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Project Lightspeed: A Case Study in Research Ethics and Accelerated Vaccine Development

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Title: Project Lightspeed: A Case Study in Research Ethics and Accelerated Vaccine Development
Language: English
Authors: Klaus Leisinger, Doris Schroeder (ORCID 0000-0002-3633-2758)
Source: Research Ethics. 2024 20(4):847-856.
Availability: SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: https://sagepub.com
Peer Reviewed: Y
Page Count: 10
Publication Date: 2024
Document Type: Journal Articles
Reports - Research
Descriptors: Scientific Research, Research Methodology, Immunization Programs, COVID-19, Pandemics, Ethics, Experimental Programs, Decision Making, Trust (Psychology), Efficiency, Governance, Compliance (Legal)
DOI: 10.1177/17470161241251597
ISSN: 1747-0161
2047-6094
Abstract: The COVID-19 pathogen led to a fast expanding pandemic because it proved lethal in certain populations but could be transmitted by persons who appeared healthy. As a result, researchers came under unprecedented time pressure to develop a vaccine. This case study focuses on the first COVID-19 vaccine, which was approved for use in humans, known as Comirnaty, the BioNTech-Pfizer COVID-19 vaccine or Vaccine BNT162b2. With the benefit of hindsight, we show how close collaboration with regulators and trust-based decisions meant that the race for a COVID-19 vaccine was won without purposefully infecting healthy participants with an infectious agent that can cause severe illness or death and for which no rescue therapy had existed.
Abstractor: As Provided
Entry Date: 2024
Accession Number: EJ1443228
Database: ERIC
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  Value: <anid>AN0180151528;[euvk]01oct.24;2024Oct10.05:02;v2.2.500</anid> <title id="AN0180151528-1">Project lightspeed: A case study in research ethics and accelerated vaccine development </title> <p>The COVID-19 pathogen led to a fast expanding pandemic because it proved lethal in certain populations but could be transmitted by persons who appeared healthy. As a result, researchers came under unprecedented time pressure to develop a vaccine. This case study focuses on the first COVID-19 vaccine, which was approved for use in humans, known as Comirnaty, the BioNTech-Pfizer COVID-19 vaccine or Vaccine BNT162b2. With the benefit of hindsight, we show how close collaboration with regulators and trust-based decisions meant that the race for a COVID-19 vaccine was won without purposefully infecting healthy participants with an infectious agent that can cause severe illness or death and for which no rescue therapy had existed.</p> <p>Keywords: Vaccine development; COVID-19; research ethics; clinical trials; project lightspeed; BioNTech</p> <hd id="AN0180151528-2">Introduction – the challenge</hd> <p>The COVID-19 pandemic put researchers under unprecedented time pressure to develop a vaccine. The speed with which the COVID-19 pathogen developed into a pandemic ([<reflink idref="bib27" id="ref1">27</reflink>]: 150) illustrates the seriousness of the challenge. Patient Zero is assumed to have been infected in China in mid-November 2019. On 30th January 2020, the World Health Organization (WHO) declared a <emph>Global Public Health Emergency</emph>, which was upgraded to a pandemic less than 2 months later on 11th March 2020. By the end of the year, the WHO – using excess deaths figures – estimated the global death toll from COVID-19 in 2020 at over 3 million ([<reflink idref="bib31" id="ref2">31</reflink>]).</p> <p>It was clear that 'vaccines are needed to protect from SARS-CoV-2, the virus causing COVID-19' ([<reflink idref="bib25" id="ref3">25</reflink>]: 1). The normal duration of vaccine development for newly emerging pathogens is estimated to range from 10 to 15 years ([<reflink idref="bib11" id="ref4">11</reflink>]). Particularly fast advances, such as the development of the ERVEBOTM vaccine for Ebola, still took 5 years from start to regulatory approval ([<reflink idref="bib30" id="ref5">30</reflink>]).</p> <p>The German firm, BioNTech started its vaccine development under the name 'Project Lightspeed' on 27th January 2020 ([<reflink idref="bib20" id="ref6">20</reflink>]: 42). Under 11 months later, on 8th December 2020, 91-year old UK resident Margaret Keenan received Comirnaty, also known as the BioNTech-Pfizer COVID-19 vaccine or Vaccine BNT162b2 ([<reflink idref="bib3" id="ref7">3</reflink>]).