Copy-editor: Rob Camp
Baden LR, El Sahly HM, Essink B, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med 2020, published 30 December. Full-text: https://doi.org/10.1056/NEJMoa2035389
Finally – after press releases, an emergency use authorization and the start of mass vaccinations – the scientific paper by Lindsey Baden et al.! Nothing new: the mRNA-1273 vaccine developed by Moderna and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), within the National Institutes of Health (NIH), has more than 90% efficacy at preventing COVID-19 illness, including severe disease. Moderate-to-severe systemic side effects, such as fatigue, myalgia, arthralgia, and headache, were noted in about 50% of participants in the mRNA-1273 group after the second dose. These side effects were transient, starting about 15 hours after vaccination and resolving in most participants by day 2, without sequelae. The incidence of serious adverse events reported throughout the entire trial was similar for mRNA-1273 and placebo. Importantly, mRNA-1273 did not show evidence in the short term of enhanced respiratory disease after infection, a concern that had emerged from animal models used in evaluating SARS and Middle East Respiratory Syndrome (MERS) vaccine constructs. The authors rightly conclude that the safety of the mRNA-1273 vaccine regimen seems to be reassuring.
Castells MC, Phillips EJ. Maintaining Safety with SARS-CoV-2 Vaccines. N Engl J Med 2020, published 30 December. Full-text: https://doi.org/10.1056/NEJMra2035343
On December 8, 2020, within 24 hours after the start of the U.K. mass vaccination program for health care workers and elderly adults, the program reported probable cases of anaphylaxis in two women, 40 and 49 years of age, who had known food and drug allergies and were carrying auto-injectable epinephrine. One week later, a 32-year-old female health care worker in Alaska who had no known allergies presented with an anaphylactic reaction within 10 minutes after receiving the first dose of the vaccine. Since then, several more cases of anaphylaxis associated with the Pfizer mRNA vaccine have been reported in the United States after vaccination of almost 2 million health care workers, and the incidence of anaphylaxis associated with the Pfizer SARS-CoV-2 mRNA vaccine appears to be approximately 10 times as high as the incidence reported with all previous vaccines, at approximately 1 in 100,000, as compared 1 in 1,000,000. Mariana Castells and Elizabeth Phillips explain what is at stake: “It is critical that we focus on safe and efficient approaches to implementing mass vaccination. In the future, these new vaccines may mark the beginning of an era of personalized vaccinology in which we can tailor the safest and most effective vaccine on an individual and a population level.” Happy New Year!
Hoffmann C, Casado JL, Härter G, et al. Immune deficiency is a risk factor for severe COVID-19 in people living with HIV. HIV Med. 2020 Dec 27. PubMed: https://pubmed.gov/33368966. Full-text: https://doi.org/10.1111/hiv.13037
In people living with HIV (PLWH), immune deficiency is a possible risk factor for severe COVID‐19, even in the setting of HIV virologic suppression. There is no evidence for a protective effect of PIs or tenofovir alafenamide. This is the result of a multi-center cohort study which evaluated risk factors for morbidity and mortality of COVID‐19 in PLWH infected with SARS‐CoV‐2 in three countries. Patients with severe COVID‐19 had a lower current CD4 T cell count and a lower CD4 T cell nadir, compared with patients with mild‐to‐moderate COVID‐19. In a multivariate analysis, the only factor associated with risk for severe COVID‐19 was a current CD4+ T cell count of < 350/µl (adjusted odds ratio 2.85, 95% confidence interval 1.26‐6.44, p = 0.01). The only factor associated with mortality was a low CD4 T cell nadir.
Figure 1. (a) Mortality: CD4 T cells of recovered and deceased (dark grey) patients. (b) Morbidity: CD4 T cells of patients with mild‐to‐moderate and severe (dark grey) COVID‐19.
Public Health England. Investigation of novel SARS-COV-2 variant: Variant of Concern 202012/01. UK Government 2020, updated 28 December. Full-text: https://www.gov.uk/government/publications/investigation-of-novel-sars-cov-2-variant-variant-of-concern-20201201
The investigation into the new SARS-CoV-2 variant which has spread rapidly within the UK. The authors found that the new variant substantially increases transmissibility.
Nasomsong W, Luvira V, Phiboonbanakit D. Case Report: Dengue and COVID-19 Coinfection in Thailand. Am J Trop Med Hyg. 2020 Dec 15. PubMed: https://pubmed.gov/33331264. Full-text: https://doi.org/10.4269/ajtmh.20-1340
The authors report a 50-year-old Thai woman who presented with acute high-grade fever, vomiting, and myalgia for 1 day. RT-PCR of the nasopharyngeal swab detected SARS-CoV-2, and RT-PCR of the blood detected dengue virus serotype 2.
Rattka M, Dreyhaupt J, Winsauer C, et al. Effect of the COVID-19 pandemic on mortality of patients with STEMI: a systematic review and meta-analysis. Heart. 2020 Dec 17:heartjnl-2020-318360. PubMed: https://pubmed.gov/33334863. Full-text: https://doi.org/10.1136/heartjnl-2020-318360
In this meta-analysis, the authors assessed outcomes of 50.123 patients from 10 studies. Did the analyzed data show that acute and timely medical care of these patients had been maintained during the pandemic in most countries? Yes, they did. Consequently, despite a significant reduction in overall admission rates of patients with STEMI during the COVID-19 pandemic (incidence rate ratio = 0.789, 95% CI 0.730 to 0.852, I2=77%, p < 0.01), there was no significant difference in hospital mortality (OR = 1.178, 95% CI 0.926 to 1.498, I2=57%, p = 0.01) compared with patients with STEMI admitted before the outbreak.
If you read French, read Hecketsweiler C. Covid-19 : Le nouveau variant britannique du SARS-CoV-2, « un risque élevé » pour l’Europe. Le Monde 2020, published 31 December. Full-text : https://www.lemonde.fr/planete/article/2020/12/31/le-nouveau-variant-britannique-du-sars-cov-2-un-risque-eleve-pour-l-europe_6064879_3244.html
Ce variant baptisé « VoC 202012/01 » présente plusieurs mutations susceptibles d’accroître sa contagiosité.
L’Algérie va acquérir le vaccin russe Spoutnik V. Le Monde 2020, published 31 December. Full-text : https://www.lemonde.fr/afrique/article/2020/12/31/l-algerie-va-acquerir-le-vaccin-russe-spoutnik-v_6064899_3212.html
La campagne de vaccination contre le Covid-19 est censée commencer en janvier dans le pays qui prévoit d’acquérir 500 000 doses.