Moderna Seeks Approval in EU and US

Moderna requests the authorization of its coronavirus vaccine for use in the European Union after confirming that it is 94.1% effective.

The final results of the trials of Moderna's vaccine against COVID-19 have confirmed 94.1% efficacy, as reported by the company in a statement. The American biotech company has already sent this data to request emergency authorization for use in the European Union, the United States, and the United Kingdom. The European Commission (EC) approved last week the signing of a contract that will allow the acquisition of "up to 160 million doses" of this experimental vaccine, once it is proven effective and safe.

On November 16, Moderna announced an efficiency of 94.5%, which it has now adjusted to 94.1%, and explained that it could begin to be distributed at the beginning of the year. At the beginning of this trial, which involved 30,000 volunteers, half received the vaccine and the other half saltwater placebo.

Of the 196 COVID-19 positives recorded among the volunteers who participated in the trial, 185 were part of the group that received a placebo, and only eleven had received the vaccine. None of those eleven people have developed a serious illness, but have only had mild symptoms. In addition, there were thirty severe cases of COVID and one death due to this disease during the study, all of which occurred in the placebo group, not the one that received the vaccine.

Moderna's vaccine, like those from Pfizer and BioNTech, uses messenger RNA technology, a novel technique that allows the use of a cell's protein-generating mechanism to generate the desired immune response against viruses such as SARS-CoV-2. Since the beginning of the pandemic, scientists have pointed to this protein as the key to defending against the coronavirus, since it plays an essential role in invading human cells and also activating the immune response.

Modern is much easier to store compared to Pfizer Vaccine

Moderna's vaccine, compared to others also based on RNA as is the case with Pfizer, does not need temperatures below 70 degrees below zero, so its transport and storage would be cheaper and accessible to rural areas or economies in development. In their case, they expect it to hold for 30 days in temperatures of 2-8 degrees and longer in the long term, up to 6 months, at -20 degrees.

The company informs in its statement that it will send the data from its phase III to a scientific publication to be reviewed independently, something that has not yet been met by any of the large pharmaceutical companies announcing their preliminary results. Moderna's vaccine will cost about $25 (21 euros) according to the pharmaceutical company, which will have shipped 20 million doses to the US before the end of 2020. However, it will not be available until next year worldwide, where it hopes to ship between 500 and a billion doses. 

How Moderna's Vaccine Approval Process Proceeds in the US

The Department of Health and Human Services declared on December 11 that the Trump administration increased its purchases of Moderna's Covid-19 vaccine with 100 million more doses. 

Following the initial purchase announcement by Moderna, the US government increases its commitment to 200 million vaccine doses, 20 million of which are set to be delivered to states by the end of the month. The remaining part will be delivered in the second quarter of 2021. The drugmaker applied for the FED's emergency use approval for the vaccine, dubbed mRNA-1273, and administered in 2 doses with 28-day intervals. The agency is expected to announce its decision next week.

Wall Street analysts forecast that Pfizer and Moderna will win $32 billion in Covid-19 vaccine revenue in 2021, reports a CNN article.