COVID-19: TCTMD’s Daily Dispatch for May Week 4

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.
 

 

May 28, 2021

The COVID-19 vaccine from Pfizer/BioNTech, already approved for use in Europeans ages 16 and older, can now be used in adolescents ages 12 to 15, the European Medicines Agency (EMA) announced Friday. The decision was based on a study, published in the New England Journal of Medicine, showing an immune response in the younger age group that was comparable to the response seen in people ages 16 to 25, as well as 100% efficacy against COVID-19. The EMA noted that it continues to closely monitor reports of myocarditis and pericarditis in people who have received the vaccine, mostly in those younger than 30.

The results of the COLCORONA trial evaluating colchicine in community-treated patients with COVID-19, released in top-line fashion in January, have now been published in the Lancet Respiratory Medicine. The publication affirms that the trial missed its primary endpoint, with colchicine failing to significantly reduce the composite of death or hospital admission for COVID-19 relative to placebo. When the analysis was restricted to the patients with PCR-confirmed COVID-19, however, colchicine had a significant benefit (OR 0.75), leading the researchers to conclude that “this safe and inexpensive anti-inflammatory agent could be considered for use in those at risk of complications.”

A strategy involving cardiovascular magnetic resonance (CMR) imaging for all college athletes who test positive for COVID-19 catches more cases of clinical or subclinical myocarditis than does a symptom-driven approach, according to findings from the Big Ten COVID-19 Cardiac Registry published in JAMA Cardiology. But the feasibility of implementing universal CMR screening is in doubt, and there are questions about whether it would ultimately prevent sudden cardiac death during athletic competition, which is already a rare occurrence. Aaron Baggish, MD, commented to TCTMD that “we are nowhere close to being ready to use cardiac MRI for screening in this group.”

A Globe and Mail story explores a question on the mind of many people living in countries where the Oxford/AstraZeneca COVID-19 vaccine, which has been linked to rare blood clots, has been rolled out: should I get my second shot or wait for another type of vaccine? Ontario and several other Canadian provinces stopped using the shot for first doses, but the vaccine is still being made available for second doses. Ontario’s chief medical officer has said, however, that people who have received a first dose of the Oxford/AstraZeneca shot can choose to receive a different vaccine for the second dose. “So, basically, it’s up to the AstraZeneca recipients to decide what they think is best for themselves. It’s not necessarily an easy decision, given the fact that there are questions about the vaccines that can’t be answered with any certainty.”

US intelligence officials told President Joe Biden they have as-yet unexamined evidence that requires additional computer analysis and might provide insights into the origins of COVID-19, the New York Times reports: “The officials declined to describe the new evidence. But the revelation that they are hoping to apply an extraordinary amount of computer power to the question of whether the virus accidentally leaked from a Chinese laboratory suggests that the government may not have exhausted its databases of Chinese communications, the movement of lab workers, and the pattern of the outbreak of the disease around the city of Wuhan.” Another news story in Nature describes how some researchers worry that the heated debate now taking place about the lab-leak theory could impede efforts to figure out where the virus originated.

Africa has issued a call for help, requesting delivery of at least 20 million doses of the Oxford-AstraZeneca vaccine in the next 6 weeks to enable countries to provide second doses to vulnerable individuals according to recommended intervals, CIDRAP News reports. A press release from the World Health Organization (WHO) regional office for Africa notes that “in addition to this urgent need, another 200 million doses of any WHO Emergency Use Listed COVID-19 vaccine are needed so that the continent can vaccinate 10% of its population by September 2021.” In related news, the COVAX program designed to deliver vaccine doses around the world said it is facing a shortfall of 190 million doses by the end of June, driven by the crisis in India. If it’s not addressed, “the consequences could be catastrophic,” stakeholders said.

