Published 19:01 IST, November 30th 2020
Moderna to ask US FDA and European regulators to allow emergency use of its COVID vaccine
US biotech company Moderna has said that it would ask US and European regulators on Monday to allow emergency use of its coronavirus vaccine.
Advertisement
US biotech company Moderna has said that it would ask US and European regulators on Monday to allow emergency use of its coronavirus vaccine. Moderna has created its shots with the US National Institute of Health and a recent study revealed that its vaccine candidate offers strong protection and is more than 94 per cent effective. Moderna is ramping up the race to being limited vaccinations as the COVID-19 pandemic worsens.
Previously, the US pharmaceutical company had said that shots effectiveness and a good safety record so far with only temporary, flu-like side effects mean they meet requirements set by the US FDA for emergency use before the final-stage testing is completed. While the European Medicines Agency (EMA) has signalled it is also open to faster, emergency clearance, FDA, on the other hand, has pledged that before it decides to roll out any COVID vaccines, its scientific advisers will publicly debate whether there’s enough evidence behind each candidate. If the US FDA gives the biotech firm the EUA, Moderna expects to have around 20 million doses ready for the US by years end.
Meanwhile, Moderna's Chief Executive Stephane Bancel has stated that the drugmaker will charge governments between $25 and $37 per dose of its COVID-19 vaccine candidate, depending on the amount ordered. “Our vaccine, therefore, costs about the same as a flu shot, which is between $10 and $50,” he told German weekly Welt am Sonntag (WamS).
According to media reports, an EU official involved in the talks said the European Commission wanted to reach a deal with Moderna for the supply of millions of doses of its vaccine candidate for a price below $25 per dose. "Nothing is signed yet, but we’re close to a deal with the EU Commission. We want to deliver to Europe and are in constructive talks,” Bancel told WamS, adding it was just a “matter of days” until a contract would be ready.
Moderna’s preliminary analysis
The analysis report of the Moderna vaccine revealed that the 'preliminary analysis suggests a broadly consistent safety and efficacy profile across all evaluated subgroups.' The biotechnological firm also plans to submit applications for authorizations to global regulatory agencies. Moderna's Phase 3 trials are randomized and including providing vaccine shots at the 100 µg dose level in 30,000 participants in the U.S., ages 18 and older. The trials also included Americans who are under the age of 65 but have high-risk chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease.
Updated 19:00 IST, November 30th 2020