COVID-19 Vaccine Timeline Is Caught In “Crucible” of US Presidential Election – Pfizer CEO Protests Medicines & Vaccines 02/10/2020 • Madeleine Hoecklin 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 email this to a friend (Opens in new window)Click to print (Opens in new window) Albert Bourla, CEO of Pfizer, speaking at the World Economic Forum The CEO of Pfizer, one of the frontrunners in the race to develop a COVID-19 vaccine, has lambasted US President Donald Trump’s politicization of the vaccine approval timeline, declaring in an open letter that the company is “moving at the speed of science” and will not “succumb to political pressure” to prematurely rush its product to market. The letter by Albert Bourla to “US colleagues” was issued shortly after President Donald Trump declared Tuesday in a televised US presidential campaign that a COVID-19 vaccine could be ready “a lot sooner” than timelines laid out recently by US Centers for Disease Control Robert Redfield and other scientific experts. Responding to a debate question about Redfield’s projection that public release of a vaccine might not be feasible until next summer, Trump said: “I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to, Moderna, Johnson & Johnson, and others. I’ve spoken to the companies and we can have it a lot sooner.” Bourla retorted that “the world will be safer if we stop talking about the vaccines’ delivery in political terms and focus instead on a rigorous independent scientific evaluation and a robust independent approval process.” Referring explicitly to Tuesday’s debate in his letter, Bourla said that “once more I was disappointed that the prevention for a deadly disease was discussed in political terms rather than scientific facts.” He added that the political rhetoric swirling around the vaccine approval timeline undermines public confidence, which is crucial for the acceptance of a vaccine: “People, who are understandably confused, don’t know whom or what to believe. Global health has too much at stake, and the public trust and acceptance of a vaccine is so important to me, that I’m writing to explain the principles we are using at Pfizer today.” Among the three pharma front-runners in late-stage trials, Pfizer is the only company that has projected that it could have “an answer by the end of October,” before the 3 November US election. President Trump had, in turn, praised Pfizer for their speed and accelerated timeline. Experts have noted that the timeline is largely driven by the shorter interval required between Pfizer’s two-dose vaccine and another candidate, being tested by Moderna, Inc. Trials of a third vaccine candidate, by AstraZeneca, have stalled due to safety concerns. While Bourla’s letter did not upend the official Pfizer projections, the CEO said the pace of approvals should be determined separately from politics: “In March, I declared a bold ambition: that Pfizer would create a vaccine…I further announced, after consulting with our scientists, that we could have vaccine data ready to submit to the FDA by end of the third quarter, in October, and hopefully a hundred million doses delivered by the end of the year. I knew our goal was ambitious, but it would also be critical to protect against the second wave of cases that could accompany the return of colder weather in the Fall. “Now, we are approaching our goal and despite not having any political considerations with our pre-announced date, we find ourselves in the crucible of the U.S. Presidential election. In this hyper-partisan year, there are some who would like us to move more quickly and others who argue for delay. Neither of those options are acceptable to me. Against this backdrop, people need to know three things: “First, we are moving at the speed of science. With a virus this ferocious, time is our enemy. This week, we will hit the grim marker of 1 million deaths globally and the number continues to climb. This danger supersedes any other timing considerations. “Second, we would never succumb to political pressure. The only pressure we feel—and it weighs heavy—are the billions of people, millions of businesses and hundreds of government officials that are depending on us. We’ve engaged with many elected leaders around the globe through this health crisis, but Pfizer took no investment money from any government. Our independence is a precious asset. “Third, our priority is the development of a safe and effective vaccine to end this pandemic…The amplified political rhetoric around vaccine development, timing and political credit is undercutting public confidence. I can’t predict exactly when, or even if our vaccine will be approved by the FDA for distribution to the public. But I do know that the world will be safer if we stop talking about the vaccines’ delivery in political terms and focus instead on a rigorous independent scientific evaluation and a robust independent approval process.” Newly Established Global Lab Network Will Compare COVID-19 Vaccines The manufacturing process of Pfizer’s COVID-19 mRNA vaccine Presuming that several vaccines, at the least, will eventually make it to marketing approval, scientists are also grappling for ways to assess what are the most effective vaccine(s) for different population groups and settings. As part of that effort, a new global laboratory network is being set up to examine data from major COVID-19 vaccine trials and assist with their selection, said Melanie Saville, director of vaccine R&D at CEPI, the Oslo-based Coalition for Epidemic Preparedness Innovations. Ultimately, the information would help inform the choice of vaccines for mass manufacture and procurement by the WHO co-sponsored COVAX initiative, which has brought 168 countries together in a vaccine purchasing pool. The non-profit coalition involving Norway as well other donor countries and health research foundations, has co-funded nine of the leading COVID-19 vaccines in advanced Phase 3 clinical trials, including candidates from Moderna, AstraZeneca, Novavax and CureVac. In an interview with Reuters, Saville said the aim is to establish a centralized network of labs across Europe, Asia, and North America. Six labs will analyze samples from trials of COVID-19 candidates, of which there are currently over 320 underway at different stages. The labs will try to improve comparisons by creating a centralized system to analyze them “as though [the] vaccines are all being tested under one roof,” said Saville, removing the inter-laboratory variability. Due to the variety of vaccine technologies used in potential COVID-19 vaccines, from viral vectors to messenger RNA, there is a high degree of complexity in the evaluation process. The network will begin by assessing early-stage human trials, later moving to Phase 3 trial data, she said. Gilead’s Remdesivir is Under Investigation by the European Medicines Agency Meanwhile, in what appeared to be a bad turn for the prospects of one key COVID-19 treatment, the European Medicines Agency announced on Friday that its safety committee was reviewing reports of acute kidney injuries in COVID-19 patients taking Gilead Sciences Inc.’s Remdesivir. Remdesivir was one of the first treatments found to shorten recovery time in COVID-19 patients and was approved for emergency use by the US Food and Drug Administration as well as by the European regulatory authority, where it has been given a conditional marketing authorisation as a treatment for COVID-19 for severely ill adults and adolescents. Emer Cooke, WHO At the time of the authorization, Remdesivir was flagged for the potential risk of renal toxicity. Subsequent reports of acute kidney injury in patients who were treated with the medication triggered action by an EMA safety committee, which has now enhanced monitoring of the drug. The EMA said in a press release that kidney injuries can also be caused by other factors, including diabetes and COVID-19 itself, so as of yet, there is no causal relationship between remdesivir and kidney injury. In response to the reports, WHO’s Emer Cooke, said that it would be examining the reports, but that the EMA investigation was still in the “early stage of development.” Image Credits: Pfizer, World Economic Forum. 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