Drugmakers are hailing great results with COVID-19 boosters and shots for school-age children, enthusing a pandemic-weary public and markets but flustering scientists who say it is important to look at real data before getting too optimistic.
Johnson & Johnson on Tuesday reported that a second dose of its vaccine provided 94% protection against symptomatic disease. The announcement gave its shares on Wall Street a boost in early trading.
Pfizer announced Monday that its scientists found an effective dose for children ages 5 to 11, raising expectations of a child vaccine by Halloween, before outside experts study trial results or the Food and Drug Administration has its say.
“Pfizer & J&J touting new vaccine results without a large package of data. We’re seeing too much science by press release,” Lawrence Gostin, a global health law professor at Georgetown University, tweeted Tuesday.
“Science by press release” has been a common refrain from scientists who have cheered advancements but worry that company statements create public expectations before the Food and Drug Administration and the Centers for Disease Control and Prevention look at the data and determine whether it withstands scrutiny.
That process can take weeks or months. Still, everyday people latch onto headline-grabbing developments from the pharmaceutical sector.
“These company press releases are not intended for you or for me. They are meant for current and potential shareholders to jack up the stock. That’s the job of the company CEO,” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine. “The problem is they are written in ways that are oblivious or tone-deaf to how the public might respond in a raging pandemic.”
Pfizer on Monday said a smaller dosage of its vaccine for children ages 5 to 11 produced positive antibody responses and fewer side effects than what teens and adults experience.
The companies said they would submit their data to the FDA “with urgency,” but the guessing game began by the afternoon. Would parents be able to have their children vaccinated by Halloween, or at least Thanksgiving?
“It is frustrating to scientists to have health data put out through press releases. Companies want to look good and raise their stock prices, while also creating expectations in the public that they will get access to their products and soon,” Mr. Gostin told The Washington Times.
But, Mr. Gostin added, touting trial results is legal and protected under the First Amendment, “unless it is simply an untruth.”
Dr. Hotez said he wished the Trump administration’s Operation Warp Speed made “communication control” a condition of the federal government’s pre-purchases of doses ahead of regulatory approval.
For now, drugmakers’ financial incentives and public pressure on government disease-fighters can lead to difficult public messaging.
Dr. Anthony Fauci and other federal officials have warned against circumventing the regulatory process to get a COVID-19 booster shot by claiming to be a first-time recipient of a vaccine. For now, only immunocompromised people are eligible for a booster.
The public has been spurred by company data and President Biden’s push for boosters.
“People see these things, and they just go out and pressure doctors to give it to them. The more you tout it as good for X or Y, you see people try to obtain it. I think the ‘worried well’ are already getting boosters,” said Arthur Caplan, director of the division of medical ethics at the New York University Grossman School of Medicine.
The FDA declined to weigh in on the press release dynamic. “To protect the integrity of the review process, FDA generally cannot disclose the existence of, or comment on, an unapproved application,” the agency said.
In some ways, having companies kick-start enthusiasm about their products isn’t unusual.
The FDA cannot authorize a vaccine for public consumption until the drugmaker conducts clinical trials, collects data and requests emergency approval.
J&J said it is committed to transparency. It discloses clinical trials in external public registries, such as ClinicalTrials.gov and the EU Clinical Trials Register. It “expeditiously” seeks publication of all results in peer-reviewed medical journals, per company policy.
Pfizer also said it tries to be open about its scientific findings.
“To instill confidence in the vaccine, we believe it is very important to let science lead the process, and be transparent in our communications every step of the way,” Pfizer told The Washington Times in a statement.
Federal officials are supposed to be insulated from public pressure on the regulatory process. But the COVID-19 pandemic, which has killed 676,000 people in the U.S. and upended normal life for about 18 months, is testing the limits.
Former President Donald Trump frequently mused that Pfizer could have released vaccine trial results before Election Day. Pfizer announced its terrific results about a week after the election. Its press release Monday sparked a familiar mix of joy and skepticism from experts.
“The press release from Pfizer reporting the preliminary estimation of the efficacy of their RNA-based COVID-19 vaccine offers great promise for changing the course of the pandemic. Pfizer report an efficacy of greater than 90% for protecting individuals from COVID-19. This is excellent news, and very welcome,” Dr. Andrew Preston, a reader in microbial pathogenesis at the University of Bath in Britain, said at the time.
“However,” he cautioned, ‘the actual data from the trial is not publicly available for full scrutiny, and it is noted that the trial is not yet complete.”
Experts say the pattern of hype turning into political pressure bled into the Biden administration.
Mr. Biden, nervous about signs of waning immunity from the vaccines, announced a plan on Aug. 18 to offer everyone booster doses of the Pfizer and Moderna vaccines starting the week of Sept. 20. After all, the companies signaled they were collecting good data on extra doses and preparing applications for booster approval.
Mr. Biden said the idea was subject to regulatory signoff, but the decision to set a date appeared to squeeze federal scientists.
FDA advisers reclaimed their power Friday by rejecting boosters for the general population and voting to limit them to seniors and people in high-risk occupations.
Biden officials promised more news. On Tuesday, J&J said trial participants’ antibody levels rose dramatically with a booster shot taken either two months or six months after the initial shot.
Roughly 15 million people in the U.S. received the one-and-done J&J vaccine against COVID-19, meaning it accounts for just under 4% of all vaccinations in the country.
Because Pfizer and Moderna account for most of the vaccinations in the U.S., much of the debate over Mr. Biden’s plan to provide boosters focused on those versions. Some J&J recipients felt left out in the cold.
The press release Tuesday brought J&J back into the conversation and could make recipients antsy for a second dose as federal agencies vet booster applications from Pfizer, Moderna and J&J that are in various stages.
The White House said it has enough inventory or doses “on order” to supply initial takers and those who need boosters. About 75 million eligible Americans haven’t come forward.
Mr. Caplan said a financial component will emerge at some point as drugmakers secure approval for extra doses and tout promising outcomes directly to the public.
“At some point, they’re going to make money selling booster,” he said. “I just don’t know when that flip is from saying, ‘We’ve got something in the warehouse’ to ‘Uh oh, we have to buy some more.’”