Early tracheostomy is associated with faster discharge from the ICU, but no difference in invasive mechanical ventilation weaning, decannulation, mortality, or perioperative complications, in patients with COVID-19, researchers report in JAMA Otolaryngology – Head & Neck Surgery. The findings indicate a low risk of SARS-CoV-2 infection among healthcare workers involved in tracheostomy in the context of enhanced use of personal protective equipment.

The US Food and Drug Administration (FDA) has recommended that healthcare professionals and facilities limit use of non-NIOSH-approved disposable respirators as part of a transition away from crisis capacity conservation strategies. The agency previously recommended that use of decontamination and bioburden reduction systems to clean disposable respirators should also be limited. The moves coincide with increases in the supply and availability of NIOSH-approved respirators.

On Friday, Japan extended a state of emergency covering Tokyo and other areas for an additional 20 days as preparations continue for the Olympic Games set to begin in July, the Associated Press reports. COVID-19 case numbers remain high and medical systems in Osaka continue to be strained. “I am aware that many people are voicing concern about holding the Olympics and Paralympics,” Prime Minister Yoshihide Suga said. “I take them seriously, and I will proceed with preparations for a safe and secure games.”

---

May 27, 2021

The US Food and Drug Administration (FDA) has issued an emergency use authorization for another monoclonal antibody—sotrovimab (which has also been known as VIR-7831), which was developed by Vir Biotechnology and GlaxoSmithKline. It is indicated for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years and older weighing at least 40 kg, or 88 lbs) who are at high risk for progression to severe COVID-19. It is not authorized for use in patients who are hospitalized or require oxygen therapy for COVID-19.

Two inactivated SARS-CoV-2 vaccines made by the Chinese company Sinopharm were 72.8% and 78.1% effective against lab-confirmed symptomatic COVID-19, according to interim results of a randomized trial published in JAMA. There were no severe cases in the vaccinated groups, compared with two in the control groups. Serious adverse events occurred in only 0.4% to 0.5% of vaccinated participants. One of the shots, which was recently cleared by the World Health Organization (WHO) for emergency use, has played a key role in vaccine rollouts in countries like Seychelles and Chile.

Apoorva Mandavilli of the New York Times details the results of two new studies showing that immunity to SARS-CoV-2 “lasts at least a year, possibly a lifetime, improving over time especially after vaccination.” Results of the studies—one published in Nature and the other published on the preprint server bioRxiv—“may help put to rest lingering fears that protection against the virus will be short-lived,” she writes.

US President Joe Biden has ordered a closer review of the origins of COVID-19 by intelligence agencies to determine whether the virus emerged due to human contact with an infected animal or due to a laboratory accident, reflecting the increased credibility the lab-leak theory has gained recently, CNBC reports. “I have now asked the intelligence community to redouble their efforts to collect and analyze information that could bring us closer to a definitive conclusion, and to report back to me in 90 days,” Biden said in a statement. In response, Chinese officials have accused Biden of playing politics, the Washington Post reports.

Nearly three-quarters of patients with COVID-19 (73%) have at least one persistent symptom beyond the acute phase of the infection, according to a systematic review published in JAMA Network Open. The most common were fatigue or exhaustion (40%), shortness of breath or dyspnea (36%), and sleep disorders or insomnia (29%). The authors caution, however, that “methodological improvements are needed to reliably quantify these risks.”

In 2020, there was a 42.1% increase in overdose-related cardiac arrests in the United States based on data from the National EMS Information System, with the biggest jumps seen in Latinx and Black individuals and those living in more-impoverished neighborhoods or the Pacific states, researchers report in JAMA Psychiatry. EMS records showed a high concordance with mortality data from the US Centers for Disease Control and Prevention (CDC). “Unprecedented overdose deaths during the pandemic necessitate investments in overdose prevention as an essential aspect of the COVID-19 response and postpandemic recovery,” the authors say. A related study in JAMA Network Open showed that opioid-related mortality increased 135% during the first 6 months of the pandemic in Ontario, Canada.

