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.

She said the FDA, listed as a World Health Organisation (WHO) Maturity Level Three Agency and a regional centre of regulatory excellence, had a stable, well-functioning and integrated regulatory system to ensure availability of quality safe and efficacious medical products, including vaccines.

Last Friday, Mrs Darko, who served on the WHO and the Council for International Organisations of Medical Sciences (CIOMS) Committee on Vaccine Safety to work with leading regulators from around the world to set standards for global vaccine safety, indicated that the FDA had authorised two vaccines to be administered in the country through the emergency use of authorisation pathway.

Checks by the Daily Graphic indicated that technical staff of the FDA had, since 2008, served as members of the WHO Pre-qualification team.

Currently, the FDA staff have been nominated to serve as assessors for COVID-19 vaccines on WHO’s Emergency Use List (EUL).

Two vaccines

“This is to assure you that the FDA has used what we call the emergency use authorisation pathway to authorise the two vaccines we have at the moment; that is, the Covishield, which was manufactured from India, and the Sputnik-V, from Russia.

“Now, the emergency use authorisation is a pathway that we use. That pathway is to ensure that a needed medical product, especially in a pandemic, is made available in a timely manner. So the only difference is that we do it quickly so it can be used,” Mrs Darko, a pharmacist with over 25 years’ experience in medicines regulation, especially clinical trials regulation, marketing authorisation and post-approval safety monitoring of medicines, said.

Mrs Darko explained that the UK AstraZeneca supplied the “active ingredients” and manufacturing techniques for the production of the vaccine to India.

She gave an assurance that due diligence had been done in the authorisation process, adding that what was being sent to Ghana was of the same quality, with safety and efficacy properties as being used in the UK and the rest of the world.

Administration of vaccines

The FDA Boss, who led efforts for Ghana to became a member of the WHO Programme for International Drug Monitoring in 2001, was of the belief that the producers of the AstraZeneca would not permit any country given the authorisation to produce the vaccine to compromise its quality, safety and efficacy.

She, however, pointed out that all the vaccines had known common reactions as part of developing immunity.

On the administration of the vaccine, Mrs Darko explained that it was important that the same vaccine used for a person in the first round should be used for the

second round, adding that “currently there are no studies on switching of vaccine.”

She, therefore, said it was not recommended for a person who took the first dose of the Sputnik-V vaccine to switch over to take the AstraZeneca vaccine for a booster in the second round, and vice versa.

Source: graphiconline

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