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The European Medicines Agency (EMA) has been attacked by cyber criminals.
Affected are "some documents in connection with the filing of approvals for the Covid-19 vaccine candidate from Pfizer and Biontech, BNT162b2," said Biontech on Wednesday evening.
There was an "unlawful access".
There is no evidence that patient data are affected.
According to the EMA, the incident will have no impact on the examination deadlines for the vaccine.
Pfizer confirmed the information.
The EMA had previously announced the hacking attack without first giving details.
It is responsible for assessing and monitoring drugs.
The shares of Biontech and Pfizer slipped on Wall Street by up to 3.5 percent.
In the past few months, there had already been several attacks on research institutions and companies in connection with Covid-19 vaccines - hackers from Russia, China and North Korea are said to have been involved in some.
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The EMA is currently aiming for approval of the Biontech vaccine by the end of December, and for the Moderna agent in mid-January.
The EMA experts have already analyzed large amounts of data from preliminary tests of the companies in the past few months, said Emer Cooke, the head of the authority, earlier this month.
The British health authorities have already granted emergency approval for the corona vaccine from the Mainz-based pharmaceutical company Biontech and its US partner Pfizer.
People in the UK have been immunized en masse since Tuesday.
In Canada, too, the health authorities gave the green light for the active ingredient from Biontech and Pfizer on Wednesday.
The vaccine had undergone accelerated testing while it was still in clinical trials.
It fulfills the "strict safety, effectiveness and quality requirements for use in Canada".
A release from Biontech said that at least 20 million vaccine doses would be delivered to Canada over the coming year.
Meanwhile, Israel received the first vaccine doses of the Biontech-Pfizer active ingredient.
These first cans arrived on Wednesday on board a DHL cargo plane at Tel Aviv's Ben Gurion Airport, which was greeted by Prime Minister Benjamin Netanyahu.
He announced that he wanted to be the “first” to be vaccinated in order to be a “role model”.