It does not look likely. The evaluation has not been completed and the National Pharmaceutical Regulatory Agency (NPRA) is still waiting for data from the manufacturer through the local importer, according to an industry source.
The problem is, the data could not be gathered because it was not incorporated in the vaccine trial design, while it was also not available in the current real-world data, he said.
“Efforts are being made to gain access to real-world data to justify registration,” the industry source added.
Sputnik V has been on many people’s minds, and opposition politicians have asked why the NPRA has not granted conditional approval for its use in an emergency situation like now, when Covid-19 cases are at a record high.
Recently, Mahathir had urged the government to expedite the Sputnik approval process to speed up the vaccination rate. Bandar Kuching MP Dr Kelvin Yii has also asked about the status of the 6.4 million doses of Sputnik vaccines Malaysia had pre-ordered.
On Tuesday, Duopharma (M) Sdn Bhd announced that it had signed an agreement with the government to supply 6.4 million doses of the vaccine but no information was made available as to when the supply would arrive or whether it would go through a fill-and-finish process at Duopharma’s Klang facility.
Yii said that without NPRA’s approval for Sputnik V, Duopharma would be unable to process these vaccines, much less import them.
Statista.com reported that over 50 countries had placed orders for Sputnik V from Russia. Developed at the Gamaleya Research Institute in Moscow, Russia registered Sputnik V in August 2020, the world’s first approved vaccine against Covid-19.
It claimed 91.6% vaccine effectiveness after the third phase of clinical trial and was used in Russia’s public vaccination programme.
Can Sputnik V’s dilemma be resolved? Former pharmaceutical services programme director Dr Ramli Zainal said that in general, it would be difficult for any vaccine to be evaluated if it did not have the needed clinical trial data
“Data for evaluation normally comes from clinical trials and it covers three major components — quality (data on manufacturing process, the factory itself, the ingredients used), efficacy and safety. Without these, it is difficult to evaluate,” he said.
Ramli said that for products already in the market, safety data can be derived from post-marketing surveillance (pharmacovigilance) programmes.
“With all this safety data, perhaps it’s possible to use this as a supporting document,” he said, adding that NPRA is a member of the World Health Organization (WHO) adverse drug event monitoring centre and could use shared data.
However, the vaccine has not been pre-qualified by WHO. It is currently being evaluated by the organisation and the European Medicines Agency (EMA), but it is also not in the US’ Food and Drug Administration’s emergency use list.
“Malaysia uses the FDA and the EMA as reference countries for approving medical products and since they had not approved it yet, this would pose a challenge,” said Ramli.
Meanwhile, the industry source said that the Drug Control Authority (DCA) could give guidelines to the NPRA to carry out a risk-benefit analysis of the vaccine for the current emergency situation.
Subsequently, if conditional approval is granted, small clinical trials could be carried out over a period of time to satisfy NPRA’s requirement, while the number of people vaccinated in a real-world setting and any adverse reactions should also guide the decision to be made, he said.