Mixing shots a bad idea; India may not meet Dec 31 target: SII founder

The Serum Institute of India is unlikely to be able to secure a license for its version of the highly efficacious coronavirus vaccine developed by US-based company Novavax, the Pune-based vaccine maker’s chairman said on Friday, when he also urged caution on mixing of doses, said booster shots may be needed for those vaccinated over six months ago, and that the expectation that all Indians will be vaccinated by the end of 2021 was unlikely to be achieved.

Cyrus Poonawalla, 80, who founded SII – now the world’s largest vaccine maker by volume – was speaking at an event in Pune, where he credited the Centre for easing regulatory processes for vaccine makers at a difficult time. He, however, stressed that the ideal gap between two doses of Covishield, which his company makes, was two months, and criticised the government for banning the export of doses.

On the vaccination target to reach all Indians by 2021, Poonawalla said: ”We are yet to increase our production to 10 crore (100 million) vaccines. No single company in the world can produce 10 crore vaccines in a month. We have promised about 110-120 crore doses annually because we invested in it prior. So you can do the math now. If other manufacturers produce 1-2 crores every month then the production would increase accordingly.”

The SII founder also said it was a “bad move by the government” to embargo exports of vaccines. “My son (SII CEO Adar Poonawalla) asked me not to open my mouth. But it is my view that exports ought to be opened,” Poonawalla said, citing SII’s supply commitments.

Over 150 countries are dependent on SII for vaccines and are blaming the company for stopping the supply during a crucial period, he said, before adding that these countries have paid “crores” in advances. The Bill and Melinda Gates Foundation and World Health Organisation (WHO) have given it ₹5,000 crore which, Poonawalla said, he offered to return. He hinted that they declined his offer in the hope that the Indian government will lift the ban soon.

India banned vaccine exports in April when the second wave of the pandemic began to peak and the need to vaccinate people in the country at a greater pace was felt acutely.

Poonawalla, however, credited the Centre for easing regulatory processes. “I must stress that my difficulties are much reduced under the Modi government. Definitely, I am not the one to give lip sympathy to government ministers but certainly, one of the major reasons why we could launch our Covid vaccine so quickly was because of the forthcoming grant of permissions, encouragement to industries and reduction of ‘Licencing Raj’. We have now got a drug controller who responds in the evening hours,” Poonawalla said.

SII-manufactured Covishield accounts for close to 90% of all coronavirus vaccine doses administered in India. In mid-July, the Union government announced that it had placed orders for 375 million doses of Covishield at a rate of ₹205 per dose. These doses will be supplied between August and December. The Union government recently told parliament that the company will produce 150 million doses a month beginning next month.

On when the Novavax vaccine, to be marketed as Covavax in India, can be launched by SII, Poonawalla said: “Novavax is a very good product, however, unless we get the licence to launch it we cannot do so. The American parent company has got some issues with the US FDA which should be cleared by the end of year. Once they get the licence, we will get the licence. We will also try to get it approved before the parent company if possible.”

The SII chairman also said that mixing of vaccine doses may lead to a blame game if the results are not idea. “If cocktail vaccines are administered and if the result is not good, then SII may say that another vaccine was not good, vice versa, the other company might say that since you mixed Serum’s vaccine, it did not give desired results,” Poonawalla said.