Moderna's vaccine begins the process for its authorization in Europe

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The Pharmaceutical Moderna, which yesterday assured that its vaccine has an efficacy of 94.5%, announced this Tuesday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)

.

The

procedure

, or staggered review, is one of the regulatory avenues that the EMA uses to

in a public health emergency situation.

Normally, all data on effectiveness, safety and quality and all necessary documentation must be submitted to the agency at the beginning of the evaluation in a formal application for marketing authorization.

In the case of

, the aforementioned agency committee evaluates the data as it becomes available in the studies in progress before the formal request is requested.

Once the Committee decides that sufficient data is available, that formal request should be made by the company.

By reviewing the data as it becomes available - in a staggered manner -

.

The CHMP already started this type of procedure with the vaccine developed by AstraZeneca and the University of Oxford on October 1.

Days later he did the same with the immunization in which Pfizer and BioNTech work.

And now he does it with Moderna, no doubt after announcing the efficacy results of his vaccine.

Thus, Moderna reported yesterday that the Data Security Oversight Board (DSMB), independent and appointed by the United States National Institutes of Health (NIH), reported that the phase 3 study of its mRNA-1273 vaccine had obtained an efficacy of 94.5%.

The study, known as COVE, enrolled more than 30,000 participants in the United States and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (Niaid) and the Advanced Biomedical Research and Development Authority (Barda).

"The start of the

process

marks an important next step as we continue to advance the mRNA-1273 vaccine in collaboration with European regulatory authorities," said Stéphane Bancel, CEO of Moderna.

"We will continue our ongoing dialogue with the EMA as we seek to develop a safe and effective vaccine. We are also

to be able to deliver approximately 500 million doses per year and possibly up to 1 billion. doses per year, starting in 2021 ".

This same Tuesday, Moderna also announced a

2021 if it is approved for use by the UK regulatory authorities.

The UK Medicines and Health Products Regulatory Agency (MHRA) began the

process

of the mRNA-1273 vaccine on October 27.

"We appreciate the collaboration with the UK Government as well as many other governments and other key partners around the world," Bancel said, adding that "for almost a decade Moderna has invested in creating and developing a novel platform. to design and manufacture a new class of messenger RNA-based vaccines. We are proud of our progress. As we move forward in the clinical development of the mRNA-1273 vaccine, it continues to be a crucial time for all of us. "

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