Omicron variant

COVID-19 Roundup: Adverse Events, Treatment Guidelines, and Omicron Variant Prevalence

Adverse Events in COVID-19 Vaccine Placebo1

A significant number of adverse events (AEs) were reported by individuals within the placebo arms of COVID-19 vaccine clinical trials, according to the results of a recent systematic review and meta-analysis. These AEs in the placebo groups of the trials, called “nocebo” responses, accounted for 76% of all systemic AEs reported following the first COVID-19 dose and 51.8% of all AEs following the second dose.

Included were 12 articles that had been published up until July 14, 2021 in the Medline (PubMed) and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Of the 45,380 participants with AE reports included, 22,578 received the placebo. All participants were aged 16 years or older and had reported their AEs within 7 days of receiving their dose.

Systemic AEs were experienced among 35.2% of the placebo group following the first dose, and 31.8% following the second dose. Headache and fatigue were the most common events. However, the vaccine groups reported significantly more AEs when compared with the placebo groups.

NIH Updates Treatment Guidelines for High-Risk Patients2

The National Institutes of Health (NIH) has updated their guidelines for the treatment of mild to moderate COVID-19 in patients who do not require hospitalization but are at high-risk of progressing to severe disease.

Recent studies have suggested that the Omicron variant does not respond as effectively to 2 of the 3 currently available monoclonal antibodies for this patient population, balmanivimab plus etesevimab, and casirivimab plus imdevimab. If the remaining monoclonal antibody, sotrovimab, is unavailable, a 3-day course of remdesivir administered intravenously is now recommended.

Among the currently available treatments for this patient population, in order of preference by the COVID-19 Treatment Guidelines Panel:

  • 300 mg of nirmatrelvir with 100 mg of ritonavir
  • 500 mg of sotrovimab
  • 200 mg of remdesivir
  • 800 mg of molnupiravir

The US Food and Drug Administration authorized the use of ritonavir-boosted nirmatrelvir and molnupiravir via an emergency use authorization in December 2021.

Prevalence of the Omicron Variant3

The omicron variant is now the dominant variant in England, according to the latest results of the Real-time Assessment of Community Transmission-1 (REACT-1) study.

The study authors utilized reverse transcription polymerase chain reaction (RT-PCR) tests of randomly selected individuals aged 5 years or older throughout England to examine the transmission of COVID-19. The findings have been updated monthly since approximately May 2020.

The results of the latest data – from 100,607 swabs collected from January 5, 2022 to January 20, 2022 – indicate that the weighted prevalence of positive swabs is three-fold higher than data from December 2021. Further, 99% of the sequenced positive swabs up to January 16, 2022 were the omicron variant, whereas 1% was the delta variant.

A previous COVID-19 infection was reported in 64.6% (n = 2315 of 3583) of individuals who tested positive in this round of data. The prevalence of infections in children and adolescents aged 5 to 17 years has increased despite a decrease in overall prevalence of COVID-19 during this round of data.

 

—Leigh Precopio

 

References:

  1. Haas JW, Bender FL, Ballou S, et al. Frequency of adverse events in the placebo arms of COVID-19 vaccine trials. JAMA Netw Open. Published online January 18, 2022. doi: 10.1001/jamanetworkopen.2021.43955
  2. The COVID-19 Treatment Guidelines Panel’s statement on therapies for high-risk, nonhospitalized patients with mild to moderate COVID-19. News release. National Institutes of Health; January 19, 2022. Accessed January 28, 2022. https://www.covid19treatmentguidelines.nih.gov/therapies/statement-on-therapies-for-high-risk-nonhospitalized-patients/
  3. Elliott P, Ealess O, Bodinier B, et al. Post-peak dynamics of a national omicron SARS-CoV-2 epidemic during January 2022. Imperial College London. Published online January 26, 2022. https://spiral.imperial.ac.uk/bitstream/10044/1/93887/7/R17_updated_final.pdf