Research Scan: October 13, 2021
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- On October 11, Merck announced that it had submitted an application to the FDA for emergency use authorization of its oral antiviral, molnupiravir. The submission follows Merck's press release on October 1, that included data from the phase 3 trials involving at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. In these patients, molnupiravir reduced the risk of hospitalization or death by approximately 50%.
- Halloween will go ahead in 2021. In the US, Dr. Fauci has said that outdoor trick-or-treating is safe. In Ontario, Dr. Moore also offered advice on celebrating Halloween safely (CBC). Ontario has released guidelines for celebrating Halloween.
FDA advisory committee will meet to discuss Moderna and J&J boosters and vaccines for 5–11-year-olds
- On October 14 and 15, the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet to discuss emergency use authorization of Moderna and Johnson & Johnson booster shots. In a supplementary briefing document, Moderna notes that the proposed booster dose is half the 2-dose primary series amount.
- On October 26, VRBPAC will meet to discuss Pfizer's request to amend its emergency use authorization to allow the use of its COVID-19 vaccine in children 5 through 11 years of age. Pfizer-BioNTech submitted their request for authorization on October 7.
European Medicines Agency says booster shots may be considered for adults 18+ at six months
- On October 4, the European Medicines Agency released a statement indicating that based on the data of the Pfizer-BioNTech COVID-19 vaccine (Comirnaty), booster doses may be considered at least 6 months after the second dose for people aged 18 years and older.
Novovax COVID-19 vaccine demonstrates 90% efficacy against mild, moderate, and severe COVID-19
- A pre-print of Novovax Phase 3 clinical trial results involving adults 18 and older suggests that efficacy of its vaccine in preventing RT-PCR-confirmed, symptomatic mild, moderate, or severe COVID-19, 7 days after the second vaccine dose, is 90.4%. Efficacy against moderate and severe COVID-19 was 100%. (Dunkle et al., medRxiv)
- The clinical trial is running in the US and Mexico and 78.7% of sequenced cases were variants of concern (mostly Alpha/B.1.1.7).
- The Novovax COVID-19 vaccine is a recombinant subunit vaccine with an adjuvant, which helps elicit a strong protective immune response. This vaccine creates a nanoparticle of the SARS-CoV-2 Spike protein (the subunit), manufactured in a lab using moth cells. The same technology is used in the hepatitis B and pertussis vaccines.
CHILDREN & SCHOOLS
More than 140,000 US children lost a primary or secondary caregiver to COVID-19
- A US study looking at COVID-19-associated primary caregiver loss and orphanhood found that from April 1, 2020 to June 30, 2021, 120,630 children experienced the death of a primary caregiver, including parents and grandparents, and 22,007 children experienced the death of a secondary caregiver (Hillis et al., Pediatrics). Hispanic, Black, and American Indian/Alaska Native children were disproportionately affected, accounting for 65% of those who lost a primary caregiver due to the pandemic.
Screen time and physical inactivity linked to worse mental health in children
- A US study looking at mental health, COVID-19 family impact, and physical activity among 1,000 children from October 22 to November 2, 2020, found that more physical activity and less screen time were associated with better mental health for children. Only 20.9% of children met the recommendation of at least 60 minutes of activity every day. Children in the study also reported a mean number of hours of screen time each day of 4.4 hours. (Tandon et al., JAMA Open Network)
COVID-19 AND MENTAL HEALTH
People with substance use issues at greater risk of breakthrough infection
- A US study involving 579,372 vaccinated individuals, 30,183 of whom were diagnosed with a substance use disorder (SUD), found that those with a SUD diagnosis were at greater risk of a breakthrough infection. The risk of breakthrough infection was greatest in individuals with cocaine use (106% increased risk) and cannabis use disorder (92% increased risk) (Wang et al., World Psychiatry).
- Increased breakthrough infection risk of SUD was associated with co-occurring diseases and adverse socioeconomic characteristics. When individuals with SUD were matched with non-SUD individuals for lifetime comorbidities and adverse socioeconomic determinants of health, the risk of breakthrough infections no longer differed, except for people with cannabis use disorder who remained at 55% greater risk.
Excess deaths among people with mental disorders and intellectual disabilities reported during pandemic
- A UK study that looked at 167,122 individuals with mental disorder diagnoses found that in the second quarter of 2020, age- and gender-standardized mortality ratios were higher compared to previous years and the pre-pandemic period, largely due to an increase in COVID-19 related mortality. During the first peak of COVID-19 infections, deaths from COVID-19 were highest in those with learning disabilities, which were nine times higher than the general population. (Das-Munshi et al., Lancet Regional Health – Europe)
- COVID-19 mortality was also about five times higher in individuals with pervasive developmental disorders and eating disorders, about four times higher for individuals with personality disorders and dementia, and about three times higher for individuals with schizophrenia-spectrum disorders.
- Individuals living with a mental disorder or intellectual disability already had an elevated risk of mortality prior to the start of the pandemic with deaths from all causes about double the population average.
The COVID-19 pandemic caused a global rise in depression and anxiety
- A study using a systematic literature review to assess the global impacts of the COVID-19 on the prevalence and burden of major depressive disorder and anxiety disorders found that an additional 53.2 million cases of major depressive disorder (a 27.6% increase) and an additional 76.2 million cases of anxiety disorders (a 25.6% increase) were reported in the 204 countries included in the analyses (COVID-19 Mental Disorders Collaborators, Lancet).
- Countries with the highest cases and the least population movement (i.e., due to lockdowns) reported the greatest increases in prevalence of the disorders.
- Increased prevalence of the disorder was greater in women than men and in young people aged 20 to 24.
More than a third of COVID-19 patients report ongoing symptoms
- A UK study investigating long COVID in over 273,618 people recovering from COVID-19 found that 36.6% of patients reported at least one symptom three to six months after initial diagnosis. Anxiety/depression, abnormal breathing, and abdominal problems were the most commonly reported symptoms (Taquet et al., PLoS Med). The incidence of long-COVID was higher in the elderly, in more severely affected patients, and in women. Symptoms of Long-COVID were also significantly higher after COVID-19 than after influenza.
HEPA filters successfully remove SARS-CoV-2 from hospital air
- A pre-print study looking at the effect of air filtration on detectable airborne SARS-CoV-2 in a UK hospital found that running a HEPA/UV sterilizer in rooms of a general COVID-19 surge ward eliminated detectable virus from the air. Prior to activation of the filter, airborne SARS-CoV-2 RNA was detected in medium (1-4μM particle size) and large (>4μM particle size) particulate. In contrast little evidence of airborne SARS-CoV-2 was detected in the COVID-19 ICU, although other pathogen bioaerosols were detected. (Conway-Morris et al., medRxiv)
Wearable biosensors can detect colds and flu before symptoms
- A challenge study looking into the ability of a wearable device identify infections in 31 participants inoculated with H1N1 flu and 18 participants inoculated with rhinovirus, found that the E4 wristband accurately picked up 92% of the H1N1 infections and 88% of the rhinovirus infections. Infections were identified by the wristband 24 hours before symptom onset 90% of the time for H1N1 and 89% of the time for rhinovirus. (Grzesiak et al., JAMA Open Net)
- The WHO reported that all regions, with the exception of Europe, reported a 7% decline in cases and a 10% decline in deaths during the week October 4 to 10, 2021. During the same week, the European region saw a 7% increase in cases and an 11% increase in deaths. The highest number of new cases continue to be reported in the US and UK. (Weekly epidemiological update - 13 October 2021)
RESEARCH BRIEFS & GUIDANCE