US FDA approves Moderna’s COVID-19 vaccine for emergency use

By Rahul Vaimal, Associate Editor
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Moderna Vaccine
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The Food and Drug Administration (FDA) of the US has approved the emergency usage of Moderna’s COVID-19 vaccine, paving the way for 6 million doses to be shipped across the country soon.

Moderna’s vaccine has shown 94 percent efficacy in preventing COVID-19 and is authorized in adults of 18 years and older. The approval comes after it was recommended by the FDA advisory panel of independent experts.

With this authorization, the US became the first country to approve a two-dose regimen from Moderna and to deploy the second vaccine in a Western country after the first, developed by Pfizer and BioNTech.

The Pfizer-BioNTech vaccine was first authorized by Britain in early December, followed by several other countries including the US last week. Less-vetted shots have also been approved in China and Russia.

The US FDA chief Stephen Hahn stated that “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic.”

Meharry Medical College President James Hildreth, who was part of a panel of experts convened by the FDA to discuss approval matters, said, “it was a remarkable achievement to have developed and authorized the Pfizer and Moderna vaccines within the space of a year. Together, they offer a glimmer of light at the end of the pandemic’s long tunnel.”

The authority has said that by this weekend itself millions of doses will start shipping out from cold-storage sites and they will be delivered to health facilities across the country.

Even though Moderna has been developing several drugs, none of them has ever got any authorization. The US-based biotech firm received $2.5 billion in federal funding for its efforts and it co-developed the COVID-19 vaccine with the National Institutes of Health.

Cutting-edge technology

Both the Pfizer and Moderna vaccines are developed using mRNA (messenger ribonucleic acid) technology, to introduce the body to the spike proteins coating the surface of the coronavirus and both are highly effective, with no serious safety issues during clinical trials.

The most commonly reported side effects were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea and vomiting and fever. Both vaccines come with warnings for people who have histories of allergic reactions.

The FDA has said that it will also be checking to see if vaccines develop an extremely rare condition of Bell’s Palsy, a relatively mild and temporary facial paralysis condition, as there were such cases during the clinical trials, but not enough to attribute causality.

Immunocompromised people may have diminished immune reactions and there was not enough data to say if there is any risk linked with giving the vaccine to pregnant people, FDA added.

Even though both Pfizer’s and Moderna’s vaccines work in the same way they differ in the formulation of the fatty particles used to deliver the mRNA, which enables Moderna’s vaccine to be kept in long term storage at -20 degrees Celsius, unlike Pfizer’s, which requires -90 degrees Celsius.

Moderna’s clinical trial involved over 30,000 people, roughly half of them were given the product and the other half a placebo, with neither recipients nor their health care providers knowing who was in each group.

The method has proposed to ‘unblind’ the whole study and offer placebo recipients the vaccine, a plan criticized by some experts who say scientists will be deprived of valuable data, and some people will end up getting the vaccine ahead of others in their priority group. The US has paid for 200 million doses, enough to vaccinate 100 million people.

Moderna is planning to ship about 20 million doses this month and 80 million more in the first quarter of 2021, with the remaining 100 million in the second quarter.