COVID-19 Vaccine For Adults: United States has given approval to Moderna’s COVID-19 vaccine. After the decision taken by FDA, the CEO of the company Stephane Bancel called it “momentous milestone” for the company.
It was on Monday when the US Food and Drug Administration (FDA) approved Moderna’s COVID19 “Spikevax” vaccine. Previously, the same vaccine had received an emergency use in the United States.
This is what FDA commissioner Janet Woodcock said in the statement released, “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,”
FDA’s approval of this vaccine is a significant step in the fight against #COVID19, marking the 2nd vaccine approved to prevent COVID-19. Rest assured that it meets our high standards for safety, effectiveness & manufacturing quality required of any vaccine approved in the U.S. https://t.co/4d973XkIeA
— Dr. Janet Woodcock (@DrWoodcockFDA) January 31, 2022
COVID-19 Vaccine For Adults
“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,” he added.
The full approval to the Moderna vaccine has been granted by the FDA which can be used by individuals aged 18 or above.
In August, however, Pfizer vaccine was given approval by the FDA which can be used for individuals aged 16 years or older.
This is what Woodcock said on this occasion, “FDA approval to the Moderna vaccine may instill additional confidence in making the decision to get vaccinated.”
After the decision taken by the FDA, the CEO of Moderna stated that the move taken by the government was a “momentous milestone” for the company.
This is what Bancel said in the statement, “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,” he added.
It was in December 2020 when Moderna vaccine was granted an emergency use in the country. The full approval given will mean that FDA will allow two doses of the Moderna vaccine. However, a booster dose will remain under an emergency use authorization.
As per FDA, the number of clinical trials conducted to check the effectiveness of Spikevax included recipients up to 14,287. It included 14,164 placebo recipients.
FDA said the most common side effects by clinical trial participants included pain at the injection site, nausea, headaches, fatigue, muscle or joint pain and swollen lymph nodes.