Modern announced on Tuesday that the European Medicines Agency (EMA) has begun to review the results of the tests of its possible vaccine against covid-19, which has been shown to be effective in 94.5% of cases in preliminary results, while which closed an agreement with the United Kingdom to provide the vaccine once it has been approved for use.
The review of the mRNA-1273 vaccine will be carried out through the subsidiary of Modern in Spain and will shortly include data from the phase 3 tests that the drugmaker first released yesterday showing a successful immune response against SARS-CoV-2.
Moderna will work with the Committee for Medical Products and for Human Use (CHMP) of the European regulator, according to the Massachusetts-based company in a statement, reports Efe.
“The beginning of the ongoing review process marks an important step as we continue to develop mRNA-1273 in collaboration with European regulatory authorities,” Moderna’s CEO said in a statement. Stéphane Bancel.
“We will continue our dialogue with the EMA as we develop an effective and safe vaccine. We are also increasing our global manufacturing capacity with strategic partners from Lonza, in Switzerland, Y Rovi in Spain, to be able to deliver approximately 500 million doses per year and possibly up to 1,000 million in 2021, “said Bancel.
Moderna also announced that it has reached an agreement with the British Government to provide the mRNA-1273 vaccine from March 2021, once it is approved for use in the general public by the UK drug regulator.
Modern is rapidly advancing its agreements to open markets to your vaccine candidate once its efficacy and safety is confirmed with new data, after yesterday the first data from the phase 3 trials indicated that they are on the right track.
The vaccine, which has been administered to part of the 30,000 volunteers in the phase 3 trials, stimulated an immune response in 5 of the 95 volunteers who became infected with Covid-19 during the trials.
The rest of those 95 had received a placebo, used to compare the evolution of the disease in the unvaccinated population. The tests depend on volunteers being infected with the virus in the real world, so an increase in infections nationwide like the one that is taking place in the US helps to speed up the process.
Moderna presented its preliminary efficacy results a week after Pfizer announced that its vaccine candidate is 90% effective, above what the US regulator requires, and they hope to start their emergency approval in weeks.
Moderna’s vaccine has the advantage that it can be stored in conventional refrigerators even above freezing, while Pfizer’s requires sophisticated freezers that keep it below minus 70 degrees.