Foreign vaccines not in free supply, working for imports soon: Centre

Aditi Tandon

Tribune News Service

New Delhi, May 27

Amid vaccine shortages and repeated questioning by states about dithering supplies, the government on Thursday said foreign vaccines were not in free supply and efforts were afoot to import them soon.

In a statement, ‘Myths and facts’ about Covid vaccines and the Indian response, the government said it was engaged with foreign manufacturers on imports and had done its best to ramp up domestic production and added that the failure of states to procure directly from foreign makers reaffirmed what the Centre had been saying all along – the vaccines are in short supply globally.

The government rebuffed suggestions of child vaccination by Delhi CM Arvind Kejriwal saying these decisions had to be guided by science and could not be a function of what some politicians suggested.

WHO has not recommended vaccination in children yet, the Centre said, adding that the compulsory licensing debate was redundant because the challenge was not acquiring the vaccine formula but technology to develop and use that vaccine.

“The Centre has remained engaged with major international vaccine manufacturers from mid-2020. Multiple rounds of discussions have happened with Pfizer, J&J and Moderna and we have offered all assistance to them to supply or manufacture vaccines in India. However, it is not that their vaccines are available in free supply. Buying vaccines internationally is not similar to buying off-the-shelf items. Vaccines are in limited supply globally, and companies have their own priorities, game-plans and compulsions in allocating finite stocks. They also give preference to countries of their origin just as our own vaccine makers have done unhesitatingly for us,” a government statement said, again “requesting” international vaccine makers to come and make in India – for India and the world.

The government said after Pfizer indicated vaccine availability, it was working with the firm for the earliest possible import and added that Sputnik vaccine tech-transfer to Indian companies had been concluded and manufacturing would start soon.

The Centre said no application of any foreign manufacturer for approval was pending with the drugs controller.

“We have eased entry of vaccines approved by US FDA, EMA, UK's MHRA and Japan's PMDA, and WHO's Emergency Use Listing into India in April. The provision has now been further amended to waive the trial requirement altogether for the well-established vaccines manufactured in other countries,” the government said two days after Delhi Deputy CM Manish Sisodia said the Centre had not approved Pfizer and Moderna.

On local production of vaccines, the government said only one Indian company (Bharat Biotech) had intellectual property rights for Covaxin and the Centre had ensured that three other companies start production of Covaxin apart from enhancing Bharat Biotech’s own plants from one to four.

“Covaxin production by Bharat Biotech is being increased from under 1 crore per month to 10 crore per month by October. Three PSUs will together aim to produce up to 4 crore doses by December. Serum Institute is ramping up Covishield production of 6.5 crore doses per month to 11 crore doses per month. Sputnik will be manufactured by six companies coordinated by Dr Reddy’s. Efforts of Zydus Cadila, BioE and Gennova are being backed for their respective indigenous vaccines through liberal funding under Covid Suraksha scheme and technical support at national laboratories,” said the government, assuring estimated production of over 200  crore doses by the Indian vaccine industry by the end of 2021.

“How many countries can even dream of such an enormous capacity, and that too across conventional as well as cutting-edge DNA and mRNA platforms?” asked the Centre.

On compulsory licensing, it said it is not an attractive option since it is not the ‘formula’ that matters, but active partnership, training of human resources, sourcing of raw materials and highest levels of bio-safety labs.

“Tech transfer is the key and that remains in the hands of the company that has carried out R&D. We have gone one step ahead of Compulsory Licensing and are ensuring active partnership between Bharat Biotech and three entities to enhance production of Covaxin. Similar mechanism is being followed for Sputnik. Moderna had said in October 2020 that it would not sue any company which makes its vaccines, but still not one company has done it, which shows licensing is the least of the issues. If vaccine-making was so easy, why would even the developed world be so short of vaccine doses?” the Centre asked.

The government also rejected accusations that it had abdicated its responsibility to the states and said the Central Government was doing all the heavy-lifting, from funding vaccine manufacturers to giving them quick approvals to ramping up production to bringing foreign vaccines to India.

“The vaccine procured by the Centre is supplied wholly to the states for free administration to people. The states know this. The Government of India has merely enabled states to try procuring vaccines on their own, on their explicit requests. The states knew the production capacity in the country and the difficulties in procuring vaccines directly from abroad. The Government ran the entire vaccine programme from January to April and it was quite well-administrated compared to the situation in May. But states, who had not even achieved good coverage of health-care workers and frontline workers in three months wanted to open up the process of vaccination and wanted more decentralisation,” said the Centre, noting that health being a state subject, a liberalised vaccine policy was drafted after incessant requests by states to give states more power.

“The fact that global tenders have not given any results only reaffirm what we have been telling the states from day one - vaccines are in short supply in the world and it is not easy to procure them at short notice,” the Centre said.