Arbitrary vaccine policy continues, 13 states/UTs not given Covaxin at all

India’s indigenous vaccine, Covaxin, developed by Bharat Biotech in association with Indian Council of Medical Research (ICMR) has not been supplied to 13 states, all of them from north-east India, and union territories, from the beginning of the vaccination drive in January 2021 until now.

Chandigarh, Manipur, Meghalaya, Mizoram, Arunachal Pradesh, Nagaland, Ladakh, Andaman and Nicobar Islands, Dadra and Nagar Haveli, Daman and Diu, Lakshadweep, Sikkim and Puducherry have not got Covaxin shots since the beginning of the drive, stated a response from the Ministry of Health and Family Welfare (MoH&FW) to queries asked by RTI activist Nilesh Prabhu using Right to Information Act.

Prabhu had asked about the total number of Covaxin and Serum Institute of India-manufactured Covishield doses supplied month and state-wise. As of July 24, 2021, only 5.72 crore Covaxin doses have been provided to states according the ministry. During the same time, 38.5 crore Covishield doses were supplied across the country.

According to the response, in March 2021, Jammu and Kashmir, Arunachal Pradesh, Manipur, Mizoram, Meghalaya Nagaland, Ladakh and Andaman and Nicobar did not get a single dose of either vaccine. In the same month, Punjab, Chhattisgarh, Himachal Pradesh, Tripura and Uttarakhand did not get Covaxin doses at all.

In May 2021, officials of Arunachal Pradesh, Manipur, Mizoram, Nagaland and Sikkim had complained that the third phase of vaccination for those in the 18-44 age bracket would be delayed due to shortage of vaccines.

Amongst the BJP-ruled states, Himachal Pradesh got only 5,000 doses of Covaxin in six months, Goa 35,980 and Tripura 70,520 doses only. Jammu and Kashmir was given only 2.45 lakh doses. Uttar Pradesh with 60.32 lakh got the highest number of Covaxin doses, followed by Maharashtra with 59.7 lakh doses.

Bharat Biotech’s public relations official said they supply their doses to the government and they would not know where it is being distributed to. When asked about the interim period when states were trying to procure the vaccines on their own, the official said, “I’m not sure about this. I will have to check and then respond”. However, the official did not respond later. This article will be updated if the company’s official responds.

National Herald sent questions to the health minister and joint secretaries of the ministry, but got no response. This article will be updated if and when they respond.

The allocation of only a single vaccine causes inequity of access as residents of 13 states were not given the choice of a second vaccine which was available to the rest of the country. The residents of these states had no choice but to take Covishield. This is especially problematic for pregnant women.

The members of the National Technical Group on Immunisation (NTAGI) had highlighted in their meeting on May 28, 2021, that Covaxin/killed vaccine should be the first choice for pregnant women. The meeting was chaired by MoH&FW secretary Rajesh Bhushan, Department of Biotechnology secretary Dr Renu Swarup and ICMR DG Dr Balram Bhargava.

Covaxin is an inactivated vaccine which means that it constitutes of killed SARS-CoV-2 virus, making it safe to be injected into the body. Killed vaccines have an established safety profile in pregnant women, stated the NTAGI report. After NTAGI's recommendations, 2.27 lakh pregnant women have been vaccinated, but the government has not revealed in its press release which vaccine was administered.

This was because of a report from Brazil where a pregnant woman who had been vaccinated with AstraZeneca had died. As a result of this adverse event the immunisation programme of pregnant women in the Brazil had been put on hold.

According to the minutes of the NTAGI meeting, pregnant women would be informed about the complications such as thrombosis and thrombocytopenia (Covishield) associated with Covid-19 vaccination.

Former Prime Minister Dr Manmohan Singh, in a letter to Prime Minister Narendra Modi in April, had stated the union government should publicise what were the firm orders for doses placed on different vaccine producers and accepted for delivery over the next six months. The former PM had stated that the government should indicate how this expected supply would be distributed across states based on a transparent formula.

The MoH&FW had claimed that all states and union territories were being allocated vaccines systematically based on are four parameters. The government claimed in a press release that vaccine allocation depended on population of the state, state’s utilisation efficiency, caseload of Coronavirus cases and vaccine wastage. The government had maintained that they were following this strategy even in a Parliamentary response on July 23.

Based on the government’s assertion of these parameters, it is not clear how the north-east states and the union territories didn’t fulfill the criteria. Several states had accused the Centre of limiting supplies to their states.

In June 2021, the Supreme Court had rapped the union government for its flawed vaccination policy and had called it “prima facie arbitrary and irrational”. The apex court had questioned the government on the decentralised procurement of vaccines where states and union territories had to procure vaccines for persons between the age group of 18-44 years from the private manufacturers on the basis of a pro rata quota set by the union government. The government was also questioned about the rationale behind differential pricing and paid vaccination for citizens under the Liberalised Vaccine Policy.

The Supreme Court had stated that it would examine if the rationality of the existing Liberalised Vaccination Policy was violative of Article 14 (equality before law) of the Indian Constitution. The Court had directed the union government review its vaccination policy as vaccinating the country’s eligible population was the “most important task in combating the pandemic in the long run”.

Shortage of Covaxin supply

The government has not been made clear how it decided priority and allocation of vaccines to states. The sequence of events has indicated fumbling at the policy and implementation levels. Six months into the rollout of the vaccines, the government policy on its distribution comes across as arbitrary.

After several months of ambiguity, the MoH&FW revealed in a Parliamentary response that Bharat Biotech has supplied only 5.45 crore doses of Covaxin from January 16 to July 16, 2021, for the National Covid Vaccination Programme against the promised 8 crore vaccines by July 2021. This translates into less than 1 crore doses a month.

The government has consistently overstated the production of COVAXIN by Bharat Biotech, underscored Malini Aisola, Co-convenor of All India Drug Action Network (AIDAN). “Past and current projections continue to be out of sync with the actual number of doses being manufactured. The production deficits (relative to projections) and supply interruptions of COVAXIN may be one of the factors in the uneven distribution across different parts of India. Bharat Biotech has been given hand-holding at all crucial stages. In fact, it has enabled Bharat Biotech to retain a monopoly on the vaccine from the beginning,” pointed out Aisola.

“Though the intellectual property rights of Covaxin are shared between ICMR and Bharat Biotech, the government gave only them the licence to produce Covaxin and not given anyone else,” underscored R Ramkumar, professor at Tata Institute of Social Science.

It was only during the crisis emerging from the Covid-19 second wave that the government began looking for more manufacturers for Covaxin and gave the contract to three PSUs. They will begin manufacturing only by the end of the year. “Even though three PSUs have been roped in, as well as a the Gujarat COVID Vaccine Consortium, terms of the engagement are not transparent and all of these firms would likely be relegated to simply contract manufacturing to serve Bharat Biotech,” asserted Aisola. It's problematic that other private firms have not been permitted to make and supply the vaccine directly, she observed.