September 25, 2022

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FDA Approved Moderna COVID-19 Vaccine for EUA

FDA Approved Moderna COVID-19 Vaccine for EUA

FDA Approved Moderna COVID-19 Vaccine for EUA.   On December 18, 2020, the US FDA issued an emergency use authorization (EUA) for Moderna’s COVID-19 vaccine, allowing it to be distributed in the United States for use by people 18 years and older.

It is reported that this is the second COVID-19 vaccine approved by the FDA after Pfizer/BioNTech’s COVID-19 vaccine.

 

 

News on Dec 17 2020

FDA recommends approval of Moderna COVID-19 vaccine

FDA recommends approval of Moderna COVID-19 vaccine. On Dec 17, an advisory committee of the US Food and Drug Administration (FDA) voted to approve the Emergency Use Authorization (EUA) of Moderna’s COVID-19 vaccine .

FDA Approved Moderna COVID-19 Vaccine for EUA
(image source:router)

According to reports, the Moderna Covid-19 vaccine is very similar to the Pfizer Covid-19 vaccine previously approved by the FDA. The vaccine is expected to become the second COVID-19 vaccine approved by the US regulatory agency.

On December 14, local time, Stephanie, a nurse at the Jewish Medical Center in Long Island, New York, made a triumphant expression after being vaccinated with the COVID-19. Photo by China News Agency reporter Liao Pan

According to the report, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 20 to 0 to unanimously approve the emergency use authorization of Moderna’s COVID-19 vaccine. The committee recommends vaccination for people 18 years and older.

It is said that the FDA advisory committee plays a key role in approving influenza and other vaccines in the United States to ensure that the vaccines are safe for public use. After voting for it last week, the FDA approved the emergency use authorization of Pfizer vaccine the next day, and then began to vaccinate across the United States.

But to obtain full approval, more data needs to be reviewed. Moderna has only submitted two months of follow-up safety data. It usually takes six months for the FDA to fully approve.

Moderna’s vaccine uses mRNA, which is messenger RNA technology, like Pfizer. Later clinical trial data showed that the vaccine is more than 94% effective in preventing the new coronavirus, can resist the risk of serious diseases, and is safe. In order to maximize its effectiveness, the vaccine needs to be vaccinated twice with an interval of four weeks.

FDA staff publicly supported Moderna’s vaccine on the 15th, and stated in the document that the clinical trial results and safety data “complied with the recommendations made in the FDA’s COVID-19 vaccine emergency use authorization guidelines.”


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