The European Commission on Wednesday granted a conditional marketing authorization for Moderna’s COVID‑19 vaccine mRNA-1273, making it the second coronavirus vaccine authorized in the EU. The decision comes hours after the European Medicines Agency (EMA) had recommended authorizing mRNA-1273 in people 18 years of age and older. Emer Cooke, executive director of the EMA, said “this vaccine provides us with another tool to overcome the current emergency,” following the recent clearance of Pfizer and BioNTech’s coronavirus vaccine Comirnaty late last month.
Stella Kyriakides, EU commissioner in charge of health, said “we are authorizing a second safe and effective vaccine from Moderna, which together with Pfizer/BioNTech, will ensure that 460 million doses will be rolled out with increasing speed in the EU, and more will come.” Moderna’s vaccine has already been authorised for emergency use in the US, Canada and Israel.
The EMA, which began reviewing Moderna’s filing for mRNA-1273 early last month, based its recommendation on an interim analysis conducted on 196 cases from an ongoing phase 3 study. Results showed an efficacy rate of 94.1% at reducing the number of symptomatic COVID-19 cases among people who had no sign of previous infection. The trial also demonstrated 90.9% efficacy in participants at risk of severe COVID-19, including those with comorbidities such as chronic lung disease, heart disease, obesity and diabetes.
EMA sticks to dosing schedule
The EU regulator advised giving two injections of Moderna’s vaccine 28 days apart, without weighing in on a debate about whether waiting longer between doses in order to be able to vaccinate more people is acceptable. Meanwhile, in a bid to protect a broader swath of the population, some US officials have also suggested halving the dose of mRNA-1273 in adults under 55, another controversial issue the EMA did not address. The FDA recently came out in favour of sticking with currently authorized dosing schedules for COVID-19 vaccines, arguing there is not enough evidence to make changes at this point.
Meanwhile, the EU has already pre-ordered 160 million doses of Moderna’s vaccine that are expected to be delivered between the first and the third quarters of 2021. The region has been offering Pfizer and BioNTech’s product, also known as BNT162b2, since December 27 to nursing-home residents and healthcare workers. However, the rollout has been hampered by logistical bottlenecks, wasted doses, challenges of bringing temperature-sensitive vaccines to distant facilities, and even reluctance by some to get the vaccination. Still, Moderna’s candidate may offer some hope for a faster rollout as it does not require storage at temperatures as low as Comirnaty, nor does it have to be diluted before use.