Home / Companies / News /  Despite US export ban lift, Serum Institute yet to get Novavax raw materials

Serum Institute of India (SII) is yet to receive raw materials from the US needed to produce the Novavax vaccine despite diplomatic interventions by India, said an official aware of the development.

The delay in receiving raw materials such as bioreactor bags and enzymes means that SII’s launch of the Novavax vaccine, branded as Covovax in India, will not likely happen before September this year as planned originally, the official said, requesting anonymity.

Earlier this week, US vaccine maker Novavax announced that its covid-19 vaccine, NVX-CoV2373, demonstrated 90% efficacy in phase 3 trials. A total of 29,960 participants who took part across the US and Mexico also showed efficacy against the Delta variant, the dominant virus variant in India.

SII is the manufacturing partner for Novavax in India where the company has committed to producing up to 1 billion doses. SII, the world’s largest vaccine maker, has been faltering on its international supply commitments.

The company said raw material shortages have led to the delay in launching the vaccine.

The US lifted the export ban on raw materials on 4 June.

“It’s fair to say that we are far ahead of where anyone thought we would be in our fight against the virus. And, importantly, we have secured enough vaccine supply for all Americans... As a result, we are removing the DPA priority ratings for AstraZeneca, Novavax and Sanofi. While the manufacturers will continue to make these vaccines, the action will allow US-based firms that supply to these manufacturers to make their decisions on the orders to fulfil first," the White House said in a statement on 2 June.

The relaxation of the Defence Production Act (DPA) was seen as a direct result of diplomatic talks between India and US with India’s foreign minister S. Jaishankar visiting Washington to appeal to the Joe Biden administration to iron out issues of vaccine distribution and other medical supplies to India.

The most critical shortage of raw materials for making the vaccines are bioreactor plastic bags used by companies to grow cells. The one-time use of sterile bags maintains the high quality critical in vaccine-making process and cuts risks of contamination. The other raw materials that are under shortage are enzymes needed to make new tech jabs such as mRNA or DNA vaccines.

A spokesperson for Pune-based SII did not respond to emailed queries.

Meanwhile, India’s vaccination drive continues to lag in terms of the percentage of population vaccinated. This is significant if the country has to avoid a potential third wave of the pandemic.

The two domestic vaccine makers, SII and Bharat Biotech, whose vaccines are under use for the vaccination drive have been under pressure to boost supplies. SII has indicated that it will increase supply by 100 million doses from the present 60-70 million doses starting July of the Covishield vaccine. The government has indicated that the country is expected to receive 2.17 billion doses through August to December. The government has estimated that SII will be providing 200 million doses of the Novavax vaccine.

SII-Novavax are also committed to supply 350 million doses of the Novavax vaccine candidate, to the COVAX Facility, an initiative led by Geneva-based GAVI, that intends to supply covid-19 vaccines to 92 low- and middle-income countries.

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