A happy new year to all of you! I hope you all made some exciting and rejuvenating resolutions for 2021 J The COVID-19 pandemic story continues. From early November 2020 onward, competing vaccines from pharma houses around the world working in various constellations of mergers with other companies were announced after relatively short research and development (R&D) periods.[1] The most prominently featured (by which I mean the ones that were no abandoned and had the most successful results) included Pfizer/BioNTech’s Comirnaty, Oxford-AstraZeneca’s AZD1222, Sinovac’s CoronaVac and Moderna’s mRNA-1273.[2] Not long after, around mid-December 2020, new mutant strains of COVID-19 have been emerging, most notably in the UK but also South Africa and Brazil.[3] The news media is currently preoccupied with the question of whether vaccine development had properly accounted for mutant strains.[4] Are the mutant strains an indication that vaccines had been developed too rapidly?
HIV/AIDS treatment in the late 1980s was slower and more carefully considered than the rather frantic COVID-19 global vaccine race we see today. HIV treatments took a great deal of slow research and development between different medical fields.[1] The research process both drew from and contributed to ongoing cancer research and molecular immunology, as the compound azidothymidine, a forgotten cancer treatment, reduced viral replication, though with serious side effects.[2] The launch of clinical trials starting in the US were also heavily debated by patient groups, news media, medical professionals and regulatory agencies, and took well over one-year. As NIH researchers began investigating the compound AZT in September 1984, the US FDA granted Investigational New Drug (IND) status in June 1985 and trials began not long after, with phase I of clinical studies initiated that month and phase II in February 1986.[3] The Phase II study, a double blind placebo multi-centre trial of patients progressing to severe AIDS-related complexes, produced remarkable statistical results: only one patient receiving treatment had died while 16 had died in the control placebo group. However, the trial was stopped due to clinical trial participant deaths. Due to toxicity concerns, rampantly discussed in the media, more and more clinical trials were launched experimenting with various dosages in major Retrovir markets.
In one year, with so much competition between over 50 (if not more) global and national vaccine ventures, is it possible for a single company to design a globally applicable vaccine that is effective enough to rest a public health approach upon? One argument that would doubt this assertion is that parallel to vaccine R&D efforts throughout 2020, research institutions were still struggling to fully grasp how the virus affected different populations, let alone systematic studies on the differences on immune responses.
In April 2020, after the first Diamond Princess cruise-contained outbreak in late January 2020 was found to be originating from Wuhan, Japan’s second wave was discovered to be a viral strain from people returning from Europe, by the Japanese National Institute of Infectious Diseases and confirmed by Cambridge University.[4] While lack of mass testing in Japan was and continues to be a noted suspicion by the general public, there were many observations given to mutant strains and their connection to mortality rates in different locations. In addition to general references to the presence and absence of certain cultural practices such as mask-wearing or handshaking, a popular theory at the time was the mandatory BCG vaccine that was applied to most countries in Asia, Africa and South America.[5] Another theory being circulated around April-June 2020 was that East Asians had a different viral immunity system that helped develop COVID-19 antibodies, for instance several statements by researchers such as Kodama Tatsuhiko at University of Tokyo’s Research Center for Advance Science and Technology (RCAST).[6]
Part II will delve deeper into the mechanics of how the major vaccines were developed. I am excited to learn, particularly on what instances of natural recovery were used to determine the shape of the clinical trials.
[1] Katie Thomas, David Gelles and Carl Zimmer, ‘Pfizer’s Early Data Shows Vaccine is more than 90% Effective’, The New York Times (9 November 2020), <https://www.nytimes.com/2020/11/09/health/covid-vaccine-pfizer.html?auth=link-dismiss-google1tap>. [2] Carl Zimmer, Jonathan Corum and Sui-Lee Wee, ‘Coronavirus Vaccine Tracker’, The New York Times (14 January 2021). <https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html>; ‘How Nine Covid-19 Vaccines Work’, The New York Times (13 January 2021), <https://www.nytimes.com/interactive/2021/health/how-covid-19-vaccines-work.html>. [3] James Hamblin, ‘The Coronavirus is Evolving before our Eyes’, The Atlantic (15 January 2021), <https://www.theatlantic.com/health/archive/2021/01/coronavirus-mutations-variants/617694/>. ; James Gallagher, ‘New coronavirus variant: What do we know?’, BBC (20 December 2020). <https://www.bbc.com/news/health-55388846>. [4] 「ファイザーービオンテック、コロナ変異種にもワクチンは有効、中和活性を確認」、化学工業日報（13 January 2021）<https://www.chemicaldaily.co.jp/ファイザーービオンテック、コロナ変異種にもワ/>. [1]See here for oral history interviews with key US National Institutes of Health scientists, such as Samuel Broder. <https://history.nih.gov/display/history/Dr.+Samuel+Broder>. [2] Alice Park, ‘The Story Behind the First AIDS Drug’, Time (19 March 2017), <https://time.com/4705809/first-aids-drug-azt/>. [3] Margaret A. Fischl, Douglas D. Richman, Michael H. Grieco, et. al., ‘The Efficacy of Azidothymidine (AZT) in the Treatment of Patients with AIDS and AIDS-Related Complex’, New England Journal of Medicine 317 (23 July 1987), 185-91. [4] Martin Fritz, ‘Why does coronavirus kill fewer people in East Asia?’, DW (12 June 2020). <https://www.dw.com/en/why-does-coronavirus-kill-fewer-people-in-east-asia/a-53781108>; Peter Forster, Lucy Forster, Colin Renfrew and Michael Forster, ‘Phylogenetic network analysis of SARS-CoV-2 genomes’, PNAS, 117(17) (28 April 2020), 9241-3. <https://www.pnas.org/content/117/17/9241>. [5] ‘The BCG World Atlas: 3rd Edition’, <http://www.bcgatlas.org/>. [6] Simon Denyer and Joel Achenbach, ‘Researchers ponder why COVID-19 appears deadlier in the U.S. and Europe than in Asia’, The Washington Post (28 May 2020). <https://www.washingtonpost.com/world/researchers-ponder-why-covid-appears-more-deadly-in-the-us-and-europe-than-in-asia/2020/05/26/81889d06-8a9f-11ea-9759-6d20ba0f2c0e_story.html>.