The US government has agreed to provide a whopping $483 million in federal funding to propel Modera’s coronavirus vaccine to FDA approval and ramp up production capacity.
The award is something of a gamble, coming before data from an ongoing phase 1 trial of Moderna’s mRNA-1273 is available. Nevertheless it will allow the biotech to hire 150 new staff members, accelerate clinical development of the vaccine and start a phase 2 trial within weeks.
The Biomedical Advanced Research and Development Authority (BARDA) is effectively picking up the tab for both mRNA-1273’s development and pandemic-scale manufacturing – in other words tens of millions of doses – assuming it works as hoped in trials.
The National Institutes of Health is conducting the first trial of mRNA-1273, which is one of three coronavirus vaccines in clinical testing so far out of around 70 in development, according to the World Health Organization (WHO).
This week the NIH completed enrolment of 45 patients according to the study’s original protocol, which tested three doses of the vaccine (25 µg, 100 µg and 250 µg). They will be followed through 12 months, and the primary goal is to test the safety and reactogenicity of a two-dose schedule of the shot, along with preliminary data on immune responses.
It has now been decided to expand the trial with an additional six patient cohorts, looking at the same three dose levels in older subjects (aged 56 to 70) and elderly patients (aged 71 or above).
If that study is positive, Moderna will start its own phase 2 trial in the second quarter, and that could be followed by a phase 3 study in the autumn – which is breakneck speed for a vaccine development programme.
The 15 new hires will mainly be allocated to the manufacturing scale-up, and will allow it to expand production from two shifts a day for five days in the week, to three shifts a day all week long.
“We believe that we would be able to supply millions of doses per month in 2020 and with further investments, tens of millions per month in 2021, if the vaccine candidate is successful in the clinic”, said Moderna’s chief executive Stéphane Bancel.
Moderna is focused on development of vaccines based around mRNA, which present antigens to the body that instruct it to make antibodies against specific targets. So far the company has not brought any mRNA-based vaccines through development.
In the case of mRNA-1273, the vaccine instructs the body to make antibodies against a stabilised form of the Spike (S) protein found on the SARS-CoV-2 virus. Moderna made the vaccine based on the genetic sequence shared by Chinese authorities in early January.
At the moment a Chinese vaccine developed by CanSino Bio and the Beijing Institute of Biotechnology is the furthest along in trials – having already started phase 2 – but with BARDA’s support Moderna could gain ground quickly.
Inovio meanwhile has a DNA-based candidate called INO-4800 in a phase 1 trial involving 40 healthy volunteers which started earlier this month.
With global cases of coronavirus now well above two million and deaths heading towards 150,000 worldwide, reducing the time to having a vaccine is critical, to save lives and scale back the lockdowns that are hitting global economies hard.
“BARDA’s goal is to have a vaccine available as quickly as possible,” said the agency’s director Rick Bright.
“Preparing now for advanced stage clinical trials and production scale-up while phase 1 is underway could shave months off development of COVID-19 vaccines,” he added.
