The German regulatory authority, the Paul-Ehrlich-Institut, has approved a phase 2/3 clinical trial in Germany of a Covid-19 vaccine candidate being developed by US pharmaceutical company Pfizer and German biotechnology company BioNTech.
“The integration of sites in Europe, and now especially in Germany, is aimed at supporting an approval in Europe," said Ugur Sahin, CEO and cofounder of BioNTech, in a news release on Monday.
The BNT162b2 mRNA-based vaccine candidate is already in similar large-scale trials in the United States. The trial involves giving the participants two doses of a 30 microgram vaccine – one on the first day and one 28 days later – with participants being followed up for up to two years after they receive the second dose.
In August, the companies presented "promising" results in early data on safety and immune responses in their ongoing Phase 1/2 study in the United States. Among both younger and older adults in the trial, the companies said the vaccine "was well tolerated with mild to moderate fever in fewer than 20% of the participants." The companies also noted in their news release that seven days after participants were given a second dose of the vaccine at 30 micrograms, the vaccine was able to elicit neutralizing antibodies in younger adults ages 18 to 55, and in older adults ages 65 to 85.
Remember: The data has not yet published in a peer-reviewed medical journal.
The companies plan to seek regulatory authorization or approval for the drug as early as October if it is successful in clinical trial testing. They plan to supply up to 100 million doses worldwide by the end of 2020 and 1.3 billion doses by the end of 2021.
Many infectious disease experts say, however, that it’s highly unlikely Pfizer will have enough data to allow for an emergency use authorization from the US Food and Drug Administration in October.