FDA Boss: Why you should trust the coronavirus vaccines

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FDA

Once again the FDA has added its voice to the many assurances being given around on the safety of the new coronavirus vaccines that are to be administered to Ghanaians as a measure at reducing the spread of the virus.

According to Delese Mimi Darko, the Chief Executive Officer of the Food and Drugs Authority, the Authority’s track records in the past, working alongside world health giants like the World Health Organization, gives it a credibility that cannot be questioned.

The FDA boss said that with the thorough work the FD has done in the past on vaccines for diseases such as yellow fever, measles and the recent malaria vaccine, Ghanaians should be rest-assured that the AstraZeneca and Sputnik-V vaccines being procured by the country are safe and will not cause any harm to lives.

She made this known during a Public Engagement on COVID-19 Vaccination Roll Out Plan organized by the Ministry of Information, the Ministry of Health, and the Ghana Health Service, to sensitize the public on the vaccines and all matters related to it.

She explains all processes for efficiency and monitoring of the vaccination process below.

“All the things we have to do to make sure that a vaccine or a medical product is safe, we have done for these two vaccines. As with every other product, the safety has to be monitored and we have put together a nationwide safety surveillance system; that is the same system that is used for all vaccines that are used in the country. And everybody that is vaccinated will be followed up actively to ensure that any adverse event that they experience will be reported, it will be managed, and the causality will be accessed. Sometimes, you might experience an adverse effect that may not be related to the vaccination. We will do this monitoring with the EPI and it will be nationwide so no matter where you are in the country, you’ll be followed up.

“We will do this through a system that will use phone calls, and we launched an app in 2019, the Med Safety App which you have on your phone, there’s an online reporting system, there’s a hotline, and there’ll be dedicated safety numbers that you can also use. We are working with the EPI to train all healthcare practitioners on what to expect following vaccination

“We have also put together a 13-member expert committee that will be working with us. We always have an expert committee that works with us on adverse events, to make sure that causality is accessed as soon as we receive a report, and we’ll be reporting back every week just to assure Ghanaians that we are doing what we’re supposed to do.

“Just to assure you that the FDA is a Maturity Level 3 and in pharmacovigilance, which is safety, we are Maturity Level 4 – very few of them in the world. And we are also a regional center of excellence in Africa for safety monitoring and we’ve been a member of the WHO Center for International Drug Monitoring since 2001. So, we have effectively monitored vaccines like the measles rubella, yellow fever, rotavirus, pneumococcal vaccines that was introduced a few years ago, and recently, we monitored effectively, the safety of the malaria vaccine so we assure you that we have a good safety system in place,” she assured.

Ghana has received the first 600,000 doses of the AstraZeneca vaccine, being one the 145 countries listed to receive vaccines from a number of suppliers through the COVAX Facility, according to the WHO.

 

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