When the modern biotech company announced positive results Monday morning of 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 share price rose as much as 30 percent. His announcement helped lift the stock market and was widely reported by news organizations, 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 goal of raising more than $ 1 billion to help develop vaccines to fund. That offer had not been mentioned in Moderna's investor and journalist briefings that morning, and the company's president later said it was decided that afternoon.
For Tuesday, a backlash was on the way. The company had not released any more data, so scientists were unable to evaluate its claim. The government agency that led the trial, the National Institute of Allergy and Infectious Diseases, did not comment on the results. And the sale of shares raised concerns about whether the company had tried to raise the price of its share offering with the news.
The Moderna episode is a case study of how the coronavirus pandemic and desperate search for treatments and vaccines are shaking financial markets and the way researchers, regulators, pharmaceutical companies, biotech investors and journalists do their jobs.
Pharmaceutical companies accustomed to releasing early data to attract investors and satisfy regulators are suddenly accused of revealing too much, or not enough, by a new and wider audience. Journalists may be reprimanded for exaggerating the first findings, while those who ignore incomplete data may be blamed for missing the news.
Scientists who take the traditional time to collect and analyze their data for publication in mainstream journals are criticized for considering life-saving information. Upstart websites outperform magazines and break the usual rules by publishing non-coveted studies, some of dubious quality. And President Trump uses his bully pulpit to promote unproven treatments.
"You have these abrupt changes, based on incomplete information," said David Maris, managing director of Phalanx Investment Partners, and a life-long analyst covering the pharmaceutical industry. "It is a crazy and speculative environment, because the pandemic has caused people to want to believe that there will be a miracle cure in a miracle time frame."
Moderna President Noubar Afeyan defended the decision to open a stock sale hours after publishing limited data. He said the company's board had been considering an offer before Monday's announcement, but finalized the decision only at the end of the day.
"It was based on our observation of the data and the conclusion that we needed to have our own resources to develop this vaccine and not just wait for government subsidies," he said. Modern has a deal receive up to $ 483 million from the US government. USA to find a vaccine.
While corporations and scientists are under incredible pressure to develop a vaccine and raise money for research and manufacturing, vaccine companies are also vying for investors' attention in the middle of a crowded field and seeking to raise prices. of its actions in a global recession.
Almost everyone is trying to compress the schedule for vaccine development that normally takes years, sometimes decades, into a year or so, and still ensure that vaccines are safe and effective.
At the same time, a torrent of information is emerging from medical journals, as well as press releases from companies and universities. Articles are published on so-called study prepress websites that have not been peer-reviewed, unlike articles in conventional medical and scientific journals. Clinicaltrials.gov, which lists medical studies, showed that 1,673 were ongoing for Covid-19, the disease caused by the coronavirus, as of May 23.
The media is quick to stay on top of the new findings and feed a hungry public of any advancement in possible treatments or vaccine candidates that promise against the highly infectious virus. Some news organizations would prefer to stick to traditional practice and ignore the first results of medical studies, pending peer-reviewed data, but they also compete to report on the latest studies.
Still, concerns routinely arise about the quality of rapidly published data and the motivations behind the ads.
"Why does a company publish early data?" Mr. Maris asked. "Clearly there is an appetite for it. People want to know that we are making progress. Having a vaccine is the clearest way of a full reopening and leaving this behind. "
Moderna's preliminary results were promising. His vaccine, the first to be tested in humans, appeared safe and stimulated antibody production in the first 45 study participants. And of the eight that have undergone further testing so far, all produced so-called neutralizing antibodies, which can prevent the virus from invading cells and should prevent disease.
But there were no details, no charts, no graphs, no numbers, nothing published in a newspaper.
Disclosure of sparse data is not unusual in the biotech world, where companies often present the first results of trials months before they are published in journals. Publicly traded companies are required to disclose material information that may lead an investor to buy or sell shares. The company said federal investigators conducting the trial would be responsible for submitting the data for review and publication.
Maris said she would let regulators decide whether the company had acted inappropriately by not announcing the sale of shares earlier, and said investors should have been informed before the company was considering a share offering. "There is something wrong with that," he said.
