Moderna to apply for EU's rolling approval for COVID-19 vaccine

Bengaluru, October 8

Moderna Inc will soon apply for real-time reviews of its experimental COVID-19 vaccine in Europe, the drug developer said on Thursday, days after the EU health regulator launched rolling reviews of shots from its rivals.

The drug developer said it was in talks with European countries and would submit the same data it plans to submit to the US Food and Drug Administration for authorisation.

The European Medicines Agency earlier this week launched real-time reviews of COVID-19 vaccines being developed by US drug-maker Pfizer and Germany’s BioNTech, following a similar announcement for AstraZeneca’s.

Real-time reviews could speed up the process of approving a successful vaccine, by allowing researchers to submit findings in real time, without waiting for studies to conclude.

Moderna, one of the furthest along in the US race for a COVID-19 vaccine, said the ongoing US trial of its candidate, MRNA-1273, was on track for a data readout by November.

The company said it would not enforce patents related to its experimental COVID-19 vaccine during the pandemic and would not pursue any litigation against companies that make use of its technology after the coronavirus outbreak ends.

The decision was taken to allow other drug-makers to develop shots using the company’s technology, said Moderna executives.

The company also said it was willing to license the technology behind the vaccine after the pandemic.

Earlier on Thursday, the Defense Advanced Research Projects Agency (DARPA) awarded Moderna $56 million to develop mobile manufacturing units for rapidly producing vaccines and therapeutics. Reuters