</p> <p>The COVID-19 pandemic not only 'touched off an unprecedented search for vaccines and treatments' ([<reflink idref="bib29" id="ref8">29</reflink>]), it also developed into a show case for research ethics discussions around human challenge trials (HCTs) versus traditional vaccine development ([<reflink idref="bib22" id="ref9">22</reflink>]). On the one hand, it was argued that purposefully 'infecting younger participants at lower risk of complication with Covid-19... could save thousands of lives' ([<reflink idref="bib23" id="ref10">23</reflink>]). This view was also promoted by the 1DaySooner initiative, which collected the names of tens of thousands of potential volunteers for HCTs in 2020 ([<reflink idref="bib1" id="ref11">1</reflink>]). On the other hand, it was maintained that HCTs for COVID-19 are 'Too Risky, Too Soon' ([<reflink idref="bib7" id="ref12">7</reflink>]) because purposefully infecting healthy participants with an infectious agent that can cause severe illness or death and for which no rescue therapy exists is a major ethical challenge ([<reflink idref="bib29" id="ref13">29</reflink>]).</p> <p>With the considerable benefit of hindsight and knowing that vaccine development was undertaken without the implementation of HCTs, this case study, based on available literature, uses a research ethics lens to analyse <emph>how</emph> it was possible to develop an effective COVID-19 vaccine in under 11 months. The first section focuses on research governance questions, in particular the close collaboration with regulators. The second section broadens the topic to a wider ethical leadership question, namely the role of trust versus intellectual property agreements in collaborations with new partners. A conclusion summarises the lessons learned.</p> <hd id="AN0180151528-3">Close collaboration with regulators</hd> <p>Standard practice in vaccine development involves the following eight main stages:</p> <p></p> <ulist> <item> (a) Design of vaccine candidates,</item> <p></p> <item> (b) toxicological studies on cell cultures and</item> <p></p> <item> (c) animals to establish the vaccine candidates' basic viability,</item> <p></p> <item> (d) clinical trials with a very small number of healthy volunteers (Phase 0) to gauge the metabolisation of the new substance in human beings,</item> <p></p> <item> (e) further trials involving several dozen healthy volunteers (Phase I) to establish the safety and immunogenicity of a vaccine candidate,</item> <p></p> <item> (f) further trials with several 1000 healthy volunteers (Phase II) to evaluate safety and immunogenicity and to accumulate data on the effects of different dosages to optimise the product, and</item> <p></p> <item> (g) further trials testing the vaccine candidate with tens of thousands of healthy volunteers to establish safety, immunogenicity and efficacy of the vaccine (Phase III) ([<reflink idref="bib26" id="ref14">26</reflink>]).</item> <p></p> <item> (h) The eighth stage involves obtaining (emergency) use authorisation for use in humans.</item> </ulist> <p>On 25th January 2020, the co-founders of BioNTech, Özlem Türeci and Uğur Şahin, decided to enter the COVID-19 vaccine development race. One day later, on 26th January 2020, Şahin had designed eight vaccine candidates ([<reflink idref="bib20" id="ref15">20</reflink>]: 29) (step a).</p> <p>The next steps require regulatory approval ([<reflink idref="bib9" id="ref16">9</reflink>]). In the case of BioNTech, that involved approval from the Paul Ehrlich Institute (PEI), the German regulator for vaccine development at the Federal Ministry of Health. Based on prior good working relationships, Şahin persuaded senior PEI staff to provide a presentation slot for a planned vaccine study within a week rather than the 3 months this normally requires ([<reflink idref="bib20" id="ref17">20</reflink>]: 46). PEI staff agreed on one condition. The BioNTech team had to provide a detailed briefing document about the vaccine development 2 days ahead of the meeting ([<reflink idref="bib20" id="ref18">20</reflink>]).