Moderna applied for approvals from US regulators and EU after full results from their last stage study proved that the vaccine is 94.1% effective with no serious safety concerns.
Baden said while these results are encouraging, they are limited by the short duration of follow-up so far.
Moderna Inc is expected to get a nod for the emergency use of its vaccine in 24 to 72 hours after the US health regulator has conducted their committee meeting, Chief Executive Officer of the drugmaker firm, Stephane Bancel said to Reuters.
The US regulator, Food and Drug Administration (FDA) said that the meeting for the same will be held on December 17 when Moderna’s request to approve emergency use of the vaccine. Basel further said that the company is ready with millions of doses of vaccines that will be shipped as soon as they get a nod from FDA while speaking at Piper Sandler healthcare conference.
Moderna is a front-runner in the drug-maker firms race in making Covid-19 vaccine and bringing it to the market with all the regulatory body approvals. The firm applied for approvals from US regulators and EU after full results from their last stage study proved that the vaccine is 94.1% effective with no serious safety concerns.
The EU medicines have already started a ‘rolling review’ of the vaccine depending on the lab data submitted by the drugmaker. The agencies will assess how well the efficacy of the vaccine and how. Safe it is for board use in Europe before taking a final decision on its rollout at a meeting scheduled for January 12.
Meanwhile, the. British regulators have already approved American drugmaker Pfizer’s and Germany’s BioNTech that have shown 95 per cent efficacy for experimental use. The U.K government has ordered 40 million doses for 20 million people. The rollout will happen in the next few days after it arrives from Belgium.