Woodcock added that "FDA approval of Spikefax is an important step in the fight once morest a pandemic COVID-19It is the second covid vaccine to receive full approval", following the Pfizer vaccine.
Woodcock said she hopes it will boost the Food and Drug Administration’s approval of a vaccine Moderna trust "Deciding to take the vaccine".
was Pfizer It was fully approved by the Food and Drug Administration, last August, for people 16 years of age and older.
It is worth noting that the full and final approval of the Spikefax vaccine from Moderna is limited to adults aged 18 years and over.
Stéphane Bancel, CEO of Moderna, described the FDA’s move as… "extremely important" company, adding in a statement "Our vaccine has been used by hundreds of millions of people worldwide to protect them from infection, hospitalization and death", according to AFP.
The Moderna vaccine was granted emergency use authorization in December 2020.
Full approval from the Food and Drug Administration relates to the first two doses of the vaccine booster dose Its use is still under emergency use approval.
The Food and Drug Administration said that Clinical trials To determine the effectiveness of Spikefax, 14,287 volunteers were included, in addition to 14,164 others who received a placebo.
The US government agency indicated that side effects The most common reported subjects were pain at the injection site, fatigue, headache, muscle or joint pain, nausea or vomiting, and swollen lymph nodes.
She added that there was an increase in the risk of developing myocarditis and myocarditis in men between the ages of 18 and 24 years following taking the second dose.
However, the US Food and Drug Administration decided that "The benefits of the vaccine outweigh the risks of myocarditis and myocarditis in people 18 years of age or older", according to the French Agency.
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Commissioner said Drug and Food Administration Acting US Secretary of State Janet Woodcock, in a statement, “The public can rest assured that Spikefax It meets the administration’s standards for safety, efficacy and manufacturing quality required for any vaccine approved for use in the United States,” according to AFP.
“The Food and Drug Administration’s approval of Spikefax is an important step in combating a pandemic,” Woodcock added COVID-19It is the second COVID-19 vaccine to receive full approval,” following Pfizer’s vaccine.
Woodcock said she hopes it will boost the Food and Drug Administration’s approval of a vaccine Moderna Confidence in making the decision to take the vaccine.
was Pfizer It was fully approved by the Food and Drug Administration, last August, for people 16 years of age and older.
It is worth noting that the full and final approval of the Spikefax vaccine from Moderna is limited to adults aged 18 years and over.
Stéphane Bancel, CEO of Moderna, described the Food and Drug Administration’s move as “extremely important” for the company, adding in a statement, “Our vaccine has used hundreds of millions of people around the world to protect them from infection, the need for hospitalization and death,” according to AFP.
The Moderna vaccine was granted emergency use authorization in December 2020.
Full approval from the Food and Drug Administration relates to the first two doses of the vaccine booster dose Its use is still under emergency use approval.
The Food and Drug Administration said that Clinical trials To determine the effectiveness of Spikefax, 14,287 volunteers were included, in addition to 14,164 others who received a placebo.
The US government agency indicated that side effects The most common reported subjects were pain at the injection site, fatigue, headache, muscle or joint pain, nausea or vomiting, and swollen lymph nodes.
She added that there was an increase in the risk of developing myocarditis and myocarditis in men between the ages of 18 and 24 years following taking the second dose.
Nevertheless, the US Food and Drug Administration decided that “the benefits of the vaccine outweigh the risks of myocarditis and myocarditis in people aged 18 years or older,” according to the French agency.