</p> <p>German regulator PEI were not the only ones amenable to accelerated processes. Regulators across the globe were adapting their approaches to aide acceleration of vaccine development ([<reflink idref="bib2" id="ref19">2</reflink>]), including the Medicines and Healthcare Regulatory Agency (MHRA) in the UK ([<reflink idref="bib16" id="ref20">16</reflink>]), the Food and Drug Administration (FDA) in the United States ([<reflink idref="bib21" id="ref21">21</reflink>]) and the European Medicines Agency ([<reflink idref="bib8" id="ref22">8</reflink>]).</p> <p>On 4th February 2020, BioNTech staff completed the briefing document detailing their plans to the PEI. The document included a:</p> <p>comprehensive rundown of every aspect of a potential drug's development, from the underlying technology to the raw materials and active ingredients that would be used, to the precise designs of preclinical safety studies on mice and primates. Normally, this would take between four and six weeks to complete. BioNTech had less than five days and was starting from scratch. It would have to move faster than it had been ever done before; indeed faster than anyone in the industry had ever moved ([<reflink idref="bib8" id="ref23">8</reflink>]: 46).</p> <p>At the regulator's (PEI) meeting with BioNTech staff on 6 February 2020, one ethically controversial proposal was raised, which would, however, accelerate the study significantly. The proposal was to run toxicological studies (steps b, c) in parallel with exposing a single healthy volunteer (step d) in a hospital setting to a very small dose of one vaccine candidate ([<reflink idref="bib8" id="ref24">8</reflink>]: 56). As Özlem Türeci put it: 'Given our previous clinical experience with m-RNA vaccines, we felt that the toxicology study in animals would not tell us much more than we already knew ([<reflink idref="bib8" id="ref25">8</reflink>]: 57)'.</p> <p>This approach had already been approved by the US FDA for Moderna, the other company working on an mRNA-based COVID-19 vaccine ([<reflink idref="bib8" id="ref26">8</reflink>]: 54). This is termed 'rolling review' and involves combined or overlapping phases in vaccine trials. The FDA also published guidance for the pharmaceutical industry about how to accelerate the development of COVID-19 vaccines ([<reflink idref="bib9" id="ref27">9</reflink>]). In contrast to the FDA, the German regulator PEI refused this acceleration of clinical studies and BioNTech formally applied for approval of the toxicological studies, to run ahead of involving healthy volunteers ([<reflink idref="bib20" id="ref28">20</reflink>]: 60).</p> <p>On the same day that the WHO announced a global pandemic, 11th March 2020, BioNTech staff injected rodents with all vaccine candidates ([<reflink idref="bib20" id="ref29">20</reflink>]: 123). On 27th March 2020, results showed that the immune reaction, catalysed by the vaccine candidates, had neutralised COVID-19 infections in rodents ([<reflink idref="bib20" id="ref30">20</reflink>]: 126). From this stage onwards, it normally takes between 18 and 30 months to complete the preclinical stages of development ([<reflink idref="bib12" id="ref31">12</reflink>]). However, BioNTech staff had discovered that interim results from the toxicological studies can be accepted by regulatory authorities in times of crisis ([<reflink idref="bib20" id="ref32">20</reflink>]) and the PEI did agree to this approach.</p> <p>Still, even an interim report on toxicological studies in animals would be time-consuming. What was originally planned were three consecutive tests in rodents with 3 weeks in between the individual doses ([<reflink idref="bib20" id="ref33">20</reflink>]: 160). It would then take at least 6 weeks until all doses had been administered and blood samples could be taken from the rodents to verify results. Further acceleration was deemed necessary. Given that the main expert for toxicology studies at BioNTech did not expect serious local reactogenicity (e.g. fever, sore injection point) in the rodents, she advised shortening the time between injections to 1 week ([<reflink idref="bib20" id="ref34">20</reflink>]: 161). As a result, BioNTech was able to produce a 900-page interim toxilogical report in under 2 months ([<reflink idref="bib20" id="ref35">20</reflink>]: 171).