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NAFDAC-approved Russian vaccine beneficiaries may be barred from Europe – Virologist

Prof Moji Adeyeye

NAFDAC DG, Prof. Mojisola Adeyeye

A medical virologist at Adeleke University, Ede, Osun State, Dr. Oladipo Kolawole, has said people vaccinated with the Russian Sputnik vaccine may not be allowed to enter European countries.

Kolawole, in an interview with our correspondent, said European Medicines Agency has not enlisted the Russian Sputnik vaccine.

The National Agency for Food and Drug Administration and Control had, on Thursday, announced the conditional approval of Russian Sputnik vaccine.

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The Director-General of NAFDAC, Mojisola Adeyeye, made this known on Thursday during a press briefing in Abuja.

 The approval is coming after the World Health Organisation, the European Union and  United Nations International Children’s Emergency Fund expressed concerns over the vaccine.

However, Kolawole said, “The vaccine produces a moderate immune response against aggressive new mutations of the coronavirus such as the Delta variant, the jabs’ developers announced Monday in a new peer-reviewed study as described by Vladimir A. Gushchin et al., 2021.

“Another challenge, for now, is that the vaccine has not been enlisted by EMA, which will make it difficult to enter European countries if vaccinated with it. But if there is the possibility of such, it is a good idea.

“The WHO and UNICEF have expressed concern over the data integrity and quality control of the vaccine production which is of great concern. These are some of the factors to consider.”

According to Reuters, the developers of Russia’s Sputnik V coronavirus vaccine have repeatedly failed to provide data that regulators deem to be standard requirements of the drug approval process.

Recall that WHO in a report had stated that during its inspection of the four Sputnik V manufacturing sites, it found some issues in the Pharmstandard Ufa Vitamin Plant in Ufa, southern Russia.

The report had also disclosed that inspectors had concerns with the data integrity and testing results.

The EU also cited the same concerns, while UNICEF in a statement said the procurement of the Sputnik vaccine by UNICEF would be under the condition of the product achieving an Emergency Use Listing from WHO, to confirm the quality, safety and efficacy of the vaccine.

However, the NAFDAC DG added that despite the vaccine not getting approval from the WHO, the agency had done a thorough assessment of the vaccine.

She said, “Sputnik V has yet to receive the EUL approval and therefore was subjected to a full six-month review by NAFDAC. The agency was granted access to the dossiers and prior assessment reports of Moderna and AstraZeneca from the WHO website at different times over the past two months.

“The agency did a thorough assessment of each vaccine and was found to have the quality, safety and efficacy attributes, with the benefits far outweighing the risks.”

Adeyeye added that two other vaccines, Moderna and AstraZeneca (SK bioscience Co limited, Republic of Korea) had been approved.

She said, “Moderna and AstraZeneca AZD1222 vaccines have received WHO EUL listing and were given expedited approvals.”

States increase advocacy

Meanwhile, some states have stepped up advocacy to prevent the third wave of the pandemic in the places.

For instance, the Edo State Covid-19 Incident Manager, Dr Andrew Obi, said the state government had not abandoned protocol enforcement, adding that it was, however,  increasing advocacy to achieve more compliance.

 He said, “People find it difficult to comply with protocol unless they are forced. We have not abandoned enforcement; but there are educative jingles and materials meant to show people the need to comply with non-pharmaceutical intervention.”

In Osun, the state government on Wednesday warned residents against disregard for safety protocols and non-pharmaceutical guidelines.

A statement by the state’s Commissioner for Information and Civic Orientation, Mrs Funke Egbemode, enjoined citizens to continue to take personal responsibility for their own safety.

The statement read in parts, “The arrival of the new Delta variant is a signal to us that we cannot let down our guards. It has ushered in a third wave in other parts of the world, and its strain has been found in Nigeria – as a matter of fact, in Oyo state. Therefore, we cannot pretend that Osun is an island considering our people engage in trade and social activities with this neighbouring state.

 “Everyone should protect himself at all times by putting on a face mask in public places, avoid crowded spaces, disinfect  hands and surfaces with alcohol-based sanitizer.”

Also, the Lagos State Commissioner for Information, Mr Gbenga Omotoso, said the state government would continue to focus on advocacy on COVID-19.

Omotoso said, “At a time, we slowed down on enforcement of COVID-19 safety protocols in the state. We stepped up advocacy to tell people that the battle against COVID-19 is for all of us.”

The commissioner added that the state government could no longer pretend about the third wave of the virus.

“We have step up advocacy; we expect that Lagosians will obey this because if they had not done well in obeying the COVID-19 protocols, we would have been in serious trouble by now,” Omotoso said.

He added that some of the international travellers that dropped wrong contact information were returning for self-isolation.

“Some of them have been coming forward to self-isolate. The Federal Government has also taken some of them before the law,” Omotoso said.

Similarly in Ogun State, the Commissioner for Health, Dr Tomi Coker, said although there was no Delta variant in the state, the government called for strict adherence to public health guidelines.

Coker in a statement called for strict adherence to guidelines “considering the increase in the cases we are experiencing nationwide at the moment.

“The first phase of the vaccination campaign has been concluded.

“However, the second phase is about to commence and we urge all those yet to be vaccinated to present themselves at the nearest vaccination center for their first and second dose. It is well established that the vaccines are safe and effective in protecting us and loved ones.”

WHO in a report had stated that during its inspection of the four Sputnik V manufacturing sites, it found some issues in the Pharmstandard Ufa Vitamin Plant in Ufa, southern Russia.

The report had also disclosed that inspectors had concerns with the data integrity and testing results.

The EU also cited the same concerns, while UNICEF in a statement said the procurement of the Sputnik vaccine by UNICEF would be under the condition of the product achieving an Emergency Use Listing from WHO, to confirm the quality, safety and efficacy of the vaccine.

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