Spikevax is the second Covid-19 vaccine to get full approval in the US, following Pfizer and BioNTech’s Covid-19 vaccine, which uses similar technology
Vials containing the Moderna Covid-19 vaccine. (Credit: Zacharie Grossen/Wikipedia.)
Moderna has received the US Food and Drug Administration (FDA) full approval for use of its Covid-19 vaccine, marketed as Spikevax, in people aged 18 and above.
It is the second Covid-19 vaccine to receive full approval in the US, following Pfizer and BioNTech’s Covid-19 vaccine, approved for use in people aged 16 and above.
Administered as a primary series of two doses, one month apart, Spikevax has been available in the US since December 2020, under emergency use authorisation (EUA).
A booster dose of Spikevax at 50µg strength has also been authorised for emergency use in normal adults, and the third dose at 100µg strength for immunocompromised adults.
The vaccine is currently approved in more than 70 countries, including Canada, Japan, the European Union, the UK, and Israel.
Moderna CEO Stéphane Bancel said: “Our Covid-19 vaccine has been administered to hundreds of millions of people around the world, protecting people from Covid-19 infection, hospitalisation and death.
“This is a momentous milestone in Moderna’s history as it is our first product to achieve licensure in the US.
“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.”
The FDA full approval was based on the totality of scientific evidence the company has shared through its submission package, including data from the Phase 3 COVE study.
Moderna has also submitted data related to its manufacturing and facilities, as required by the FDA for licensure.
In the Phase 3 trial, Moderna’s Covid-19 vaccine showed superior efficacy and favourable safety, around six months after the second dose.
The most common side effects include pain, redness and injection site swelling, fatigue, headache, muscle pain, chills, nausea, swollen lymph nodes and fever.
FDA has thoroughly evaluated the post-authorisation safety surveillance data with respect to inflammation of the heart muscle (myocarditis) and tissue surrounding the heart (pericarditis) after vaccination with the Moderna Covid-19 vaccine.
According to the US health agency, the data showed elevated risks, mostly within seven days from the second dose, with the highest risk observed in males aged 18 to 24 years.
FDA acting commissioner Janet Woodcock said: “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.
“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.
“While hundreds of millions of doses of Moderna Covid-19 Vaccine have been administered to individuals under emergency use authorisation, we understand that for some individuals, FDA approval of this vaccine may instil additional confidence in making the decision to get vaccinated.”