Moderna’s COVID-19 vaccine became the second coronavirus vaccine in the United States to receive full approval from the Food and Drug Administration (FDA) for use in individuals 18 years of age and older on Jan. 31. Prior to receiving FDA approval, the Moderna COVID-19 vaccine had been authorized for emergency use in the U.S. since Dec. 18, 2020.
When approval was announced, the FDA and Moderna said the vaccine would now be marketed in the U.S. under the name Spikevax. VERIFY viewer Lisa asked on Facebook when the FDA-approved Spikevax would be released. But that implies that Spikevax and the Moderna COVID-19 vaccine authorized under emergency use aren’t the same.
Are Spikevax and the Moderna COVID-19 vaccine the same?
Yes, Spikevax and the Moderna COVID-19 vaccine are the same.
WHAT WE FOUND
Spikevax has the same formulation as the Moderna COVID-19 vaccine that was authorized for emergency use (EUA) by the U.S. Food and Drug Administration (FDA) on Dec. 18, 2020, according to the FDA and Moderna. The FDA says Spikevax is administered as a primary series of two doses, one month apart, and since it has the same formulation, it can be used interchangeably with the Moderna COVID-19 vaccine that is authorized under emergency use to protect against COVID-19.
“The FDA’s approval of Spikevax is a significant step in the fight against the COVID-19 pandemic, marking the second vaccine approved to prevent COVID-19,” said acting FDA Commissioner Janet Woodcock. “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.”
Brand Institute, a Florida-based branding agency, partnered with Moderna to create the Spikevax name. The company says the name refers to the "spike" glycoprotein, which is one of the key characteristics of SARS-CoV-2.
“The mRNA vaccine, Spikevax, gives instructions for cells to produce copies of the ‘spike’ protein, which subsequently becomes a target for the generation of neutralizing antibodies against it. In doing so, the body develops immunity to SARS-CoV-2 viral infection,” Brand Institute said.
Although Spikevax is now the vaccine’s official name, the Moderna COVID-19 vaccine remains available under EUA as a two-dose primary series for individuals over the age of 18, as a third, additional dose for individuals over the age of 18 who are considered immunocompromised, and as a single booster dose for individuals 18 years of age and older who received their first two shots at least five months before. It is also authorized for use as a “mix and match” single booster dose for people over the age of 18 who have already received one or two primary doses of the Pfizer or Johnson & Johnson COVID-19 vaccines.
Spikevax has already received approval from regulators in more than 70 countries, including Canada, Japan, the European Union, the United Kingdom and Israel, said Moderna’s CEO Stéphane Bancel.
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