USA – The US Food and Drug Administration approved Moderna Inc’s COVID-19 vaccine for people aged 18 and up, making it the virus’s second fully approved vaccine.

Since December 2020, the Moderna vaccine has been approved for emergency use in the United States, and it will now be sold under the brand name Spikevax.

Last year, Pfizer and BioNTech’s COVID-19 shot, which uses similar technology, received full approval in the United States for people aged 16 and older after first receiving emergency approval.

“While hundreds of millions of doses of [Spikevax] have been administered to individuals under EUA, we understand that for some individuals, FDA approval…may instill additional confidence in making the decision to get vaccinated,” remarked acting FDA Commissioner Janet Woodcock.

“The public can be assured that Spikevax meets [our] high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the US,” she added.

The vaccine is also 98 percent effective in preventing severe disease, according to the FDA.

Moderna’s vaccine is cleared for use in more than 70 countries, including Canada and the European Union.

In June 2021, the company asked for its vaccine to be authorized for use in 12- to 17-year-olds, but the FDA has yet to respond.

Both the Moderna and Pfizer/BioNTech vaccines have been linked to rare cases of heart inflammation called myocarditis, particularly among young men.

Some studies have suggested that Moderna’s vaccine is more likely to cause the side effect than the Pfizer/BioNTech shot.

In October, Moderna said the FDA was evaluating the risk of myocarditis after vaccination and that the review was delaying authorization of its vaccine in adolescents.

While short-term follow-up indicates that the majority of cases have been resolved, the agency noted that some people have required intensive care support. Spikevax’s label already includes a warning about these risks.

Moderna’s milestone

Moderna stated that, in addition to the updated safety and efficacy analyses, it submitted the manufacturing and facility data required by the FDA for licensure.

“This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the US,” said CEO Stéphane Bancel, noting that “the full licensure of Spikevax in the US now joins that in Canada, Japan, the EU, the UK, Israel, and other countries, where the adolescent indication is also approved.”

According to the company, 807 million doses of the vaccine were shipped globally in 2021, with approximately 25% of those going to low- and middle-income countries.

Meanwhile, in the United States, a booster dose of Spikevax at the 50µg dose level is approved for emergency use in adults, and a third dose of the vaccine at the regular 100µg dose level is approved for emergency use in immunocompromised individuals aged 18 and older.

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