Pfizer, BioNTech nab fast track tag, prep for major phase 3 COVID-19 vax test this month

Pfizer and German mRNA partner BioNTech have grabbed an FDA fast track label as they look to start a late-stage, 30,000-patient COVID-19 vaccine test before the month is out.

As Moderna has been apparently squabbling with the government and making last-minute protocol changes to its late-stage effort, Pfizer and BioNTech have quietly gained some timeline ground as they, like Moderna, are now planning a July start date.

The phase 2b/3 trial could start “as soon as later this month,” the partners said in a statement this morning, and they are “anticipating enrolling up to 30,000 subjects.”

Should it past muster, the partners are looking to manufacture up to 100 million doses by the end of 2020 and “potentially more than 1.2 billion doses by the end of 2021.” The trial programs are made up for experimental vaccines under the BNT162 project.

It’s also grabbed, perhaps inevitably, an FDA fast track for two of the four vaccines, namely the two most advanced: BNT162b1 and BNT162b2. This designation can speed the review of the drugs and vaccines.

The fast track comes after some initial U.S. results out earlier this month from an early clinical test of 45 patients that showed all of them who received 10 micrograms or 30 mcg of the mRNA vaccine candidate generated antibodies that were 1.8 times and 2.8 times higher, respectively, than the average of a group of patients who had confirmed prior infections, although it did come with side effects.

Early data from the German trial of BNT162b1 “are expected to be released in July,” the two said. While this will be keenly awaited, the planned phase 2b/3 will be the real test.

“The FDA’s decision to grant these two COVID-19 vaccine candidates Fast Track designation signifies an important milestone in the efforts to develop a safe and effective vaccine against SARS-CoV-2,” said Peter Honig, senior vice president for global regulatory affairs at Pfizer.

“We look forward to continue working closely with the FDA throughout the clinical development of this program, Project Lightspeed, to evaluate the safety and efficacy of these vaccine candidates.”