Brussels Gives a Free Pass to Moderna

Brussels Gives a Free Pass to Moderna

Europe already has its second vaccine against SARS-CoV-2. The European Commission has quickly approved Moderna's alternative this Wednesday after the positive recommendation made by the European Medicines Agency (EMA).

"We have authorised the @moderna_tx vaccine, the 2nd vaccine approved in the EU." twitted the European Commission president, Ursula von der Leyen. The company expects the first deliveries to begin next week.

At a meeting of the EMA's Committee for Medicinal Products for Human Use (CHMP), experts evaluated data from human trials and confirmed their efficacy and safety, a necessary preliminary step for the European Commission (EC) to authorize their marketing.

The approval comes at a time when the third wave of the pandemic appears to be sweeping across Europe. In this way, Moderna's product against Covid-19 joins that of Pfizer/BioNTech, approved on December 21 and injected from December 27 to the most vulnerable people in the 27 member states.

The EC has granted conditional marketing authorization (CMA), a process that usually takes up to 60 days, but has been reduced to hours, in the same way, that happened with Pfizer/BioNTech.

Made by Rovi

"This vaccine gives us another tool to overcome the current emergency," said Emer Cooke, executive director of the EMA in a statement. "It is a testament to the efforts and commitment of everyone involved that we have had this second positive vaccine recommendation just under a year since the WHO declared the pandemic."

The US laboratory will provide 160 million doses thanks to the agreement reached by the EC. By the proportional distribution to the population, Spain will account for around 16.8 million injections, enough to inoculate 8.4 million people.

Currently, the exact price of this product is unknown due to the confidentiality agreements between Brussels and the company, but it is estimated to be slightly less than 21 euros per dose, the most expensive version of all the commercial agreements signed by the company. Commission.

Moderna's vaccine will be produced for the whole world, except for the US market, at Laboratorios Rovi's San Sebasti√°n de los Reyes (Madrid) plant. This Madrid company will receive the antigen from the Swiss company Lonza and be in charge of the final formulation, filling vials and finishing at its factory.

The EU becomes one of the first markets for Moderna's vaccine, which is already being distributed in the US, Canada, and Israel. The company announced in November that its solution protects from Covid-19 infections by 94.1%. Similar to Pfizer's, it uses messenger RNA (mRNA) technology, and for its distribution, it must be frozen at less than 20º below zero (compared to 75º below zero for its competitor).

Moderna has set itself to produce between 600 and 1 billion doses to distribute around the world, a figure lower than the 1.3 billion expected by the Pfizer consortium and its German partner BioNTech.

The Von der Leyen Executive recently reached an agreement with Moderna to double that supply, initially planned at 80 million doses, because the burden of vaccination in Europe in the coming weeks will fall solely on the compound of this company and that of Pfizer / BioNTech, which contributes 300 million units. In fact, Brussels is negotiating to buy another 300 million doses from the latter consortium to speed up the immunization process.

For now, these two products will be the lifesavers that European countries cling to in their fight against the coronavirus because the rest of the experimental vaccines for which the EC has supply agreements will still take some time to arrive. The next expected - and which the EMA is already analyzing - are those of Janssen (Johnson & Johnson group) and AstraZeneca, which began to be inoculated in the United Kingdom this week. However, further behind are the CureVac and Sanofi (which recently announced that after a first failure, it does not expect its own development until the end of the year).

Vaccine details

"As with all medicines, we will closely monitor data on the safety and efficacy of the vaccine to ensure the continued protection of the EU population. Our work will always be guided by scientific evidence and our commitment to safeguarding the health. of EU citizens," said Cooke, the director of the EMA.

Before it is now injected into the population, this product has been tested in a large, very large clinical trial of 30,000 people, which showed that it effectively prevented Covid-19 in people aged 18 years and older, according to the agency.

The trial showed a 94.1% reduction in the number of symptomatic cases of the disease in people who received the vaccine (11 out of 14,134 people) compared to those who received placebo (185 out of 14,073 people). It is given as two injections in the arm, 28 days apart.

For now, these two products will be the lifesavers that European countries cling to in their fight against the coronavirus, because the rest of the experimental vaccines for which the EC has supply agreements will still take some time to arrive. The next ones that are expected - and that the EMA is already analyzing - are those of Janssen (Johnson & Johnson group) and AstraZeneca, which began to be inoculated this week in the United Kingdom. However, further behind are the investigations of CureVac and Sanofi (which recently announced that after a first failure, it does not expect its development until the end of the year).