New York: When biotech company Moderna announced last week positive results from a small, preliminary trial of its coronavirus vaccine, the company’s chief medical officer described the news as a “triumphant day for us.”
Moderna’s stock price jumped as much as 30 per cent. Its announcement helped lift the stock market and was widely reported by news organisations, including The New York Times.
Nine hours after its initial news release — and after the markets closed — the company announced a stock offering with the aim of raising more than $1 billion to help bankroll vaccine development. That offering had not been mentioned in Moderna’s briefings of investors and journalists that morning, and the company chairman later said it was decided on only that afternoon.
By Tuesday, a backlash was underway. The company had not released any more data, so scientists could not evaluate its claim. The government agency leading the trial, the National Institute of Allergy and Infectious Diseases, had made no comment on the results. And the stock sale stirred concerns about whether the company had sought to jack up the price of its stock offering with the news.
The Moderna episode is a case study in how the coronavirus pandemic and the desperate hunt for treatments and vaccines are shaking up the financial markets and the way that researchers, regulators, drug companies, biotech investors and journalists do their jobs.
Drug companies accustomed to releasing early data to attract investors and satisfy regulators suddenly find themselves accused of revealing too much, or not enough, by a new, broader audience. Journalists may be scolded for hyping early findings, while those who ignore sketchy data may be blamed for missing the news.
Scientists who take the traditional time to gather and analyse their data for publication in mainstream journals are criticised for sitting on life-saving information. Upstart websites beat the journals and break the usual rules by publishing unvetted studies, some of dubious quality. And President Donald Trump uses his bully pulpit to promote unproven treatments.
“You have these wild swings based on incomplete information,” said David Maris, managing director of Phalanx Investment Partners and a longtime analyst covering the pharmaceutical industry. “It’s a crazy, speculative environment because the pandemic has caused people to want to believe that there’s going to be a miracle cure in a miracle time frame.”
Moderna’s chairman, Noubar Afeyan, defended the decision to open a stock sale hours after releasing limited data. He said the company’s board had been considering an offering before Monday’s announcement but finalised the decision only late in the day.
At the same time, a torrent of information is blasting from medical journals as well as company and university news releases. Articles are posted on so-called preprint websites of studies that have not been peer-reviewed by experts, unlike articles in mainstream medical and science journals. Clinicaltrials.gov, which lists medical studies, showed that 1,673 were underway for Covid-19, the disease caused by the coronavirus, as of May 23.
News outlets are rushing to stay on top of new findings and feed a public hungry for any advances in potential treatments or vaccine candidates that hold promise against the highly infectious virus. Some news organisations would prefer to maintain traditional practice and ignore early results of medical studies, waiting for peer-reviewed data, but they are also competing to report on the latest studies.
Still, concerns arise routinely about the quality of rapidly posted data and the motivations behind announcements.
Releasing sparse data is not unusual in the biotech world, where companies often present early trial results months before they are published in journals. Publicly traded companies are required to disclose material information that might lead an investor to buy or sell shares. The company said federal researchers who are conducting the trial would be responsible for submitting the data to be reviewed and published.
Maris said that he would leave it to regulators to decide if the company had acted inappropriately in not announcing the stock sale sooner and added that investors should have been told earlier that the company was considering a stock offering.
“There’s something wrong with that,” he said.
Moderna, based in Cambridge, Massachusetts, went public in 2018 and has been a favourite of biotech investors, given its focus on the hot area of immuno-oncology and its partnerships with companies like Merck and AstraZeneca, and with the Vaccine Research Centre at the National Institute of Allergy and Infectious Diseases.
Its technology, based on genetic material called messenger RNA, or mRNA, is considered highly promising.
“Messenger RNA is one of the hot new platforms,” Dr. Anthony Fauci, director of the infectious disease institute, said in an interview Thursday, adding that it can be adapted quickly to produce new vaccines and scaled up easily.
Although Moderna has other vaccines in its pipeline, none have come to market, and the viability of its mRNA vaccine-making platform — the basis of the company — is on the line. It is a front-runner in the coronavirus vaccine race, and its stock has risen more than 250 per cent since the beginning of the year. It closed at $69 a share Friday afternoon, down 26 per cent from a high Monday of $87.
Moderna is not the only company that has failed to release detailed scientific data. Little has been known about another closely watched product, remdesivir, an experimental treatment for Covid-19 developed by drugmaker Gilead.
On April 29, Gilead announced that it was “aware of positive data” about remdesivir’s performance in a federal trial. A few hours later, from the Oval Office, Fauci said the drug could modestly speed recovery in patients. Although he said it was not a “knockout,” Fauci — his agency ran that trial, too — said the drug could become the standard of care.
A few days afterward, the Food and Drug Administration granted emergency authorisation to use remdesivir to treat Covid-19.
Weeks passed with no detailed data about the clinical trial being published, even though doctors were administering the drug with little information to guide them.
“It was a highly conflicted statement from a highly respected and deservedly respected scientist,” said Gary Schwitzer, publisher of HealthNewsReview. Org, a watchdog publication that argues for more accurate science journalism. “So it brings you back to, what do we believe? Whom do we believe?”
Fauci said he and his research team decided to report some results when the study was stopped after an independent safety board found that the treated patients were recovering faster than those receiving placebos. For ethical reasons, all patients had to be offered the drug.
The information would likely have leaked out — especially given that, two weeks earlier, information from another remdesivir trial had been disclosed to the news site STAT, sending Gilead’s stock up.
Fauci announced that patients treated with remdesivir recovered in 11 days, compared with 15 days for those getting placebos.
“That was all the data we had,” he said.
The full results were published Friday in The New England Journal of Medicine.
The fast pace of research has caught many news organisations off guard, prompting case-by-case discussions on tight deadlines to decide whether — and how — to cover scientific news even when the quality of studies wouldn’t normally meet their standards.
Scientific articles normally take months to go through peer review. But now, many papers are being published on preprint servers, where scientists are posting research before it is accepted by a journal. The site medRxiv, which was founded in June, had 10 million views in April and has posted nearly 3,100 papers related to Covid-19 since January. A similar site, bioRxiv, has posted about 760 papers on the virus.
“People recognised that there was an urgent need to disseminate information,” said Dr. Harlan Krumholz, a cardiologist and health care researcher at Yale University and a co-founder of medRxiv, which is pronounced “med archive.” “People recognised that even weeks matter in this moment when we don’t know very much.”
Asked about criticism that sites like medRxiv encourage the rash publication of bad science, Krumholz said these conversations were healthy and noted that articles in peer-reviewed journals could also be flawed. Submissions go through basic vetting to ensure the research is legitimate.
“Engage in whether it’s good science or not,” he said. “Let’s engage in the consequences of this.”