4/20/2024

Janusmed kön och genus

Janusmed kön och genus – Vaccin mot covid-19 (mRNA)

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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Vaccin mot covid-19 (mRNA)

Vaccin mot covid-19 (mRNA)

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  1. Kelada M, Anto A, Dave K, Saleh SN. The Role of Sex in the Risk of Mortality From COVID-19 Amongst Adult Patients: A Systematic Review. Cureus. 2020;12(8):e10114.

  2. Lakbar I, Luque-Paz D, Mege JL, Einav S, Leone M. COVID-19 gender susceptibility and outcomes: A systematic review. PLoS One. 2020;15(11).

  3. Mesas AE, Cavero-Redondo I, Álvarez-Bueno C, Sarriá Cabrera MA, Maffei de Andrade S, Sequí-Dominguez I et al. Predictors of in-hospital COVID-19 mortality: A comprehensive systematic review and meta-analysis exploring differences by age, sex and health conditions. PLoS One. 2020;15(11):e0241742.

  4. Figliozzi S, Masci PG, Ahmadi N, Tondi L, Koutli E, Aimo A et al. Predictors of adverse prognosis in COVID-19: A systematic review and meta-analysis. Eur J Clin Invest. 2020;50(10):e13362.

  5. Ortolan A, Lorenzin M, Felicetti M, Doria A, Ramonda R. Does gender influence clinical expression and disease outcomes in COVID-19? A systematic review and meta-analysis. Int J Infect Dis. 2020;99:496-504.

  6. Centrum för epidemiologi och samhällsmedicin. Kön och risk för allvarlig sjukdom och död i covid-19. Stockholm: Centrum för epidemiologi och samhällsmedicin (CES); 2021.

  7. Falagas ME, Mourtzoukou EG, Vardakas KZ. Sex differences in the incidence and severity of respiratory tract infections. Respir Med. 2007;101(9):1845-63.

  8. Wray S, Arrowsmith S. The Physiological Mechanisms of the Sex-Based Difference in Outcomes of COVID19 Infection. Front Physiol. 2021;12:627260.

  9. Griffith DM, Sharma G, Holliday CS, Enyia OK, Valliere M, Semlow AR et al. Men and COVID-19: A Biopsychosocial Approach to Understanding Sex Differences in Mortality and Recommendations for Practice and Policy Interventions. Prev Chronic Dis. 2020;17:E63.

  10. Schiffer VMMM, Janssen EBNJ, van Bussel BCT, Jorissen LLM, Tas J, Sels JEM et al. The "sex gap" in COVID-19 trials: a scoping review. EClinicalMedicine. 2020;29:100652.

  11. European Medicines Agency (EMA). Note for guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465/95) [updated 1997-12-17, cited 2021-04-08].

  12. Klein SL, Marriott I, Fish EN. Sex-based differences in immune function and responses to vaccination. Trans R Soc Trop Med Hyg. 2015;109(1):9-15.

  13. Flanagan KL, Klein SL, Skakkebaek NE, Marriott I, Marchant A, Selin L et al. Sex differences in the vaccine-specific and non-targeted effects of vaccines. Vaccine. 2011;29(13):2349-54.

  14. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020;383(27):2603-2615.

  15. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R et al; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021;384(5):403-416.

  16. Demonbreun AR, Sancilio A, Velez ME, Ryan DT, Pesce L, Saber R et al. COVID-19 mRNA Vaccination Generates Greater Immunoglobulin G Levels in Women Compared to Men. J Infect Dis. 2021;224(5):793-797.

  17. Wheeler SE, Shurin GV, Yost M, Anderson A, Pinto L, Wells A et al. Differential Antibody Response to mRNA COVID-19 Vaccines in Healthy Subjects. Microbiol Spectr. 2021;9(1):e0034121.

  18. Watson S, Caster O, Rochon PA, den Ruijter H. Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century. EClinicalMedicine. 2019;17:100188.

  19. Kroenke K, Spitzer RL. Gender differences in the reporting of physical and somatoform symptoms. Psychosom Med. 1998;60(2):150-5.

