BANGALORE – Faced with an acute shortage of Covid vaccines, the Indian government has contracted three state-owned vaccine makers to boost production of Covaxin, one of the two approved Covid-19 vaccines in the country.
Vaccine policy experts lauded the decision as long overdue but said the government must marshal more such manufacturers to ensure vaccine and health security beyond the second wave of the pandemic.
The government’s Apr 17 decision comes amid soaring infections and inadequate vaccine production by the two main manufacturers, both private companies. These are the Serum Institute of India, which makes AstraZeneca’s vaccine, and Bharat Biotech, which makes Covaxin.
India recorded more than 363,000 infections and over 4,100 deaths in the past 24 hours. It needs to vaccinate 70 per cent of its population of 945 million people to achieve herd immunity. But 117 days after vaccinations began, less than 10 per cent of India’s population have received it.
Government data shows vaccination rates crashed by half in late April as supplies of vaccines dried up. India expanded vaccination to all adults from May 1 but the biggest states have announced that they will use their limited stocks to give those over 45 years of age their second dose.
Prime Minister Narendra Modi’s government blames the supply crunch on the unexpected uptick in demand for vaccines along with rising infections, but experts say poor planning contributed to the crisis.
“We are facing an acute vaccine shortage because the government’s vaccine policy depended excessively on only two manufacturers, and these two companies exaggerated their supply capabilities,” said Ms Malini Aisola, co-convenor of the All India Drug Action Network, a movement that campaigns for affordable healthcare.
Presently, Serum can produce 70 million doses a month of the AstraZeneca vaccine, known locally as Covishield, and Bharat Biotech can make 10 million doses of Covaxin a month. Both had promised to make 200 million doses a month together by May.
On March 17, the health ministry set up a six-member intergovernmental panel to explore how to ramp up vaccine production.
A month later, it permitted three state-owned companies – Hyderabad-based Indian Immunologicals Ltd, Bharat Immunologicals and Biologicals Ltd (BIBCOL) in Bulandshehr, Uttar Pradesh and Mumbai-based Haffkine Institute, one of the country’s oldest biomedical research institutes that helped end the 1896 plague – to scale up the manufacture of Covaxin. It will also invest in installing the facilities required.
The Indian government co-owns Covaxin, and two government institutes were involved in developing it.
The new units will reportedly double Covaxin’s doses manufactured to 20 million per month by June. By August, they are projected to make 60-70 million doses per month and around 100 million by September.
Dr KV Subramaniam, Life Sciences consultant and former managing director of Indian Immunologicals, welcomed the “long overdue decision” to include existing state-owned units in production, but noted that the timelines might be impractical.
Only companies with highly-secure Biosafety Level 3 (BSL3) production facilities can make Covaxin, as it involves the cultivation of large batches of the highly infectious coronavirus before inactivating them.
As India’s biggest producer of anti-rabies vaccine, which is also a inactivated virus technology like Covaxin, Indian Immunologicals is the only experienced manufacturer with BSL3 facilities. It also has four times the manufacturing capacity of Bharat Biotech for the rabies vaccine, said Mr Subramaniam.
“Indian Immunologicals could take six months to produce Covaxin (as it has BSL3 production facilities), but Haffkine and BIBCOL could take more than a year to make Covaxin since they do not have the requisite equipment or qualified manpower and would need to build all this. They should have been contracted sooner,” he said.
Furthermore, Covaxin accounts only for a tenth of the jabs given in India. The rest are that of Covishield, whose rights AstraZeneca owns, making it complicated for the Indian government to sub-contract vaccine makers unless they get a voluntary licence like Serum did.
On May 12, Serum assured the health ministry that it would ramp production up from 70 to 100 million. But experts say this might still not meet domestic demand in the face of a third wave or annual booster doses needed against a mutating virus.
“For ensuring long term, sustainable, affordable supply of vaccines, India needs to use its large, experienced public sector vaccine manufacturers. It will ensure stable supply and minimal prices because it’s under government control, and will not have market uncertainties like private companies,” said Dr Y Madhavi, senior principal scientist, National Institute of Science, Technology and Development Studies, Delhi, who has researched India’s vaccine policy for decades.
Today, 80 per cent of vaccines the Indian government procures for its nationwide immunisation programme are from private companies in India or abroad.
In 2010, it took a Supreme Court decision and a rebuke from a parliamentary committee for the health ministry to reopen three suspended state-owned units that used to make 80 per cent of the vaccines used annually in India until 2008. These were the Central Research Institute, Kasauli; BCG Vaccine Laboratory, Guindy; and Pasteur Institute of India, Conoor.
By 2016, the government had invested funds in making the companies compliant with good manufacturing practises, but gave them no purchase orders. Dr Madhavi said these units can meet India’s vaccine needs under this pandemic and later, if “they are given functional autonomy and freed from bureaucratic interference.”
There are other vaccines in the pipeline. India has allowed the import of foreign-made vaccines from Pfizer, Moderna and Johnson & Johnson. Hyderabad-based Biological E has its own vaccine candidate, and is also contracted to make Johnson & Johnson’s single dose vaccine in India.
India’s drug regulator recently approved the Russian vaccine Sputnik V for emergency use. Russia had entered into advance agreements in 2020 with five Indian manufacturers to make Sputnik for Indian and foreign use.
India has also approved Phase 2 and 3 clinical trials of Covaxin for children aged 2 to 18; if it clears the trials, it would be the only Covid vaccine for children under the age of 12. US health advisers have endorsed the use of Pfizer’s vaccine in children between 12 and 15 years.
“We cannot depend on imported vaccines because foreign vaccine makers are tied up in fulfilling orders to wealthy countries and when they reach India, supplies will be very limited”, said Ms Aisola. “The only sustainable and affordable solution is to produce vaccines locally.”
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