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Moderna Covid-19 vaccine set for EU approval

European Medicines Agency has recommended that the vaccine be rolled out

The European Medicines Agency, the EU’s drug regulator, has recommended that the bloc should approve the use of the Covid-19 vaccine developed by the company Moderna—paving the way for the EU to roll out its second vaccine against the pandemic.

Moderna’s vaccine was judged “safe and effective” by the EMA on 6 January and will now be assessed by the European Commission, which is a formality. When the EMA recommended the approval of a Covid-19 vaccine jointly developed by the companies BioNTech and Pfizer on 21 December, that vaccine was approved by the Commission on the same day.

“This [Moderna] vaccine provides us with another tool to overcome the current emergency,” said EMA executive director Emer Cooke. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared.”

Commission president Ursula von der Leyen said her institution was “working at full speed to approve [Moderna’s vaccine] and make it available in the EU”.

The vaccine was found to have 94.1 per cent efficacy in a trial involving about 28,000 people—a similar rate to the BioNTech and Pfizer vaccine, which is already being administered in the EU. The trial found 90.9 per cent efficacy in trial participants at risk of “severe Covid-19”, such as people with chronic lung disease or heart disease, the EMA said.

The United States approved the Moderna vaccine on 18 December, having approved the BioNTech and Pfizer vaccine on 11 December. The slower pace of the EU approvals and EU member states’ slower administration of the BioNTech and Pfizer vaccine have provoked some criticism, but the EMA said its process would “assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns”.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, described the EMA decision as “extremely good” news.

He said: “We need many vaccines to be shown to be efficacious, to have no serious harms and to be of high quality. This is firstly because we need as many doses as we can get in this pandemic. Secondly, it is possible that we will find differences in some aspect of efficacy or safety between vaccines and having multiple options will enable this coronavirus to be suppressed worldwide.”