An investigation by the BMJ found that some of the experts on national COVID-19 vaccine advisory committees in the United Kingdom and the United States have significant industry relationships that are not always disclosed. “Both the FDA and the UK government require panelists to disclose conflicts only from the previous 12 months, which can miss significant financial payments that occurred in recent years,” investigative journalist Paul Thacker writes. “We also found examples where panelists disclosed to committees their grants, patents, and other industry relationships in their publications, but it seems that the committees did not find these matters worth making public, and they remained undisclosed until now.”

The first winners of $1 million and a full college scholarship have been chosen in Ohio’s lottery meant to encourage people to get vaccinated amid waning vaccine demand in the state, NPR reports.
 

---

May 26, 2021

Doctors are “exhausted, frustrated, and depressed” as they continue to deal with a surge of COVID-19 cases across India, where more than 1,200 physicians have died from the disease, according to a Bloomberg story. “Bloomberg spoke to a dozen doctors who described a nightmare scenario: continued high-risk exposure to the virus, a never-ending flow of patients and deaths, and long hours in sweat-drenched PPE kits that made even washroom breaks difficult. It’s leading to burnout, anxiety, and insomnia among a large number of India’s 1.3 million doctors and complicates the fight to contain the world’s worst coronavirus outbreak.”

The situation also remains dire in Malaysia, which has more daily COVID-19 infections per million people than does India, CNBC reports, noting that Malaysia’s 7-day average has exceeded India’s since Sunday. “The rapid increase has come as Malaysia—and many developing countries around the world—struggles to secure supplies of COVID vaccines.”

European Union leaders have agreed to donate at least 100 million COVID-19 vaccine doses to poorer nations by the end of the year, backing “a text in which they pledge to continue efforts ‘to increase global vaccine production capacities in order to meet global needs,’” the Associated Press reports.

France will require travelers from the United Kingdom to quarantine for an as-yet unspecified amount of time, Reuters reports. The move was made due to the spread of a more-infectious variant first detected in India in the UK and follows recent ones made by Austria, which banned direct flights and tourist visits from the UK, and Germany, which implemented a 2-week quarantine for British travelers.

Among patients with COVID-19, testosterone levels were inversely associated with disease severity and circulating inflammatory cytokine concentrations in men, but not in women, researchers report in JAMA Network Open. “These findings suggest that low testosterone concentrations may play a mechanistic role in worse outcomes observed in men with COVID-19, underscoring the need for clinical trials to test this hypothesis.”

US Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, offered a cautious message for Americans as they prepare for a long Memorial Day weekend, the unofficial start to summer. She was quoted in the New York Times as saying, “If you are vaccinated, you are protected, and you can enjoy your Memorial Day. If you are not vaccinated, our guidance has not changed for you, you remain at risk of infection. You still need to mask and take other precautions.”

A letter in the Journal of Neurology, Neurosurgery & Psychiatry describes three cases of vaccine-induced immune thrombotic thrombocytopenia presenting as ischemic stroke after receipt of the Oxford/AstraZeneca COVID-19 vaccine. “Our observations suggest that, in addition to venous thrombosis, the neurological spectrum of VITT can include arterial occlusion,” the authors write. An accompanying editorial provides important context: “During the current period of COVID-19 vaccination, a high index of suspicion is required to identify thrombotic episodes following vaccination. However, it is important to remember that these side effects are rare and much less common than both cerebral venous thrombosis and ischemic stroke associated with COVID-19 infection itself.”

South Korea’s handling of the COVID-19 pandemic has been widely viewed as a success. After conducting a review, the US Food and Drug Administration (FDA) has released a report about what it learned. The agency doesn’t make any recommendations about what the United States should do in response to an emerging infectious disease, but delves into the lessons South Korea learned from prior public health emergencies, how it developed COVID-19 tests, and details about its national strategy to contain the virus.

