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  • FDA Authorizes Moderna Vaccine for Emergency Use in the US

    By: Sumaya Hussein (husseinsumaya1@gmail.com)

    Thumbnail photo courtesy of Reuters

    The Food and drug Administration (FDA) authorized the COVID-19 vaccine developed by Moderna, which joins the Pfizer-BioNTech as the second vaccine available for use in the US.

    The announcement on Friday came a day after a committee of outside experts endorsed the use of the Moderna vaccine across the US, saying the benefits outweigh the risks.

    “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day,” said FDA Commissioner Stephen Hahn, in a press release.

    Moderna experiemental COVID-19 vaccine. Photo courtesy of Getty Images.

    The vaccine which was 94% effective against symptomatic COVID-19 in clinical trials can now be given to adults 18 years and older. Data presented by Moderna also hints that the vaccine could prevent asymptomatic infection as well.

    Both the Moderna and Pfizer vaccine will be available under Emergency Use Authorization, a designation that lets the FDA sign off on products faster than the normal review process during an emergency like a pandemic.

    The Moderna vaccine can be easily stored compared to the Pfizer vaccine, which requires to be kept at ultra-cold temperatures.

    Moderna can be stored in a refrigerator for up to 30 days, making it easier to distribute to places without the infrastructure to maintain extremely low temperatures.

    “We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease,” Stéphane Bancel, CEO of Moderna said in a press release.

    The United States ordered 200 million doses of the Moderna vaccine, enough to vaccinate 100 million people.

    Patient receiving a dose of the Moderna vaccine. Photo courtesy of the New York Times.

    The first doses will be given to health care workers and residents in long-term care facilities within days.

    Moderna has about 5.9 million doses ready for shipment set to begin during the weekend, according to operation Warp Speed, the US government’s vaccine development program. The first Moderna vaccines are expected to be administered on Monday.

    Moderna has said it plans to deliver approximately 20 million doses to the US government this year, and will provide the 200 million doses by end of June 2021.

  • FDA to approve Moderna Vaccine in the US

    By: Sumaya Hussein (husseinsumaya1@gmail.com)

    Thumbnail photo courtesy of Getty Images

    Food and Drug Administration (FDA) say that Moderna’s vaccine is safe and 95% effective, clearing the way for US emergency authorization.


    This comes one day after Americans across the country began receiving doses of the Pfizer vaccine.
    Once approved by the FDA vaccine panel, Moderna will become the second coronavirus vaccine to be allowed in the US and shipments could begin within 24 hours.

    A patient receiving a dose of the Moderna Vaccine. Photo courtesy of New York Times

    Moderna’s data was released by the FDA on Tuesday, ahead of the vaccine panel’s meeting to discuss the drug on Friday. The 54-page document said there were “no specific safety concerns” and that serious adverse reactions were rare. The data also suggests that its vaccine begins to prevent asymptomatic infections after the first dose. This is highly effective because this helps significantly slow the spread of the coronavirus. FDA analysts found that the Moderna vaccine was effective “across age groups, gender, racial and ethnic groups, and participants with underlying conditions”. In addition, the research “suggested benefit of the vaccine in preventing severe Covid-19.”


    The issues of effectiveness against severe disease have been raised about the studies of vaccines for Covid. The Moderna study found 30 cases of severe disease in the control group, versus zero in the vaccine group.

    The FDA found no specific safety concerns that would preclude its authorization of the vaccine. Most common side effects included injection-site pain, fatigue, headache and chills.
    Severe adverse reactions were rare but occurred more frequently after the second dose of the vaccine than after the first.


    For instance, about 9.1% of vaccine recipients had an injection site reaction that was classified as “grade 3,”. This the FDA defines as severe of medically significant, but not immediately life-threatening. In comparison, fewer than 1% of the control group had grade 3 injection-site reactions.
    Some 16.5% of vaccine recipients had systemic adverse reactions – such as fever and fatigue- with the severity of at least grade 3 and 3.7% among the control group. Severe fatigue was more common after the second dose after the first. The FDA last week authorized emergency use of the vaccine from Pfizer and BioNTech, which began distribution this week.


    Unlike the Pfizer vaccine, Moderna’s does not require ultra-cold storage during shipping. Instead, it requires temperatures of around -20C for shipping – similar to a regular freezer. The Pfizer vaccine requires temperatures closer to -70C, making transport logistics much more difficult.

    A shipment of the Pfizer vaccine delivered to US on Monday. Photo courtesy of Wall Street Journal.


    The primary goal of the studies of both Pfizer’s and Moderna’s vaccines was to measure whether they prevented symptomatic COVID-19 disease, including severe disease.
    However, people can still become infected affected and transmit the virus without showing any symptoms.

    A Pfizer executive said last week that the company was studying whether its vaccine protects against asymptomatic Covid-19 and hope to complete the analysis early next year.