Episode 29: I wasn’t going to get the COVID Vaccine until I answered these questions by Jimmy Pruitt

If offered the COVID Vaccine, would you receive it?

— The Pharm So Hard Podcast (@pharmso_hard) December 13, 2020

Why did I make this episode?

• Family
• Friends
• Co-Workers

Why I wasn’t going to get the COVID Vaccine

• Skeptical of
  • The speed at which the vaccine was produced
  • Unfamiliarity with the mRNA Technology used
  • Efficacy in patient-oriented outcomes
  • Safety of the untested vaccine

Questions that I needed to answer

Who was influencing my thoughts on the vaccine?

Why does it seem like this vaccine is rushed?

How did COVID vaccines develop so quickly?

Has any other vaccine get developed in a short turnaround time?

What steps were “skipped” to make this vaccine become developed?

What are mRNA vaccines and how do they work?

Are these vaccines really effective or are they just another press release?

What outcomes were actually studied?

Are the vaccines safe for me to take?

PFIZER-BIONTECH COVID-19 VACCINE (BNT162, PF-07302048) VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE BRIEFING DOCUMENT

VRBPAC-12.10.20-Meeting-Briefing-Document-Sponsor

Pfizer Phase 3 Data

Oxford Data

References

https://www.fda.gov/media/144246/download

Ghaebi M, Osali A, Valizadeh H, Roshangar L, Ahmadi M. Vaccine development and therapeutic design for 2019-nCoV/SARS-CoV-2: Challenges and chances. J Cell Physiol. 2020;235(12):9098-9109. doi:10.1002/jcp.29771

Wu SC. Progress and Concept for COVID-19 Vaccine Development. Biotechnol J. 2020;15(6):e2000147. doi:10.1002/biot.202000147

Heaton PM. The Covid-19 Vaccine-Development Multiverse. N Engl J Med. 2020;383(20):1986-1988. doi:10.1056/NEJMe2025111

Widge AT, Rouphael NG, Jackson LA, Anderson EJ, Roberts PC, Makhene M, Chappell JD, Denison MR, Stevens LJ, Pruijssers AJ, McDermott AB, Flach B, Lin BC, Doria-Rose NA, O’Dell S, Schmidt SD, Neuzil KM, Bennett H, Leav B, Makowski M, Albert J, Cross K, Edara VV, Floyd K, Suthar MS, Buchanan W, Luke CJ, Ledgerwood JE, Mascola JR, Graham BS, Beigel JH; mRNA-1273 Study Group. Durability of Responses after SARS-CoV-2 mRNA-1273 Vaccination. N Engl J Med. 2020 Dec 3. doi: 10.1056/NEJMc2032195. Epub ahead of print. PMID: 33270381.

Lurie N, Saville M, Hatchett R, Halton J. Developing Covid-19 Vaccines at Pandemic Speed. N Engl J Med. 2020 May 21;382(21):1969-1973. doi: 10.1056/NEJMp2005630. Epub 2020 Mar 30. PMID: 32227757.

Jackson LA, Anderson EJ, Rouphael NG, et al. An mRNA Vaccine against SARS-CoV-2 – Preliminary Report. N Engl J Med. 2020;383(20):1920-1931. doi:10.1056/NEJMoa2022483

Broadbent AJ, Subbarao K. Influenza virus vaccines: lessons from the 2009 H1N1 pandemic. Curr Opin Virol. 2011;1(4):254-262. doi:10.1016/j.coviro.2011.08.002

https://www.cdc.gov/flu/pandemic-resources/2009-pandemic-timeline.html

https://theconversation.com/covid-19-vaccines-were-developed-in-record-time-but-are-these-game-changers-safe-150249

‘A huge experiment’: How the world made so much progress on a Covid-19 vaccine so fast

https://www.nbcnews.com/science/science-news/what-mrna-how-pfizer-moderna-tapped-new-tech-make-coronavirus-n1248054

RNA vaccines: a novel technology to prevent and treat disease

https://news.mit.edu/2020/rna-vaccines-explained-covid-19-1211

https://www.fda.gov/media/144246/download

https://www.nejm.org/doi/10.1056/NEJMoa2034577

Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O’Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. 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. Lancet. 2020 Dec 8:S0140-6736(20)32661-1. doi: 10.1016/S0140-6736(20)32661-1. Epub ahead of print. PMID: 33306989; PMCID: PMC7723445.

Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 10. doi: 10.1056/NEJMoa2034577. Epub ahead of print. PMID: 33301246.

Funk CD, Laferrière C, Ardakani A. A Snapshot of the Global Race for Vaccines Targeting SARS-CoV-2 and the COVID-19 Pandemic. Front Pharmacol. 2020 Jun 19;11:937. doi: 10.3389/fphar.2020.00937. PMID: 32636754; PMCID: PMC7317023.

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