Advisory group insists on strict due diligence for Sputnik V vaccine

If the Sputnik V vaccine doesn’t receive regulatory approval by September – when the doses on island are set to expire – a “hard decision” may have to be made on whether to bypass that approval and start administering the shot in Antigua and Barbuda.
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By Orville Williams

[email protected]

After facing some scrutiny regarding local use of the Sputnik V Covid-19 vaccine, the advisory body tasked with assessing the vaccines is insisting that the necessary due diligence must be done before they can give the go-ahead for the shot to be administered in Antigua and Barbuda.

A few weeks ago, Information Minister Melford Nicholas disclosed that, despite approval from the Pharmacy Council for the use of Sputnik V, the rollout of the doses was being stalled due to hesitancy within the National Technical Working Group (NTWG) toward the jab.

The hesitancy was said to have come from the absence of emergency-use approval for the Sputnik V from the World Health Organization (WHO).

Nicholas talked up the growing desire within the population to receive the Russia-manufactured shot and questioned the reasoning behind the NTWG’s delay in giving the green light, referring to the situation where the Oxford/AstraZeneca vaccine was approved for use locally, before the WHO approval had been given.

Speaking to Observer late this week, Deputy Chairman of the NTWG, Dr Courtney Lewis, confirmed that the absence of WHO approval was just one of the reasons for the delay, with the other caused by a language barrier.

“The safety and efficacy reports on Sputnik V thus far are all in Russian [and] we want them to submit everything to us in English, in their own interpretation, so that we can read it, analyse it and come to a conclusion,” he said.

The question many might ask following that explanation is, why not get an interpreter to convert the material to English, so that the process can be sped up?

His response is that, “The difficult thing that happens when you have someone translate is you put your own interpretation into what someone is saying, when what you want is for them to give you – straight from their mouth – what they want you to know.”

The Sputnik V has been approved for use in more than 60 countries across the world, including EU states Hungary and Slovakia, although the European Medicines Agency (EMA) has yet to give authorisation.

In fact, Italian Prime Minister Mario Draghi was quoted just yesterday saying the Sputnik “has not yet managed to obtain and perhaps will never have the approval of the EMA”.

That sort of approval is the other factor that the NTWG has considered, as it looks to tread carefully and avoid any negative repercussions that could come with a premature endorsement.

One of these possible repercussions, Dr Lewis explained, is the health officials losing the trust of the public if the green light was to be given and, later on, the vaccine does not get the requisite regulatory approval due to sustained concerns over safety.

“We need some kind of established regulatory body to give the green light and say that all the different tests and regulations that have been put in place on the vaccine have shown that it’s actually safe for distribution to the wider masses.

“We have that approval for the AstraZeneca that we’re administering now, but [the same] has not been released for the Sputnik V,” he said.

“It’s a slippery slope…because there are other countries that are using Sputnik V and not waiting for the regulatory bodies to give approval, because their populations are in such dire need.

“In Antigua and Barbuda, there is so much vaccine hesitancy that we do not want to jump the gun and give something because we think the public needs it,” he added.

The Health Ministry received a donation of 1,000 Sputnik V vaccine doses in April and the government has voiced its intent to acquire more doses via commercial means in the future.

As the wait continues for the regulatory approval, the doses already in hand are said to have a September expiry date and Dr Lewis warned that a “hard decision” will have to be made close to that time, whether to continue to avoid the risk or to go ahead and use the doses without approval before they expire.

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