(CNN Español) — German biotech company BioNTech, which has been working on a COVID-19 vaccine with US pharmaceutical giant Pfizer, will submit documentation for the emergency use of its vaccine to the US Food and Drug Administration on Friday ( FDA), the company’s CEO Uğur Şahin told CNN’s Frederik Pleitgen in an interview on Wednesday.
“We comply with the requirements defined by the FDA and, of course, we communicate the manufacturing data,” Sahin said of the company’s communication with the US drug regulator. “In parallel, we are in close contact with the European regulators where we have already started to transfer the documents and they started the review ”.
BioNTech’s CEO went on to say that he expected the approval process to be completed and distribution to begin before the end of the year.
“Depending on how quickly this is actually achieved [revisión], we could get a conditional authorization or approval as early as 2020, which could help us start the distribution of the first batches of vaccines in 2020, ”Sahin said, explaining that he could not say for sure how long the review process will take. “When we ship packages, we receive questions, and of course addressing questions takes time.”
The chief executive of the German biotech company went on to say that if everything goes according to plan, Covid-19 could be under control by mid-2021.
“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 am confident that if all goes well, and we have a supply of Very organized vaccines, we could have a normal summer and winter in 2021 ”.
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However, according to Sahin, governments around the world will have to help. “The objective must be, that of all governments, to ensure that there is a high vaccination rate in the population before we enter the autumn.”
The news comes after Pfizer announced that a final analysis of the phase 3 trial of its coronavirus vaccine showed it to be 95% effective in preventing infections, even in older adults, and did not cause serious safety concerns.
“The risk of contracting covid 19 if you are vaccinated is 20 times lower compared to not having any vaccine. Of course, this is very promising and encouraging, ”he said.