By Raju Vernekar
Pune, April 17:
Amid the reports of vaccine shortage in the country, the Pune-based “Serum Institute of India” (SII) CEO Adar Poonawalla, on Friday, urged US President Joe Biden to lift the embargo on vaccine raw material exported out of the country so that vaccine production can be ramped up.
“Respected @POTUS, if we are to truly unite in beating this virus, on behalf of the vaccine industry outside the U.S., I humbly request you to lift the embargo of raw material exports out of the U.S. so that vaccine production can ramp up. Your administration has the details,” said Poonawalla in a tweet.
Poonawalla’s tweet came following Oxford-AstraZeneca’s legal notice to the SII, for delays in deliveries. The Serum chief had earlier admitted that SII has been facing problems in sending out the required number of batches of COVID-19 vaccines due to bureaucratic and government-related hurdles. He had also said that SII would need around Rs.3,000 crore to ramp up COVID-19 vaccine production capacity. The SII has already delivered over 100 million doses to India and exported around 60 million doses to other countries.
The CEO had earlier stated that the US has implemented the Defence Act that bans the export of raw materials leading to difficulties to several vaccine manufacturers. Poonawalla called the restriction “as good as banning vaccines”. Poonawalla, whose company is also manufacturing the “Novavax coronavirus vaccine”, said that the production of the same has been stalled because of the raw material shortage. The unavailability of the raw materials, such as the specific medium needed to grow microorganisms, would prevent Serum Institute from scaling up the production of the vaccine developed by “Novavax”. The firm had been planning to make up to 40 million shots of the vaccine monthly.
“There is a long list of raw materials which we import from the US – filters, bags, certain media solutions, etc. Developing new suppliers in the eleventh hour will take a bit of time. We will do that. We will not be dependent on the US after six months. The problem is we need it now”, Poonawalla stated.
The raw materials required by SII
The list of raw materials that SII imports from the US include the “adjuvant” and large sterile plastic bags used to grow vaccine cells. An adjuvant is a substance that is used to increase the efficacy of a vaccine and helps the immune system generate antibodies. While vaccine manufacturers can establish a fresh supply chain for raw materials like filters and sterile plastic bags, the disruption in the supply of adjuvant can hamper production for a longer period. Authorized vaccines are made with a certain adjuvant and any change in the vendor of that adjuvant would lead to fresh clinical trials and approvals.
Poonawalla said that “AstraZeneca has sent us legal notice and the Indian government is also aware of that. I cannot comment on the legal notice as it is confidential, but we are examining all avenues to amicably manage and resolve legal disputes over contractual obligations that Serum Institute is not able to fulfill due to its prioritization of Indian supplies”.
The Serum Institute is currently manufacturing the anti-coronavirus vaccine “Covishield”, developed by AstraZeneca and Oxford University. The “Covishield” is not only being used in India but also exported to several nations.
In November last year, American pharmaceutical company Pfizer Inc. cut short its vaccine production target by half, citing a shortage of raw material. Pfizer, which is producing mRNA Covid-19 vaccines, had earlier planned to roll out over 1.2 billion shots this year, but reduced the target by half due to raw material shortage in the United States and Europe.
The vaccine shortage in India
Multiple states including Maharashtra, Punjab, Rajasthan have already written to the Centre, flagging dwindling COVID-19 vaccine stocks. Many districts in Karnataka, Odisha, and Kerala have also said that their vaccine stock is rapidly getting over.
A surge in COVID-19 cases
In the meanwhile India’s tally surged to 14.52 million with 234,692 fresh infections and 109,997 active cases in the second wave of COVID-19 on Saturday. The daily fatalities remained above 1,000 as 1,341 people died due to the viral infection, pushing the death toll to 175,649.
