Clearance bottlenecks block new COVID vaccines that can help ease shortage

Vaccines like Sputnik V, Covovax and Novavax are yet to get clearance and reach medical facilities even though the Indian government had been preparing to manufacture them

Even as several Indian states are raising alarm over COVID-19 vaccine shortage, vaccines other than the currently used Covishield and Covaxin are yet to hit the shelves due to a gamut of reasons including clearance bottlenecks and shortage of raw materials.

India has been planning to launch vaccines like Russia-made Sputnik V, Covovax, developed by Novavax and produced in India by Serum Institute of India and Janssen Pharmaceutical’s Janssen vaccine.

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Sputnik V, which has been developed by Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology and tested in India through a bridging study by Dr Reddy’s Laboratories awaits the approval of the Central Drugs Standard Control Organisation (CDSCO) for emergency use even though application was sent for the same in February.

Last week, the Subject Expert Committee (SEC) had asked Dr Reddy’s to furnish complete information on the vaccine’s safety and immunogenicity from its bridging trials in India. The panel has also sought information related to the vaccine’s stability in order to gauge its potency and safety.

Indian Express quoting sources said, Dr Reddy is yet to submit the sought information.

“We had our meeting with SEC last week and will await the feedback from the CDSCO. We will provide an update once we have the feedback,” IE quoted a spokesperson of the pharma company as saying.

It is to be noted that MoUs have already been signed by the Russian Direct Investment Fund with Indian producers like Hetero Biopharma, Gland Pharma and Panaceo Biotec to produce more than 600 million doses of the vaccine every year.

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Meanwhile, Covovax, which according to SII is slated for a September launch, is facing roadblocks due to potential shortage of raw materials for its production in India. SII CEO Adar Poonawalla recently said that the decision of the US government to curb export of raw materials like filters and plastic bags will affect the Covovax’s production in India.

While SII, as per its agreement with Novavax, was supposed to manufacture 1 billion doses of the vaccine in 2021, the quantity will be halved due to shortage of raw materials. The vaccine is currently undergoing bridging studies in India.

As far the Jansssen vaccine is concerned, it is still not known if the vaccine will be launched in India as no bridging studies have been conducted on it yet, even though the company has collaborated with Biological E to produce 600 million shots in the country.

With India witnessing a second wave of the pandemic, experts have been calling for more vaccines to control further transmission of the disease.

“I think it’s time that we get new vaccines into play in India, because we definitely need more vaccines. We need to vaccinate faster as we implement much stronger public health measures for transmission control,” Dr Srinath Reddy, president of Public Health Foundation of India told Indian Express, adding that the currently-used vaccines may not be enough.

According to reports, India has only 70 million doses against a population of 1.3 billion.