</p> <p>Less than a month after the toxicology studies in rodents had started, on 22nd April 2023, the regulator approved Phase I and Phase II clinical studies for four vaccine candidates based on interim toxicology reports in rodents. A press release ([<reflink idref="bib4" id="ref36">4</reflink>]) noted that:</p> <p>The dose escalation portion of the Phase 1/2 trial will include approximately 200 healthy subjects between the ages of 18 to 55 and will target a dose range of 1 µg to 100 µg aiming to determine the optimal dose for further studies as well as evaluate the safety and immunogenicity of the vaccine.</p> <p>One day after obtaining the approval, the first human healthy volunteer was injected with one of the vaccine candidates ([<reflink idref="bib20" id="ref37">20</reflink>]: 175). Astonishingly, the Oxford Team, which was developing the vaccine that later became known as the AstraZeneca vaccine, did the same thing on the same day. They injected the first healthy volunteer with a COVID-19 vaccine candidate. It seems that the BioNTech team was ahead of the Oxford Team by only 1 hour ([<reflink idref="bib20" id="ref38">20</reflink>]: 175). At this point, Moderna was ahead of both competitor teams ([<reflink idref="bib20" id="ref39">20</reflink>]: 177).</p> <p>During the summer of 2020, results from the Phase I and II studies were so encouraging that the PEI approved Phase III studies on 7th September 2020. At this point, the number of candidate vaccines had been reduced to one: BNT162b2. According to the regulator ([<reflink idref="bib5" id="ref40">5</reflink>]), 'the placebo-controlled trial evaluates the safety and efficacy of BNT162b2 in up to 30,000 participants between 18 and 85 years of age'.</p> <p>Phase III studies were undertaken in Germany, the US, Brazil, Argentina, South Africa and Turkey and expanded to well over 40,000 healthy volunteers ([<reflink idref="bib20" id="ref41">20</reflink>]: 202). The best possible scientific result would be high infection numbers in the placebo group, whilst showing full protection in the vaccine arm of the study without major adverse effects. Whilst AstraZeneca, Johnson & Johnson and Eli Lilly had to interrupt their Phase III COVID-19 vaccine studies to follow up on potential adverse effects, no such effects were observed for the BioNTech vaccine ([<reflink idref="bib20" id="ref42">20</reflink>]: 212). Once the Phase III clinical trials were underway, the waiting began for enough COVID-19 infections to occur across all research participants for statistical significance. This is needed to enable the trial's independent data monitoring committee to analyse and compare the data for infections in the placebo and the vaccine arms of the study.</p> <p>On 8th November 2020, the figures were clear. Ninety-four out of 43,538 healthy volunteers had contracted COVID-19: Ninety were in the placebo arm and only four in the vaccine arm of the study ([<reflink idref="bib20" id="ref43">20</reflink>]: 214). This meant an approximate 90% efficacy of the BioNTech vaccine ([<reflink idref="bib18" id="ref44">18</reflink>]).</p> <p>During the development of the BioNTech/Pfizer COVID-vaccine, the 2023 Nobel Prize Laureate for Medicine, Dr Katalin Karikó (together with Drew Weissman), was working on mRNA studies at the German laboratories of BioNTech. According to the New York Times, when she heard that the vaccine study results were positive, she turned to her husband, and said: 'Oh, it works, I thought so' ([<reflink idref="bib13" id="ref45">13</reflink>]).</p> <p>Whilst full regulatory approval of the final vaccine still required time (the US FDA only provided its full approval on 23th August 2021 ([<reflink idref="bib10" id="ref46">10</reflink>])), emergency use authorisation in the UK ([<reflink idref="bib19" id="ref47">19</reflink>]) made it possible for 91-year old Margaret Keenan to receive the BioNTech/Pfizer vaccine on 8th December 2020. As noted earlier, she was the first person world-wide to receive a COVID-19 vaccine outside of a research study.</p> <p>This initial authorization [from the UK] was followed by a rapid succession of authorizations or approvals for emergency use of BNT162b2 in several countries, with Bahrain, Canada, Mexico, Saudi Arabia and the USA being among the earliest (all prior to 14 December 2020) ([<reflink idref="bib14" id="ref48">14</reflink>]: 495f).</p> <p>From toxicological studies on cell cultures and animals, to healthy volunteer studies in all required phases, the BioNTech vaccine was developed and approved in under 11 months without avoiding any of the standard research ethics requirements for clinical trials.