reports, representing a setback for a hard-hit industry starting to emerge from the pandemic. In a statement, Royal Caribbean’s Celebrity Cruises “said that the passengers tested positive during required testing before leaving the ship. The travelers are asymptomatic and are in isolation under observation by a medical team. Testing and contact tracing is in place for close contacts.”
June 10, 2021
The Indian state of Bihar has discovered thousands of unreported COVID-19 deaths, leading to a substantial revision in its total on Wednesday (from 5,424 to 9,429) and “lending weight to suspicion that India’s overall death tally is significantly more than the official figure,” Reuters reports. India, with about 360,000 reported deaths, ranks third behind the United States (about 600,000) and Brazil (about 480,000).
The death rates for heart disease, stroke, hypertension, diabetes, and other conditions rose in the United States last year, according to data from the US Centers for Disease Control and Prevention (CDC). Some experts, the Associated Press reports, attribute the increases to patients avoiding hospitals out of fear of COVID-19 despite having symptoms that would normally warrant medical attention. “The heart disease death rate—which has been falling over the long term—rose to 167 deaths per 100,000 population from 161.5 the year before,” the story notes. “It was only the second time in 20 years that the rate had ticked up.” In 2015, the rate increased by less than 1%.
An analysis of SARS-CoV-2 samples collected in the United States, published in Morbidity and Mortality Weekly Report, shows that the Alpha variant (B.1.1.7) first detected in the United Kingdom accounted for about two-thirds of all infections by the end of April 2021, increasing from just 0.2% at the beginning of the year. The Gamma variant (P.1) first identified in Brazil made up about 5% by the end of April. Together, the results “[demonstrate] the potential for new variants to emerge and become predominant,” the authors say.
Concerns are growing about the Delta variant (B.1.617.2) that first emerged in India because it may be the most-transmissible one discovered so far, it appears to have some resistance to protection conferred by vaccination and prior infection, and there’s preliminary evidence suggesting it might cause more-severe disease. As Andrew Joseph writes in STAT, experts say the emergence of Delta makes vaccination against COVID-19 even more critical, as initial studies indicate the various shots “retain the large bulk of their effectiveness against the variant.”
The World Health Organization’s (WHO) system for naming SARS-CoV-2 variants using the Greek alphabet has been published in Nature Microbiology, and a Nature editorial backs its adoption. “Their present solution, although not perfect, is a simple, straightforward alternative for variants that are otherwise being named after places. It will reduce the use of geographical origins as the default when referring to variants, and thus avoid an unintended stigma,” according to the editorial.
Strict restrictions have returned to parts of China, where hundreds of millions of people remain unvaccinated and SARS-CoV-2 outbreaks have started to crop up, the New York Times reports. The latest flare up—blamed on the Delta variant—has occurred in Guangzhou, where authorities have deployed mass testing and locked down neighborhoods with more than 180,000 residents.
A US Food and Drug Administration (FDA) advisory committee is meeting to discuss what data are needed to support authorization or licensure of COVID-19 vaccines in pediatric populations on Thursday. In a presentation during the meeting, a CDC official said that data from two vaccine safety monitoring systems suggest an increase in myocarditis or pericarditis cases after the second dose of mRNA-based vaccines—from Pfizer/BioNTech or Moderna—in young men, Reuters reports. “We clearly have an imbalance there,” he said. Authorities in the US and Europe have been monitoring this issue.
The advisory committee’s discussion is not related to any specific product, but it’s occurring on the same day Moderna applied for an emergency use authorization from the FDA to allow its vaccine to be used in adolescents ages 12 to 17. The vaccine from Pfizer/BioNTech is already authorized for use down to age 12 in the US and elsewhere. Studies in younger children are ongoing.
A Scottish study in Nature Medicine explored thrombocytopenic, thromboembolic, and hemorrhagic events in people receiving their first dose of the Oxford/AstraZeneca or Pfizer/BioNTech vaccines. No signals were found for the latter, but the Oxford/AstraZeneca shot was associated with “small increased risks of idiopathic thrombocytopenic purpura, with suggestive evidence of an increased risk of arterial thromboembolic and hemorrhagic events.” Reuters has more on the rarity of the complications.
A pilot program that had all residents of Qatar returning to the country’s Hamad International Airport getting tested for SARS-CoV-2 showed that the positivity rate was significantly lower for those who were either fully vaccinated or who had documentation of prior infection than for those with no record of either, according to a study in JAMA. “Nevertheless, both vaccine immunity and natural immunity were imperfect, with breakthrough infections recorded,” the authors say. “This highlights the need to maintain PCR testing for arriving travelers.”
