insights

COVID-19 Vaccines in Phase 3 Trials

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In the recent webinar COVID-19 Vaccines: Current Evidence and Clinical Considerations webinar, panelists from IFM’s COVID Task Force leadership, along with guest subject matter expert Heather Zwickey, PhD, and IFM educator James Carter, MD, discussed the ongoing evaluation of COVID-19 vaccines in the presence of uncertainty, concerns, and incomplete data, as well as the issue of vaccine hesitancy among BIPOC communities. The webinar is a part of IFM’s Resistance, Resilience, and Recovery: Patient Care in a Pandemic online course and is the second in a series of monthly webinars updating practitioners about the latest medical research on mitigating COVID-19 infection and addressing chronic COVID syndrome.


TRANSCRIPT

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CLICK TO VIEW THE PANDEMIC PRE-VACCINE PROTOCOL TOOLKIT ASSETCOVID-19 Functional Medicine Resources

As discussed by the panelists in the webinar COVID-19 Vaccines: Current Evidence and Clinical Considerations, in order to properly assess each vaccine, IFM has created this informational dashboard for each approved vaccine, as well as those in phase 3 clinical trials. We continue to monitor outcomes data for each vaccine after its initial release and will update this dashboard accordingly.

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References

  1. American Society of Health-System Pharmacists. COVID-19 vaccine candidate tracking sheet. Updated February 8, 2021. Accessed February 12, 2021. https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/Coronavirus/docs/Vaccine-candidate-tracking-table.ashx?la=en&hash=445ED31EC216D4F4E33C920AE151530C986F9255.
  2. US Food and Drug Administration. Fact sheet for healthcare providers administering vaccine (vaccination providers) emergency use authorization (EUA) of the Pfizer-Biontech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). Revised January 2021. Accessed February 12, 2021.  https://www.fda.gov/media/144413/download.
  3. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603-2615. doi:10.1056/NEJMoa2034577
  4. US Food and Drug Administration. Fact sheet for healthcare providers administering vaccine (vaccination providers) emergency use authorization (EUA) of the Moderna COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). Revised December 2020. Accessed February 12, 2021. https://www.fda.gov/media/144637/download
  5. Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403-416. doi:10.1056/NEJMoa2035389
  6. Johnson & Johnson. Johnson & Johnson announces single-shot Janssen COVID-19 vaccine candidate met primary endpoints in interim analysis of its Phase 3 ENSEMBLE Trial. Published January 29, 2021. Accessed February 12, 2021. https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial
  7. Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK [published correction appears in Lancet. 2021; 397(10269):98]. Lancet. 2021;397(10269):99-111. doi:10.1016/S0140-6736(20)32661-1
  8. Logunov DY, Dolzhikova IV, Shcheblyakov DV, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia Lancet. Published online February 2, 2021. doi:10.1016/S0140-6736(21)00234-8
  9. Novavax. Novavax COVID-19 vaccine demonstrates 89.3% efficacy in UK Phase 3 Trial.Published January 28, 2021. Accessed February 12, 2021. https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3
  10. Polack FP, Thomas SJ, Kitchin N, et al. Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine. N Engl J Med. 2020;383(27):2603-2615. doi:10.1056/NEJMoa2034577
  11. Mahase E. Covid-19: Pfizer vaccine efficacy was 52% after first dose and 95% after second dose, paper shows. BMJ. 2020;371:m4826. doi:10.1136/bmj.m4826
  12. Hunter PR, Brainard JS. Estimating the effectiveness of the Pfizer COVID-19 BNT162b2 vaccine after a single dose. A reanalysis of a study of ‘real-world’ vaccination outcomes from Israel. Medrxiv. Published January 1, 2021. doi:10.1101/2021.02.01.21250957
