FDA outlines comprehensive COVID-19 vaccine safety monitoring measures

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A total of 200,000 doses of Sinopharm COVID-19 vaccines donated by the Red Cross Society of China to the Bangladesh Red Crescent Society are shipped on Oct. 25. (Photo courtesy of the Red Cross Society of China)
A total of 200,000 doses of Sinopharm COVID-19 vaccines donated by the Red Cross Society of China to the Bangladesh Red Crescent Society are shipped on Oct. 25. (Photo courtesy of the Red Cross Society of China)

The Food and Drugs Authority (FDA) has outlined comprehensive safety monitoring measures to ensure that all COVID-19 vaccines deployed in Ghana are safe for the public.

In a release signed by Mrs Delese A A Darko, FDA Chief Executive Officer and made available to the Ghana News Agency in Tema said 13,714,484 doses of the five vaccines granted Emergency Use Authorisation (EUA) by the FDA has been issued as at April 13, this year.

The statistics indicated that COVID-19 Vaccines administered are: 8,780,598 doses of Oxford or AstraZeneca; 2,495,708 doses of Pfizer; 1,356,808 doses of Johnson and Johnson; 1,063,397 of Moderna; and 17,982 doses of Sputnik V.

She said the 15th meeting by the Joint COVID-19 Vaccine Safety Review Committee (JCVSRC) on April 13 also reviewed all safety reports received from the vaccinations in Ghana as well as from international sources.

Mrs Darko said the committee established that reports on side effects COVID-19 Vaccine received in Ghana were generally consistent with what was expected from the vaccinations.

The FDA CEO said the commonly side effects reported were headache, fever, chills, pains at injected side, and body pains, are usually minor and resolved within a day or two.

She added that the JCVSRC carefully reviewed the preliminary data from the ongoing active monitoring of ‘mRNA COVID-19 Vaccines’ (Pfizer and Morderna vaccines) in pregnancy across the country and concluded that there were no safety concerns.

She said the committee, therefore, wished to encourage pregnant women to get vaccinated because available evidence showed that there were health benefits of receiving the mRNA vaccines in pregnancy far outweigh any potential risk.

Mrs Darko entreated all those who received COVID-19 vaccines and all other vaccines to report any side effects encountered to the FDA to aid in early identification and quick mitigation of any potential issues.

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