The US plans to buy 500 million doses of COVID-19 vaccine from Pfizer/BioNTech to donate to countries around the world, with 200 million distributed this year and the remaining distributed in the first half of 2022, the Washington Post reports. The doses will be shared by the World Health Organization (WHO)-backed COVAX initiative, with a focus on low- and middle-income countries. President Joe Biden is expected to announce the plan this week at the G7 meeting in the UK.
June 9, 2021
In contrast to declining COVID-19 numbers in the United States and elsewhere, infections are surging in Africa, where cases have risen for the fourth consecutive week, CIDRAP News reports based on data from the World Health Organization (WHO). Most cases are concentrated in a handful of countries—Eritrea, Namibia, South Africa, Uganda, and Zambia. The WHO report noted that there is only enough COVID-19 vaccine in Africa to vaccinate 1% of its population. The Associated Press delves deeper into the extreme vaccine shortage on the continent.
On Wednesday, European Union (EU) lawmakers approved a travel certificate system that will allow for freer travel between European countries without the need for quarantines and extra testing, the Associated Press reports. Several countries have already starting using the system, which certifies that a traveler has been fully vaccinated, has recently tested negative, or has recovered from COVID-19. Of note, “people coming from outside the EU, the overwhelming majority of whom should be vaccinated to enter, will be able to get a certificate if they can convince authorities in the EU country they enter that they qualify for one.” Meanwhile, in the US, the Centers for Disease Control and Prevention (CDC) issued new travel advice for more than 120 countries, CNN reports.
A study of patients 18 and younger who developed severe COVID-19, published in JAMA Network Open, showed that more than one-quarter (28.7%) had at least one underlying condition, most commonly asthma, obesity, neurodevelopmental disorders, and certain mental health conditions (anxiety and fear-related disorders and depressive disorders). The strongest risk factors for hospitalization were type 1 diabetes and obesity, and the strongest risk factors for severe illness among those hospitalized were type 1 diabetes and cardiac/circulatory congenital anomalies. “Healthcare practitioners could consider the potential need for close observation and cautious clinical management of children with these conditions and COVID-19,” the researchers write.
The highly-transmissible Delta variant of SARS-CoV-2 (B.1.617.2), which was first detected in India, is becoming more common in the United States, now accounting for more than 6% of all infections and possibly more than 18% in some Western states, NPR reports. The strain has already become the most common one in the United Kingdom. “The good news is that the vaccines look like they can protect people against the Delta variant,” the story concludes, although adequate protection requires full vaccination. Citing the Public Health England analysis reported in last week’s Dispatch, the NPR story notes that a single dose of the Pfizer/BioNTech vaccine is just 33% effective against the Delta variant, rising to 88% after the second dose.
Pfizer and BioNTech are moving forward with trials of their COVID-19 vaccine in children, using lower doses than are given to adults in an attempt to minimize side effects, USA Today reports: “If those trials prove safety and immune response, the companies expect to request federal authorization in September or October to provide the vaccine to children ages 5 to 11, and a little later in the fall for younger children.”
It looks like the US will fall short of President Biden’s goal to have 70% of Americans vaccinated with at least one shot by July 4, the Associated Press reports. “About 15.5 million unvaccinated adults need to receive at least one dose in the next 4 weeks for Biden to meet his goal. But the pace of new vaccinations in the US has dropped below 400,000 people per day—down from a high of nearly 2 million per day 2 months ago.” That waning interest in vaccination, in addition to concerns about rare blood clots, has left unused Johnson & Johnson (Janssen) shots piling up and nearing their expiration dates, as highlighted in a KHN story.
People consuming plant-based or pescatarian diets are less likely to have moderate-to-severe COVID-19 compared with those following other types of diets, according to a case-control study in BMJ Nutrition, Prevention & Health. Self-reported dietary habits were not associated with overall COVID-19 infection or duration. “Those who reported following plant-based diets or pescatarian diets had higher intake of vegetables, legumes, and nuts, and lower intake of poultry and red and processed meats,” the authors say. “Our results suggest that a healthy diet rich in nutrient-dense foods may be considered for protection against severe COVID-19.”