  13.  Centers for Disease Control and Prevention. The Vaccine Adverse Reporting System (VAERS) Results. Accessed February 12, 2021. https://wonder.cdc.gov/vaers.html
  14. CDC COVID-19 Response Team; Food and Drug Administration. Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine — United States, December 21, 2020–January 10, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(4):125-129. doi:10.15585/mmwr.mm7004e1
  15. Centers for Disease Control and Prevention. Vaccine considerations for people with underlying medical conditions. Updated December 29, 2020. Accessed February 12, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/underlying-conditions.html
  16. Pfizer-BioNTech COVID-19 Vaccine Emergency Use Authorization Review Memorandum. Published November 20, 2020. Accessed February 12, 2021. https://www.fda.gov/media/144416/download
  17. 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;384(5)403-416. doi:10.1056/NEJMoa2035389
  18. Centers for Disease Control and Prevention. The Vaccine Adverse Reporting System (VAERS) Results. Accessed February 12, 2021. https://wonder.cdc.gov/vaers.html
  19. CDC COVID-19 Response Team; Food and Drug Administration. Allergic reactions including anaphylaxis after receipt of the first dose of Moderna COVID-19 vaccine — United States, December 21, 2020–January 10, 2021. MMWR Morb Mortal Wkly Rep. 2021;70(4):125-129. doi:10.15585/mmwr.mm7004e1
  20. Centers for Disease Control and Prevention. Vaccine considerations for people with underlying medical conditions. Updated December 29, 2020. Accessed February 12, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/underlying-conditions.html
  21. Moderna COVID-19 Vaccine EUAFact Sheet for Healthcare Providers. Updated December 20, 2020. Accessed February 12, 2021. https://www.fda.gov/media/144637/download
  22. Johnson & Johnson. Johnson & Johnson announces single-shot Janssen COVID-19 vaccine candidate met primary endpoints in interim analysis of its Phase 3 ENSEMBLE Trial. Published January 29, 2021. Accessed February 12, 2021. https://www.jnj.com/johnson-johnson-announces-single-shot-janssen-covid-19-vaccine-candidate-met-primary-endpoints-in-interim-analysis-of-its-phase-3-ensemble-trial
  23. Sadoff J, Le Gars M, Shukarev G, et al. Interim results of a phase 1-2a Trial of Ad26.COV2.S Covid-19 vaccine. N Engl J Med. Published online January 13, 2021. doi:10.1056/NEJMoa2034201
  24. Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK [published correction appears in Lancet. 2021;397(10269):98]. Lancet. 2021;397(10269):99-111. doi:10.1016/S0140-6736(20)32661-1
  25. Fontanet A, Autran B, Lina B, Kieny MP, Karim Abdool SS, Sridhar D. SARS-CoV-2 variants and ending the COVID-19 pandemic. Lancet. Published online February 11, 2021. doi:10.1016/S0140-6736(21)00370-6
  26. Knoll MD, Wonodi C. Oxford-AstraZeneca COVID-19 vaccine efficacy. Lancet. 2021;397(10269):72-74. doi:10.1016/S0140-6736(20)32623-4
  27. Logunov DY, Dolzhikova IV, Shcheblyakov DV, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. Published online February 2, 2021. doi:10.1016/S0140-6736(21)00234-8
  28. Novavax. Novavax COVID-19 vaccine demonstrates 89.3% efficacy in UK Phase 3 Trial. Published January 28, 2021. Accessed February 12, 2021. https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3
  29. Novavax. Novavax COVID-19 vaccine demonstrates 89.3% efficacy in UK Phase 3 Trial. Published January 28, 2021. Accessed February 12, 2021. https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3
  30. Novavax. Novavax COVID-19 vaccine demonstrates 89.3% efficacy in UK Phase 3 Trial. Published January 28, 2021. Accessed February 12, 2021. https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3
  31. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine – United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69(50):1922-1924. doi:10.15585/mmwr.mm6950e2
  32. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine – United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69(5152):1653-1656. doi:10.15585/mmwr.mm695152e1