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The US approves Moderna as the second vaccine

Moderna has been approved by the US government as the country’s second Covid-19 vaccine, clearing the way for millions of doses to be released. The country has the world’s highest numbers of Covid-19 deaths and cases. It has recorded at least 311,529 deaths and 17,269,542 infections, according to Johns Hopkins University. The Food and Drug Administration (FDA) authorised the US-made jab about a week after approving a Pfizer/BioNTech vaccine which is now being distributed. The US has agreed to purchase 200 million doses of Moderna, and six million is ready to be ready to ship.

“To go from having a sequence of a virus in January to having two vaccines available in December is a remarkable achievement,” said Dr James Hildreth, CEO of Meharry Medical College in Tennessee. An FDA advisory panel on Thursday voted 20-0 with one abstention that the benefits of the Moderna vaccine outweighed the risks for those aged 18 and over, and authorisation followed on Friday. Meanwhile, the regulators reported earlier this week that the Moderna vaccine was safe and 94% effective.

While Pfizer is a pharmaceutical behemoth, Moderna — short for modified RNA — is a biotech company based in Cambridge, Massachusetts. Established in 2010, Moderna has never brought a product to market or gotten any of its nine or so vaccine candidates approved for use by the FDA. It had also never brought a product to phase three of a clinical trial previously. However, the company’s scientists had already been collaborating with researchers from the National Institutes of Health on a vaccine for another coronavirus, Middle Eastern Respiratory Syndrome (MERS). When Chinese researchers released the genomic sequence for the novel coronavirus in mid-January, they had a jump start.

The vaccine, called mRNA-1273, had development help from the National Institute of Allergy and Infectious Diseases. The US Biomedical Advanced Research and Development Authority, known as BARDA, supported late-stage clinical trials and has helped scale-up manufacturing. 

The Moderna vaccine was effective in preventing Covid-19 cases in total and in limiting severe Covid-19 during the trial. The vaccine’s efficacy against Covid-19 was 94.1%, occurring at least 14 days after the second dose, according to a briefing document released by an advisory committee to the FDA. In Moderna’s trial, 15,000 study participants, were given a placebo, which is a shot of saline that has no effect. Over several months, 185 of them developed Covid-19, with 30 developing severe forms of the disease. One of them died. Another 15,000 participants, were given the vaccine, and only 11 of them developed Covid-19. None of the 11 became severely ill. The vaccine was effective across age groups, genders, racial and ethnic groups, and participants with medical comorbidities associated with a high risk of severe Covid-19, according to the briefing document. About 10% of study participants were Black and 20% were of Hispanic or Latino.

Moderna’s coronavirus vaccine candidate is similar to the Pfizer-BioNTech vaccine that was authorized and shipped out to the first Americans earlier this week. But there are a few key differences. Most importantly, Moderna’s vaccine can be stored in normal freezers and does not require a super-cold transportation network, making it more accessible for smaller facilities and local communities.

By Jumana Jabeer

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