BioNTech vaccine: Company to seek emergency clearance in US on Friday, CEO says

Sahin said the company will file documents for the emergency use of the vaccine with the United States Food and Drug Administration (FDA).

The BioNTech / Pfizer vaccine announcement, followed this week by an equally effective rival of American company Moderna, raised spirits – and stock markets – across the world, as control of the virus finally appeared to be in place. view.

“Depending on how fast this [review] is really accomplished, we could get authorization, or conditional approval already in 2020, which could help us start the distribution of the first batches of vaccine as early as 2020, ”Sahin said, adding that he could not say exactly how many long the review process would take.

“When we submit packages, we get questions and of course answering questions takes time,” he said.

Sahin told CNN’s Fred Pleitgen that BioNTech had already sent manufacturing data to the US regulator.

“We have met the requirements set by the FDA and of course we have released the manufacturing data,” he said Wednesday.

“Our goal is to deliver several hundred million doses in the first four to five months of 2021 and this will already have an impact on the control of Covid-19,” he said.

“I have no doubts that if all goes well and we have a very organized vaccine supply, we can have a normal summer and winter 2021.”

The CEO of BioNTech stressed the important role governments must play in the next phase of the pandemic.

“[The] The goal must be, for all governments, to ensure that there is a high vaccination rate in the population before we go into the fall, ”he said.

A couple of scientific power

Sahin and his wife Ozlem Tureci have dedicated their lives to the field of oncology and infectious diseases. The couple created BioNTech in the German city of Mainz in 2008.

Both scientists come from Turkish backgrounds. Sahin was born in Iskenderun, a town on the Mediterranean coast of Turkey.

He met Tureci, the daughter of a Turkish doctor, when the two embarked on their scientific careers.

In May, the couple told CNN they felt obligated to “provide something for society” given the work they had done in their field over the past two decades.

“It doesn’t matter where you come from. It matters what you do,” Sahin said Wednesday when asked about his roots. He said he and Tureci were both “dedicated to science” and shared the same vision.

“We have never focused on ourselves. We have always focused on our vision,” he said.

Sahin also praised the duo’s team at BioNTech, noting that some of the students he mentored have become leading scientists in the company.

He said the team’s next duty was to enable the vaccine supply.

The BioNTech and Pfizer vaccine should be stored at about minus 75 degrees Celsius, which is about 50 degrees cooler than any other vaccine currently in use in the United States.

Concerns have been raised regarding vaccine transport 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 has been so rapid, we have not been able to create better and more stable conditions,” he said.

“We believe that by the second half of 2020 we will have developed a formulation comparable to any other type of vaccine.”