In media appearances and conversations with investors, Pfizer’s CEO almost always mentions a word that is so politically dangerous, most of its competitors worry: October.
“Currently, our model – our best case – predicts that we will have an answer by the end of October,” CEO Dr. Albert Burla told Today earlier this month. In other interviews, he said he expected a “convincing reading” by then, with an application for an emergency permit that could be submitted “immediately”.
Still, from all other accounts, the idea that it will be ready in October is exaggerated. Even if the vaccine shows promising signs in clinical trials – still large, if – by then the company will not have collected enough data to say with statistical certainty that it is safe and effective.
Repeating a date that flies ahead of most scientific predictions, Dr. Burla makes high-stakes gambling. If Pfizer releases a vaccine before it has been thoroughly tested – something the company has promised not to do – it could pose a major threat to public safety. Perception also matters: If Americans think the vaccine is in a hurry to reassure Mr. Trump, many may refuse to fire.
But there is a significant plus, worth billions of dollars, in being the first in the US vaccine market. And staying in the president’s favor – especially when he keeps talking about ways to lower drug prices – may not be bad for a company that brought in nearly $ 40 billion in 2019 from sales of expensive, branded drugs.
“The huge financial advantage is getting out of the gate first,” said Dr. Megan Rani, an 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 them not to rush their vaccine.
And given the White House’s ongoing efforts to intervene in the decisions of federal health agencies, some scientists fear that vaccine approval could come under similar pressure.
“What I’m worried about is that politics or financial gain could lead to an earlier release than is scientifically appropriate,” Dr. Rani said.
A Pfizer spokesman said he would not be close to completing his clinical trial by the end of October. When Dr. Burla referred to a “convincing reading” the following month, she said he had in mind that an external panel of experts monitoring the trial might have found promising signs that the vaccine was working.
Pfizer’s trial plans allow the panel to review the data after only 32 volunteers became ill with Covid-19. Even if most of these cases were in the placebo group, regulators in the Food and Drug Administration are likely to need data from more volunteers before deciding on a permit, according to people familiar with the government’s vaccine approval process.
The FDA also told vaccine manufacturers that they would have to monitor at least half of patient safety data for two months before the agency could provide emergency access. This would shift the earliest possible date to at least November.
In a statement, Pfizer said it would continue to collect health data from test volunteers for two years and planned to provide the agency with bimonthly safety data “to help inform the FDA of the final determination of a permit or approval.”
In public interviews, state health officials denied the October date. Both Dr. Moncef Slavey, chief scientific adviser to Operation Warp Speed, the federal effort that has given billions of dollars to vaccine manufacturers, and Dr. Anthony C. Fauci, the country’s best infectious disease physician, said that October is unlikely.
Pfizer’s leading competitors in the vaccine race, Moderna and AstraZeneca, are less vague about the weather, saying they expect something before the end of the year. In a recent interview, Moderna’s CEO, Stefan Bansel, said: “October is possible because very few things in life are impossible.” The better word, he said, is “unlikely.”
“They will not be approved before the election,” said Ronnie Gal, an analyst at Wall Street firm Bernstein. “Time just doesn’t work.”
One of the key factors in understanding how Pfizer climbed to the top of the vaccine race is in its trial plans, known as the protocol.
Although Moderna and Pfizer began testing on the same day, Pfizer was “built for speed,” as one Wall Street firm, SVB Leerink, describes it.
Participants in the Pfizer study received two doses of vaccine at 21-day intervals, while those in Moderna waited 28 days in between. Pfizer began looking for sick volunteers seven days after the second dose, while Moderna did so every 14 days. And Pfizer’s plan allows an external review panel to look at early data after only 32 volunteers became ill with Covid-19. Moderna’s plan does not allow a first peek into 53 cases.
Some experts suggest that Pfizer volunteers are in places where the virus is spreading rapidly, making it more likely that they have been exposed to the virus and put the vaccine to the test. While the trial against Moderna takes place only in the United States, Pfizer is international, with locations created or planned in the United States, Brazil, Turkey and Argentina.
