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. Moderna has created its shots with 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 race to being limited vaccinations as COVID-19 pandemic worsens. 

Previously, US pharmaceutical company h said that shots effectiveness and a good safety record so far with only temporary, flu-like side effects mean y meet requirements set by US FDA for emergency use before final-st testing is completed. While European Medicines ncy (EMA) has signalled it is also open to faster, emergency clearance, FDA, on or hand, has pledged that before it decides to roll out any COVID vaccines, its scientific visers will publicly debate wher re’s eugh evidence behind each candidate. If US FDA gives biotech firm EUA, Moderna expects to have around 20 million doses rey for US by years end. 

RE: UK Secures ditional 2 Million Doses Of Moderna's COVID-19 Vaccine

Meanwhile, Moderna's Chief Executive Stephane Bancel has stated that drugmaker will charge governments between $25 and $37 per dose of its COVID-19 vaccine candidate, depending on amount ordered. “Our vaccine, refore, costs about 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 talks said European Commission wanted to reach a deal with Moderna for supply of millions of doses of its vaccine candidate for a price below $25 per dose. "thing is signed yet, but we’re close to a deal with EU Commission. We want to deliver to Europe and are in constructive talks,” Bancel told WamS, ding it was just a “matter of days” until a contract would be rey.

RE: Pfizer, Moderna, Oxford, Sputnik V: As Covid Vaccines Publish Results, Here's What We Kw

Moderna’s preliminary analysis 

analysis report of Moderna vaccine revealed that 'preliminary analysis suggests a broly consistent safety and efficacy profile across all evaluated subgroups.' biotechlogical firm also plans to submit applications for authorizations to global regulatory ncies. Moderna's Phase 3 trials are randomized and including providing vaccine shots at 100 µg dose level in 30,000 participants in U.S., s 18 and older. trials also included Americans who are under of 65 but have high-risk chronic diseases that put m at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease.

RE: EU Seals 6th Vaccine Deal, Secures 160 Million Moderna Shots

RE: EU Seals 6th Vaccine Deal, Secures 160 Million Moderna Shots