Moderna requests approval for its vaccine in Europe and the United States
The vaccine race is entering its final phase with hopeful new news as the Moderna pharmaceutical company requested urgent approval today, from the European Union and the United States to market its vaccine, one of the formulas, along with that of Pfizer, which are probably the first to be used in Spain.
Moderna announced that the results of its phase 3 clinical trial to test its formulation, mRNA-1273, confirm an efficacy of 94.1%. The successful preliminary results, which have now been corroborated by a study involving 30,000 volunteers in the United States, have prompted the company to apply to the US FDA for authorization for the "emergency" use of this vaccine, as Pfizer did a few days ago with theirs.
Alongside each other, Moderna, as announced earlier today, also asked the European Medicines Agency for a "conditional authorization" for the marketing of mRNA-1273 in the EU, which just a week ago announced the acquisition of 160 million doses of the vaccine (80 million in a first batch, followed by another 80 million later).
However, Moderna's vaccine is only one of the EU's choices as the European Commission has closed agreements to purchase vaccines from five other companies:
- the BioNTech consortium and Pfizer;
- AstraZeneca-University of Oxford;
- Janssen Pharmaceutica NV (Johnson & Johnson);
The Commission has ordered 1.2 billion doses in advance with these other five groups, of which more than 580 million would be in reserve. Spain is responsible for 10% of these amounts.
Moderna has decided to request urgent processing of permits in its two main world markets after its new studies have yielded as promising data as previous ones. If two weeks ago the first analyzes revealed a 94.5% efficacy of the formula, the tests of the last days point to an almost identical percentage of immunity: 94.1%.
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Thus, Moderna reported that of 196 participants in its last clinical trial who were infected with Covid-19, 185 belonged to the placebo group and 11 to the vaccinated group. "No serious form of the disease was registered in the vaccinated group," said the pharmacists, who claim that the vaccine has a 100% success rate in preventing serious cases.
Of the rest of the western projects for which reliable data are available, only the Pfizer formula achieves similar efficacy to Moderna's vaccine, so few EU technicians doubt that vaccination campaigns will start with the compounds of these two laboratories.
The delivery of Moderna's vaccine to the EU, according to the agreement signed last week between the pharmaceutical company and the commission, could begin as early as the first quarter of 2021 if the Human Medicines Committee of the European Medicines Agency (EMA), approves it for use. The agency began a "continuous review" of this vaccine on November 17th.
In addition to the EMA, Moderna has also sent the data from the successful clinical trial to other regulatory agencies in Canada, Switzerland, the United Kingdom, Israel and Singapore, and intends that the WHO shortly classify the vaccine within its list of medicines for emergency use.