Covid Vaccines : Moderna to apply for US and European emergency authorization today

Tuesday, 01 December 2020 - 8:57

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Continuing the spate of excellent news about COVID-19 vaccines, the biotech company Moderna announced the final results of the 30,000-person efficacy trial for its candidate in a press release yesterday (30 Nov) according to foreign media.

Moderna will apply for US and European emergency authorization for its COVID-19 vaccine on Monday after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns. Moderna also reported that the vaccine's efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 1.5 million people.

The company plans to file a request for emergency use authorization (EUA) for its vaccine with the U.S. Food and Drug Administration (FDA), and is also seeking a similar green light from the European Medicines Agency.

The filing sets Moderna's product up to be the second vaccine likely to receive US emergency use authorization this year following a shot developed by Pfizer and BioNTech which had a 95% efficacy rate in trials.

Pfizer has already applied for emergency use authorization in the United States and Europe, putting it about a week ahead of Moderna.

Moderna’s vaccine against SARS-CoV-2, the virus that causes COVID-19, relies on a novel technology that uses messenger RNA (mRNA) to code for a protein called spike that studs the surface of the pathogen. Pfizer and BioNTech have developed a similar mRNA vaccine against COVID-19 and also reported excellent results with an efficacy of 95%, in the final analysis of their 45,000-person trial. 

While both of the vaccines use a new technology called synthetic messenger RNA (mRNA) others, such as Britain's AstraZeneca, are using more traditional methods to develop their vaccines.

Moderna received $1 billion from the U.S. government’s Operation Warp Speed to help develop its mRNA vaccine.

Moderna CEO Stéphane Bancel has stated that Moderna plans to charge $32 to $37 per dose of the vaccine in developed countries, but will have cheaper pricing for other parts of the world.

Pfizer filed an EUA request for its vaccine last week, which led FDA to announce it will convene a meeting of its vaccine advisory committee to discuss the data in depth on 10 December. According to Moderna FDA might convene the committee again as early as 17 December to review its EUA application. 

Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.