by Thomas Meek
LONDON, 4 Sep (APM) - The chief executives of several pharmaceutical companies have warned on the reputational risks of fast-tracking a Covid-19 vaccine before it is proved to be safe and effective.
Pfizer's CEO Albert Bourla on Thursday said the general population is sceptical of the regulatory process for a vaccine as the science has become "politicised".
"Many people will feel that just for the sake of political gains or not, vaccines will be submitted or not submitted," he said during a virtual press conference hosted by global pharma trade body IFPMA. "This is the worst situation that society can be."
Bourla's comments come amid a heated debate on the independence of the U.S. Food and Drug Administration (FDA), with President Donald Trump suggesting that the regulator is slowing down approval of Covid-19 vaccines and treatments until after the U.S. election (APMHE 68643).
The day after Trump made these comments on Twitter, the FDA granted a controversial emergency use authorisation (EUA) to convalescent plasma for the treatment of Covid-19 (APMHE 68641). The National Institutes for Health (NIH), another U.S. health agency, then said there was no evidence to support use of the treatment (APMHE 68751).
FDA commissioner Stephen Hahn has also faced flack for suggesting a coronavirus vaccine could be authorised before the completion of Phase III trials (APMHE 68722, APMHE 68729).
Pfizer is one of numerous companies working on a vaccine for the virus, with Phase III results expected next month for the programme, which is part of a collaboration with BioNTech.
CEO Bourla said in the press conference he wanted to assure everyone that the company is not facing political pressures on the vaccine's development.
"We will never ourselves submit for authorisation or approval any vaccine before we feel that it is safe and effective," he said.
"I took over as CEO of Pfizer last year - it was the 107th anniversary of the company. It's a long institution and I don't plan to reduce the reputation of the institution in a year or two.
"We will not cut corners. Our Phase III study will be the only one that will allow us to say if we have an effective and safe vaccine. If we don't have results from the Phase III study, we will not submit either for approval nor for authorisations. I'm sure most of the reliable companies will do that."
Merck & Co
Merck & Co has several vaccines on the market and is also working on Covid-19 vaccine projects, although is further behind in development than Pfizer.Ensuring a rigorous regulatory approach to Covid-19 vaccine development is crucial for building public confidence in vaccines in general, said CEO Kenneth Frazier in the same press conference.
"The issue of vaccine confidence is a critical one, it is not just an issue related to Covid- 19. We have seen in the wake of the pandemic that vaccinations for diseases like measles have fallen off in part because people are worried about the safety of a vaccine in general.
"I think at the end of the day the most important thing for us to do is to reinforce to the public our commitment to safety as the number one thing. I think we all understand we need to move with urgency given the pandemic but we will not sacrifice safety under any set of circumstances."
He added that Merck will not submit a product for emergency use authoritarian or general approval before the company has a "quantum of truth" through Phase III studies that the vaccine is safe and effective for a large population.
Transparency
Thomas Cueni, director general of IFPMA, also commented on the issue and the potential impact on the anti-vaccination movement."We are all concerned about anti-vax movement, about confidence in the vaccines. That's why what we heard about how we do want the agencies to fulfil the highest possible standards."
He also noted that both industry and regulatory agencies such as FDA and the European Medicines Agency (EMA) have adapted to speed up their processes without compromising quality, but that transparency is key as part of this process.
"This is a period where an extraordinary amount of transparency is required. We have seen occasionally your expectation is not fulfilled but you publish the results good or bad and the industry is fully committed."
Both Frazier and Bourla also backed the need for greater transparency, suggesting that all data that form the basis for any regulatory application are fully available.
Roche and Lilly
Roche and Eli Lilly are developing therapeutics rather than vaccines, but it is just as essential that regulatory and development standards are upheld in this area, said each company's CEO in the same press conference.Severin Schwan, who heads Roche, said: "There is no way that we can lower the standards in conducting our trials."
And Roche has been transparent about one of its failures after interleukin-6 (IL-6) inhibitor Actemra (tocilizumab) failed in a Phase III trial (APMHE 68342).
"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. So it demonstrates how important that is," said Schwan.
Lilly is developing antibodies against Covid-19. And CEO David Ricks said the company has "no intention" of pursuing approvals for products that it does not think meet the standards for safety and efficacy.
"We will publish all our data; we'll subject it this time with scrutiny and we would expect the regulators to follow the normal data on that regard."
Ricks also raised the accelerated processes of the FDA, saying that stages of the regularly process that would normally take several months have been condensed to one week for Covid-19 treatments.
"The procedural innovation has been strong and I think both the industry and the regulators get credit for adapting quickly under these conditions."
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