</p> <p>In summary, the following accelerations were faciliated through close collaboration between BioNTech and the German regulator PEI:</p> <p></p> <ulist> <item> A 1 week, instead of a 3 months' wait for the first consultation meeting with the regulator.</item> <p></p> <item> Under 1 week instead of over 1 month to prepare a full briefing document for the regulator.</item> <p></p> <item> Accelerated preclinical development, including acceptance of interim results of toxicological studies by the regulator PEI and accelerated studies in rodents.</item> <p></p> <item> Implementation of combined and overlapping clinical trial phases with rolling review of data being conducted by regulators.</item> <p></p> <item> Emergency approval of the vaccine in under 11 months.</item> </ulist> <p>In addition to very close collaboration with regulators, one other main factor was responsible for the acceleration success: trust-based collaborations with new partners.[<reflink idref="bib5" id="ref49">5</reflink>]</p> <hd id="AN0180151528-4">Trust-based collaborations with new partners</hd> <p>As early as February 2020, 1 month after taking the decision to develop a COVID-19 vaccine, BioNTech staff started the search for a global partner to run phase III clinical trials ([<reflink idref="bib20" id="ref50">20</reflink>]: 200) and provide the manufacturing capacity to deliver hundreds of millions of vaccines. Pfizer and Fosun[<reflink idref="bib6" id="ref51">6</reflink>] were approached. At the time, BioNTech had 1300 employees, Pfizer 70,000 ([<reflink idref="bib20" id="ref52">20</reflink>]: 156).</p> <p>When Pfizer showed significant interest in collaboration, one ethical leadership decision was highly unusual but vital to accelerating the vaccine development, namely BioNTech's decision to release vaccine candidates to Pfizer <emph>before</emph> a collaboration agreement had been finalised.</p> <p>The collaboration between BioNTech and Pfizer was officially announced on 17th March 2020, through a declaration of intent published at the Securities and Exchange Commission of the US government ([<reflink idref="bib24" id="ref53">24</reflink>]). After such a declaration of intent, the drafting process for a full collaboration agreement – which involves pharmaceutical intellectual property - normally takes at least 6 months ([<reflink idref="bib20" id="ref54">20</reflink>]: 155). During this time, no proprietary technology (like BioNTech's vaccine candidates) would normally be shared. One day after the letter of intent was signed, Uğur Şahin, the co-founder of BioNTech, instructed his disbelieving team to 'share everything' ([<reflink idref="bib20" id="ref55">20</reflink>]: 154).</p> <p>This decision subordinated financial interests to live-saving interests, even though BioNTech 'had accumulated more than €400 million of debt in 11 years [and] needed to raise more money soon' ([<reflink idref="bib20" id="ref56">20</reflink>]: 38). The willingness to share proprietary knowledge with a much more powerful competitor (Pfizer) shows ethical leadership in extremely difficult circumstances ([<reflink idref="bib15" id="ref57">15</reflink>]). In today's globally competitive business world, priority was given to saving lives over corporate interests.</p> <hd id="AN0180151528-5">Lessons learned</hd> <p>As this COVID-19 case study has shown, it is possible to develop a life-saving vaccine with over 90% efficiency in under 1 year in accordance with existing principles of good clinical practice.</p> <p>Around the world, regulators worked closely with vaccine developers to consult on study design and on which stages of research, if any, could overlap. Not only was the BioNTech-Pfizer COVID-19 vaccine developed faster than any competitor vaccine, it was developed faster in one of the most highly regulated research governance systems in the world. The German regulator required that all vaccine development stages from toxicological to animal studies, and all phases of clinical trials had to be adhered to. Efficiency was achieved by the combining and overlapping of vaccine development phases and by regulators implementing rolling review of clinical trial data.