  20. Barsky AJ, Peekna HM, Borus JF. Somatic symptom reporting in women and men. J Gen Intern Med. 2001;16(4):266-75.

  21. Holm L, Ekman E, Jorsäter Blomgren K. Influence of age, sex and seriousness on reporting of adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf. 2017;26(3):335-343.

  22. Assessment report - Comirnaty (tozinameran). European Medicines Agency (EMA) [www]. [updated 2021-02-19, cited 2021-04-08].

  23. Assessment report - COVID-19 Vaccine Moderna (modified mRNA, encoding full length SARS-CoV-2 spike protein (CX-024414)). European Medicines Agency (EMA) [www]. [updated 2021-03-11, cited 2021-04-08].

  24. EudraVigilance. Amsterdam: European Medicines Agency (EMA) [updated 2021-04-17, cited 2021-04-23.]

  25. COVID-19 vaccine safety update - SPIKEVAX. European Medicines Agency (EMA) [www]. [updated 2021-07-14, cited 2021-10-06].

  26. COVID-19 vaccine safety update - COMIRNATY. European Medicines Agency (EMA) [www]. [updated 2021-07-14, cited 2021-10-06].

  27. Karlstad Ø, Hovi P, Husby A, Härkänen T, Selmer RM, Pihlström N et al. SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort Study of 23 Million Residents. JAMA Cardiol. 2022.

  28. Statistikdatabas för diagnoser. Stockholm: Socialstyrelsen. 2020 [cited 2021-10-06.]

  29. Cooper LT, Keren A, Sliwa K, Matsumori A, Mensah GA. The global burden of myocarditis: part 1: a systematic literature review for the Global Burden of Diseases, Injuries, and Risk Factors 2010 study. Glob Heart. 2014;9(1):121-9.

