Viral infections

COVID Roundup: Monoclonal Antibodies, Long COVID-19, Additional Vaccine Doses

FDA Authorizes Monoclonal Antibody for COVID-19 Prevention1

Under a revised emergency use authorization, the US Food and Drug Administration (FDA) has authorized the use of a monoclonal antibody, REGEN-COV (casirivimab and imdevimab), for the postexposure prophylaxis of SARS-CoV-2 in high-risk individuals.

The monoclonal antibody is authorized for use in adults and children aged older than 12 years who weigh at least 40 kg, who are at high risk of progression to severe disease or outcomes and have been exposed to COVID-19 or are at high-risk of exposure. REGEN-COV is recommended for individuals who are not fully vaccinated or those with immunocompromising conditions who are not expected to have an adequate immune response to complete vaccination. REGEN-COV is not intended to replace vaccination against COVID-19.

The authorized dose for REGEN-COV is casirivimab, 600 mg, and imdevimab, 600 mg, administered together intravenously or through subcutaneous injection. For individuals with continued exposure, repeat doses of casirivimab, 300 mg, and imdevimab, 300 mg, once every 4 weeks is authorized. Common adverse effects include erythema, pruritus, and ecchymosis.

REGEN-COV is also authorized for the treatment of mild to moderate COVID-19 in this patient population, following a positive SARS-CoV-2 viral test result.

Long COVID-19 in Children2

Up to 1 in 7 children (14%) who recover from COVID-19 may experience long-haul symptoms, according to the preliminary results of The Children and Young People with Long COVID (CLoCK) study.

The researchers sent questionnaires to 220,000 young people aged between 11 to 17 years who were included in the Public Health England database from January 2021 to March 2021. Included in the analysis were 3065 children and adolescents who had tested positive for COVID-19 and 3739 who had tested negative. Participants completed the questionaries 15 weeks after their COVID-19 test was conducted.

The results indicated that 65.5% of individuals who had tested positive and 53.3% of individuals who had tested negative reported 1 or more symptoms at 15 weeks. Of the individuals who tested positive, approximately 30% had 3 or more symptoms. Of those who tested negative, 16% had 3 or more symptoms. Headaches and tiredness were among the most common symptoms reported.

The percentage of individuals with lasting COVID-19 symptoms is lower than previously reported. Prior studies have indicated that up to 51% of children and adolescents may have long COVID-19.

Third COVID Dose for Individuals With Cancer3

The National Comprehensive Cancer Network (NCCN) has recently updated its COVID-19 vaccination guidelines to recommend a third dose of the primary COVID-19 vaccine series in certain immunocompromised individuals, including those with cancer.

This recommendation follows the recommendations of the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

Among those who should receive a third dose are:

  • Individuals with solid, new, or recurring tumors who are receiving treatment within 1 year of their initial COVID-19 vaccine dose, regardless of the type of cancer therapy
  • Individuals with active hematologic malignancies, regardless of whether they are currently receiving cancer therapy
  • Individuals who received a stem cell transplant (SCT) or engineered cellular therapy, especially within the last 2 years
  • Individuals who received allogeneic SCTon immunosuppressive therapy or with a history of graft-vs-host disease, regardless of the time of transplant
  • Individuals with an additional immunosuppressive condition, or those being treated with immunosuppressive agents unrelated to their cancer therapy
  • Individuals who live in the same household with an immunocompromised person

 

To limit exposure, the third dose should be administered to these patients in a health care delivery setting. The third dose should be 4 weeks after the second dose.

Double Vaccination for Long COVID4

Adults who have received both doses of a COVID-19 vaccine may be less likely to have long COVID-19 symptoms if they become infected with SARS-CoV-2, according to the results of a recent prospective, community-based, case-control study.

The researchers utilized the United Kingdom-based, COVID Symptom Study mobile app to study post-vaccination infection and symptoms for COVID-19. A total of 1,240,009 app users aged 18 years or older reported their first vaccine dose, of whom 0.5% (n = 6030) reported a later SARS-CoV-2 infection. Of the 971,504 individuals who received a second dose, 0.2% (n = 2370) reported a later infection. 

Following the first vaccine dose, frailty was associated with infection in adults aged 60 years or older, and those living in highly deprived areas had an increased risk of post-vaccination infection. The risk of infection following the first vaccine dose was lower in individuals without obesity.

When compared with those without vaccination, vaccination was associated with reduced risks of hospitalization, having more than 5 symptoms in the first week of illness following either vaccination dose, and long COVID-19 symptoms of 28 days or more following the second dose.  Infected vaccinated individuals also did not report symptoms as frequently as infected unvaccinated individuals and were more likely to be asymptomatic.

“To minimize SARS-CoV-2 infection, at-risk populations must be targeted in efforts to boost vaccine effectiveness and infection control measures,” the researchers concluded. “Our findings might support caution around relaxing physical distancing and other personal protective measures in the post-vaccination era, particularly around frail older adults and individuals living in more deprived areas, even if these individuals are vaccinated, and might have implications for strategies such as booster vaccinations.”

 

—Leigh Precopio

 

References:

  1. FDA authorized REGEN-COV monoclonal antibody therapy for post-exposure prophylaxis (prevention) for COVID-19. News release. US Food and Drug Administration; September 3, 2021. https://www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-regen-cov-monoclonal-antibody-therapy-post-exposure-prophylaxis-prevention-covid-19
  2. Stephenson T, Pereira SP, Shafran R, et al. Long COVID – the physical and mental health of children and non-hospitalized young people 3 months after SARS-CoV-2 infection; a national matched cohort study (the CLoCK) Study. Res sq. Published online August 10, 2021. https://www.researchsquare.com/article/rs-798316/v1
  3. Recommendations of the National Comprehensive Cancer Network (NCCN) COVID-19 Vaccination Advisory Committee. News release. NCCN COVID-19 Vaccination Advisory Committee; August 30, 2021. https://www.nccn.org/docs/default-source/covid-19/2021_covid-19_vaccination_guidance_v4-0.pdf?sfvrsn=b483da2b_70
  4. Antonelli M, Penfold RS, Merino J, et al. Risk factors and disease profile of post-vaccination SARS-CoV-2 infection in UK users of the COVID Symptom Study app: a prospective, community-based, nested, case-control study. Lancet Published online September 01, 2021. https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(21)00460-6/fulltext