Pfizer CEO: HHS claims of ‘concealed safety concerns’ on mRNA vaccines are ‘completely inaccurate’

Pharmaceutical rivals don’t often come to each other’s defense. But after the US Department of Health and Human Services terminated a contract with drugmaker Moderna to develop an mRNA bird flu vaccine, claiming that “mRNA technology remains under-tested,” Pfizer’s chief executive is speaking up. “MRNA probably is the most utilized vaccine in the history of humanity,” Pfizer CEO Dr. Albert Bourla said Friday, noting that there have been about 1.5 billion mRNA vaccine doses against Covid-19 administered worldwide from his company alone – not counting those from Moderna. “So it is extremely well-tested.” HHS said Wednesday that it was canceling at least $590 million in federal funding the previous administration had granted for Moderna to use its mRNA technology to develop pandemic influenza vaccines, including those against H5 avian flu viruses. The H5N1 strain has infected at least 70 people and killed one in the US since last year. “We concluded that continued investment in Moderna’s H5N1 mRNA vaccine was not scientifically or ethically justifiable,” an HHS spokesperson said, claiming, “the reality is that mRNA technology remains under-tested, and we are not going to spend taxpayer dollars repeating the mistakes of the last administration, which concealed legitimate safety concerns from the public.” Asked his response to those comments, Bourla responded, “both of them are completely inaccurate.” The pharma giant’s chief spoke with CNN on Friday as Pfizer presented new data on a colorectal cancer drug at the American Society of Clinical Oncology, or ASCO, conference in Chicago, the world’s largest meeting on cancer research. Pfizer’s drug, Braftovi, was shown to double the length of time patients with an aggressive form of colorectal cancer lived with treatment: an average of 30 months compared with 15 in a clinical trial. It’s a “very, very important finding,” Bourla said, noting that colorectal cancer rates, “particularly among younger people, are skyrocketing right now.” And while Pfizer is making big bets on cancer research, its CEO said he’s not taking his foot off the pedal with investment in vaccines either, despite a “very big gap” between the company and HHS – particularly Secretary Robert F. Kennedy Jr. – on their approaches to the subject. “The science is proven,” Bourla said. “The things they will do that will reduce, maybe, vaccination rates will come back and bite us.” Diseases will return, he said, and “that will not take a long time.” Already, the US is experiencing one of its largest measles outbreaks since the disease was declared eliminated in this country in 2000, and rates of whooping cough, or pertussis, have increased as well. The recurrence of disease probably “means that immediately they will have to reverse it,” Bourla said, suggesting that there will be public health efforts to increase vaccination rates in response, and “they will go back to what every country in the world is doing.” Bourla worked with the first Trump administration to advance the company’s Covid-19 vaccine through Operation Warp Speed in 2020, although he noted that Pfizer didn’t accept federal funding to support vaccine development, only for the purchase of vaccines after the fact. He said that despite the gap on vaccines, “when you speak with them, including Secretary Kennedy, I have found several topics that we are in, surprisingly, alignment.” Taking on cancer is one key area of agreement, according to the company. Bourla cited executive orders from President Donald Trump encompassing issues like addressing shorter market exclusivity for pills compared with injectable medicines under the Inflation Reduction Act – something the industry calls the “pill penalty” – drug discounts to hospitals in a program known as 340B, and ratcheting up scrutiny on pharmacy benefit managers’ role in drug pricing. “We are working to address those things as we agree to disagree on the things that divide us,” Bourla said. He noted that he is against the administration’s proposed 40% budget cut for the National Institutes of Health, emphasizing that the US is “the dominant scientific force in biomedical sciences right now, and it is because we have created this ecosystem,” in which NIH funding supports academic research that can lead to new discoveries picked up by the pharmaceutical industry and made into medicines. “If we break any link of this chain of this large ecosystem,” Bourla said, “that’s not good for us, and actually, it’s a gift to our friends in China.” Bourla also took issue with HHS’s actions on Covid-19 vaccines in the past two weeks: saying that the US Food and Drug Administration will change the way it approves updated shots for people who aren’t in vulnerable groups and that the US Centers for Disease Control and Prevention will no longer recommend Covid-19 vaccines to healthy children and pregnant women. In previous years, Covid-19 vaccines had been updated in a similar way to seasonal flu shots, based on evidence that they generate an immune response; clinical trials that are required to show a vaccine’s effect in preventing cases of disease are thought to take too long, potentially, to be feasible every season. What’s more, the FDA and its advisers had previously deemed the vaccine updates small enough to not change their safety profile. Asked whether Pfizer would be able to run clinical trials quickly enough to make updated vaccines available to everyone, not just those in vulnerable groups, Bourla said, “You are raising some very real concerns that we have.” Bourla noted that the implications of the Trump administration’s changes to US health agency policies aren’t entirely clear. But “the issue is that that is not based on any scientific data. It’s just based on a belief.” “The appropriate process has not been followed; this is not just: the secretary or someone at a high level issues, let’s say, a new rule,” he said. “You need to follow a process which is reviews, experts, professional staff of FDA and all of that.” Dorit Reiss, a professor of law at UC Law San Francisco, suggested that HHS’s “bad administrative procedure” in announcing the updated CDC recommendations “will be an issue” if they’re challenged in court. Would Pfizer consider filing a lawsuit? “My initial reaction is that I would prefer to find solutions but not create tensions,” Bourla replied. “But of course, if we feel that we have to, we will.” Overall, the CEO emphasized that he has found the administration willing to engage in discussions, noting that “we maintain a very, very close relationship” with the White House. “I can’t complain they don’t listen to us,” Bourla said.