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Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium.
As the EMA gives Moderna's COVID vaccine the thumbs up, the European Commission has quickly followed up with its own approval.
Today, the traditional day of gift-giving, provided vaccine-starved Europe with the present of another authorized vaccine against COVID, as the European Medicines Agency(EMA) gave Moderna's product a green light, and the European Commission followed up within hours with its formal approval.
The twelfth day of Christmas, when the three kings brought their gifts to Bethlehem, couldn't have come soon enough for the European authorities, beleaguered by complaints over delays and deficiencies in product authorization and accusations of mis-managing the procurement of vaccines.
The authorization procedure has been fast. EMA started a rolling review of the Moderna data in November, and the company submitted its application for marketing authorization on November 30th. EMA's human medicines committee assessed the data and recommended today by consensus that a formal conditional marketing authorization is granted. On the basis of EMA's positive opinion, the Commission immediately verified all the elements supporting the marketing authorization and consulted EU member states—who are responsible for the vaccines marketing and the use of the product in their countries—before granting the authorization. Emer Cooke, EMA executive director, said, “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 WHO."
On the basis of a trial involving 30,000 people in a two-dose regimen and showing a 94.1% efficacy across genders, racial and ethnic groups, the indication is to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. The company is required to provide monthly safety reports in addition to the regular updates required by the legislation and conduct studies to monitor the safety and effectiveness when used by the public. In addition, independent studies of COVID-19 vaccines coordinated by EU authorities will also give more information on the vaccine’s long-term safety and benefit in the general population.
A relieved Ursula von der Leyen, the president of the European Commission, announced, “We are providing more COVID-19 vaccines for Europeans." With the Moderna vaccine, the EU will receive 160 million doses, on top of the 300 million doses of Comirnaty from BioNTech/Pfizer.
But when? 460 million doses will be rolled out "with increasing speed", said European health commissioner Stella Kyriakides. That isn't very precise—but the Commission says, "between the first and the third quarters of 2021".
"And more vaccines will come," assured von der Leyen. "We'll have more than enough safe and effective vaccines for protecting all Europeans.” Through its advance purchase agreements with half-a-dozen manufacturers, "Europe has secured up to two billion doses of potential COVID-19 vaccines." But for when? Certainly not in the immediate future. "In the next one to two months we will have submissions for marketing authorization of possibly another one to two vaccines, which I cannot be sure about at the moment," said Kyriakides. In addition, although Moderna plans to boost global manufacture to as much as 600 million doses for 2021, there is no information on how much of that additional production would be allocated to the EU. Meanwhile, national governments continue to squabble over the allocation of Comirnatyn, the only vaccine currently available in the EU.
And when will all these jabs get into European citizens' arms? With EU supplies arriving "with increasing speed", it is up to individual EU countries "to ensure that the pace of vaccinations follows suit," said Kyriakides. But today EU officials admitted that there are "dramatic variations across the EU" in the speed of roll-out, insisting, "It is member states who have primary responsibility for organizing vaccination campaigns."
The three kings haven't got the EU out of the woods yet. Widespread reports of delays in delivery of vaccines, complaints over secrecy and mis-management of the procurement and accusations of slow national roll-outs are marring the celebrations. And the European Parliament's health committee has summoned EU officials on January 12th "to explain before the parliament the management of the vaccination campaign by the Commission." Will the Easter bunny be able to complete the job? or will it be down to Santa Claus at the end of 2021?