BioNTech and Pfizer will seek emergency US authorization for vaccine on Friday, CEO says
German company BioNTech and its partner, drug giant Pfizer, will ask the US on Friday to allow emergency use of their Covid-19 vaccine candidate, CEO Ugur Sahin told CNN during an exclusive interview on Wednesday.Posted — Updated
Sahin said the company will file paperwork for the emergency use of the vaccine with the US Food and Drug Administration (FDA).
A final analysis of the Phase 3 trial of the vaccine shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns, Pfizer said Wednesday.
The announcement of the BioNTech/Pfizer vaccine, followed this week by a similarly effective rival from the US company Moderna, raised spirits -- and stock markets -- across the world, as control of the virus finally appeared to be in sight.
Sahin expects the vaccine's approval process to be completed and distribution to begin before the end of 2020. He said that if everything goes to plan, Covid-19 could be under control halfway through 2021.
"Depending on how fast this [review] is really accomplished, we might get an authorization, or conditional approval already in 2020 which might help us start distribution of the first vaccine batches already in 2020," Sahin said, adding that he couldn't say exactly how long the review process would take.
"When we submit packages we receive questions and of course addressing the questions takes time," he said.
Sahin told CNN's Fred Pleitgen that BioNTech had already sent manufacturing data to the US regulator.
"We met the requirements defined by the FDA and we of course communicated the manufacturing data," he said Wednesday.
"Our goal is to supply several hundred million of doses in the first four to five months of 2021 and this is will already have an impact in the control of Covid-19," he said.
"I am confident that if everything goes well, and we have a very organized vaccine supply, that we could have a normal summer and winter 2021."
The BioNTech CEO did stress the important role governments had to play in the next phase of the pandemic.
"[The] goal must be, of all governments, to ensure that there is a high vaccination rate in the population before we go into autumn," he said.
A scientific power couple
Sahin and his wife Ozlem Tureci have dedicated their lives to the field of oncology and infectious diseases. The pair set up BioNTech in the central German city of Mainz in 2008.
Both scientists come from Turkish backgrounds. Sahin was born in Iskenderun, a city on Turkey's Mediterranean coast.
He met Tureci, the daughter of a Turkish physician, when the pair were both embarking on their scientific careers.
In May, the couple told CNN they felt compelled to "provide something for society," given the work they had done in their field over the last two decades.
"It is not important from where you come. It's important what you do," Sahin said Wednesday when asked about his roots. He said he and Tureci were both "devoted to science" and shared the same vision.
"We never focused on ourselves. We always focused on our vision," he said.
Sahin also praised the pair's team at BioNTech, noting that some of the students he mentored had gone on to become leading scientists at the company.
He said the team's next duty was to enable supply of the vaccine.
The BioNTech and Pfizer vaccine needs to be stored at about minus 75 degrees Celsius, which is about 50 degrees colder than any vaccine currently used in the US.
Concerns have been raised about the vaccine's transportation and storage needs. Sahin said BioNTech is working on a formula for its vaccine that could allow it to be shipped at room temperature.
"Since the development was so fast, we were not able to work out better, more stable conditions," he said.
"We believe that in the second half of 2020 we will have come up with a formulation which is comparable to any other type of vaccine."
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