An Ambitious COVID-19 Vaccine Development Plan For Pfizer And BioNtech
Executive Summary
Pfizer said it is dosing patients now with an mRNA-based vaccine and expects human data in May/June, with a goal to have a vaccine available for emergency use possibly by October.
Pfizer Inc. laid out an ambitious timeline to bring a COVID-19 vaccine to patients as early as the fall, potentially with an emergency use authorization. Worldwide R&D President Mikael Dolsten outlined the plan during the company's first quarter sales and earnings call on 28 April.
The company is developing a messenger RNA-based vaccine with BioNTech under a collaboration expanded in April to include an investigational COVID-19 vaccine. The two companies have already been partnered on a flu vaccine collaboration since 2018. (Also see "Pfizer and BioNTech To Initiate COVID-19 Vaccine Clinical Trials In April" - Scrip, 9 Apr, 2020.) Messenger RNA vaccines represent a promising, but entirely novel vaccine approach.
The partners moved rapidly, building on their experience in flu, and began testing one vaccine in humans in April. Data in rodents has been encouraging, Dolsten said, and the first data in primates will be available in the next few weeks. The first human data could come in late May or June from the first experiments performed on plasma of vaccinated patients.
"This is a unique trial design with continuous data flow that should allow us to progress, share data with regulators," he said. "We expect the flow of data coming May/June and then move into expanded trials that could allow emergency use or accelerated approval coming in the fall, possibly October and onwards."
The companies are testing four different vaccine candidates, which he said will give them more flexibility to choose the most effective one or two to move forward into pivotal studies.
"To the best of my knowledge, we're the only ones currently having self-amplified mRNA in the clinic, which would allow you to dose at a lower dose than any other construct," he said.
If Pfizer were to successfully meet that timeline, the company would certainly break a record for developing a vaccine for a novel virus like SARS-Cov-2. It would also require cooperation from regulatory authorities to forgo typical data requirements and review timelines, though the US Food and Drug Administration has shown a willingness to grant emergency use authorizations, at least to allow broader use of existing medicines to treat COVID-19. This would be the first mRNA vaccine of any type, however.
Many other pharmaceutical manufacturers are also rushing to develop vaccines, both mRNA and more traditional vaccines, but Pfizer/BioNtech’s is one of the fastest timelines that has been outlined thus far. Moderna has been a leader in mRNA vaccine development and is also testing in human trials. (Also see "Moderna's Vaccine Portfolio Primed For Boost From Its COVID-19 Work" - Scrip, 16 Apr, 2020.)
CEO Albert Bourla said the company is committed to manufacturing the vaccine this year if the development is successful and regulators approve it. He said Pfizer could be ready to supply millions of vaccines this year and hundreds of millions in 2021.
Pfizer said it has increased its R&D budget for 2020 for the company to include a $500m investment in the development of treatments and vaccines to fight COVID-19. The company paid BioNTech $185m upfront plus a $113m equity investment and future milestones in the vaccine development plan.
Pfizer is also developing a protease inhibitor as a potential antiviral treatment for COVID-19.
"We invested in clinical materials over a month ago, ahead of understanding antiviral activity, to accelerate the potential clinical studies areas of focus by September of this year," Bourla said.
The company said its business remains resilient amid the current COVID-19 pandemic but does expect some drug revenues will be impacted by stay-at-home orders and fewer new patient starts. (Also see "Pfizer Q1: Headwinds And Tailwinds From COVID-19" - Scrip, 28 Apr, 2020.)