Internationally recognised regulatory agency yet to Approve the Approved Russian vaccine in Nigeria

Internationally recognised regulatory agency yet to Approve the Approved Russian vaccine in Nigeria

Internationally recognised regulatory agency yet to Approve the Approved Russian vaccine in Nigeria—

ON Thursday, July 15, 2021, the National Agency for Food and Drug Administration and Control, NAFDAC, announced that it had approved the Russian Sputnik Vaccine for use in the fight against the Coronavirus pandemic in Nigeria. The Agency’s Director- General, Mojisola Adeyeye, announced that NAFDAC subjected the vaccine to relevant scientific tests before approving it.

This, however, came against the background of international reservations about the vaccine. No major internationally recognised regulatory agency has okayed the vaccine because of a number of inadequacies which make it suspicious. Indeed, the World Health Organisation, WHO, the European Medicines Agency, EMA, and the United Nations International Children’s Emergency Fund, UNICEF, have already discountenanced the Russian vaccine.

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The WHO, which conducted an inspection of four Sputnik manufacturing sites in Southern Russia, identified six problems which militate against its approval for universal use. These had to do with data integrity, testing results and quality control. The WHO inspectors also found it was difficult to trace and identify vaccine batches, among other concerns.

We wonder if NAFDAC actually monitored the thumb-down reports by these international agencies, including EMA to which Russia belongs. If it did, one expected the Agency to still choose to err on the side of caution by withholding this approval for the time being.

The UNICEF had applied this caution by affirming that only Sputnik’s approval by the WHO will assure it of its quality, safety and efficacy.

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But NAFDAC’s Adeyeye insisted thus: “Sputnik V is yet to receive the EUL approval and therefore was subjected to full six months review by NAFDAC.


The Agency was granted access to dossiers and prior assessment reports of Moderna and AstraZeneca from the WHO website over the past six months. The Agency did a thorough assessment of each vaccine and (all) were found to have the quality, safety and efficacy attributes, with the benefits far outweighing the risks”.

The Federal Government has always insisted that all remedies to fight the pandemic, including the vaccines, would be subjected to scientific tests by our experts of which NAFDAC is a frontline agency. But in a situation whereby the decision of our indigenous regulators clashes with that of other regional and universal experts, caution is demanded.

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The number of Nigerians stepping forward for the voluntary jab remains abysmal, with only 1.4m people (0.7 per cent) fully vaccinated. The conspiracy theories about the universally approved vaccines continue to keep people away. The situation will be worsened when a clearly suspect vaccine is let loose among the people.

We call on the Federal Government’s Task Force on COVID-19 to ignore the NAFDAC approval and wait until the Sputnik V has been fully confirmed safe for universal administration by the WHO. It is better to be safe than sorry.

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