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NAFDAC, WHO certify Covidshield vaccine as AstraZeneca’s patent

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NAFDAC


•Panel reviews safety concerns, makes positive observations

National Agency for Food and Drug Administration and Control (NAFDAC) and the World Health Organisation (WHO) have confirmed Covidshield vaccine as same AstraZeneca/Oxford University jab produced commercially in India.

NAFDAC, in a statement yesterday by its Director General, Prof. Mojisola Adeyeye, clarified: “AstraZeneca and Oxford University (AZOU) originally developed the ChAdOx1 recombinant adenoviral vector vaccine to be used for prevention of COVID-19 disease. AZOU gave the licence of its vaccine to Serum Institute of India PVT Ltd (SIIPL) to manufacture this vaccine at commercial scale.

“SIIPL is the largest vaccine manufacturer in the world and the company got the licence by signing manufacturing agreement with AstraZeneca (AZ)/Oxford University to manufacture this vaccine. SIIPL gave the vaccine the trade name COVISHIELDTM.

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“COVISHIELDTM is the result of a cooperation and a technology transfer from AstraZeneca-University of Oxford to SIIPL.” Adeyeye said SIIPL is now the world’s largest vaccine manufacturer by production and sales (totalling more than 1.5 billion doses), including polio, diphtheria, tetanus, pertussis, Hib, BCG, r-hepatitis B, measles, mumps and rubella therapies.

The NAFDAC DG said SIIPL vaccines are accredited by WHO and used in some170 countries across the globe. According to WHO, more than 20 million doses of the AstraZeneca vaccine have been administered in Europe and more than 27 million jabs of the Covishield cure in India.

The global agency spoke in a statement by its Global Advisory Committee on Vaccine Safety (GACVS) COVID-19 subcommittee on safety concerns relating to AstraZeneca.

The panel met virtually March on 16 and 19, 2021 to review available information on thromboembolic events (blood clots) and thrombocytopenia (low platelets) after vaccination.

The subcommittee reviewed clinical trial data and reports based on safety complaints from Europe, United Kingdom, India and Vigibase, the WHO global database of individual case safety reports.

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Based on a careful scientific review, the team observed among others that the AstraZeneca COVID-19 vaccine, including Covishield, has continued to have a positive benefit-risk profile, with tremendous potential to prevent infections and reduce deaths across the world.

The observation did not suggest any overall increase in clotting conditions such as deep venous thrombosis or pulmonary embolism following administration of the vaccines.

Meanwhile, as vaccination resumes today at the 88 sites across Lagos, the state government is urging eligible persons to observe extant safety protocols and adhere to professional advice.

The Commissioner for Health, Prof. Akin Abayomi, who spoke yesterday in Lagos, reiterated that only healthcare workers, COVID-19 response team (RRT), ports of entry staff, laboratory network, judiciary, military, police, other security agencies, petrol station workers, teachers, media, other frontline workers and persons of age 70 years and above would be attended to.

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