The US Food and Drug Administration (FDA) recently updated the emergency use authorization for the REGEN-COV antibody therapy consisting of casirivimab and imdevimab (Regeneron), which is used to treat mild-to-moderate COVID-19. Changes include a reduction in the authorized dose, the addition of subcutaneous injection as an alternate route of administration, and the addition of a new co-formulated product in a single vial.
Houston Methodist, which is requiring its employees to get vaccinated against COVID-19, suspended 178 workers who did not get fully vaccinated without pay for 2 weeks, the Washington Post reports. The vast majority of the hospital system’s employees—24,947—were fully vaccinated by the Monday deadline.
The EU and the United States are preparing to jointly call for a new World Health Organization (WHO)-led study on the origins of the COVID-19 pandemic “that is free from interference,” according to a draft document seen by Reuters ahead of a summit in Brussels next week. “However,” the story notes, “EU diplomats made it clear that the EU's support to [US President Joe] Biden on the virus origins is mostly symbolic.” The Associated Press has an explainer on the US probe into how SARS-CoV-2 first emerged. The Wall Street Journal yesterday reported on a US government national laboratory document prepared in May 2020 that said the theory that the virus leaked from a laboratory in Wuhan, China, should be investigated further.
June 8, 2021
Aspirin 150 mg/day does not reduce mortality in patients hospitalized with COVID-19 over usual care, according to results released today in a press release from the RECOVERY investigators. The rate of 28-day mortality was 17% in both study arms (P = 0.35), with consistent results across subgroups. “Although aspirin was associated with a small increase in the likelihood of being discharged alive this does not seem to be sufficient to justify its widespread use for patients hospitalized with COVID-19,” Peter Horby, MD, PhD, joint chief investigator for the trial, said in the release.
Moderna has applied to have its COVID-19 vaccine authorized for use in adolescents ages 12 to 17 in both Canada and Europe, based on positive results from its phase II/III TeenCOVE study, which were released last month. The company said it plans to apply for a similar emergency use authorization in the United States as well. The European Medicines Agency (EMA) said Tuesday that it had started evaluating Moderna’s application, a process it expects to complete in July.
The initial months of COVID-19 vaccination in the United States—when older adults were prioritized for the shots—saw greater declines in COVID-19 incidence, emergency department visits, hospital admissions, and deaths among adults 65 and older versus younger adults, according to a study in Morbidity and Mortality Weekly Report. “These age-stratified results provide ecologic evidence of the likely contribution of vaccination coverage to reducing COVID-19 outcomes,” the authors say.
Real-world data out of Israel, published in JAMA Network Open, indicate that a first dose of the COVID-19 vaccine from Pfizer/BioNTech conferred a 51% reduction in the risk of infection 13 to 24 days after the shot compared with the initial 12 days, with 54% effectiveness against symptomatic COVID-19. The findings are consistent with results from a phase III trial.
Researchers are looking into whether the Delta variant (B.1.617.2) of SARS-CoV-2 that has been fueling a surge of COVID-19 cases in India, and has now spread to more than 60 countries, causes more-severe disease, Bloomberg reports. Indian physicians have linked the strain to hearing impairment, severe gastric upset, and blood clots leading to gangrene, which are not typically seen in COVID-19. And preliminary evidence out of the United Kingdom, which has seen a recent increase in infections with the Delta variant, suggests the variant carries a higher risk of hospitalization.
In the New York Times, Carl Zimmer delves into the findings of a preprint study that might help explain how the SARS-CoV-2 variant that first emerged in the United Kingdom (B.1.1.7)—now dubbed the Alpha variant—spread so widely across the world. The study “points to one secret to its success: Alpha disables the first line of immune defense in our bodies, giving the variant more time to multiply,” Zimmer writes.
A World Health Organization (WHO) official said Monday that high vaccination rates can help fend off the risks posed by emerging SARS-CoV-2 variants, estimating that “coverage of at least 80% is needed to significantly lower the risk that ‘imported’ coronavirus cases like those linked to new variants could spawn a cluster or a wider outbreak,” the Associated Press reports.
In the early months of the COVID-19 pandemic, clinicians and immunologists were flummoxed by signs that SARS-CoV-2 appeared to produce a late, systemic inflammatory condition in children that shared several features with Kawasaki disease. Now, in an unexpected corollary, researchers in Korea say that the incidence of true Kawasaki disease has dropped markedly during this same period, likely due to the nonpharmaceutical interventions put in place to stop the spread of COVID-19. TCTMD Managing Editor Shelley Wood has the story.
