US FDA approves Moderna COVID-19 vaccine also for prevention

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The U.S. Food and Drug Administration (FDA) has approved a second COVID-19 vaccine, manufactured by Moderna which will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older. 
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Moderna COVID-19 Vaccine has been available under emergency use authorization (EUA) for individuals 18 years of age and older since 18 December, 2020.

"Spikevax meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality required for approval," the FDA said in a statement on Monday.

The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,

said Acting FDA Commissioner Janet Woodcock, M.D.

“While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated,” she added.

How Spikevax is used

Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart.

Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series.

Moderna COVID-19 Vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older (at the 50 µg dose level).

A booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level is authorised for emergency use in the U.S. under EUA for adults 18 years and older. A third dose of the Moderna COVID-19 vaccine at the 100 µg dose level is authorized for emergency use in immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

It is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. 

"Safe and effective vaccines are our best defense against the COVID-19 pandemic, including currently circulating variants," said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

The public can be assured that this vaccine was approved in keeping with the FDA’s rigorous scientific standards.

Stéphane Bancel, Chief Executive Officer of Moderna, said in a separate statement that

Our COVID-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from COVID-19 infection, hospitalization and death.

"This is a momentous milestone in Moderna's history as it is our first product to achieve licensure in the U.S. The full licensure of Spikevax in the U.S. now joins that in Canada, Japan, the European Union, the UK, Israel, and other countries, where the adolescent indication is also approved," he added.

Two products are now fully approved for the U.S. market, as a vaccine developed by U.S. pharmaceutical company Pfizer and Germany's BioNTech received approval last August. The decision also allows Moderna to sell its vaccine directly to consumers.

Moderna is currently waiting for the FDA to approve its vaccine for use in children aged 12 to 17. The company is conducting clinical trials on booster doses for adults and first doses for children. According to U.S. guidelines, a booster shot with Moderna's vaccine is recommended five months after the second dose.

According to the U.S. Centers for Disease Control and Prevention (CDC), around 74% of U.S. adults have received two doses of COVID-19 vaccine. But the numbers are much lower for booster doses, which experts say is key to achieving protection against the Omicron variant. According to data from the US Public Health Service, only 44% of adults with two jabs in the United States have received a booster dose.

 

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