Pfizer, BioNTech finish dosing in COVID-19 vax test; emergency use could start in the fall

Pfizer and partner BioNTech are keeping pace with the speed of the sweeping pandemic as they finish dosing in the first cohort of their COVID-19 inoculation test.  

In a brief update, the biotech-pharma partners said that the first cohort of BioNTech’s phase 1/2 clinical trial has been dosed in BioNTech’s native Germany and comes just a week after they were given the all-clear to run trials in the country.

It’s a small study, with just 12 participants, but all have been dosed with BioNTech’s vaccine candidate BNT162 six days after the trial started. Pfizer said it plans to run a U.S. study of BNT162 upon regulatory approval, “which is expected shortly.”

The full dose escalation portion of the phase 1/2 trial will run to around 200 healthy subjects between the ages of 18 to 55 and will target a dose range of 1 µg to 100 µg, “aiming to determine the optimal dose for further studies as well as to evaluate the safety and immunogenicity of the vaccine,” the companies said in a statement.

The study will also assess the effects of repeated vaccination following a prime injection for the three vaccine candidates that contain uridine-containing mRNA or nucleoside-modified mRNA.

A fourth vaccine candidate, which contains self-amplifying mRNA, will be evaluated after a single dose of vaccine. Subjects with a higher risk of severe COVID-19 disease will be included in the second part of the study.

This a new methodology when it comes to researching vaccines, but the pair is hoping the way it works will help speed up the normal process of vaccine development and prove both safe and efficacious for mass use. Fellow German biotech CureVac and U.S. unicorn Moderna are working on a similar approach.

In a call with analysts for its first-quarter financials Tuesday, Pfizer CEO Albert Bourla spoke about its deal with BioNTech and his hopes for the vaccine itself. “This is new technology. But we are very familiar with both the technology and the company [BioNTech], because we are working with them the last two years in a joint project to develop with the same technology, a flu vaccine.

“So, we jumped into the COVID-19 when the need emerged jointly together. And we are applying, of course all the learnings that we had with the technology during the last two years.”

He added that, in terms of timing: “If the technical success and regulatory approvals are there, we will have doses available during the last quarter of this year.” He also thanked the FDA for helping speed up the regulatory process.

Mikael Dolsten, Pfizer’s chief scientific officer, said that the “flow of data” from the first trial should be coming in “May, June, and then move into expanded trials that could allow emergency use or accelerated approval coming in the fall, possibly October and onwards.”

Drilling down into timelines, he said: “When it comes to the specific Lightspeed program, as it's called, that has basically in two to three months moved from the drawing table to dosing patients right now. It contains, as we have announced four different vaccine candidates that will be studied in humans. The first one already dosed. And that allows us more than anyone to cherry pick from a new disease like COVID-19, what mRNA [ph] type, what antigen is the most effective and allows us to pick one or two to move into pivotal studies. So, that covers unmodified mRNA, modified and self-amplifying. To the best of my knowledge, we are the only one currently having self-amplified mRNA in the clinic, which would allow you to dose, at lower dose than any other construct.

“We already have animal data from rodents on the various constructs that are encouraging. And we also have data from patients here that shows that the two antigens that we pick seem to be the most relevant for intervening and utilizing viruses. And by having picked two, spike or the smaller components receptor binding domain again, I think we will be able to cherry pick what turns out to translate most effectively in man.”

He said he thinks Pfizer and BioNTech “have the most comprehensive SARS-CoV-2 vaccine program currently ongoing and it's specifically related to mRNA.”

Pfizer said it was committing around $500 million to R&D for the COVID-19 programs.