CEOs pledge rigorous Phase III testing for COVID-19 vaccines
O’Day: Gilead able to meet global demand for Veklury in real time beginning in October
As concerns grow around political pressure on FDA’s review process for COVID-19 countermeasures, a group of five biopharma CEOs reiterated Thursday that industry will not submit a COVID-19 vaccine or therapeutic for emergency use authorization or approval until randomized controlled trials clearly demonstrate their safety and efficacy.
The executives also delivered updates on their companies’ progress in developing COVID-19 countermeasures, with Gilead Sciences Inc. (NASDAQ:GILD) Chairman and CEO Daniel O’Day saying that the Bay Area biotech will be able to meet global demand for Veklury remdesivir beginning in October.
During an International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) media briefing, O’Day and the CEOs from Eli Lilly and Co. (NYSE:LLY), Merck & Co. Inc. (NYSE:MRK), Pfizer Inc. (NYSE:PFE) and Roche (SIX:ROG; OTCQX:RHHBY) repeatedly pushed back against any notion that industry would allow or welcome any shortcuts when it comes to the authorization of COVID-19 vaccines or therapeutics.
“There are many people who feel that for the sake of political gains or no gains vaccines will be submitted or not submitted,” Pfizer Chairman and CEO Albert Bourla said during the briefing. “I want to assure everyone that first of all we do not have any political pressures and it is irrelevant. We will never ourselves submit for authorization or approval of any vaccine before we feel that it is safe and effective.”
Bourla added that he had no plans to tarnish Pfizer’s scientific reputation based on the development of a single product. “We will not cut corners. Our Phase III study will be the only one that will allow us to say whether we have an effective and safe vaccine. If we have any doubts from the Phase III study, we will not submit either for approval or for authorization,” he said.
Lilly Chairman and CEO David Ricks reiterated that safety and efficacy are the sector’s primary concerns. “This industry and certainly our company has no intention of pursuing approvals for products that we don’t think meet the standard for safe and effective,” he said. “I don’t think the regulators are interested in that either, but there’s a lot of discussion about it. We will publish all of our data, we’ll subject it to scientific scrutiny, and we would expect the regulators to follow the normal state on that regard.”
Ricks is also president of IFPMA.
Roche CEO Severin Schwan noted that the Phase III failures of IL-6 inhibitors including Roche’s Actemra tocilizumab in severe COVID-19 patients underscores the importance of seeing the trials through before any decision is made on a therapeutic or a vaccine.
“There’s no way that we can lower the standards in conducting our trials,” Schwan said. “There were lots of people who thought that Actemra would be useful as a monotherapy, and only in a very robust, well conducted trial we could show that it’s actually not the case. That demonstrates how important that is.”
The statements came just days after FDA Commissioner Stephen Hahn suggested in an interview with the Financial Times that a COVID-19 vaccine could be authorized before completion of Phase III testing.
That comment and missteps in the communications around FDA’s decisions for EUAs for hydroxychloroquine and convalescent plasma have raised questions around whether FDA has been compromised by political pressure to approve a vaccine ahead of the U.S. presidential election in November (see “Editor’s Comment: “FDA Should Maintain ‘Social Distance’ from the White House”).
Adding to the concerns, multiple reports claimed CDC Director Robert Redfield had informed state governors in an Aug. 27 letter to be ready to distribute a COVID-19 vaccine by Nov. 1. The agency did not respond to BioCentury’s requests for comment on the letter, which was first reported by McClatchy.
Both Bourla and Merck Chairman and CEO Kenneth Frazier supported the use of FDA advisory committees as an extra layer of transparency to protect against any political influence.
“In the context of COVID-19, I think it is particularly important to make sure that data that forms the basis for an emergency use authorization is fully available; it is published; and it gets reviewed not only by FDA but any advisory committee that is in place,” Frazier said. “The scientific community can actually pore through that paper and ensure the public that it has been looked at objectively, and we can say based on that data, it is appropriate to see the use of this vaccine in a large number of people.”
The statements come on the same day BIO released an open letter calling on industry to adhere to scientific rigor and for FDA to continue as an independent gold-standard regulatory body “free from external influence” (see “BIO Leaders Urge Industry to Hew to Norms”).
Among the CEOs’ updates on their COVID-19 vaccines and therapeutics, O’Day said Gilead’s expanded manufacturing capacity would enable the company to meet global demand for Veklury in real-time.
He detailed how Gilead has shrunk the complex manufacturing process for Veklury from one year to six months, and said that the company expects manufacturing capacity to reach more than 2 million courses of therapy by year-end, a more than 40x increase in supply from January.
Bourla reiterated Pfizer and partner BioNTech SE (NASDAQ:BNTX) could conduct their first analysis of Phase III data for their mRNA vaccine BNT162b2 in October. He said 23,000 patients have been enrolled in the Phase III trial, which is expected to be fully enrolled in a few days. He added that a “significant number of patients” have already started getting the second booster dose of the vaccine.
Whether Pfizer can hit the October milestone will depend on the rate of events in patients. If the study is fully enrolled by the end of the first full week of September, the last patients enrolled won’t get their second vaccination until near September’s end. A high event rate in the placebo arm may be required to see compelling data by October, a factor Bourla himself admitted.
If the data are positive, Bourla said Pfizer would be ready to seek emergency use authorization immediately. “We have already worked on the rest of the file, which means that if the vaccine is safe we will start submitting to the FDA on a rolling basis, and other regulatory agencies,” he said. “If we have enough events, we may be able to say the product is safe and efficacious in the October time frame and submit immediately for approval.”
Frazier said Merck’s antiviral and vaccine programs will enter late-stage testing this year, with MK-4482 expected to enter pivotal trials in the coming weeks. The pharma licensed the ribonucleoside analog from Ridgeback Biotherapeutics L.P. in May, and is collaborating with Ridgeback on clinical development and manufacturing. COVID-19 vaccines V590 and V591 are expected to begin large-scale trials later this year, Frazier said.