Modern, based in Cambridge, Massachusetts, went public in 2018 and has been a favorite with biotech investors, given its focus in the area of immuno-oncology and its partnerships with companies like Merck and AstraZeneca, and with the Vaccine Research Center 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 new platforms," Dr. Anthony Fauci, director of the institute for infectious diseases, said in an interview on Thursday, adding that it can be rapidly adapted to produce new vaccines and easily expanded.
Although Moderna has other vaccines in its portfolio, none has been released, and the viability of its mRNA vaccine manufacturing platform, the company's base, is at stake. It is a leader in the coronavirus vaccine race, and its stocks have increased more than 250 percent since the beginning of the year. It closed at $ 69 a share on Friday afternoon, down 26 percent from a $ 87 Monday.
Dr. Afeyan acknowledged that the companies were now subject to much more intense scrutiny with so much interest in the outcome of drug development.
"People basically say, you know, you shouldn't do this," said Dr. Afeyan. "And if you don't publish data, people will say, why are you withholding the data? People trade without knowing the data. So it is a difficult situation to do science, and we have no choice because we are trying to develop a vaccine. "
With so many different interests demanding the latest information, including governments around the world, the company was unable to withhold it from the public, he said. "As a public company, if we have it, we can't give this to them and hide it from other people."
Dr. Fauci said that while companies often publish partial data, "my preference, and what my group will do, will be to wait until we get the solid data and then publish it in a document that says, 'In the first phase this is what we saw. & # 39; "
Still, he finds Moderna's preliminary results encouraging. The neutralizing antibody levels in the eight people tested for them seemed high enough to be protective, Dr. Fauci said. But he emphasized that eight is a small number.
"I have to stress that it is still limited," he said, "and that is why I simply retain my enthusiasm, but still have a certain cautious optimism."
Dr. Fauci said the big question remained: Will the vaccine work?
"When a vaccine is being developed," he said, "nothing is guaranteed."
Moderna is not the only company that has not published detailed scientific data. Little is known about another closely watched product, remdesivir, an experimental treatment for Covid-19 developed by drug maker Gilead.
April 29 Gilead announced that he was "aware of the positive data,quot; on remdesivir's performance in a federal trial. A few hours later, from the Oval Office, Dr. Fauci said the drug could moderately speed recovery in patients. Although he said it was not a "knockout," Dr. Fauci, his agency also conducted that trial, said the drug could become the standard of care.
A few days later, the Food and Drug Administration granted an emergency authorization to use remdesivir to treat Covid-19.
The weeks passed without detailed data on the clinical trial being published, despite doctors administering the drug with little information to guide them.
"It was a very conflicting statement from a highly respected and deservedly respected scientist," said Gary Schwitzer, editor of HealthNewsReview.Org, a surveillance publication that advocates for more accurate science journalism. "Then it brings you back, what do we believe in? Who do we believe?
Dr. Fauci said that he and his research team decided to report some results when the study was stopped after an independent safety board found that treated patients recovered faster than those receiving placebos. For ethical reasons, all patients should be offered the medication.
The information is likely leaked, especially since, Two weeks earlier, information from another remdesivir trial had been released to the STAT news site, shipping Gilead stocks.
Dr. Fauci announced that remdesivir-treated patients recovered within 11 days, compared to 15 days for those receiving placebos.
The rapid pace of research has caught many news organizations by surprise, prompting case-by-case discussions about tight deadlines for deciding whether and how to cover scientific news, even when the quality of the studies would not normally meet their standards. standards.
Scientific papers typically take months to go through a peer review. But now, many articles are published on preprint servers, where scientists publish research before a journal accepts it. The place MedRxiv, which was founded last June, had 10 million visits in April and has published nearly 3,100 Covid-19 related articles since January. A similar site, bioRxiv, has published some 760 articles on the virus.
"People recognized that there was an urgent need to disseminate information," said Dr. Harlan Krumholz, a cardiologist and health care researcher at Yale University and co-founder of medRxiv. which is pronounced "med archive,quot;. "People recognized that even weeks are important right now when we don't know much."
When asked about criticism that sites like medRxiv encourage hasty publication of bad science, Dr. Krumholz said these conversations were healthy, noting that articles in peer-reviewed journals could also be flawed. Submissions go through basic research to ensure the research is legitimate.
"Get involved in whether it's good science or not," he said. "Let's participate in the consequences of this."