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  • REGULATORY NEWS UPDATE 2

    1. Regulator approves Pfizer vaccine for children from 12 years and older in South Africa

    South Africa approved Pfizer's vaccine for use for children from the age of 12 years and older, a boost to the country's immunisation program. The move follows a review of updated safety and efficacy information and doesn't translate into a procurement decision, the South African Health Products Regulatory Authority said Sunday, 12th September 2021

    2. Less than 3.5 % of Africans vaccinated against COVID-19: Africa CDC

    Less than 3.5% of Africans are vaccinated against COVID-19, far short of its official target of 60%, Director of Africa's Centers for Disease Control, John Nkengasong, said on Tuesday, 14th September 2021.
    World Health Organization (WHO) head Tedros Adhanom Ghebreyesus said at the same briefing that the continent was being"left behind by the rest of the world" and that this would allow the coronavirus to keep circulating.

    Meanwhile, African Union Special Envoy on COVID-19, Strive Masiyiwa said the continent is not relying on vaccine donations.He says member states are prepared and able to pay for vaccines but are being denied access to the vaccines due to export restrictions in several countries.

    3. Russia's Sputnik V vaccine shows 97.2% efficacy against Covid-19

    The Russian Direct Investment Fund (RDIF) has reported that the Sputnik V vaccine demonstrated a 97.2% efficacy against Covid-19 during the vaccination campaign in Belarus. The efficacy of the vaccine was assessed based on data from more than 860,000 individuals inoculated between January and July this year.

    The latest real-world data of the Ministry of Health of the Republic of Belarus showed that Sputnik V was demonstrated to have increased efficacy and a greater safety profile against Covid-19.
    Furthermore, no severe adverse events or deaths linked to the vaccine were reported, RDIF noted.

    THE FDA MISSION

    The FDA exist to ensure the safety, quality and efficacy of human and veterinary drugs, food, biological products, cosmetics, medical devices, household chemical substances and clinical trials, and the control of tobacco products through the enforcement of relevant standards to protect public health.

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