Biotech company Moderna said it will today ask for approval of its COVID-19 vaccine in both Europe and the US.
The firm made the announcement as it said that the most recent trial results showed its vaccine was 94.1% effective. Moderna said the vaccine was 100% effective against severe COVID-19. This was largely in line with preliminary results earlier this month.
The company will file for conditional approval from the European Medicines Agency and for an emergency use authorisation from the US Food and Drug Administration.
“This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and importantly, the ability to prevent severe COVID-19 disease,” said Stéphane Bancel, chief executive officer of Moderna.
“We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalisations and death,” he continued.
It came after results showed that 196 of the 30,000 participants in Moderna’s phase three trials contracted COVID-19. Just 11 of those cases were among people who received the Moderna candidate vaccine.
The company, which worked with the US National Institutes of Health (NIH), has said it expects an advisory committee meeting with the US FDA on December 17.
It is just behind US pharmaceutical company Pfizer, which is working with German biotech company BioNTech, which filed for US authorisation on November 20. The European Medicines Agency is also doing a rolling review of the vaccine candidate.
Moderna has an agreement with the European Commission for 80 million doses of the vaccine, with the option for the EU to secure a total of up to 160 million doses.
The vaccine’s side effects were generally “mild or moderate” and included pain at the injection site, fatigue, muscle pain and headache, the company said earlier this month.
There was one COVID-19-related death in the study which occurred in the group that did not receive the candidate vaccine.
The company said there were no serious safety concerns identified related to the vaccine.
The vaccine is based on new technology that contains mRNA or genetic instructions that help the body to recognise the coronavirus’ spike protein — which it uses to enter the body’s cells.
Two other companies Pfizer and AstraZeneca recently released efficacy information about their vaccines, as well, fuelling hopes that a vaccine could be approved by the end of this year or early next year.
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