Moderna has announced that its COVID-19 vaccine candidate – mRNA-1273 – is 94.5% effective, based on an interim analysis from its phase 3 COVE study.
Following the initial positive results, the UK government has secured access to five million doses of Moderna’s COVID-19 vaccine, announcing that the vaccine doses it has secured could be delivered to the UK as early as Spring 2021, with the potential to secure more doses next year.
“[This] is on top of the 350 million doses the UK has already secured from a range of other vaccine developers, putting us towards the front of the international pack on a per capita basis,” said Business Secretary Alok Sharma.
The interim data from the phase 3 COVE study is based on analysis of COVID-19 cases that was confirmed and adjudicated starting two weeks after the second dose of the mRNA-based vaccine within the COVE trial.
Preliminary data from this analysis included 95 cases – with 90 of these COVID-19 cases occurring in the placebo group and five in the vaccinated group – reflecting a point estimate of vaccine efficacy of 94.5%.
The analysis also included a concurrent review of the available safety data by the independent data safety monitoring board (DSMB), which did not report any significant safety concerns regarding the vaccine.
A further secondary endpoint analysed severe cases of COVID-19 cases within the study, with 11 observed, all of which occurred within the placebo group and none within the mRNA-1273 vaccinated arm.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, chief executive officer of Moderna.
The positive data readout closely follows an announcement from Pfizer and BioNTech last week, which revealed that their COVID-19 vaccine candidate BNT162b2 was over 90% effective at preventing the infectious disease.
Pfizer and BioNTech’s interim analysis was conducted after 94 participants in the study contracted COVID-19, with the cases split between the placebo and vaccinated groups reflecting the above efficacy rate for the vaccine.
Moderna could potentially have an advantage over Pfizer/BioNTech’s vaccine, thanks to its storage temperature requirements.
In a statement released yesterday, Moderna said that mRNA-1273 remains stable at standard home or medical refrigerator temperatures (2°C to 8°C) for 30 days and at -20° C for up to six months.
Pfizer and BioNTech’s vaccine, however, must be stored at an ultra-low temperature – below 70°C (94F) – raising certain logistical issues if the vaccine receives regulatory approval soon.
Following Moderna’s positive data readout, the European Medicines Agency (EMA) also announced that it has launched a rolling review of mRNA-1273.
The EMA’s human medicines committee (CHMP) has already started evaluating the first batch of data for the vaccine – which includes non-clinical data – and will then evaluate data from the large-scale trials of the vaccine.
Moderna also said yesterday that it intends to submit the vaccine to the US Food and Drug Administration (FDA) for an emergency use authorisation (EUA) ‘in the coming weeks’.