With its coronavirus vaccine expected to be ready in the coming months, absent a setback, Pfizer Inc. already is discussing orders for what could be a massive commercial opportunity.
Pfizer Chairman and CEO Albert Bourla said 26 June that he remains cautiously optimistic the COVID-19 vaccine program will be successful and that "we do anticipate making a profit on the vaccine."
Pfizer's optimism and potential availability in the fall appears to have spurred interest from world governments. Bourla said discussions about pricing already are under way.
“The numbers that we’re discussing with governments, because we cannot set the price based on the volume, because obviously it’s going to be very high, it is prices that already exist for other vaccines,” he said during a session at the Milken Institute Summer Series. “And of course, during the pandemic given the big volumes we will try to provide discounts.”
Gilead Sciences Inc. set precedent for pricing pandemic-related products with commercial intent when it announced remdesivir would cost $3,120 per 5-day course cost for private payers and $2,340 for developed country government payers, which should eventually lead to a profit for the company. (Also see "Gilead Sets Remdesivir Price, Commits Nearly All Near-Term Supplies To US" - Scrip, 29 Jun, 2020.)
However, Bourla said thoughts about pricing the vaccine have been secondary. “I think that the price of the vaccine was something that I never thought [about] because as I said we never put calculations - this is how much it will cost us, this is how much we are going to make,” Bourla said. “We only put calculations if we do that we may save the world.”
Bourla had said previously that return on investment would not drive the company’s decision about the coronavirus vaccine. (Also see "Pfizer’s Bourla On COVID-19 Vaccine: "There Is No ROI That Will Drive Our Decision"" - Scrip, 22 Jun, 2020.) Pfizer’s intent for the commercial prospects of the vaccine is now clearer, now that he's linked it to traditional vaccines. Pfizer's vaccine portfolio includes Trumenba for meningococcal group B, as well as the pneumococcal 13-valent vaccine Prevnar 13.
The mRNA vaccine against COVID-19 Pfizer is developing in conjunction with BioNTech SE could be ready in the fall. A Phase III clinical trial is expected to begin in July and Bourla said safety and efficacy data could be available in September. He said the company could then talk with the US Food and Drug Administration about “potential approval in the October timeframe.”
Indeed, several vaccine candidates are in line to request an emergency use authorization from the FDA later this year. (Also see "COVID-19: The Race To Develop A Vaccine" - Scrip, 9 Jun, 2020.)
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a separate interview during the session that data is looking good for the vaccines in development, but warned that trials will take weeks or months to enroll. He expects that by late fall or early winter, efficacy data should be clear.
Moderna Inc. also expects to begin enrollment of a Phase III trial for its mRNA vaccine candidate in July. (Also see "Moderna: Speed Of COVID-19 Vaccine Now Hinges On Enrolling The Right Patients" - Pink Sheet, 22 Jun, 2020.)
1 Billion Doses Possible In 2021 If Stars Remain Aligned
Pfizer created separate manufacturing networks to handle the anticipated demand in the US and Europe. Bourla said there may be other countries where there is no commercial opportunity, but indicated those areas also will have access to the vaccine.
Pfizer is expecting to have up to 100 million vaccine doses available this year, an increase from initial projections of tens of millions of doses. Bourla said manufacturing could reach 1 billion doses in 2021.
The manufacturing, as well as the clinical trial projections, however, depend on a clean development process. Bourla said repeatedly during the Milken Institute session that the stars have to remain aligned to meet the timeline.
“Frankly, I’m surprised that things are still aligned,” he said.
Like many companies, Pfizer is ramping up manufacturing at-risk in order to have product available for distribution upon receiving FDA clearance or an emergency use authorization.
Several vaccine developers also have pledged to work together and will devote manufacturing capacity to a successful candidate if their product fails Eli Lilly & Co. CEO David Ricks said that a similar agreement should be in place for monoclonal antibodies, another potential coronavirus treatment. (Also see "Lilly CEO: Monoclonal Antibody Companies Should Share Coronavirus Manufacturing Capacity" - Pink Sheet, 25 Jun, 2020.)
Pfizer Declined Federal Funding To Avoid Questions, Bourla Says
Pfizer is among those short-listed for Operation Warp Speed, the US government’s program to accelerate coronavirus vaccine development, but the company is not participating in government clinical trial coordination or taking federal dollars.
Bourla said that the decision to forego federal assistance was difficult, but ultimately he decided that federal involvement would have slowed development. He also reiterated that Pfizer did not need the money or government expertise to run the trials.
“When you take money, the people that are giving the money want to know how you spent them and what exactly you are doing,” he said. “Speed was of essence right now. I wanted to make sure that we give to our people autonomy to move fast and run and be able to produce a vaccine.”
Bourla said Pfizer continues to communicate with Warp Speed staff and may need logistics support later, such as “how to make sure that the vaccine will reach all vaccination points.”
Pfizer Chief Business Officer John Young also said that the company did not want to spend a month negotiating with US officials and BioNTech about funding conditions. (Also see "BIO 2020 Notebook: FDA's Hahn On COVID-19 Lessons To Be Learned; NIH's Fauci On Health Care Disparities; Pfizer's Young On Forgoing Gov't Vaccine Funds" - Pink Sheet, 11 Jun, 2020.)
Operation Warp Speed intends to narrow a list of 14 vaccine candidates down to seven, which will then go to clinical trials. Among the requirements to join the program is the ability to scale up manufacturing quickly. (Also see "Manufacturing Pace Is Key For COVID-19 Vaccine Candidates Hoping To Jump To ‘Warp Speed’" - Pink Sheet, 16 Jun, 2020.)