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COVID-19 vaccines safe, effective – FDA assures public


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The Food and Drugs Authority (FDA) says adequate safety and quality assurance has been done in authorising the two COVID-19 vaccines to be administered in the country.
It said no safety and efficacy standards were bypassed or compromised, except that the emergency use authorisation pathway allowed for expedited review for the public good.
Assurance
Giving the assurance in an interview with the Daily Graphic in Accra yesterday, the Chief Executive Officer (CEO) of the FDA, Mrs Delese Mimi Darko, said the two vaccines were Covishield, AstraZeneca Vaccine, manufactured by Serum Institute of India, and Sputnik-V, manufactured by Generium in Russia. ....

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Darnitsa digitalizes its pharmacovigilance system to meet the requirements of foreign regulators


Darnitsa digitalizes its pharmacovigilance system to meet the requirements of foreign regulators
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Darnitsa pharmaceutical company is developing its pharmacovigilance system, its digitalization allowing the company to meet the modern requirements of foreign regulators, said Head of the Department for Regulatory Issues of Darnitsa Oleksandr Torhun.
‘The modern system of pharmacovigilance will allow Darnitsa in the long term to successfully meet the demands of those regulators that require more extensive data for registration dossiers. In fact, we are proactive in this case. After all, the capabilities of the new system are much wider than the classic format of pharmacovigilance,” the press service of the company quotes Torhun. ....

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Local trial of COVID-19 vaccines critical – Clinical Pharmacologist


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A clinical pharmacologist, Professor Alex Dodoo, has suggested that Ghana should conduct local clinical trials for COVID-19 vaccines to help settle on a suitable one for the people.
All vaccines, he said, might have side effects, depending on various conditions in the geographical areas they might be used, hence the need to do clinical trials locally.
In an interview with the Daily Graphic in Accra, Prof. Dodoo posed some questions: “Which of them [vaccines] is Ghana going for and what is the global experience? Based on the global experience, should we go for it? Do we use it as intended by other countries or should we blend?” ....

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