In Argentina, which has seen an influx of coronavirus infections since August, 33,000 volunteers quickly signed up for about 4,500 slots, said Dr. Fernando Pollack, principal investigator of the Pfizer study at Buenos Aires Military Central Hospital.
“We have many years of experience in these kinds of experiments and we have never seen these numbers before,” Dr. Pollack said in an interview. He declined to comment on whether he knew of any Covid-19 cases among volunteers.
At all their test sites, Pfizer said, 24,000 volunteers received the second dose of the vaccine, more than half of the 44,000 expected to enroll.
Despite Pfizer’s confident statements, victory is not guaranteed. About 15 percent of vaccines in the later stages of testing do not reach approval.
Dr Mark Goldberger, an infectious disease expert at the Global Partnership for Antibiotic Research and Development and a former FDA official, noted that the agency had scheduled a meeting of external experts to discuss experimental coronavirus vaccines on October 22nd.
“Until then, it would take a lot of effort to get the data,” he said. “It’s in the realm of possibilities, but there are things that could overcome them – a production problem, a safety problem, the efficiency is not as good as they expect.”
Taking first place in the vaccine race is not just about praising rights, although the impetus for public relations to develop a vaccine that can free the world from a deadly pandemic cannot be overstated.
Mr Gal, a Bernstein analyst, said Pfizer could gain a significant commercial advantage by taking control of the early coronavirus vaccine market. Unlike Johnson & Johnson and AstraZeneca, which said they would not take advantage of their products during the pandemic, Pfizer did not make such promises.
He also did not take federal money to develop his vaccine, instead signing a $ 1.95 billion deal to sell the first 100 million doses of his vaccine to the US government. Dr Burla said the company had not accepted federal investment in its research and development so that the government could not control the price of the vaccine later.
“We didn’t take money so we didn’t have any restrictions,” Dr. Burla said on September 16 at an event hosted by investment bank JP Morgan. “Because I can imagine that if you take money, then you have to explain a little about your prices.”
While smaller companies like Moderna have already benefited financially from rising stock prices, Pfizer has not seen such a boom in shares. Mr Gal estimated the initial vaccination as a $ 18 billion market. “So, as long as they are able to capture any amount of material, even for a company like Pfizer, it’s no small feat,” he said.
Pfizer is also betting more when it comes to doing business with the federal government. Moderna does not sell approved products, but Pfizer has a wide portfolio of vaccines and drugs. The federal government is also a major customer – paying for treatment and vaccines through Medicare – and making serious decisions on everything from drug approval to drug pricing policy.
Although Mr Trump has called for the vaccine to be approved quickly, he has used harsh rhetoric against the industry. Earlier this month, he issued an executive order aimed at reducing the price of some drugs, tying them to prices in other countries. The measure was strongly opposed – and likely to be challenged in court – by the pharmaceutical industry.
Earlier this month, the president praised Pfizer, calling him a “great company” and saying he had spoken to Dr. Bourla, who was a “great man.”
Dr Burla, who spent most of the past month giving media interviews and participating in industry panels, insisted the company’s accelerated schedule had nothing to do with politics. “We have politicians or journalists talking about the efficacy or safety of medicines, which, of course, is not appropriate,” Dr Burla said on the company’s investor day on September 15. “Scientists need to lead these discussions.”
Ultimately, Pfizer’s strategy may be to manage public expectations, said Brandon Barford, a partner at research firm Beacon Policy Advisors. Pfizer can now explain any delay in October by saying, “We are extremely cautious.” And you get fame for that. “
But if the opposite happens and Pfizer is seen pushing for a vaccine before it’s ready, “the potential consequences are huge,” said Dr. Rani of Brown University. “We can’t afford to get a vaccine for Covid-19 that is either dangerous or ineffective.”
Sharon LaFraniere, Daniel Politi, Noah Weiland and Katherine J. Wu contributed to the reporting.