Methotrexate may weaken the response to vaccination with the Pfizer/BioNTech shot in patients with immune-mediated inflammatory diseases, a small study in the Annals of Rheumatic Diseases suggests. Additional strategies may be needed to boost the effectiveness of vaccination in this scenario, the authors say.

There are growing calls to cancel the Tokyo Olympic Games, scheduled to start in July, with The Asahi Shimbun, a major Japanese newspaper urging Prime Minister Yoshihide Suga to do just that in an editorial published Wednesday. “The COVID-19 pandemic has yet to be brought under control, rendering it inevitable that the government will have to declare another extension of the state of emergency currently covering Tokyo and other prefectures,” it reads. “It is simply beyond reason to hold the Tokyo Olympics and Paralympics this summer.” Along the same lines, authors of a perspective in the New England Journal of Medicine recommend a beefed-up risk-management approach for the Tokyo Olympics if they are to go on, but they acknowledge that cancelling them altogether may be the safest option.

 

---

May 25, 2021

Moderna announced Tuesday that its COVID-19 vaccine was 100% effective in its TeenCOVE study of adolescents ages 12 to 17 (and 93% effective using a COVID-19 definition that encompassed milder disease). The company plans to submit the data to global regulators early next month. The vaccine from Pfizer/BioNTech has already been cleared for use down to age 12 in many countries around the world.

Haiti has implemented a nightly curfew and a mask mandate as part of an 8-day “health emergency” responding to a recent surge in COVID-19 cases, the Associated Press reports. The country has had one of the lowest COVID-19 death rates in the world during the pandemic.

Infection numbers are still rising elsewhere around the globe as well. India remains an epicenter, but record increases have been recorded recently in Argentina, Bahrain, Nepal, and Taiwan, CNBC reports. “The increase in infections has come as progress of vaccinations remains uneven across the world. Generally, developed countries such as the US and the UK are ahead in vaccinating their populations while poorer nations in Africa and parts of Asia are lagging due to limited supply of shots.”

From March to August 2020, the first 6 months of the pandemic, there were more drug overdoses, homicides, and unintentional injuries—and fewer suicides—than expected in the United States, researchers report in JAMA. Those findings come on the background of about 257,000 excess deaths and 174,000 COVID-19 deaths during the same time period.

A column in the Washington Post details why the theory that SARS-CoV-2 originated in a laboratory in Wuhan, China, has gained credibility since the beginning of the pandemic: “For one, efforts to discover a natural source of the virus have failed. Second, early efforts to spotlight a lab leak often got mixed up with speculation that the virus was deliberately created as a bioweapon. That made it easier for many scientists to dismiss the lab scenario as tin-hat nonsense. But a lack of transparency by China and renewed attention to the activities of the Wuhan lab have led some scientists to say they were too quick to discount a possible link at first.”

The director-general of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus, MD, called on all countries to vaccine at least 10% of their residents by September and at least 30% by the end of the year, The Hill reports. To reach the initial target, 250 million more people in low- and middle-income countries need to get vaccinated, with all health workers and others in at-risk groups at the front of the line, he noted. “This is crucial to stop severe disease and death, keep our health workers safe, and reopen our societies and economies,” he said.

According to data in Morbidity and Mortality Weekly Report, there were 10,262 SARS-CoV-2 infections in fully vaccinated people reported from 46 US states and territories through the end of April, at which point about 101 million Americans had received all recommended vaccine doses. Most breakthrough infection were in females (63%), with a median patient age of 58. Overall, 10% of these cases involved hospitalization, and 2% of patients died.

Extended follow-up of the CORIMUNO-TOCI-1 randomized trial suggests that tocilizumab may reduce death through 90 days and the likelihood of receiving noninvasive/invasive ventilation or dying through 14 days in patients hospitalized with COVID-19 with C-reactive protein levels of 15 mg/dL or higher. No such benefits were seen in patients with lower CRP levels, researchers report in JAMA Internal Medicine. Evidence regarding the utility of tocilizumab for treatment of COVID-19 has been mixed during the pandemic.

