Emergency-approved vaccines are safe, says the director of the vaccines division of the US FDA, Gruber. Nevertheless, the native German is under high pressure.
By Ute Brucker, SWR
Towards the end of the video switch, Marion Gruber then briefly switches to German. The head of the vaccines department of the American FDA (US Food & Drug Administration) had previously spoken to the SWR explains in English why she sees “good news” regarding vaccines from manufacturers Biontech / Pfizer and Moderna.
The doctor of biology is currently one of the most important and powerful figures worldwide – when it comes to corona vaccines. She and her team at the FDA at the Silver Spring site near Washington have to decide whether to approve the completely new mRNA vaccines for millions of Americans through emergency approval.
“Nothing that would make me really nervous”
This exam has not yet been completed, but Gruber looks confident. Your agency has data from more than 40,000 subjects for the Biontech / Pfizer vaccine alone. According to the manufacturer, the vaccine is 95 percent effective. But is it also safe for people?
Of course, more data will be needed in the future, because an emergency approval is not the same as the final approval. But: “So far, I haven’t seen anything for the vaccines that we are examining at the moment that would make me really nervous.”
Weighing benefits against risks
The FDA is reviewing how safe and effective the vaccine is and what side effects are occurring. The principle is that the benefits must be significantly greater than any risks. In doing so, the American authority relies on the data from the manufacturing companies, but also carries out its own analyzes. Gruber emphasizes this several times in an interview.
From the manufacturing process and quality control to the results of the studies on human subjects, which Biontech / Pfizer is carrying out, for example, in the USA, but also in Brazil and Germany: the FDA checks all of this with its own system. After all, “millions of healthy people all over the world” would be vaccinated.
From the north German village to the FDA
Gruber has headed the US Medicines Agency’s vaccines division for eight years. The native German grew up in a small village in Northern Germany, near Itzehoe. She studied biology in Ulm and did her doctorate in 1986 at the Christian-Albrechts-Universität zu Kiel – magna cum laude.
She came to the USA through a postdoctoral fellowship and ended up with the FDA in 1989 “via a few detours”. She has been working there since 1995 with the subject of vaccines, rose to head and “really enjoys” her work.
But now Great Britain has rushed ahead with approval and wants to start vaccinating risk groups as early as next Tuesday. As the first country in the worldwide “race for vaccine approval”, as the “New York Times” headlined. Critics in the US are now accusing the FDA of being too slow, of allowing themselves to be left behind by the British. Stress for “Marian”, as her colleagues call her?
The pressure on the authorities is great
Everyone who worked on vaccine development felt pressure at the moment, says the scientist and remains friendly but stoic: “We try to free ourselves from any external pressure. We do our work because it is very important that we have one perform a thorough review. “
Even the outgoing US President Donald Trump failed to get the FDA to approve the vaccines before the presidential election. The FDA has not been dictated by a schedule, but will soon set it up. Next Wednesday there will be a hearing with external experts on the application of the companies Biontech / Pfizer, one week later it will be about the vaccine candidate from the US company Moderna.
“Very quickly afterwards,” said Gruber, the FDA will make its decision on the emergency approval. She does not want to say whether it is a matter of a few days or weeks.
“People can trust us”
She still feels a strong connection to Germany, her parents live here and her two daughters. She flies to Germany as often as possible, which the corona pandemic prevented this year. Gruber knows that there is also skepticism about a corona vaccination in this country because the vaccines were developed in such a short time.
How would she answer relatives when asked if it wasn’t dangerous? “I would tell people that we are making sure that the vaccines that are now authorized through the emergency approval are really safe and effective. People can have confidence in us. I would advise everyone to take the vaccine,” and corrects that little Anglicism then in “to get vaccinated.”