LONDON – The EMA has recommended approval of Moderna Inc.’s COVID-19 vaccine, becoming the fourth western regulator to do so, after Israel approved the product on Jan. 5 and the FDA and Health Canada in December.

Moderna’s is the second COVID-19 vaccine to pass EMA scrutiny, after the agency issued a positive opinion on Pfizer Inc./Biontech SE’s Comirnaty on Dec. 21.

“This vaccine provides us another tool to overcome the current emergency,” said Emer Cooke, executive director of the EMA, announcing the approval. “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 by the World Health Organization,” she said.

The comment reflects the defensive stance the EMA is taking over criticisms about it being slower than other regulators in reviewing COVID-19 vaccines files, in particular that the U.K. Medicines and Healthcare products Agency (MHRA) was first to approve Pfizer/Biontech’s Comirnaty.

Under that pressure, the EMA’s expert committee on human medicines, CHMP, brought forward meetings to examine the Comirnaty and Moderna files, and put out a statement after office hours on Dec. 30 when MHRA approved the Astrazeneca vaccine, saying it needed more information from the company.

In defense of the pace of its reviews, the EMA has underlined that it is alone in granting conditional marketing approvals, rather than emergency use authorizations. That puts extra onus on the companies to file follow-up data and to conduct further studies, such as pediatric trials and investigations of the safety of vaccinating pregnant women, and gives it as a regulator greater oversight, the EMA said.

The second approval of a COVID-19 vaccine for use across the 27 EU member states comes as the level of infection and the number of deaths is rising across Europe, according to data collated by the European Center for Disease Prevention and Control.

Even countries like Germany and Denmark, which were relatively successful in containing the first wave of the pandemic, are seeing the number of cases threatening to become unmanageable in the current second wave.

The federal government in Germany has faced particular criticism that Comirnaty, a vaccine discovered and partly developed by a local company, Mainz-based Biontech, was available in other countries first.

In large part that is because EU countries chose not to use national approval routes and instead to rely on the EMA’s central authorization process. At the same time, they handed procurement of COVID-19 vaccines to the European Commission, pooling their procurement heft and ensuring all member states would have equal access.

Acting on behalf of member states, the European Commission has made an advance purchase agreement for 80 million doses of the Moderna vaccine, and has an option to buy 80 million more.

Speaking at a press conference just in advance of the EMA approval for Moderna’s vaccine, German Health Minister Jens Spahn said the reason the country’s vaccination campaign has been slow to gather pace “is not insufficient quantities ordered, but rather low production capacities.”

Spahn added, “We want to protect those first who are most vulnerable. Once the people in need of care and the elderly have been vaccinated, the pandemic will lose a large part of its horror.”

There will be enough vaccine for everyone in Germany, Spahn promised. “As of today, I assume that we will be able to offer everyone a vaccination [by] the summer, because we have ordered enough vaccine, from several manufacturers,” he said.

On Jan. 4, Cambridge, Mass.-based Moderna said it currently has the resources in place to manufacture 600 million doses in 2021, and is investing to build capacity with the aim of increasing that to 1 billion doses.

Of current production, 200 million doses will be delivered in the U.S. in the first half of 2021, with the company reporting that 18 million doses have been supplied to the U.S. government to date.

The Canadian government has an agreement to purchase 40 million doses, as has South Korea. Switzerland has ordered 7.5 million doses, Israel 6 million and the U.K. 7 million.

Lonza Ltd. is manufacturing the Moderna vaccine in the U.S. and Europe, while Catalent Inc. is doing fill and finish in the U.S., and Recipharm and ROVI in Europe.