COVID-19 Vaccine: US FDA Grants Full Approval To Moderna's Covid 'Spikevax' Vaccine

Spikevax meets the FDA's rigorous standards for safety, effectiveness, and manufacturing quality required for approval said the agency in a statement.

The US Food and Drug Administration (FDA) on Monday granted full approval to Moderna's Covid-19 "Spikevax" vaccine. The vaccine, named Spikevax, is approved for use in people ages 18 and older. Spikevax meets the FDA's rigorous standards for safety, effectiveness, and manufacturing quality required for approval said the agency in a statement.

"While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated," said Acting FDA Commissioner Janet Woodcock. "Today's milestone puts us one step closer to altering the course of this pandemic in the US," she said.

Moderna's COVID-19 Vaccine -- What You Need To Know

1. Moderna's Covid-19 vaccine is the second one in the US to receive full approval from the FDA.
2. Moderna's Covid-19 vaccine has been available under the FDA's emergency use authorization for individuals 18 years of age and older since December 18, 2020.
3. The FDA has only given a nod to the two doses of Moderna's COVID vaccine. Booster dose with Moderna's Spikevax still remains under an emergency use authorization.
4. The most common side effects of Moderna's Spikevax vaccine against COVID-19 are: pain at the injection site, fatigue, headaches, muscle or joint pain, chills, nausea or vomiting, and swollen lymph nodes.
5. According to the FDA, there was an increased risk in men aged 18 to 24 of myocarditis -- inflammation of the heart muscle -- and pericarditis -- inflammation of the tissue surrounding the heart -- following vaccination with the second dose.
6. However, the FDA has also said that these side effects are temporary and the benefits of the vaccine outweigh the side effects of the vaccine shots.

Moderna stated in a release that its COVID-19 vaccine has been administered to hundreds of millions globally, and has been providing protection from severe infection, hospitalisation and death.

(With inputs from Agencies)