BioNTech CEO Uğur Şahin said that the company, which has been working on a Covid-19 vaccine with Pfizer, will file paperwork for the emergency use of its vaccine with the United States Food and Drug Administration (FDA) on Friday.

 

In an exclusive interview with CNN’s Frederik Pleitgen, Şahin went on to say he expected the approval process to be completed and distribution to begin before the end of the year: “Depending on how fast this [review] is really accomplished, we might get an authorisation, or conditional approval already in 2020 which might help us start distribution of the first vaccine batches already in 2020.”

 

The BioNTech CEO said that the vaccine provides hope for a return to normality: “I am confident that if everything goes well, and we have a very organised vaccine supply, that we could have a normal winter 2021 -- a normal summer and winter 2021.”

 

Concerns have been raised that it would be difficult to distribute the BioNTech/Pfizer vaccine because it needs to be stored at around minus 75 degrees Celsius. But Şahin tells CNN that this is a temporary issue, “We are working on formulation which could allow us to ship the vaccine even maybe at room temperature.”

 

The news comes after Pfizer announced that a final analysis of the Phase 3 trial of its coronavirus vaccine showed it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns. “The risk of getting Covid-19 if you are vaccinated is twentyfold less as compared to having no vaccine. This of course is a very promising and encouraging result,” Şahin said. 

On FDA approval Sahin said: “We met the requirements defined by the FDA and we of course communicated the manufacturing data.”

 

On European approval, he said: “In parallel we are in close touch with European regulators where we have already started to transfer the documents and they started the review.”

 

“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,” Şahin said on vaccine distribution.

 

On returning to normal, he said: “I am confident that if everything goes well, and we have a very organised vaccine supply, that we could have a normal winter 2021 -- a normal summer and winter 2021.”

 

On vaccine timeline Sahin said: “Depending on how fast this [review] is really accomplished, we might get an authorisation, or conditional approval already in 2020 which might help us start distribution of the first vaccine batches already in 2020.”

 

"The risk for getting Covid-19 if you are vaccinated is twentyfold less as compared to having no vaccine. This of course is a very promising and encouraging result."

 

“We are working on formulation which could allow us to ship the vaccine even maybe at room temperature and this type of development is happening in parallel.”

 

“Since the development was so fast, we were not able to work out better, more stable conditions. 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.” -- Tradearabia News Service