KUALA LUMPUR – October 4, 1957 is a historic date for the Russians, who launched the world’s first artificial satellite, Sputnik 1, into space, paving the way for rapid global development on the cosmic front.
More than 60 years later, the federation’s own Covid-19 vaccine would also become the first authorised for use, hence the resemblance in its name, Sputnik V – ostensibly inspired by the revolutionary breakthrough and successful race to space.
Despite a slow adoption rate in the initial phases – likely due to Russia’s decision to authorise it in August last year, months before the final stage of its clinical trials – interest in the vaccine has now been piqued.
This has been largely attributed to Sputnik V having finally gone through Phase 3 trials, and prestigious medical journal The Lancet declaring last month that the shot is safe, with an efficacy rate of 91.6%.
The jab is also cheaper than most, better at handling mutations of Covid-19, and can be stored at between 2°C and 8°C, unlike some vaccines that require ultra-low temperatures.
And, many countries have started purchasing and rolling out Sputnik V, with about 50 nations having so far approved or penned deals to procure it.
Time running out
However, the question remains: why is it taking so long for Malaysia to approve its use?
Malaysia, through Duopharma (M) Sdn Bhd, signed an agreement with the Russian Direct Investment Fund (RDIF) on January 26 for the purchase of 6.4 million doses of Sputnik V, which is developed by the state-backed Gamaleya National Research Institute.
The vaccines were supposed to arrive by the end of this month, but so far, Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has yet to give its approval.
Science, Technology and Innovation Minister Khairy Jamaluddin previously said the regulatory body has to obtain additional information on several vaccines before approval is given.
But with Malaysia’s vaccine roll-out schedule, and the nation continuing to record coronavirus cases in the quadruple digits, certain quarters have been asking that Sputnik V’s delivery be expedited.
There is also concern that delaying its arrival could see supply running out.
Things get ‘stuck’
Trade Representative of the Russian Federation in Malaysia Nikita Ponomarenko said negotiations with Malaysian officials on the distribution of Sputnik V began as early as last June.
The collaboration sees the sharing of information and expertise in research and development, as well as the development of vaccine production facilities in Malaysia.
This could see Sputnik V being developed here by next year, if all goes well.
The respective ministers from both countries have also been involved in a series of virtual meetings.
Ponomarenko said the response from the Malaysian side has been seemingly “very good and reflective”.
“But, somewhere, at certain levels, things got stuck,” he told The Vibes.
“There were some problems with the registration of the vaccine.
“Negotiations started almost a year ago, but things are still not moving.”
He said RDIF and Duopharma have been submitting the necessary documents to NPRA since December.
“Maybe, there is some missing information from our side, but we will try to answer whatever questions are raised.
“In fact, there is daily communication between NPRA and Duopharma, but NPRA keeps asking for more clarification.
“Why is it taking so long to be approved? I ask myself that question. I wish I could answer.”
Ponomarenko did not discount the possibility that the delay is influenced by Western media, which he said has given the vaccine bad publicity.
The European Union has yet to approve its use, although recent studies have shown Sputnik V to be safe and effective.
Ponomarenko acknowledged the independence of NPRA and said he will respect any decision made, as it was highlighted by Khairy in the past that the body is uncompromising in ensuring safety and quality.
‘We can’t read Russian’
Health Minister Datuk Seri Dr Adham Baba has clarified that NPRA has yet to approve Sputnik V as RDIF and Duopharma have not yet responded to all queries raised by the regulator.
But, he did not elaborate on what information is pending or required, and whether the hold-up in approval will cause a delay in the vaccine’s roll-out.
He noted that the initial dossier relating to the vaccine submitted to NPRA was fully in the Russian language, with the English version submitted only recently.
Asked to clarify if a new time frame has been set for the roll-out of Sputnik V, Dr Adham said the matter must be deliberated by NPRA before any distribution plan can be announced.
“They (NPRA) need to convene a meeting and discuss the proposal to purchase the vaccine first.
“Once NPRA approves the vaccine, then the process of procurement (can be initiated).”
Meanwhile, a spokesman for the Covid-19 Vaccine Supply Access Guarantee Special Committee, which is co-chaired by Khairy and Dr Adham, said the government will not interfere with NPRA’s work.
It is important for Putrajaya to not be seen as pressuring or influencing the independent body, added the health minister. – The Vibes, March 14, 2021