</p> <p>Despite adhering to these very strict research ethics regulations, the BioNTech-Pfizer COVID-19 vaccine was faster than competitors, including competitors who were using the allegedly accelerating human challenge trial set-up, for instance, two studies in the UK purposefully infected volunteers with COVID 19 ([<reflink idref="bib32" id="ref58">32</reflink>]). To date, the results of only one COVID-19 human challenge study have been published and 'what is striking about this study is the length of time from inception to publication—2 years' ([<reflink idref="bib29" id="ref59">29</reflink>]), about twice as long as the time needed for the BioNTech-Pfizer vaccine.</p> <p>Prioritising the saving of millions of lives by what one might call 'rolling legal agreements' was an ethical leadership decision that is exceptional. The vaccine development process was accelerated significantly by risking the security of company assets (BioNTech vaccine candidates). The completion of legal agreements for proprietary technology can add up to 6 months to standard collaborations but BioNTech leaders decided to share the vaccine candidates with only a letter of intent in place. One could note that this shows a deeply developed sense of responsibility, that is, the ability to respond to extraordinary circumstances with extraordinary decisions and activities.</p> <p>Since Karikó and Weissman's groundbreaking findings on how mRNA can interact with human immune systems, for which they gained the 2023 Nobel Prize in Medicine, other mRNA-based vaccines for communicable diseases are in development. For influenza, shingles, HIV, malaria, rabies, tuberculosis and zika clinical studies are at least in Phase I and some in Phase II of clinical development ([<reflink idref="bib28" id="ref60">28</reflink>]).</p> <p>The elephant in the room of all COVID-19 vaccine success stories, including the BioNTech-Pfizer COVID-19 vaccine, is the 'unprecedented investment' ([<reflink idref="bib29" id="ref61">29</reflink>]). Improving pandemic preparedness cannot be ensured without further 'long-term investment in basic research and knowledge accumulation for pathogens of concern' ([<reflink idref="bib6" id="ref62">6</reflink>]: 1645).</p> <p>What is reassuring about this case study – from an ethics perspective – is that a major breakthrough in vaccine development speed was compatible with the full protection of human participants in vaccine research through existing principles of good clinical practice.</p> <p>We would like to thank Emma Law for excellent comments on an earlier draft and three anonymous reviewers for their very helpful comments.</p> <ref id="AN0180151528-6"> <title> References </title> <blist> <bibl id="bib1" idref="ref11" type="bt">1</bibl> <bibtext> 1Day Sooner. (2020). Open letter: Challenge trials for COVID-19. 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There are no submission charges and no Article Processing Charges as these are fully funded by institutions through Knowledge Unlatched, resulting in no direct charge to authors. For more information about Knowledge Unlatched please see here: <ulink href="http://www.knowledgeunlatched.org">http://www.knowledgeunlatched.org</ulink>. Funded by the European Union and SERI under grant agreement 101058094. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union, SERI or the Research Executive Agency. Neither the European Union nor SERI nor the granting authority can be held responsible for them.'</bibtext> </blist> <blist> <bibtext> None required.</bibtext> </blist> <blist> <bibtext> Doris Schroeder</bibtext> </blist> <blist> <bibtext>Graph https://orcid.org/0000-0002-3633-2758</bibtext> </blist> <blist> <bibtext> For efficiency gains through intensive shift working, postponing holidays etc, see [20]. For the significant contribution two German philanthropist financiers made to the mRNA research at BioNTech see a series of articles in the German [17].)</bibtext> </blist> <blist> <bibtext> The second collaboration with a large vaccine manufacturer, Shanghai-based Fosun, is not detailed here due to space constraints.