LONDON – CEOs of five leading pharma companies have hit back against any suggestion COVID-19 vaccines and therapies could be approved in advance of phase III data, saying it is imperative the highest standards of quality, safety and efficacy are upheld everywhere.
The most important thing is to reinforce to the public our commitment to safety as the number one priority, said Kenneth Frazier, CEO of Merck & Co. Inc. “We will not submit for emergency use authorization any vaccine candidate before we have a quantum of proof from phase III studies,” he said.
The sentiment was echoed by Albert Bourla, CEO of Pfizer Inc., who said, “Political pressure is irrelevant. We will never submit for approval any vaccine before we know it is safe. We will never cut corners – our phase III study will be the only one that will allow us to submit.”
The critical importance of gold standard phase III trials in dealing with the COVID-19 pandemic already has played out in the case of the anti-IL-6 antibody Actemra (tocilizumab), as Severin Schwan, CEO of Roche Holding AG, noted.
“The idea was that for severe COVID-19 pneumonia patients who suffer an overreaction of the immune system, Actemra could help to dampen the immune response. We had a lot of anecdotes around that,” Schwan said.
But the phase III trial started in response did not read out positively. The rush to develop treatments for COVID-19 is understandable, but “there’s no way we can lower the standards in conducting our trials,” said Schwan. “And the results of the Actemra trial demonstrate the point. Lots of people thought it would be effective as a monotherapy – this shows how important it is to do a randomized control trial,” he said.
The comments were made in an online briefing organized by the industry body, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), to update on progress in developing vaccines and therapies, and warn against any regulatory shortcuts, after recent reports that the FDA is being leant on to approve a vaccine before the U.S. presidential election.
David Ricks, CEO of Eli Lilly and Co. and president of IFPMA, said a new style of engagement with the FDA, EMA and other regulators is certainly speeding things up. Typically, it takes two to three months to get a date to submit a file and discuss the data, and two to three months to get feedback. Now it is happening in a week.
“The procedural innovation has been strong,” Ricks said. But it is important to ensure the public understands no corners are being cut as a result. “We need to do randomized controlled trials that show efficacy,” said Ricks. “This industry and certainly our company, has no interest in getting approvals for ineffective products.”