Moderna Covid-19 vaccine all set for FDA emergency approval (Lead)

After an eight hour debate, a high powered vaccine advisory panel overwhelmingly endorsed Moderna’s Covid-19 vaccine for emergency use approval (EUA) by the US Food and Drug Administration (FDA), potentially adding the second vaccine into America’s mass vaccination effort against a raging pandemic.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the FDA voted 20-0 in favour of getting Moderna’s shots into the arms of American 18 years and older, with one expert abstaining. Exactly a week ago, the same panel endorsed Pfizer and BioNTech’s Covid-19 vaccine in a 19-4 vote. The EUA came within the next 24 hours. Vaccinations using Pfizer’s shot began December 14 in the US.

Around 5 p.m. EST Thursday the VRBPAC put a single question up for vote: “Based on the totality of scientific evidence available, do the benefits of the Moderna Covid19 vaccine outweigh its risks for use in individuals 18 years of age and older?”

“It’s not about whether we know everything, it’s about whether we know enough,” is how Dr. Paul Offit, one of the panel members, explained his support for Moderna’s vaccine.

If Moderna’s vaccine is approved by the FDA, it will become the second shot to be greenlighted in America. 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 per cent of vaccine recipients reported possible “hypersensitivity”.The Moderna vaccine was more than 94 per cent effective overall at preventing COVID-19 illness, and 86 per cent 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 randomized 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 Dr. 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. Covid-19 is blamed for the deaths of more than 300,000 Americans this year.

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