</bibtext> </blist> </ref> <aug> <p>By Klaus Leisinger and Doris Schroeder</p> <p>Reported by Author; Author</p> </aug> <nolink nlid="nl1" bibid="bib27" firstref="ref1"></nolink> <nolink nlid="nl2" bibid="bib31" firstref="ref2"></nolink> <nolink nlid="nl3" bibid="bib25" firstref="ref3"></nolink> <nolink nlid="nl4" bibid="bib11" firstref="ref4"></nolink> <nolink nlid="nl5" bibid="bib30" firstref="ref5"></nolink> <nolink nlid="nl6" bibid="bib20" firstref="ref6"></nolink> <nolink nlid="nl7" bibid="bib29" firstref="ref8"></nolink> <nolink nlid="nl8" bibid="bib22" firstref="ref9"></nolink> <nolink nlid="nl9" bibid="bib23" firstref="ref10"></nolink> <nolink nlid="nl10" bibid="bib26" firstref="ref14"></nolink> <nolink nlid="nl11" bibid="bib16" firstref="ref20"></nolink> <nolink nlid="nl12" bibid="bib21" firstref="ref21"></nolink> <nolink nlid="nl13" bibid="bib12" firstref="ref31"></nolink> <nolink nlid="nl14" bibid="bib18" firstref="ref44"></nolink> <nolink nlid="nl15" bibid="bib13" firstref="ref45"></nolink> <nolink nlid="nl16" bibid="bib10" firstref="ref46"></nolink> <nolink nlid="nl17" bibid="bib19" firstref="ref47"></nolink> <nolink nlid="nl18" bibid="bib14" firstref="ref48"></nolink> <nolink nlid="nl19" bibid="bib24" firstref="ref53"></nolink> <nolink nlid="nl20" bibid="bib15" firstref="ref57"></nolink> <nolink nlid="nl21" bibid="bib32" firstref="ref58"></nolink> <nolink nlid="nl22" bibid="bib28" firstref="ref60"></nolink>
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  Data: Project Lightspeed: A Case Study in Research Ethics and Accelerated Vaccine Development
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  Data: <searchLink fieldCode="AR" term="%22Klaus+Leisinger%22">Klaus Leisinger</searchLink><br /><searchLink fieldCode="AR" term="%22Doris+Schroeder%22">Doris Schroeder</searchLink> (ORCID <externalLink term="https://orcid.org/0000-0002-3633-2758">0000-0002-3633-2758</externalLink>)
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  Data: <searchLink fieldCode="SO" term="%22Research+Ethics%22"><i>Research Ethics</i></searchLink>. 2024 20(4):847-856.
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  Data: SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: https://sagepub.com
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  Data: 10
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  Data: Journal Articles<br />Reports - Research
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  Data: <searchLink fieldCode="DE" term="%22Scientific+Research%22">Scientific Research</searchLink><br /><searchLink fieldCode="DE" term="%22Research+Methodology%22">Research Methodology</searchLink><br /><searchLink fieldCode="DE" term="%22Immunization+Programs%22">Immunization Programs</searchLink><br /><searchLink fieldCode="DE" term="%22COVID-19%22">COVID-19</searchLink><br /><searchLink fieldCode="DE" term="%22Pandemics%22">Pandemics</searchLink><br /><searchLink fieldCode="DE" term="%22Ethics%22">Ethics</searchLink><br /><searchLink fieldCode="DE" term="%22Experimental+Programs%22">Experimental Programs</searchLink><br /><searchLink fieldCode="DE" term="%22Decision+Making%22">Decision Making</searchLink><br /><searchLink fieldCode="DE" term="%22Trust+%28Psychology%29%22">Trust (Psychology)</searchLink><br /><searchLink fieldCode="DE" term="%22Efficiency%22">Efficiency</searchLink><br /><searchLink fieldCode="DE" term="%22Governance%22">Governance</searchLink><br /><searchLink fieldCode="DE" term="%22Compliance+%28Legal%29%22">Compliance (Legal)</searchLink>
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  Data: 10.1177/17470161241251597
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  Data: 1747-0161<br />2047-6094
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  Label: Abstract
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  Data: The COVID-19 pathogen led to a fast expanding pandemic because it proved lethal in certain populations but could be transmitted by persons who appeared healthy. As a result, researchers came under unprecedented time pressure to develop a vaccine. This case study focuses on the first COVID-19 vaccine, which was approved for use in humans, known as Comirnaty, the BioNTech-Pfizer COVID-19 vaccine or Vaccine BNT162b2. With the benefit of hindsight, we show how close collaboration with regulators and trust-based decisions meant that the race for a COVID-19 vaccine was won without purposefully infecting healthy participants with an infectious agent that can cause severe illness or death and for which no rescue therapy had existed.
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      – TitleFull: Project Lightspeed: A Case Study in Research Ethics and Accelerated Vaccine Development
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