AstraZeneca & Pfizer Announce Plans For Phase III COVID-19 Vaccine Trials Drug & Diagnostics Development 28/05/2020 • Svĕt Lustig Vijay Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) (Top, left-right) Pascal Soriot, CEO AstraZeneca; Emma Walmsley, CEO GSK (Bottom, left-right) Albert Bourla, CEO Pfizer; Paul Stoffels, CSO Johnson&Johnson The UK-based Pharma firm AstraZeneca and US-based Pfizer announced they are planning to start Phase III trials as early as July for an experimental COVID-19 vaccine in the United States and the United Kingdom. The massive trials would enroll over 30,000 people, and AstraZeneca’s hope is to have an effective vaccine by the end of the year. Pfizer is aiming for an even more ambitious timeline to have a vaccine ready for approval by the US Food and Drug Administration and European Medical Agency by October, announced Albert Bourla, chairman and CEO of Pfizer. “If things goes well, and the stars are aligned, we will have conclusive or enough evidence of safety and efficacy so that we can feel comfortable and the FDA will feel comfortable, and EMA will feel comfortable to have a vaccine around the end of October,” said Bourla, speaking at a briefing by pharma industry leaders, hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). GlaxoSmithKline (GSK) and Johnson&Johnson were also present at the briefing. Pfizer’s Phase I clinical trials will conclude in June, Bourla added. AstraZeneca meanwhile is conducting studies in Kenya, in South Africa, in Brazil, with the hope that trials in many other countries will start “anytime soon.” “The hope is that we will have a [Covid-19] vaccine, hopefully several, by the end of this year,” said Pascal Soriot, CEO of AstraZeneca. Not for Profit Approach – But Vaccine Will Likely Be Rolled Out First In Countries With Stronger Infrastructure Johnson & Johnson, GSK and AstraZeneca executives said that they were taking a “not-for-profit” approach to vaccine development and sale, at least for now. “We do it not-for-profit for the pandemic period, as we want to [ensure] equitable access over the world…and especially to get vaccines to make sure we get a stop to the pandemic,” said Stoffels of Johnson & Johnson. “We can actually provide this vaccine in a fairly equitable manner to everybody around the world. And finally, just like everybody else, we do it at no profit,” said Soriot. Said GSK’s CEO Emma Walmsley: “We’re on record saying we don’t expect to profit during this period because we want to invest in short term profit in pandemic preparedness and in donations.” While Pfizer’s CEO Albert Bourla did not commit to a ‘not-for-profit’ approach explictly, he acknowledged that vaccine pricing will have to approached differently in times of the pandemic: “Typically the industry is pricing their product based on the value that they bring. And this is impossible to happen right now. In times of pandemic, you can’t have pricing policies that respect [demand and the rules of an open market]…I don’t know what will be the price reduction because I’ve never thought about it.” Bourla also stressed that the lack of infrastructure would still be a barrier to global rollout of a new COVID-19 vaccine. Albert Bourla speaking at a May 28 press briefing “Technologies [we are developing] right now require -80 °C,” said Bourla. “The technology is not very convenient for Africa because they will likely lack basic infrastructure…[the vaccine] will come to the Western world first but [in the] second wave, we are working on making sure that we can develop and manufacture products that are not requiring [refrigeration in Africa]”. “Not all vaccine candidates can go all over the world,” agreed Stoffels, saying this will depend on its features. Even so, Bourla said that Pfizer was “absolutely engaged”’ in joining coalitions like the European Union-led ACT Accelerator to ensure equitable access for COVID-19 health technologies. Patent Pool Gets Cold Shoulder Thomas Cueni speaking at a May 28 press briefing The pharma leaders spoke just a day before the World Health Organization was to launch a new COVID-19 patent pool, which is supposed to group intellectual property of any coronavirus-related technologies – to ensure accessibility in low and middle income countries. IFPMA head Thomas Cueni said he would not be joining Friday’s ceremony, which followed the announcement two weeks ago Costa Rica, Chile and the WHO. “I don’t quite see what the new initiative adds [in comparison to existing mechanisms] I’m too busy [to participate],” Cueni said. Cueni and other industry leaders have said that infrastructure shortcomings, manufacturing challenges and supply chains are likely to be bigger access obstacles than patents in the current race to achieve universal access to a pandemic vaccine. Distribution Bottlenecks Likely One of the main issues with mass-producing a vaccine is not necessarily the amount of vaccine itself, but getting enough vials, said Soriot. “The challenge is not so much to make the vaccine itself, it is to fill the vial. And there’s not enough vials in the world,” he said. In light of limited vial supplies and the fact that some 15 billion vaccine doses might be needed, said Cueni, pharmaceuticals like AstraZeneca and Johnson & Johnson are trying to squeeze a handful of vaccine doses within each vial to distribute more of the vaccine with less vials: “Like everybody else, we are looking into five or ten doses per vial,” said Soriot. And as vial makers scramble to produce more vials, they face an unprecedented challenge as they have never had to produce such quantities – Planning needs to happen ‘now’ to tackle the vaccine distribution issue: “If we go to 15 billion vaccines, that has never been done in history from a filling capacity as well as vials… planning [is not] for next month…we need to start planning now,” he said Who Gets Priority? Reports of some countries signing pre-purchase agreements for COVID-19 vaccines have surfaced in the past few weeks, sparking concerns that some countries will jump the line in the queue for an effective vaccine. Last week, the French-based company Sanofi sparked outrage in Europe when they announced that they would first sell the vaccine in the United States – which had invested heavily in R&D at the company’s US locations as well as making pre-purchase agreements. After protests by French government officials, Sanofi’s CEO retracted the statements. But so far, the Pfizer CEO said the company had not signed any pre-purchase contracts for their vaccine, currently concluding Phase I clinical studies that will likely yield results by June 2020. “We haven’t signed contracts and also I think it is known that Pfizer is not taking any money from any government, the US government or any other government to advance our vaccines. We don’t do that,” said Bourla. Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to print (Opens in new window) Combat the infodemic in health information and support health policy reporting from the global South. Our growing network of journalists in Africa, Asia, Geneva and New York connect the dots between regional realities and the big global debates, with evidence-based, open access news and analysis. To make a personal or organisational contribution click here on PayPal.