All eyes on Pfizer as Trump pushes October vaccine

Albert Bourla, Pfizer CEO, testifies at a Senate Finance Committee hearing in Washington on February 26, 2019. Despite the slim chance that its coronavirus vaccine will be ready by October 2020, Pfizer has big incentives to hint that it might be; Image: Erin Schaff / The New York Times

In media appearances and in conversations with investors, Pfizer’s CEO almost always mentions a word that is so politically dangerous that most of his competitors avoid it: October. “Right now, our model, our best case, predicts that we will have a response by the end of October,” CEO Dr. Albert Bourla told the “Today” show earlier this month. In other interviews, he has said he expected a “conclusive reading” by then, with an emergency clearance request that could be submitted “immediately”. Bourla’s remarks have put his company squarely in the crosshairs of President Donald Trump, who has made no secret of his desire for positive vaccine news to increase his chances on Election Day, Nov. 3. “We are going to have a vaccine very soon. Maybe even before a very special date, ”Trump said recently. And yet, by all other reports, the idea that it will be ready in October is implausible. Even if the vaccine shows promising signs in clinical trials, still a big yes, the company will not have collected enough data by then to say with statistical confidence that it is safe and effective. By repeating a date that goes against most scientific predictions, Bourla is taking a long shot. If Pfizer launches a vaccine before it has been thoroughly tested, something the company has promised it will not do, it could pose a major threat to public safety. Perception matters too: If Americans see the vaccine rushed to placate Trump, many may decline to get the vaccine. But there is a significant advantage, to the tune of billions of dollars, in being first to the US market with a vaccine. And staying in the chair’s goodwill, particularly when he continues to talk about ways to cut drug prices, might not be a bad thing for a company that raised nearly $ 40 billion in 2019 from sales of high-priced brand-name drugs. . “There is a huge financial advantage in being the first out,” said Dr. Megan Ranney, associate professor of emergency medicine and public health at Brown University. She was one of 60 public health officials and others in the medical community who signed a letter to Pfizer urging her not to rush her vaccine. And given the persistent efforts of the White House to interfere in the decisions of federal health agencies, some scientists fear that the approval of a vaccine could come under similar pressure. “What worries me is that politics or financial gain could drive publication earlier than scientifically appropriate,” Ranney said. Pfizer won’t be anywhere near completing its clinical trial by the end of October, according to a company spokeswoman. When Bourla referred to a “conclusive reading” next month, she said, she meant that the external board of experts monitoring the trial may have found promising signs that the vaccine is working by that date. Pfizer’s test drawings allow the panel to look at data after only 32 volunteers became ill with COVID-19. Even if most of those cases were in the placebo group, regulators at the Food and Drug Administration would likely need data from more volunteers before making a decision on licensing, according to people familiar with the government’s vaccine approval process. . The FDA has also told vaccine manufacturers that they will need to track at least half of patient safety data for two months before the agency grants emergency access. That would push the earliest date to at least November. In a statement, Pfizer said it would continue to collect data on the health of trial volunteers for two years and that it planned to send two months of safety data to the agency “to help inform the final determination of FDA clearance or approval.” . In public interviews, government health officials have refuted the October date. Both Dr. Moncef Slaoui, the chief scientific advisor to Operation Warp Speed, the federal effort that has awarded billions of dollars to vaccine manufacturers, and Dr. Anthony S. Fauci, the nation’s leading infectious disease physician , they have said that October was unlikely. Pfizer’s main competitors in the vaccine race, Moderna and AstraZeneca, have been more vague on timing, saying they expect something before the end of the year. In a recent interview, Moderna CEO Stéphane Bancel said: “October is possible, because very few things in life are impossible.” The best word, he said, is “unlikely.” “They will not be approved before the election,” said Ronny Gal, an analyst at Bernstein’s Wall Street firm. “Time just doesn’t work.” A key to understanding how Pfizer jumped to the top spot in the vaccine race lies in its test blueprints, known as a protocol. Although Moderna and Pfizer began testing on the same day, Pfizer’s is “built for speed,” as one Wall Street firm SVB Leerink described it. Participants in Pfizer’s trial receive two doses of a vaccine 21 days apart, while Moderna’s wait 28 days between them. Pfizer begins looking for sick volunteers seven days after the second dose, while Moderna does so at 14 days. And Pfizer’s plan allows an external review panel to look at the first data after only 32 volunteers fell ill with COVID-19. Moderna’s plan does not allow a first look at up to 53 cases. Some experts have speculated that Pfizer volunteers are in places where the virus is spreading rapidly, so they are more likely to have been exposed to the virus and put the vaccine to the test. While Moderna’s trial is conducted in the United States only, Pfizer’s is international, with established or planned locations in the United States, Brazil, Turkey, and Argentina. At all of its test sites, Pfizer said, 24,000 volunteers have received the second dose of the vaccine, more than half of the 44,000 expected to sign up. Despite Pfizer’s confident pronouncements, victory is not guaranteed. About 15% of vaccines in advanced stage trials fail to reach approval. Dr. Mark Goldberger, an infectious disease expert with the Global Antibiotics Research and Development Association and a former FDA official, noted that the agency has scheduled a meeting of outside experts to discuss experimental coronavirus vaccines on Sept. 22. October. effort to get the data by then, ”he said. “It’s within the realm of possibility, but there are things that could trip them up: a manufacturing problem, a safety problem, the efficacy is not as good as they hope.” Coming to the top in the vaccine race isn’t just about bragging, though the public relations push in developing a vaccine that could rid the world of a deadly pandemic cannot be overstated. Gal, the Bernstein analyst, said Pfizer could gain a significant business advantage by taking control of the initial market for a coronavirus vaccine. Unlike Johnson & Johnson and AstraZeneca, which have said they will not benefit from their products during the pandemic, Pfizer has made no such promises. It has also not taken federal money to develop its vaccine, but instead signed a $ 1.95 billion deal to sell the first 100 million doses of its vaccine to the United States government. Bourla has said the company did not accept federal investment in its research and development so the government could not control the price of the vaccine later on. “We don’t take money to have no restrictions,” Bourla said Sept. 16 at an event organized by investment bank JP Morgan. “Because I imagine, if you accept money, then you have to – a little – explain its price. Bourla, who spent much of the past month giving media interviews and appearing on industry panels, has insisted that the company’s fast-paced timeline has nothing to do with politics. “We have politicians or journalists talking about the efficacy or safety of drugs, which, of course, is not appropriate,” Bourla said on the company’s investor day on Sept. 15. “Scientists should have these discussions.” Ultimately, Pfizer’s strategy may be to manage public expectations, said Brandon Barford, a partner at Beacon Policy Advisors, a research firm. Pfizer could now explain any delay last October “by saying, ‘We’re being more cautious.’ And they congratulate you on that. “But if the opposite happens, and Pfizer is seen to be pushing a vaccine before it is ready, the” potential consequences are enormous, “said Ranney of Brown University.” We cannot afford that unsafe or ineffective vaccine for COVID-19 is released. ”

© 2019 New York Times News Service