12/26/2024

Janusmed kön och genus

Janusmed kön och genus – schimpans-adenovirusvektor, kodar för SARS-CoV-2 spike-protein, rekombinant

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 (adenovirusvektor)

Vaccin mot covid-19 (adenovirusvektor)

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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. Cavaleri, M. Consideration on studying drugs and vaccines in women during the COVID-19 pandemic. The EMA Perspective. Presented at Gender Differences in COVID-19 Pandemic Around the World [Internet]. May 6, 2021;

  15. Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinson H, Snape M, Tarrant R, Voysey M, Green C, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020;396(10249):467-478.

  16. Ewer KJ, Barrett JR, Belij-Rammerstorfer S, Sharpe H, Makinson R, Morter R et al. T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial. Nat Med. 2021;27(2):270-278.

  17. European Medicines Agency. Assessment report - Vaxzevria (chimpanzee adenovirus vector, encoding SARS-CoV-2 spike protein, recombinant). European Medicines Agency (EMA) [www]. [updated 2021-01-29, cited 2021-04-22].

  18. Vaxzevria (chimpanzee adenovirus vector). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-04-14, cited 2021-04-22]

  19. COVID-19 Vaccine Janssen (adenovirus serotype 26 (Ad26) vector). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-04-22, cited 2021-04-23]

  20. Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B et al. Safety and Efficacy of Single-Dose Ad26COV2S Vaccine against Covid-19. N Engl J Med. 2021.

  21. 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.

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

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

  24. 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.

  25. Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine (ChAdOx1-S [recombinant]) – COVID-19 Vaccine AstraZeneca (Other viral vaccines). European Medicines Agency (EMA) [www]. [updated 2021-03-24, cited 2021-04-22].

  26. AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets. European Medicines Agency (EMA) [www]. [updated 2021-04-14, cited 2021-05-10].

  27. COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets. European Medicines Agency (EMA) [www]. [updated 2021-04-20, cited 2021-04-23].

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

  29. European Medicines Agency. Assessment report - COVID-19 Vaccine Janssen (adenovirus serotype 26 (Ad26) vector). European Medicines Agency (EMA) [www]. [updated 2021-03-11, cited 2021-04-22].

  30. 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. Cavaleri, M. Consideration on studying drugs and vaccines in women during the COVID-19 pandemic. The EMA Perspective. Presented at Gender Differences in COVID-19 Pandemic Around the World [Internet]. May 6, 2021;
  15. Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinson H, Snape M, Tarrant R, Voysey M, Green C, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial. Lancet. 2020;396(10249):467-478.
  16. Ewer KJ, Barrett JR, Belij-Rammerstorfer S, Sharpe H, Makinson R, Morter R et al. T cell and antibody responses induced by a single dose of ChAdOx1 nCoV-19 (AZD1222) vaccine in a phase 1/2 clinical trial. Nat Med. 2021;27(2):270-278.
  17. European Medicines Agency. Assessment report - Vaxzevria (chimpanzee adenovirus vector, encoding SARS-CoV-2 spike protein, recombinant). European Medicines Agency (EMA) [www]. [updated 2021-01-29, cited 2021-04-22].
  18. Vaxzevria (chimpanzee adenovirus vector). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-04-14, cited 2021-04-22]
  19. COVID-19 Vaccine Janssen (adenovirus serotype 26 (Ad26) vector). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-04-22, cited 2021-04-23]
  20. Sadoff J, Gray G, Vandebosch A, Cárdenas V, Shukarev G, Grinsztejn B et al. Safety and Efficacy of Single-Dose Ad26COV2S Vaccine against Covid-19. N Engl J Med. 2021.
  21. 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.
  22. Kroenke K, Spitzer RL. Gender differences in the reporting of physical and somatoform symptoms. Psychosom Med. 1998;60(2):150-5.
  23. Barsky AJ, Peekna HM, Borus JF. Somatic symptom reporting in women and men. J Gen Intern Med. 2001;16(4):266-75.
  24. 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.
  25. Signal assessment report on embolic and thrombotic events (SMQ) with COVID-19 Vaccine (ChAdOx1-S [recombinant]) – COVID-19 Vaccine AstraZeneca (Other viral vaccines). European Medicines Agency (EMA) [www]. [updated 2021-03-24, cited 2021-04-22].
  26. AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets. European Medicines Agency (EMA) [www]. [updated 2021-04-14, cited 2021-05-10].
  27. COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets. European Medicines Agency (EMA) [www]. [updated 2021-04-20, cited 2021-04-23].
  28. EudraVigilance. Amsterdam: European Medicines Agency (EMA) [updated 2021-04-17, cited 2021-04-23.]
  29. European Medicines Agency. Assessment report - COVID-19 Vaccine Janssen (adenovirus serotype 26 (Ad26) vector). European Medicines Agency (EMA) [www]. [updated 2021-03-11, cited 2021-04-22].
  30. Statistik för vaccination mot covid-19. Folkhälsomyndigheten [www]. [updated 2021-04-09, cited 2021-04-23].