The second European milestone in the vaccine race comes in a context of utmost urgency and pressure for Brussels.
The European Commission has granted this Wednesday the commercial authorization of the vaccine of the American company Moderna against covid-19, becoming the second antidote with the approval of the Community Executive for its use in the European Union.
The green light has come just hours after the European Medicines Agency (EMA) recommended, in an extraordinary meeting, its approval.
The decision implies that this vaccine may begin to be sent to member states for injection immediately, thus adding to the previously mentioned one from Pfizer, approved in record time on December 21, and whose vaccination campaign began a week later. , on the 27th, stumbling, limping and between harsh criticism in some countries.
"This vaccine provides us with another tool to overcome the current emergency," said Emer Cooke, executive director of the EMA, in a statement.
"That we have this second recommendation for a positive vaccine just one year after the WHO declared the pandemic is proof of the efforts and commitment of all those involved," he added.
The conditional approval, granted after the evaluation of the agency's so-called Human Use Products Committee, comes at a critical time for the EU, as fear of an upturn in infections after the holidays spreads across the continent. Christmas, in a cocktail that no longer knows if it is the second or third wave of the pandemic, spiced up by panic over virus mutations, and with several governments imposing tougher containment measures (in the United Kingdom they have again the March situation) or by prolonging the existing ones to avoid relapse, as Germany and Italy have announced.
The UK currently has more than a million infected with coronavirus
Vaccination proceeds at different speeds in Europe
The European Commission authorizes the marketing of the Pfizer and BioNTech vaccine against covid-19
Currently, the entire EU - except for Finland, much of Greece and a couple of individual regions of France and Spain (Canary Islands and Asturias) - is in red, although with very different incidents, according to the map produced weekly by the European Center for Disease Control and Prevention (ECDC).
This body already warned in a report last week: "The danger of increased pressure on healthcare systems in the coming weeks is high."
In the midst of this growing pressure due to the epidemiological situation, the EMA was about to advance its conclusions to another extraordinary meeting held on Monday, but finally delayed the evaluation to this Wednesday.
The virologist and advisor to the Belgian Government Marc Van Ranst disassociates the urgent approval of the Moderna vaccine from the specific context of the current pandemic.
"I don't think this will put any pressure [on the regulator]," Van Ranst replies.
“If they approve it, it means the vaccine is fine.
But they are not going to look for shortcuts, of that I am sure ”.
160 million doses
According to the agreement signed by the Commission with Moderna, Brussels will have 160 million doses of this new vaccine (originally it signed a contract for the acquisition of 80 million with a purchase option for another 80 million, which it has already exercised), which They will be distributed throughout the 27 EU countries as they are produced, and their distribution will be based on the population, as agreed in the so-called European Vaccine Strategy in June.
The EMA has given its approval for its inoculation in people over 18 years of age.
"And more vaccines will come," said the president of the Commission, Ursula von der Leyen, in a statement.
“Europe has secured up to 2 billion doses of potential vaccines against covid-19.
We will have more than enough safe and effective vaccines to protect all Europeans. "
Its technology, based on messenger RNA, is similar to that of Pfizer / BioNTech and, like this one, it also requires a double injection to immunize the patient.
Its effectiveness of 94.1%, demonstrated in this case in a trial with 30,000 people, is also similar.
But it has a great logistical advantage over its European competitor: Moderna's requires about -20ºC for its conservation, and it can last for about 30 days at refrigerator temperature, facilitating its distribution, transport and storage, since they are already existing standards. in vaccination circuits, while that of Pfizer / BioNTech requires more extreme temperatures of -70ºC.
Problems at the start of vaccination
Logistical problems have marked the first 10 days of the vaccination campaign.
And criticisms of all kinds have rained down: against the EU strategy, against governments, against the laboratory that produces them, or against a combination of these, depending on the country and according to individual cases.
In Germany, where the Pfizer / BioNTech vaccine is very close to them (it has been created in this country and is produced in neighboring Belgium), despite leading the European vaccination campaign in number of injected doses, the Minister of Health has He was accused of not getting enough merchandise and a campaign start fast enough, while his ministry continued to defend the EU's coordinated strategy at all costs.
