Moderna Inc’s coronavirus vaccine was cleared by US regulators on Friday, as it became the second to receive emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) this month.
This is a piece of good news to a nation with a staggering COVID-19 death toll of over 307,000 lives lost.
The decision of the FDA to grant authorization for the use of the vaccine means that 2 of the 6 vaccine candidates identified by Operation Warp Speed are now available to the general public.
This authorization is coming a day after FDA’s panel of outside experts voted 20-0, with one absention, to endorse its use, and a week after the FDA authorized a vaccine from Pfizer Inc and German partner BioNTech SE.
The vaccine from Pfizer and BioNTech, based on similar technology, has been put into the arms of thousands of U.S. healthcare workers this week in a massive nationwide rollout. Moderna injections are expected to begin in coming days for adults 18 years old and up.
FDA Commissioner, Stephen Hahn, in a statement, said, “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 that is causing vast numbers of hospitalizations and deaths in the United States each day.’’
The speed of vaccine development is a stunning scientific success, although there is some hesitancy among the public.
Top U.S. infectious disease scientist, Anthony Fauci, in a statement, said, “It is my hope that all Americans will protect themselves by getting vaccinated when the vaccine becomes available to them. That is how our country will begin to heal and move forward.’’
Moderna said it intended to apply for full US approval in 2021, as the vaccine is also the first product from the company to get regulatory clearance for use.
Moderna’s vaccine, just like the one developed by Pfizer and BioNTech, is based on messenger RNA technology that had not been previously used before. The vaccine was shown to be nearly 95% effective with no serious safety concerns.
The vaccine, developed in partnership with the National Institutes of Health, had relatively minor side effects including pain around the injection site and swelling.
The biotech company is working with the US government for the distribution of 5.9 million shots as early as this weekend.
Moderna’s shot is expected to be used in harder-to-reach locations, such as rural hospitals. The vaccine needs to be stored and shipped frozen, but does not require the ultra-cold temperatures of the Pfizer/BioNTech shot.
U.S. President Donald Trump on Twitter expressed delight at the authorization as he said, “Congratulations, the Moderna vaccine is now available! The vaccine must be transported to hospitals and other centres before injections begin.”
Moderna said it would deliver approximately 20 million doses to the U.S. government this year and expected to have between 100 million and 125 million globally in the first quarter of next year, with 85-100 million of those for the United States.
What you should know
It can be recalled that Moderna Inc, over a month ago, certified its Covid-19 vaccine to be almost 95% effective in treating coronavirus and was able to prevent the most severe infections. The Trump administration, through its Operation Warp Speed, made available over $950 million to Moderna to develop the vaccine.
The US government has deals with Moderna to spend billions of dollars to provide a total of 200 million doses by the end of June 2021. This should be enough to immunize 100 million people, and there is an option to procure another 300 million doses.
Other vaccines that are still being tested, include a one-shot injection from Johnson & Johnson, and a two-shot course from AstraZeneca and Oxford University.
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