Long-term, serious end-organ damage is uncommon in children with the pediatric inflammatory multisystem syndrome associated with SARS-CoV-2 infection (PIMS-TS), also called the multisystem inflammatory syndrome in children (MIS-C), according to a study in the Lancet Child & Adolescent Health. By 6 months, systemic inflammation had resolved in all but one patient. Moreover, the researchers note, “We found that whereas cardiac, gastrointestinal, renal, hematology, and otolaryngology outcomes largely resolved at 6 months, muscular fatigue and emotional lability were common.”

---

May 24, 2021

India has passed 300,000 COVID-19 deaths, remaining the country with the third-highest total behind the United States (about 590,000) and Brazil (about 449,000). As the Associated Press describes, “From the remote Himalayan villages in the north, through the vast humid central plains and to the sandy beaches in the south, the pandemic has swamped India’s underfunded healthcare system after spreading quickly across the country.”

As a region, Latin America and the Caribbean have recorded more than 1 million COVID-19 deaths as of Saturday, CBS News reports based on data from the Johns Hopkins COVID-19 Dashboard. The director of the Pan American Health Organization (PAHO), Carissa Etienne, MBBS, called this “a tragic milestone for everyone in the region” in a statement.

In the US, the 7-day average of new COVID-19 cases fell below 30,000 for the first time since June 2020, coming in at 27,815 on Friday, the Washington Post reports. Though there are still some hot spots around the country, most areas have a low-to-moderate viral burden, according to a government report.

Agencies in the United States and Europe are assessing reports of myocarditis developing in people who have received one of the mRNA-based COVID-19 vaccines, although no definitive link has yet been established. A group of US Centers for Disease Control and Prevention (CDC) advisors has said “most cases appear to be mild, and follow-up . . . is ongoing.” The American Heart Association/American Stroke Association (AHA/ASA) reiterated its stance that the benefits of vaccination outweigh any potential heart risks. 

A Wall Street Journal story is fueling renewed calls to dig deeper into the possibility that SARS-CoV-2 could have escaped from a lab. According to the story, a US intelligence report shows that three researchers from China’s Wuhan Institute of Virology went to the hospital in November 2019 “with symptoms consistent with both COVID-19 and common seasonal illness,” adding detail to information provided by the US State Department near the end of President Donald Trump’s term. Reuters has more.

On Monday, Japan opened mass vaccination centers in Tokyo and Osaka focused on getting shots into the arms of its elderly population ahead of the Olympic Games, which are scheduled to start in the country in about 2 months, Reuters reports. Hospitals in Osaka are currently under pressure from a wave of new infections.

Malta’s health minister said that by providing 70% of its adult population with at least one dose of COVID-19 vaccine, the country has become the first in Europe to achieve herd immunity, Reuters reports; 42% of adults living in the small Mediterranean island nation have received two doses.

Pfizer announced Monday that it has started a study that will test the coadministration of its 20-valent pneumococcal conjugate vaccine candidate along with a third, booster dose of the Pfizer/BioNTech COVID-19 vaccine in older adults. Participants will have received the second dose of COVID-19 vaccine at least 6 months before enrolling in the new study.

The Oxford/AstraZeneca and Pfizer/BioNTech vaccines are as effective against a SARS-CoV-2 variant first detected in India (B.1.617.2) as they are against variant first detected in the United Kingdom (B.1.1.7), according to data from Public Health England. “Britain's health minister said the data was groundbreaking and he was increasingly hopeful that the government would be able to lift more COVID restrictions next month,” Reuters reports.

French President Emmanuel Macron said health workers who die from COVID-19 will be honored with a special “died in the service of the republic” status, which “would allow the children of the deceased to become wards of the state with a right to receive material and moral support from the government,” according to France 24.