Two days prior to discussing distribution approval, the U.S. Food and Drug Administration rated the company’s COVID-19 drug positive.
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Following approval of the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration (FDA) reported that the vaccine from the US pharmaceuticals Moderna is safe and effective. The drug could get approval for distribution this week when experts meet to discuss its emergency approval.
The FDA confirmed that the Modern There are no “specific safety concerns” in adults over the age of 18 that “prevent” the issuing of an emergency permit.
“The FDA has determined that the manufacturer has provided adequate information to ensure the quality and consistency of the vaccine for product approval.”, reads the document supplied by the US agency.
The effectiveness reported among study participants 94.5% and 100% for people over 65 years of age. That is, none of the 3,527 volunteers in this age group had an infection. Of the 10,407 people aged 18 to 65 years examined, there were 5 positive. Neither of them developed a severe COVID-19 picture.
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Moderna vaccine has “mild” side effects
The formula is called MRNA-1273had some side effects like Pain at the injection site (90% of the cases), fatigue (70%), a headache (60%), muscle pain (60%), Joint pain (45%) and chills (Four five%). Few of these effects were “severe” and were more common in young than in older adults. The Lymphadenopathyor swollen lymph nodes occurred in 1.1% of those vaccinated compared to 0.6% of the group who received the placebo.
1.5% of the vaccinated population presented “Hypersensitivity”that is, allergic or inflammatory reactions of the immune system. In comparison, 1.1% of the unvaccinated reported such a reaction.
The FDA report is part of the documents delivered for Thursday’s meeting where experts discuss whether to approve an application Emergency approval for Moderna’s vaccine.
The vaccine Pfizer and BioNTech It was approved on Friday evening after the committee approved the formula the previous day through broad consensus that was adopted that Monday in the United States.
The FDA granted the first emergency approval for a vaccine to prevent COVID-19 disease caused by SARS-CoV-2 in people aged 16 and over. https://t.co/lEPJX5eMn1 pic.twitter.com/w8Wfxx47zI
– USA FDA in Spanish (@FDAenEspanol) December 14, 2020
US plan to deliver this month 40 million cans of vaccines, enough to vaccinate 20 million people. That includes both Pfizer-BioNTech as ModernThis would be the second formula available to fight the virus SARS-CoV-2 in this country.
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