  30. Mattsson G, Levin C, Magnusson P. ABC om - perikardit och myokardit. Lakartidningen. 2018;115.

  31. Statistik för vaccination mot covid-19. Folkhälsomyndigheten [www]. [updated 2021-04-09, cited 2021-04-23].

  1. Kelada M, Anto A, Dave K, Saleh SN. The Role of Sex in the Risk of Mortality From COVID-19 Amongst Adult Patients: A Systematic Review. Cureus. 2020;12(8):e10114.
  2. Lakbar I, Luque-Paz D, Mege JL, Einav S, Leone M. COVID-19 gender susceptibility and outcomes: A systematic review. PLoS One. 2020;15(11).
  3. Mesas AE, Cavero-Redondo I, Álvarez-Bueno C, Sarriá Cabrera MA, Maffei de Andrade S, Sequí-Dominguez I et al. Predictors of in-hospital COVID-19 mortality: A comprehensive systematic review and meta-analysis exploring differences by age, sex and health conditions. PLoS One. 2020;15(11):e0241742.
  4. Figliozzi S, Masci PG, Ahmadi N, Tondi L, Koutli E, Aimo A et al. Predictors of adverse prognosis in COVID-19: A systematic review and meta-analysis. Eur J Clin Invest. 2020;50(10):e13362.
  5. Ortolan A, Lorenzin M, Felicetti M, Doria A, Ramonda R. Does gender influence clinical expression and disease outcomes in COVID-19? A systematic review and meta-analysis. Int J Infect Dis. 2020;99:496-504.
  6. Centrum för epidemiologi och samhällsmedicin. Kön och risk för allvarlig sjukdom och död i covid-19. Stockholm: Centrum för epidemiologi och samhällsmedicin (CES); 2021.
  7. Falagas ME, Mourtzoukou EG, Vardakas KZ. Sex differences in the incidence and severity of respiratory tract infections. Respir Med. 2007;101(9):1845-63.
  8. Wray S, Arrowsmith S. The Physiological Mechanisms of the Sex-Based Difference in Outcomes of COVID19 Infection. Front Physiol. 2021;12:627260.
  9. Griffith DM, Sharma G, Holliday CS, Enyia OK, Valliere M, Semlow AR et al. Men and COVID-19: A Biopsychosocial Approach to Understanding Sex Differences in Mortality and Recommendations for Practice and Policy Interventions. Prev Chronic Dis. 2020;17:E63.
  10. Schiffer VMMM, Janssen EBNJ, van Bussel BCT, Jorissen LLM, Tas J, Sels JEM et al. The "sex gap" in COVID-19 trials: a scoping review. EClinicalMedicine. 2020;29:100652.
  11. European Medicines Agency (EMA). Note for guidance on preclinical pharmacological and toxicological testing of vaccines (CPMP/SWP/465/95) [updated 1997-12-17, cited 2021-04-08].
  12. Klein SL, Marriott I, Fish EN. Sex-based differences in immune function and responses to vaccination. Trans R Soc Trop Med Hyg. 2015;109(1):9-15.
  13. Flanagan KL, Klein SL, Skakkebaek NE, Marriott I, Marchant A, Selin L et al. Sex differences in the vaccine-specific and non-targeted effects of vaccines. Vaccine. 2011;29(13):2349-54.
  14. Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020;383(27):2603-2615.
  15. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R et al; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021;384(5):403-416.
  16. Demonbreun AR, Sancilio A, Velez ME, Ryan DT, Pesce L, Saber R et al. COVID-19 mRNA Vaccination Generates Greater Immunoglobulin G Levels in Women Compared to Men. J Infect Dis. 2021;224(5):793-797.
  17. Wheeler SE, Shurin GV, Yost M, Anderson A, Pinto L, Wells A et al. Differential Antibody Response to mRNA COVID-19 Vaccines in Healthy Subjects. Microbiol Spectr. 2021;9(1):e0034121.
  18. Watson S, Caster O, Rochon PA, den Ruijter H. Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century. EClinicalMedicine. 2019;17:100188.
  19. Kroenke K, Spitzer RL. Gender differences in the reporting of physical and somatoform symptoms. Psychosom Med. 1998;60(2):150-5.
  20. Barsky AJ, Peekna HM, Borus JF. Somatic symptom reporting in women and men. J Gen Intern Med. 2001;16(4):266-75.
  21. Holm L, Ekman E, Jorsäter Blomgren K. Influence of age, sex and seriousness on reporting of adverse drug reactions in Sweden. Pharmacoepidemiol Drug Saf. 2017;26(3):335-343.
  22. Assessment report - Comirnaty (tozinameran). European Medicines Agency (EMA) [www]. [updated 2021-02-19, cited 2021-04-08].
  23. Assessment report - COVID-19 Vaccine Moderna (modified mRNA, encoding full length SARS-CoV-2 spike protein (CX-024414)). European Medicines Agency (EMA) [www]. [updated 2021-03-11, cited 2021-04-08].
  24. EudraVigilance. Amsterdam: European Medicines Agency (EMA) [updated 2021-04-17, cited 2021-04-23.]
  25. COVID-19 vaccine safety update - SPIKEVAX. European Medicines Agency (EMA) [www]. [updated 2021-07-14, cited 2021-10-06].
  26. COVID-19 vaccine safety update - COMIRNATY. European Medicines Agency (EMA) [www]. [updated 2021-07-14, cited 2021-10-06].
  27. Karlstad Ø, Hovi P, Husby A, Härkänen T, Selmer RM, Pihlström N et al. SARS-CoV-2 Vaccination and Myocarditis in a Nordic Cohort Study of 23 Million Residents. JAMA Cardiol. 2022.
  28. Statistikdatabas för diagnoser. Stockholm: Socialstyrelsen. 2020 [cited 2021-10-06.]
  29. Cooper LT, Keren A, Sliwa K, Matsumori A, Mensah GA. The global burden of myocarditis: part 1: a systematic literature review for the Global Burden of Diseases, Injuries, and Risk Factors 2010 study. Glob Heart. 2014;9(1):121-9.
  30. Mattsson G, Levin C, Magnusson P. ABC om - perikardit och myokardit. Lakartidningen. 2018;115.
  31. Statistik för vaccination mot covid-19. Folkhälsomyndigheten [www]. [updated 2021-04-09, cited 2021-04-23].