The ongoing Phase I/II trial, taking place in the US, is testing BNT162b1, an mRNA vaccine candidate against the novel coronavirus.
The companies revealed snippets of the data from the trial, which showed that all recipients of the trial receiving 10 or 30 µg of BNT162b1 had elevated antibodies against the virus.
There were 45 healthy adults included in the study, with 24 administered two doses of 10 and 30 µg, 12 who received a single 100 µg, and nine who were the placebo control.
However, the higher dose of 100 µg was found to provide no significant increases in immunogenicity but did show greater numbers of local reactions and systemic events. As a result of this, the participants only received a single dose of this strength of vaccine.
“These preliminary data are encouraging in that they provide an initial signal that BNT162b1 targeting the RBD SARS-CoV-2 is able to produce neutralizing antibody responses in humans at or above the levels observed in convalescent sera – and that it does so at relatively low dose levels,” said Ugur Sahin, CEO of BioNTech.
The companies will now use the data gathered to determine the dose level for further trials. The Phase IIb/III trial is expected to begin in late July 2020 and could contain 30,000 healthy participants.
In addition to BNT162b1, the two companies have a further three mRNA vaccine constructs that are being clinically tested.
Manufacturing capacity
Alongside trial results, the two companies revealed that they will be able to manufacture up to 100 million doses of vaccine by the end of 2020.
Further than this, they stated that there is potential for more than 1.2 billion doses to be produced by the end of 2021.
Last month, Pfizer announced that it was looking to outsource the manufacture of part of its portfolio in order to free up space to produce the vaccine.
While BioNTech has completed several fundraising efforts in the last few weeks, as it looks to scale its vaccine manufacturing capabilities.
Aside from in-house manufacturing, the companies are also working with partners to increase capacity for the manufacture of the mRNA vaccine, such as with Acuitas therapeutics that is producing lipid nanoparticles for the formulation of the mRNA vaccines.
Vaccines reaching late-stage trials
Pfizer and BioNTech’s announcement arrives as a greater number of companies are beginning to enter late-stage trials for their vaccines.
Moderna, which is also working on a mRNA vaccine, has entered late-stage trials and partnered with Catalent for the fill-finish of its vaccine – AstraZeneca has also reached the same stage.
Inovio also released positive results earlier this week on its vaccine, though with fewer details on the trial.
