BioNTech says vaccine could be approved in mid-December under ideal conditions

Regulators in the United States and Europe could approve Pfizer and BioNTech’s investigational vaccine for Covid-19 in mid-December, the German company president said on Wednesday, following the publication of positive test results.

In a conversation with Reuters TV, Managing Director Ugur Sahin said if all goes well, the US Food and Drug Administration may grant emergency use authorization towards the end of the first half of December or the start of the second.

Conditional approval from the European Union could be obtained in the second half of December, he added.

“It will depend on the applications we receive and whether all the conditions are met,” he said.

Early Wednesday, the partners revealed test results showing their vaccine had a 95% effectiveness rate in different age groups and no serious side effects, a major step in the race to end the pandemic.

Sahin said any coronavirus vaccine that passes regulatory hurdles in the coming months will be picked up by health systems around the world, regardless of its relative merits, as demand will far exceed supply.

“I don’t expect a competitive situation in the first nine months because every dose of approved vaccine someone can administer is welcome and likely will be used.”

Moderna Inc. released preliminary data on its vaccine on Monday, which showed an efficacy of 94.5%. AstraZeneca, which is working on a vaccine with the University of Oxford, hopes to publish the results of its massive trial before the end of the year.

“The first five or eight companies (to get approval) will not stand in the way of the other … I guess it won’t be until mid-2021 that each vaccine will have to stand out with a specific profile,” said Sahin said.

He added that BioNTech and Pfizer are working on a refined formulation of the vaccine that will not require ultra-cold storage to facilitate handling in developing countries.

The more robust version will likely launch in the second half of next year, he added.

At this time, BioNTech vaccine should be stored and transported at -70 ° C, but it can be stored in a normal refrigerator for up to five days or up to 15 days in a thermal transport box.



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