Top global pharma executives involved in the development of COVID-19 vaccines have stated their commitment to not rushing the release of any potential vaccine without it passing through the full clinical trial process and proving to be safe and effective. Albert Bourla of Pfizer and Kenneth Frazier of Merck (MSD globally) both made this commitment, with Bourla also hitting out against attempts by politicians to use COVID-19 for their own political gain.
Speaking at the IFPMA virtual media briefing on 3rd September, ‘COVID-19 therapeutics: innovation, trials and access’, Pfizer CEO Bourla revealed that Pfizer’s efforts to create a vaccine using the innovative but still unproven Messenger RNA (mRNA) technology are already “in a very advanced stage” and that 23,000 of the necessary 30,000 volunteer patients for its pivotal Phase III trial that began in July have been recruited. The trials are taking place across 125 sites in the USA, Argentina and Brazil, with Pfizer hoping to know by October whether the vaccine, developed in partnership with German firm BioNTech, is effective. Bourla stated his commitment to submitting the candidate for immediate approval if so.
There is so much politicized science right now that many people will feel that just for the sake of political gains, vaccines will or will not be submitted
Albert Bourla, Pfizer
However, he warned against the politicisation of the vaccine development process, with candidates in the November US presidential election set for November 3rd potentially seeking to use vaccines to gain a political advantage. “There is so much politicized science right now that many people will feel that just for the sake of political gains, vaccines will or will not be submitted,” he stated. “That is the worst situation a society can be in.”
Seeking to assuage fears that Pfizer may rush through the development of its vaccine under political pressure, Bourla noted, “I want to assure everyone that we do not have any political pressures… we will never ourselves submit [any drug] for authorization or approval before we feel it is safe and efficacious.” Harking back to the company’s long history, Bourla added, “When I took over last year, it was the 170-year anniversary of the institution… I don’t plan to reduce this reputation in a year or two.”
With politicians pushing for speedy access to any potential vaccines and the recent news from China, which has been administering experimental coronavirus vaccines to large numbers of state workers and Russia, which has approved its own COVID-19 vaccine before the completion of Phase III trials, Bourla concluded, “We will not cut corners. Our Phase III studies will be the only ones that will tell us if we have a safe and effective vaccine. If we don’t have results from Phase III studies, we will not submit for approval nor authorization… that’s something I’m sure most other [pharma] companies would do.”
We all understand the need to move with urgency given the pandemic, but we will not sacrifice safety under any set of circumstances
Kenneth Frazier, Merck (MSD)
Merck (MSD) entered the COVID-19 vaccine race in May with the acquisition of Austrian biotech Themis Bioscience and its vaccine technology in addition to a partnership with non-profit research organization IAVI to develop a separate candidate using the same technology as in MSD’s Ebola Zaire virus vaccine. CEO Kenneth Frazier was as bullish as Bourla in stating his opposition to rushing the vaccine development process amid political pressures and vaccine scepticism.
“The most important thing for us to do is reinforce our commitment to safety to the public. We all understand the need to move with urgency given the pandemic, but we will not sacrifice safety under any set of circumstances.” Frazier added, “We will not submit for approval – that is emergency use approval or more general approval – any vaccine candidate before we have approved Phase III studies that allow us to make a reasonable estimate of what the safety and efficacy of that vaccine in the larger population is.”
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