The Canadian government is looking at June 22 as the date to begin easing COVID-19 restrictions at the US border—put in place early during the pandemic—as long as the current pace of vaccinations continues, Politico reports: “As vaccination rates rise, both national governments are under intensifying pressure to produce a reopening plan as a way to help struggling tourism industries and families who have been separated for more than a year.” Prime Minister Justin Trudeau has signaled that restrictions at the border—the world’s longest—would only be eased for fully vaccinated travelers.
On Monday night, workers at Houston Methodist protested a new policy requiring all employees to be vaccinated against COVID-19, the New York Times reports. Last month, 117 employees sued the hospital over the mandate. Guidance from the federal government says employers can require vaccinations for on-site workers. A viewpoint in JAMA argues that mandatory COVID-19 vaccination of healthcare workers is “a logical addition to institutional safety programs,” with another viewpoint delving into issues around requiring vaccinations in schools, universities, and businesses.
June 7, 2021
Prime Minister Narendra Modi said Monday that free COVID-19 vaccines will be provided to all adults in India, an announcement that “came after weeks of criticism of a bungled vaccine rollout that has covered fewer than 5% of India's estimated adult population of 950 million,” Reuters reports. Up until now, free vaccines were offered only to elderly individuals and frontline workers, with state governments and private hospitals administering vaccines for a fee to people ages 18 to 45.
There is concern that lagging COVID-19 vaccination rates in the US South could lead to surges in case numbers over the summer, the New York Times reports. In 15 states, only about half of adults or fewer have received at least one dose, and in two of them—Alabama and Mississippi—it would take about a year to get one-dose coverage of 70% at the current pace of vaccinations.
The European Medicines Agency (EMA) is advising healthcare professionals to rely on recommendations from medical societies (with a list provided) when assessing patients for possible thrombosis with thrombocytopenia syndrome (TTS) after receipt of COVID-19 vaccines from Oxford/AstraZeneca or Johnson & Johnson (Janssen).
In an opinion piece in the Wall Street Journal, two researchers argue that science backs up the theory that SARS-CoV-2 first emerged after escaping from the Wuhan Institute of Virology in China, pointing to the genetic footprint of the virus.
Residents and staff of long-term care facilities with evidence of prior SARS-CoV-2 infection appear to be protected against reinfection for up to 10 months, according to data published in the Lancet Healthy Longevity. Risk of infection was a relative 85% lower in residents and 61% lower in staff who were antibody-positive versus antibody-negative at baseline.
CIDRAP News provides details on two meta-analyses confirming that neurologic and psychiatric conditions are common in patients with COVID-19. The first, in the Journal of Neurology, Neurosurgery & Psychiatry, shows that the most common symptoms were anosmia (43.1%), weakness (40.0%), fatigue (37.8%), and dysgeusia (37.2%). The second, in BMC Infectious Diseases, revealed central and peripheral nervous system involvement, associated with a greater risk of hospitalization, in up to 36% of cases.
Efforts are afoot to make sure the dramatic expansion in the use of telehealth during the pandemic remains moving forward, according to a KHN story. “The broad effort reaches across the nation’s diverse healthcare system, bringing together consumer groups with health insurers, state Medicaid officials, physician organizations, and telehealth vendors. And it represents an emerging consensus that many services that once required an office visit can be provided easily and safely—and often more effectively—through a video chat, a phone call, or even an email.”
Results of the ACTION trial, presented last month at the virtual American College of Cardiology 2021 Scientific Session as reported by TCTMD, have now been published in the Lancet. The study showed that therapeutic-dose anticoagulation (mostly with rivaroxaban) did not improve clinical outcomes and increased bleeding in patients hospitalized with COVID-19 and elevated D-dimer levels compared with standard prophylactic anticoagulation.
Adults and children with COVID-19 and the multisystem inflammatory syndrome in children (MIS-C) have low plasma bioavailability of the amino acid arginine compared with healthy controls, researchers report in PNAS. “This may contribute to immune dysregulation and endothelial dysfunction in COVID-19,” they say.
Canada will allow a cross-border travel exemption for teams participating in the National Hockey League (NHL) playoffs, after no travel was allowed across the US-Canadian border during the regular season, the Associated Press reports. “When in Canada, teams will be required to stay in a bubble and be tested daily for COVID-19, similar to the tight restrictions that allowed the NHL to stage and complete its playoffs in two hub cities last year. Teams will be assigned designated hotels and have no interaction with the public.”