The upcoming trials in 30,000 volunteers in a real-world setting will give experts a comprehensive look at its effectiveness and feasibility.
Since the first recorded use of ‘immunisation’ in humans to prevent smallpox (in 1796), the development and scope of vaccines has seen some, incremental progress. A new technology in development – messenger RNA vaccines – holds the potential to disrupt the entire approach to vaccine development.
An mRNA molecule developed by American firm Moderna Therapeutics – mRNA-1273 – is among the leading candidates in human trials for a working vaccine against the COVID-19-causing SARS-CoV-2 virus. Since the start of the pandemic that has brought the world to a halt, the company’s stock price has tripled.
Moderna isn’t the only company focused on mRNA, but it is currently the front runner in developing the technology, with over 20 different mRNA vaccines in their pipeline.
In 2010, the company saw the biggest initial public offering (IPO) on record for a biotech company, raising a whopping $600 million for 8 percent of the company’s shares. In the ten years since, Moderna has come to be the most valued biotechnology company in the world. All because it has gone further than any other venture in developing a game-changing platform for mRNA vaccines in medicine.
The novel coronavirus was declared a pandemic of international concern by the WHO in April.
Experts, trial volunteer advise ‘cautious optimism’
The COVID-19 vaccine developed by Moderna became the first mRNA candidate to began human trials on 16 March. It is now one of many mRNA candidates in COVID-19 clinical trials.
German companies BioNTech (in partnership with Pfizer) and CureVac, US firm Translate Bio (with Sanofi) and Shanghai-based Fosun Pharma, all have an experimental mRNA vaccine in different stages of approval and trials. If one or more of these vaccines prove effective, it will be the first proof-of-concept for the development and use of mRNA vaccines in infectious diseases.
According to the listing by Moderna for its mRNA-2173 COVID-19 vaccine in the US government clinical trial registry, the company has been given approval for final (Phase 3) trials in 30,000 healthy volunteers starting 27 July.
This comes after the vaccine saw promising results in Phases 1 and 2, but it wasn’t without its hitches. In the 45-person Phase 1 human trial, four participants reported having “Grade 3” adverse events — side effects that are severe or medically-significant but not life-threatening, according to a STAT News report.
One of them, 29-year-old Ian Haydon, went public with his experience. Twelve hours after the booster dose of the mRNA vaccine was given to him, Hayden had a fever over 103 degrees, called for medical assistance, and fainted in his home after being released from an emergency care facility that day. While the experience was all but pleasant, he recovered within a day and hasn’t reported any side-effects since.
Hayden decided to speak out, according to STAT News, hoping that his experience counterbalances the desperation from the public to push a working vaccine to market without much regard for consequences. A similar sentiment has been expressed by many experts in their comments about the experimental mRNA vaccine trials.
“I would agree with [Hayden] in that human trials are meant to take the time they take. The Moderna vaccine has sought approval to combine Phase 1 and 2, now on its way to starting Phase 3 trials by 27 July,” says Dr Shahid Jameel, virologist and Chief Executive Officer of the Wellcome Trust-DBT India Alliance.
But there are still questions about the released results that need answering.
For instance, over 90 percent of patients in Phase 1 trials are white Caucasians. This indicates that race wasn’t a key factor in the earlier trial stages. Research has shown time and again that race is a key determinant in the effectiveness of a vaccine intended for a diverse range of people. In the case of a COVID-19 vaccine, it’s even more important, due to its global relevance.
A fair mix of different racial groups is something that can – and should – be accounted for in the upcoming Phase 3 trials, according to Dr Jameel. “The upcoming trials in 30,000 volunteers in a real-world setting should give us a more comprehensive look at [the vaccine’s] feasibility.”
The medical research community is eager to see Moderna’s Phase 3 trials. A successful Phase 3 will be a big endorsement for the mRNA vaccine platform, which promises to improve speed, reduce costs, and revive the limited scope of vaccine development as it stands today.
Jonathan Watts, an associate professor at the RNA Therapeutics Institute at the University of Massachusetts Medical School, who doesn’t have ties to Moderna, told Biopharma Dive, “I’m cautiously optimistic that this could be a game-changing technology for things that have been really hard until now.”
Moderna’s mRNA vaccine for COVID-19
The first published results released from Phase 1 and 2 this week show that Moderna’s experimental mRNA vaccine did what it was designed to: produce COVID-19 antibodies that can direct the immune system to the SARS-CoV-2. The published study also says a booster shot – given four weeks after the first one – was needed to produce a strong enough immune response against the virus.
Dr Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, which conducted the Moderna clinical trial, said the results, nonetheless, were promising enough to give the company a go-ahead for the next phase of trials.
“The hallmark of a vaccine is one that can actually mimic natural infection and induce the kind of response that you would get with natural infection. And it looks like, at least in this limited, small number of individuals, that is exactly what’s happening,” Dr Fauci told STAT News. “The data really look quite good…there were no serious adverse events.”
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mRNA vaccines – a key that opens many doors
The mRNA vaccine platform Moderna has been developing for a decade now is a single platform that gives researchers the tools to tackle a diverse range of diseases. The company’s mRNA platform can theoretically be applied to any potential infection – be it in the case of persistent threats from infections like HIV and influenza, or addressing unmet needs in future encounters with viruses (like SARS-CoV-2) and bacteria that are unknown today.
Moderna, for one, is working on around 25 mRNA vaccines and therapies for a range of conditions including rare metabolic disorders, cancers, heart failure, and a host of pathogens including the Zika virus, the Epstein-Barr virus, and now the SARS-CoV-2 virus.
The technology is also guaranteed to slash the costs and time it takes to manufacture vaccines since it leaves the tedious task of manufacturing viral proteins to the cell instead of biotech companies.
“The major benefit is that it’s easy to produce (and) it will also probably be relatively easy to do an upscaling of production, which of course, is very important if you think about deployment [throughout] the world,” Professor Isabella Bekeredjian-Ding, head of the microbiology at Germany’s Paul Ehrlich Institut, which provides scientific advice to companies (including CureVac) on vaccine development, told Horizon.
With promising results to show for its Phase 1 and 2 trials, Moderna is now on its way to do just that – scale up production and test its experimental mRNA vaccine in 30,000 healthy volunteers.
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