insights

COVID-19 Vaccines in Phase 3 Trials

The recording of the April webinar "IFM COVID-19 Update: Introduction to Post-Acute Sequalae of SARS-CoV-2 (PASC)" will be located on this page beginning Friday, April 23.

In the March webinar IFM COVID-19 Update: Deepening Our Understanding of COVID-19 Vaccines, panelists from IFM’s COVID Task Force leadership, along with guest subject matter expert Heather Zwickey, PhD, IFM educator James Carter, MD, and scientific study design expert Chris D’Adamo, PhD, provided updates on the evidence regarding the overall effectiveness and safety of new vaccines as well as the latest data on the new SARS-CoV-2 variants. The recording of this webinar, and the recording of the February webinar, COVID19 Vaccines: Current Evidence and Clinical Considerations, are both available below. They are a part of a monthly series updating practitioners about the latest medical research on mitigating COVID-19 infection and addressing chronic COVID syndrome as a component of IFM’s Resistance, Resilience, and Recovery: Patient Care in a Pandemic online course.

March 2021
MARCH TRANSCRIPT
February 2021
FEBRUARY TRANSCRIPT

As discussed by the panelists, 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. 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
  2. Centers for Disease Control and Prevention. COVID-19 Vaccinations in the United States. Updated April 14, 2021 Accessed April 15, 2021 https://covid.cdc.gov/covid-data-tracker/#vaccinations
  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. US Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee Meeting February 26, 2021: FDA Briefing Document Janssen Ad26.COV2.S Vaccine for the Prevention of COVID-19. Revised February 26, 2021. Accessed February 28, 2021. https://www.fda.gov/media/146217/download
  7. 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
  8. Medicines & Healthcare Products Regulatory Agency. Information for healthcare professionals on COVID-19 vaccine AstraZeneca. Updated February 23, 2021. Accessed March 12, 2021. https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca
  9. European Medicines Agency. EMA recommends COVID-19 vaccine AstraZeneca for authorization in the EU. Updated January 29, 2021. Accessed March 12, 2021. https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-astrazeneca-authorisation-eu#:~:text=COVID%2D19%20Vaccine%20AstraZeneca%20is,Commission%20on%2029%20January%202021.&text=This%20is%20the%20third%20COVID,EMA%20has%20recommended%20for%20authorisation.
  10. 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
  11. 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. 2021. doi:10.1016/S0140-6736(21)00234-8
  12. 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
  13. 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
  14. 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
  15. Amit S, Regev-Yochay G, Afek A, Kreiss Y, Leshem E. Early rate reductions of SARS-CoV-2 infection and COVID-19 in BNT162b2 vaccine recipients. Lancet. 2021;397(10277):875-877. doi:10.1016/S0140-6736(21)00448-7
  16. Dagan N, Barda N, Kepten E, et al. BNT162b2 mRNA Covid-19 vaccine in a nationwide mass vaccination setting. N Engl J Med. Published online February 24. 2021. doi:10.1056/NEJMoa2101765
  17.  Pfizer. Pfizer and BioNTech confirm high efficacy and no serious safety concerns through up to six months following second dose in updated topline analysis of landmark COVID-19 vaccine study. Updated April 1, 2021, Accessed April 15, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-confirm-high-efficacy-and-no-serious
  18. Centers for Disease Control and Prevention. Science Brief: Background rationale and evidence for public recommendations for fully vaccinated people. Updated March 8, 2021. Accessed March 16, 2021. https://www.cdc.gov/coronavirus/2019-ncov/more/fully-vaccinated-people.html#ref29
  19. Parry HM, Tut G, Faustini S et al. BNT162b2 vaccination in people over 80 years of age induces strong humoral immune responses with cross neutralization of P.1 Brazilian variant. Updated March 31, 2021. Accessed April 15, 2021. http://dx.doi.org/10.2139/ssrn.3816840
  20. Centers for Disease Control and Prevention. The Vaccine Adverse Reporting System (VAERS) Results. Accessed February 12, 2021. https://wonder.cdc.gov/vaers.html
  21. Center for Disease Control and Prevention. Allergic reactions including anaphylaxis after receipt of the first dose of Pfizer-BioNTech COVID-19 vaccine – United States, December 14-23, 2020. Published January 15, 2021, Accessed February 28, 2021. https://www.cdc.gov/mmwr/volumes/70/wr/mm7002e1.htm?s_cid=mm7002e1_w
  22. 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
  23. US Food and Drug Administration. 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
  24. Center for Disease Control and Prevention. Interim Estimates of vaccine effectiveness of BNT162b2 and mRNA-1273 COVID-19 vaccines in preventing SARS-CoV2 infection among health care personnel, first responders, and other essential and frontline workers – Eight U.S. locations, December 2020 – March 2021. Updated April 2, 2021. Accessed April 15, 2021. https://www.cdc.gov/mmwr/volumes/70/wr/mm7013e3.htm
  25. Wu K, Werner AP, Koch M, et al. Serum neutralizing activity elicited by mRNA-1273 vaccine – preliminary report. N Engl J Med. Published online February 17. 2021. doi:10.1056/NEJMc2102179
  26. 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
  27. 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
  28. Muir KL, Kallam A, Koepsell SA, Gundabolu K. Thrombotic Thrombocytopenia after Ad26.COV2.S Vaccination [published online ahead of print, 2021 Apr 14]. N Engl J Med. 2021;10.1056/NEJMc2105869. doi:10.1056/NEJMc2105869
  29. Centers for Disease Control and Prevention. Cases of cerebral venous sinus thrombosis with thrombocytopenia after receipt of the Johnson & Johnson COVID-19 vaccine. Updated April 13, 2021. Accessed April 15, 2021. https://emergency.cdc.gov/han/2021/han00442.asp
  30. Voysey M, Costa Clemens SA, Madhi SA, et al. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials [published online ahead of print, 2021 Feb 19]. Lancet. 2021;397(10277):881-891. doi:10.1016/S0140-6736(21)00432-3
  31. Madhi SA, Baillie V, Cutland CL, et al. Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant [published online ahead of print, 2021 Mar 16]. N Engl J Med. 2021;NEJMoa2102214. doi:10.1056/NEJMoa2102214
  32. Knoll MD, Wonodi C. Oxford-AstraZeneca COVID-19 vaccine efficacy. Lancet. 2021;397(10269):72-74. doi:10.1016/S0140-6736(20)32623-4
  33. Greinacher A, Thiele T, Warkentin TE, Weisser K, Kyrle PA, Eichinger S. Thrombotic Thrombocytopenia after ChAdOx1 nCov-19 Vaccination [published online ahead of print, 2021 Apr 9]. N Engl J Med. 2021;10.1056/NEJMoa2104840. doi:10.1056/NEJMoa2104840
  34. European Medicines Agency. AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets. Updated April 7, 2021. Accessed April 15, 2021. https://www.ema.europa.eu/en/news/astrazenecas-covid-19-vaccine-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood
  35. 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
  36. 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