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13 maltatoday | SUNDAY • 20 SEPTEMBER 2020 OPINION ASTRAZENECA is resuming clinical tri- als for the COVID-19 vaccine, ChAdOx1 nCoV-19, following confirmation that is safe to do so. The trials were paused when one of the participants developed an "un- explained illness". The pause is over, but the concerns that it raises about transparency are not. When AstraZeneca announced the pause on September 8, it was reported initially as a sign of biopharma compa- nies taking a prudent approach to safety protocols. This was underlined by the fact that on the same day as the announcement, the CEOs of nine biopharma compa- nies, including AstraZeneca, signed the We Stand With Science pledge to make clear their ongoing commitment to de- veloping and testing potential COV- ID-19 vaccines in accordance with high ethical standards and sound scientific principles. In doing so, these companies had been seeking to pre-empt concerns some people have that medicines regulators in the US in particular might prema- turely approve a vaccine in the face of political pressure and thereby put the public at risk. Yet the announcement that trials had resumed came in the face of criticism from some quarters that AstraZeneca had been withholding information from the public. It announced the pause af- ter being questioned about it by health news site STAT News and. The compa- ny gave no details about the nature of the participant's illness. Those details were instead revealed by STAT News later the same week, which stated that AstraZeneca CEO Pascal Soriot had elaborated on the reasons behind the pause during a private con- ference call with investors, set up by US investment bank JP Morgan. Soriot reportedly told them the participant in question was a woman in the UK who experienced neurological symptoms consistent with the rare but serious spi- nal inflammatory disorder, transverse myelitis. It was also reported to have emerged during the call that trials had already been halted once, in July, after a partic- ipant experienced neurological symp- toms which it later transpired were MS and unconnected to the trial. Given the global public attention on the vaccine race, the lack of publicly available infor- mation from the company and the other partners in the project is surprising. This is happening in a climate where many people would already be very re- luctant to take a COVID-19 vaccine. Vaccine hesitancy and scepticism was common before the pandemic, and is not getting better: a third of Americans say they may refuse a vaccine, while in the UK only half of people would defi- nitely agree to be vaccinated. There is a real risk that lack of trans- parency about clinical trials might fuel vaccine scepticism and ultimately lead to large sections of the population re- fusing vaccination. This would impede rollout and potentially exacerbate the pandemic. The risks of silence A key reason for declining public con- fidence in vaccines is the tendency for biopharma companies to treat clinical trials data as proprietary intellectual rights that must be protected as confi- dential information and trade secrets. AstraZeneca said that it could not dis- close further medical information on the reasons for the trial pause. The EU regulation on clinical trials states that such information will be publicly available unless certain ex- ceptions apply, including the need to protect commercially confidential in- formation unless there is an overriding public interest in disclosure. On one level, biopharma companies are legitimately protecting their com- mercial investments by keeping trials data confidential. But with COVID-19, there is surely an overriding public in- terest in disclosure. Even before clinical trail results are submitted to a medi- cines agency, public disclosure should be paramount. Also, the notion that clinical trials da- ta should be considered proprietary in- formation is based on the presumption that it is private finance paying for the trials. But in the case of COVID-19 vac- cines, vast amounts of public money are contributing to the investment. In the case of the Oxford-AstraZene- ca vaccine, the public money involved is widely acknowledged in official data- bases which make clear that the trials are being funded by the University of Oxford, with the UK government hav- ing given the university an additional £65.5 million towards the project. The vaccine was in fact co-invented by the university and spin-out company Vaccitech. A straZeneca is involved under a licens- ing agreement, with responsibility for global development, manufacturing and distribution. Given that the terms of this agreement are confidential, it is difficult to comment further, but it is hard to justify confidential trials when so much public money is involved – particularly given the levels of vaccine hesitancy. Political pressure Coupled with this is the enormous political pressure to get vaccines ap- proved. It has been widely reported that the US Food and Drug Administration (FDA) is being heavily pressed by the Trump administration to approve a vaccine ahead of the presidential elec- tion on November 3. Most Americans now think the FDA may move with undue haste to approve vaccines before phase 3 trials have been concluded. This has led FDA Commis- sioner Stephen Hahn to insist that the agency will not rush the process. The FDA has also issued recommenda- tions on developing and licensing COV- ID-19 vaccines, while stating that it will use an independent advisory committee to monitor industry compliance, but the voluntary nature of that initiative has failed to boost public confidence. Even biopharma companies acknowl- edge that people are sceptial about the heavily politicised fast-tracked vaccine timeline. The timing of the We Stand With Science pledge is therefore signif- icant. But despite the pledge and the re- sumption of trials, AstraZeneca's pub- lic reaction to its trial problem is a sign of the private sector applying old rules to new circumstances. COVID-19 is a game-changer in terms of how the pub- lic funds clinical trials and scrutinises vaccine safety. We need to build public confidence in vaccines and better communication is vital. Biopharma companies may not yet have come to terms with these new realities, and this risks entrenching vac- cine hesitancy further. This article is republished from The Conversation Why AstraZeneca should be more open about vaccine process Duncan Matthews is Professor of Intellectual Property Law, Queen Mary University of London Duncan Matthews There is a real risk that lack of transparency about clinical trials might fuel vaccine scepticism and ultimately lead to large sections of the population refusing vaccination