Moderna COVID-19 vaccine nears approval, FDA confirms safety

New York: As America begins a historic vaccination campaign, the US Food and Drug Administration posted a preliminary analysis confirming the safety and effectiveness of the Covid-19 vaccine developed by Moderna in collaboration with the National Institutes of Health, bringing it ever closer to an emergency use authorisation.

If Moderna’s vaccine is approved, it will become the second shot after Pfizer to be greenlighted in America. A panel of FDA experts will debate the Moderna vaccine’s efficacy in a day-long session December 17. In Pfizer’s case, the vaccine got a 17-4 vote from the panel after 9 hours of discussions.

Moderna’s vaccine is based on the same technology as Pfizer’s – mRNA. The actual virus is not embedded inside these vaccines and people who get the shots can’t catch the virus from it. Instead, the vaccine contains a piece of genetic code that trains the body’s immune system to recognize the spike protein on the surface of the Covid-19 virus and helps mount an organic defence when the attack comes.

The FDA uncovered “no specific safety concerns” or allergic reactions in the Moderna trials. Typical reactions included temporary fever, fatigue and aches, especially after the second dose as the vaccine revs up the immune system. These are similar to the reactions seen in Pfizer’s vaccine. About 1.5% of vaccine recipients reported possible “hypersensitivity”.The Moderna vaccine was more than 94% effective overall at preventing COVID-19 illness, and 86% effective in people 65 and older.

Moderna’s safety data is based on an interim analysis of approximately 30,350 participants over 18 years of age randomised 1:1 to vaccine or placebo with a median of 7 weeks of follow-up after the second dose.

The US is hoping to vaccinate 20 million people by December end, comprising healthcare workers and nursing home staff and residents. The average American can expect to get a shot in the “second quarter” of next year, according to Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases.

Around 3 million Pfizer shots are out in the first round of shipments. The government is holding back the second dose to ensure that people who got the first shots get the second round. Apart from this total first round of 6.4 million doses, an extra 500,000 doses are being kept for any emergency. States are getting vaccine doses based on population 18 and older.

Assuming that the Moderna vaccine also gets regulatory approval, US officials expect they will have enough doses to vaccinate 20 million people by December end – which means they will have 40 million shots available between Pfizer/ BioNTech and Moderna. Moderna’s second shot is timed four weeks after the first.

By February end, there will be enough to vaccinate 100 million Americans, according to data shared by the Trump administration’s vaccine czar Moncef Slaoui.