The ambitious vaccination drive of India got off to a slow start. The initial plan was to vaccinate 250 million people by July this year. Hiccups due to import restrictions placed by America and low amount vaccine doses ordered by the government slowed down the process.
The new vaccination plan by the government is to procure 216 crore doses of vaccine by December 2021. A bunch of indigenous and globally manufactured vaccine are undergoing trials. The government is relying on the availability of these vaccines to vaccinate the people.
In terms of numbers, India is third on the list for the number of people vaccinated. To date, India has administered 18,29,26,460 (182 million) doses of vaccine.
Updates on Vaccine Trials and Production
India is administering the vaccines Covaxin and Covisheild to its citizens. The Sputnik V vaccine was given clearance by the Drug Controller General of India (DGCI) to be used in the immunisation program. Zycov-D manufactured by the Zydus Cadila could be the next vaccine to hit the markets.
Foreign vaccine manufacturers in collaboration with Indian pharmaceutical companies are conducting vaccine trials. This is being done simultaneously along with the development of indigenous vaccinations. A host of Indian companies are involved in manufacturing vaccines to immunise Indians against the coronavirus.
Bharat Biotech developed the indigenous Covaxin in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
In phase III interim trials of the vaccine, it showed 100 per cent efficacy in severe Covid-19 infections. It reported 78 per cent efficacy against mild and moderate cases. Overall, it achieved an interim efficacy of 81 per cent in phase III trials.
The safety and efficacy results from the final analysis will be made available in June. The final report will be submitted to a peer-reviewed publication.
Recent reports indicate that tests conducted by ICMR-Bharat Biotech find Covaxin effective against the Indian and the UK strain of the SARS Cov-2 virus.
Bharat Biotech submitted to the Centre their production plan for the next four months. It is part of the initiative to ramp up the production of vaccines. Dr V Krishna Mohan, the Whole-time Director of Bharat Biotech, conveyed to the government production of Covaxin would be raised to 3.32 crore doses in July. It would produce 7.82 crore doses in August and maintain the same in September.
The DGCI recently granted permission to Bharat Biotech for phase II/III clinical trials on those aged between two to 18 years. Being an inactivated vaccine, it considered being safe. Covaxin is available in 18 states in the country. At first, each dose was priced at Rs 600. It is now providing doses to states at Rs 400.
Bharat Biotech is working on another vaccine for coronavirus. It will be administered in the form of nasal drops. Named BBV154, it is a non-replicable viral vector vaccine. The vaccine is capable of only producing the vaccine antigen.
Serum Institute of India (SII)
The Serum Institute of India (SII) is working in collaboration the Astra Zeneca and Oxford. The vaccine is administered with the name ‘Covishield’ in India. Covishield is a non-replicable viral vector vaccine.
The CEO of SII, Adar Poonawalla told on television that America put an export ban on raw materials required for the manufacture of vaccines. He urged the Biden administration to lift the export ban. He added the blocking of raw materials by the US would delay vaccines in India.
Data from interim trials of Covishield (ADZ122) in the US, Peru and Chile showed the vaccine had an efficacy of 79 per cent when the second dose was given after four weeks of the first dose. The Indian government extended the duration between two doses of Covishield. It increased the duration between doses from 8 weeks to 12 weeks.
The SII also submitted its production plan for the next four months to the Centre. Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII informed the government that SII would produce 10 crores doses in August. The same number of doses would be produced in September.
SII priced each dose of the vaccine at Rs 400. Later, the cost was slashed to Rs 300. It will provide vaccines to the state governments at Rs 300.
The SII is developing another vaccine in collaboration with US manufacturer Novavax. The drug is undergoing phase II/III bridging trials. There is a delay in the rollout of the vaccine due to the export ban imposed by America.
Gamaleya – Dr Reddy Laboratories
Dr Reddy Laboratories partnered with the Russian Direct Investment Fund (RDIF) to conduct clinical trials of the Sputnik V vaccine. Gamaleya National Research Institute of Epidemiology and Microbiology developed the vaccine. The vaccine has a global efficacy of 91 per cent.
Dr Reddy Labs has a target of vaccinating 125 million people in India with Sputnik V. It expects to achieve its target in 8-12 months. The first 36 million doses will be imported from Russia. The rest will be manufactured in India.
Six other Indian pharmaceutical companies will manufacture Sputnik V. The companies – Gland Pharma (252 million), Hetero Biopharma (100 million), Virchow Biotech (200 million), Panacea Biotech (100 million), Stelis Biopharma (200 million) and Shilpa Medicare (100 million)- together will produce 952 million doses.
Sputnik V is administered in two doses. The time gap between the two doses is 21 days. Two consignments of the vaccine landed in Hyderabad. Post testing of the vaccine at the Central Drug Laboratory (CDL), Kausauli; it will be used in the vaccination drive.
The two shots of the vaccine are two complementary vectors. Both are administered through intramuscular injections. The first component of the virus is the adenoviral vector Ad26. The second component is the adenoviral vector Ad5. The vaccine is priced at Rs 995 per dose.
ZyCov-D manufactured by Zydus Cadila is the second indigenous Covid-19 vaccine. It is a DNA type vaccine.
The vaccine is in phase III of clinical trials. It conducted two clinical trials in phase I. 150 people participated in it. Phase II had two clinical trials. The trial was expanded to 1,048 people. The third of clinical trials are underway. 28,216 people are taking part in it.
Biological E Limited
Biological E Limited is manufacturing two vaccines. It will produce the Johnson and Johnson’s Janssen vaccine. Johnson and Johnson will transfer technology to Biological E for the manufacture of the vaccine.
Alongside the Janssen vaccine, the company will produce its indigenous vaccine. The production of this vaccine will start in September. 7.5 crore doses of this vaccine will be available for use in the country.
Pune-based Gennova Biopharmaceutical is working on its indigenous Covid-19 vaccine. The government of India is providing support for the development of this vaccine. It is producing the vaccine using the m-RNA process. It is similar to the vaccines produced by Moderna and Pfizer.
The success of this vaccine is believed to be a great success for Indian scientists. The vaccine can work on new mutations with slight modifications. It is estimated that ‘HGCoV-9’ will be available for use from September.
Talks with Moderna and Pfizer for the supply of their vaccines were inconclusive. With Moderna and Pfizer not wanting to own liability in case of side effects from their vaccines, the Indian government is not keen on them.