Biotech giant Moderna on Thursday said the US Food and Drug Administration (FDA) has given it emergency approval to proceed with phase 2 clinical trials of a vaccine candidate it is developing to fight the deadly coronavirus. Moderna said that the approval of phase 2 clinical trials is an important step in its development of a Covid-19 vaccine that the company expects to be ready by next year.
Following the news, shares of Moderna rallied more than 16 per cent. Biotech companies and drugmakers across the world are working towards developing a vaccine for the coronavirus. More than a 100 coronavirus vaccine candidates are at different stages of trail, with around 10 per cent of them managing to reach the clinical trial stage so far.
Moderna gets crucial approval
Moderna has been one of the frontrunners in developing a vaccine for the coronavirus. The biotech company on Thursday said that the FDA's approval for the phase 2 clinical trial of its vaccine candidate is a "crucial step". Moderna plans to begin the phase 2 trials with 600 participants in the coming days.
The company is also gearing up for a phase 3 clinical trial of the vaccine candidate as early as this summer. Moderna last week tied up with Swiss contract drugmaker Lonza to ramp up production of the experimental coronavirus candidate.
"We are accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective," CEO Stephane Bancel said in a statement. Moderna last week had said that it could start manufacturing its yet-unconfirmed Covid-19 vaccine "as early as July".
Moderna leads from the front
Of all the drugmakers developing vaccine for the deadly coronavirus, Moderna has shown fast progress. Much like other companies Moderna too is ramping up manufacturing ahead of approval so that it can start distributing the doses at the earliest if the vaccine candidate proves effective against the virus and safe for humans.
Moderna's 10-year partnership with Lonza is in a bid to accelerate production, which the company said will begin as soon as it "gets the green light". Moderna's mRNA-1273 has been developed by its researchers and those from the National Institutes of Health and was the first candidate to enter phase 1 human trial in March. The National Institutes of Health said that developing a candidate didn't take much time as the organizations were already partnered and researching on "related coronaviruses".
The vaccine candidate uses synthetic messenger RNA to immunize against the virus. Such treatments have an advantage. These kinds of treatments help the body in immunizing against a certain virus and require less time to be developed and manufactured.
There are currently no drugs or therapies to treat Covid-19 and drugmakers across the world are speeding up development to come up with a vaccine, which most say will take at least 12 to 18 months. More than a 100 Covid-19 vaccine candidates are in development stage, with only 10 managing to reach the clinical trial stage so far, according to the World Health Organization.
