A PRIVATE PUSH FOR COVID VACCINE
In the 26 days after the launch of India’s vaccination programme on January 16, 700,000 people in the country were vaccinated against Covid. It was the fastest vaccination campaign in the world at the time. The US, known for having one of the best public healthcare facilities in the world, took two more days to reach the same number. Yet, after that, the numbers began to fall. India was vaccinating roughly 250,000 people per day, while the US hit 1.2 million per day. As on March 1, less than 1 per cent of India’s total population had received the first dose of the Covid vaccine. It became clear that to achieve any kind of mass immunity and to break the chain of viral transmission, the vaccination rate had to pick up.
Several private sector lobbies wrote to the ministry of health and family welfare (MoHFW), assuring them that the only way forward was to open the vaccine drive to the free market. Profit incentives would drive them to vaccinate more people daily. So, on March 2, private players were drafted into the third phase of the programme.
At present, vaccines are being administered at around 27,000 hospitals, of which around 12,000 come under the private sector. Within 24 hours of the announcement, nearly 5 million people had registered for vaccination on the Centre’s CoWin portal. “Initially, only hospitals under the Ayushman Bharat Yojana or those empanelled under government or state schemes were allowed to provide the vaccine,” says Dr Girdhar J. Gyani, director general, Association of Healthcare Providers (India). The nonprofit, along with other health organisations, had written to the ministry to allow NABH and NBE accredited hospitals to join the vaccination drive. On March 2, the Centre clarified that states can decide to include larger private hospitals and standalone clinics provided they have “adequate vaccinators, space to observe the vaccinated, cold chain storage and arrangement for management of adverse events following immunisation”. It has also directed the states to increase vaccination slots to 15 days a month. Dr Gyani welcomes the move and says: “Ayushman Bharat Yojana is for insurance, it has nothing to do with size or service. Many clinics that fall under the scheme are eye hospitals or dental clinics. In Mumbai, for instance, none of the large hospitals— Hiranandani, Lilavati, Reliance—fall under any of the government schemes, so states must consider the accreditation and capability of the hospital.”
In Delhi, the list of hospitals where one can receive the vaccine went up from 54 to 136 overnight. It remains to be seen if other states will follow. “Health is a state subject and the final implementation lies with the individual governments. But clear and transparent guidelines from the Centre will ensure there are no administrative snags,” says public health expert Dr Mira Shiva.
While the decision to expand the vaccination drive has been welcomed, there are concerns that giving full control to the states to pick the hospitals that can vaccinate could potentially give rise to corruption. “There needs to be a clearer definition of what makes a hospital ‘adequate’. The term ‘adequate’ is vague, and vague policies can give rise to corruption,” says a source from a large private hospital in Mumbai.
Where the Centre has regained control is over the actual procurement of the vaccine. Hospitals will have to procure their doses not from the Serum Institute of India (SII) directly, but from the government supply chain. Experts believe government control over supply is not necessarily a bad thing. It can help prevent hoarding, inflation of prices and, most importantly, rise of a black market for fake vaccines. The Centre
has clearly communicated to the states to not hoard vaccines since there is adequate supply and because the vials have a short shelf life. “The goal is to vaccinate priority groups as fast as possible, keeping in mind all safety considerations,” says Dr V.K. Paul, chairman of the vaccine committee.
What has public health experts concerned, though, is that in order to seek private services, one has to pay Rs 250 for vaccines that still fall under emergency use authorisation (EUA) in India. An EUA means the efficacy and safety data of the drug is not yet entirely conclusive, but the product is safe and effective enough to be given to those most at risk. While in the US, an EUA is being granted only after sufficient efficacy data from phase 3 trials has been generated, the same is not true of India. Covaxin is yet to release phase 2 and 3 data. Trials for Covishield in Europe have been published, but data from the bridging trial conducted in India has not been released. The trials concluded about two months ago, but SII is yet to confirm when the results will be given to the regulator. Without it, the company might not be granted full market authorisation for the vaccine.
Many health advocacy firms and vaccine experts have voiced their concerns over the fact that it is still unclear how long the vaccine’s protection lasts and what the ideal dosage is. The safety of the vaccines, too, continues to be a topic of debate. Despite a very low rate of adverse reactions to the vaccines in phase 1 and 2 trials, there are some who allege that the monitoring system was patchy in some states and that vaccinerelated deaths were not properly investigated. It is a claim that authorities have rejected. However, as the vaccine reaches a larger group of people in phase 3, the monitoring and addressal systems will be put to the test. “Not addressing the adverse reactions to the vaccine in this phase will be hard, considering the sheer number of people who will be receiving it,” says Malini Aisola, co-convenor, All India Drug Action Network.
The pandemic, meanwhile, is still far from over. Last week, 380,000 average cases were recorded around the world. Different countries have gone with different game plans to tackle the virus. Limited supply is one reason why India is choosing to vaccinate only certain groups first. At present, SII has the capacity to manufacture enough to cover the priority groups in India and Bharat Biotech is slowly picking up pace. According to a source in the MoHFW, the Pfizer vaccine will not be available in the country at all. The silver lining, however, is that several other homegrown vaccines are moving towards getting EUA—Zydus Cadilla being the frontrunner. There are chances of the Sputnik V and Johnson & Johnson vaccines getting approval. SII has also received approval to conduct a bridging study for Novavax’s vaccine candidate.
As fresh cases continue to be registered across the country, with spikes in states like Maharashtra and Kerala, a lot rides on the success of the vaccination programme. While inoculating vulnerable groups is one strategy, given that we don’t know how long the protection lasts, mass and quick vaccination (a strategy adopted by the US, UK, France, China, Russia and Germany, among others) is still the most effective way to break the chain of transmission. ■