In France, where in the first week just over 500 people were vaccinated and the president, Emmanuel Macron, came to assure, privately, that they were going at the pace of a “family walk”, according to
Le journal du dimanche
, they have already stepped on the accelerator : just two days later they had exceeded the threshold of 2,000 people.
Prime Minister Jean Cantex assured this Tuesday that they would soon see an "exponential curve" of vaccinated, while denouncing the "sterile controversies that have never ever saved any life."
Faced with criticism, Brussels has always defended its management of "not putting all eggs in the same basket", as the Health Commissioner, Stella Kyriakides, has repeatedly called it.
The European vaccine strategy has never been to have a single puncture and rush to a massive immunization in January, but to gradually deploy a wide portfolio of injections, which are in different stages of preparation, have different technology and they will be approved and arriving throughout the year.
Virologist Van Ranst also downplays cranking at different speeds.
Vaccines, in his opinion, is a long-distance race.
"We are only at the beginning, almost still giving the ceremonial injections from the beginning of the campaign," he says.
“And more vaccines will arrive.
This has always been the scheme ”.
"It is a battle that we are winning, but it will take months"
The issue of vaccination, which monopolizes the European agenda these days, also sneaked in on Tuesday at the inauguration ceremony in Lisbon of the rotating presidency of the community club, whose witness Portugal inherits from Germany for the next six months.
Both the Portuguese Prime Minister, António Costa, and the President of the European Council, Charles Michel, demanded in a press conference to lower the level of "anxiety" and "impatience" generated by the distribution of the antidote.
“We already have the vaccine, we are distributing it and it is in all member states.
It is a battle that we are winning, but it will take months ”, calmed the Portuguese leader, adding that, according to the plan drawn up by the EU, most of the doses will not be injected until the second and third quarters of 2021, and the campaign of vaccination will last even until next year.
"We have to be aware that the discovery of the vaccine, its production, acquisition, distribution and administration cannot be done in a single day."
For his part, Michel announced from the Portuguese capital a new virtual meeting with the heads of state and government of the community club to be held at the end of January to coordinate the deployment of vaccines.
"We are working day and night with the States to increase the number of doses of vaccines available to citizens, but we also have to respect the independence of the European Medicines Agency", he said before the imminent meeting of the EMA.
The high level of anxiety has set the pace at the beginning of the year.
Rafael Vilasanjuan, analyst at the Barcelona Institute for Global Health (ISGlobal) and a member of the board of directors of Gavi, the Vaccination Alliance, considers that the noise and criticism of recent days have created a snowball that has exerted "A lot of pressure" on the EMA.
"There is a kind of idea that the miracle will happen as soon as there is a vaccine," explains Vilansanjuan.
"But then you have to put it on your arm," he adds, alluding to all those factors that come after approval and which are precisely those that are delaying and complicating the campaign: production (which has a limited capacity), logistics distribution (complex because we are facing new vaccines, with temperature requirements), the vaccination strategy (the population sectors that are prioritized according to the phase).
And all this added to a start that has taken place in the middle of a few holidays, which weighs down equipment and personnel capable of vaccinating, already saturated.
“The discourse on the political agenda is that everyone will be vaccinated before the end of the year.
It is a horizon, but not a reality yet.
And this is what generates tension ”, concludes the IS Global analyst.
In any case, to also put into context the times managed, very short compared to anything that has happened before, Vilansanjuan highlights the great scientific feat before which we find ourselves: “Never in the history of humanity has a universal campaign been carried out: for all countries, for everyone ”.
Moderna's was also the second vaccine to receive, on December 20, the go-ahead for emergency use in the United States, where thousands of doses have already been administered.
This vaccine has also been approved for use in countries such as Canada and Israel, and the company has signed distribution agreements, among others, with Switzerland, the United Kingdom, Japan and Qatar.
This week the laboratory announced production forecasts of 600 million doses in 2021, thus increasing its previous estimates by 100 million.
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