Joe Biden clearly leads in almost all surveys that there is still no clear turnaround in the corona pandemic in sight, and then there is also Donald Trump’s recent Covid 19 illness. The chances for the current US president to be re-elected are not looking too rosy.
An approved vaccine against the novel coronavirus before the US election on November 3, 2020 could possibly change something. Donald Trump announced early on that approval of a vaccine before this point in time was very likely.
But even if the vaccine development of the US company Pfizer and its German partner Biontech is well advanced and the vaccine is already in the final phase III, approval by November 3rd seemed very optimistic from the start.
As recently as September, Pfizer-Biontech had cautiously stoked hopes that the vaccine could possibly be approved for an approval process as early as mid-October. But it was already clear: From a scientific point of view, a fixed date simply cannot be named with certainty. Too much depends on how the data situation develops – and also on when the responsible authorities give the green light for an approval process.
The FDA early put a brake on hopes for a vaccine ahead of the US election
In the US, the final decision on this is made by the Food and Drug Administration (FDA), the American drug agency. There, the schedule communicated by Trump was viewed as unrealistic early on. Because the FDA had expressly requested that every vaccine, in addition to proof of its effectiveness, must also provide detailed evidence of the safety of the substance.
Those vaccinated with the test vaccine should have to be examined for possible medium-term and possibly rare side effects for at least two months before it could be approved. It was therefore clear: With this time perspective, approval before the election is impossible – even if its effectiveness is certain in October.
US President Trump saw this FDA demand, which is not common for vaccine development, as a political campaign directed against him. He considered political possibilities to get the vaccine approved in advance, even against the will of the FDA.
The FDA, on the other hand, emphasized that approval of a vaccine would be based on purely scientific criteria and that political events should not play any role in approval. The safety and reliability of the vaccine is a top priority.
“We assume that we will reach this milestone in the third week of November”
But now the decision seems to have been finally made: There will be no vaccine before the election on November 3rd. Albert Bouria, CEO of Pfizer, a leader in vaccine development, published an open letter on October 16 on the company’s website. In it he gives a concrete timetable – without any cross-reference to political implications.
The open letter states that three criteria must be met for approval: the vaccine must be proven to prevent infection in at least half of those vaccinated, and secondly, it must be proven on the basis of thousands of test subjects vaccinated that no excessive short- and medium-term side effects occur and third, it must be possible to manufacture the vaccine in large quantities and of consistent quality.
The crucial passage of the letter follows shortly thereafter: “The second requirement is proof that the vaccine is safe. Our internal standards and the standards required by the supervisory authorities are set high. On the basis of our current data situation and our current working speed, we assume that we will reach this milestone in the third week of November. “
Much to President Trump’s displeasure, there will be a vaccine ready for approval several weeks after the election at the earliest. Mass production and delivery of the vaccine will then, even in the best of cases, take weeks or months.