Even as experts have raised concerns and questions over rushed approvals by India’s drug regualator, in particular for Bharat Biotech’s COVID-19 vaccine Covaxin, it appears that the biggest challenge Kerala may face is vaccine hesitancy.
On January 3, India’s drug regulator approved two COVID-19 vaccines- Covaxin and Covishield which was developed by Oxford-AstraZeneca and produced by Serum Institute of india (SII), for ‘restricted use’ in an emergency situation, subject to certain conditions. Several experts have criticised the decision, given that Phase 3 clinical trials for Covaxin are still underway while the bridging study for Covishield is yet to be fully analysed. Efficacy for Covaxin is yet to be established with Bharat Biotech stating that this report will be submitted. India’s drug regulator approved Covishield based on the efficacy data from its clinical trial in the UK and Brazil.
Concerns over safety and the efficacy of the vaccines have reverberated in Kerala and could pose a challenge for the state government in carrying out the vaccination. “I won’t take the vaccine. I would rather wait for the safety and efficacy to be ensured,” says Sreekala*, a frontline COVID-19 worker who works in a City Corporation.
The concern over the two vaccines have also been exacerbated by the war of words between the Pune-based SII and the Hyderabad-based Bharat Biotech. Speaking to TNM, Dr Abraham Varghese, State President of Indian Medical Association admitted that comments over the side-effects of the vaccine could impact the state’s vaccination drive. “The drawback as of now for the vaccination is the negative remarks on the ‘side effects’ randomly made by a few health care professionals on television debates too. When people aren’t convinced, there will start a word of mouth negative campaign on the safety of the campaign. This would adversely affect the drive,” he said.
A source in the Health Department also admitted that the hesitancy to take the vaccine may prove a challenge. “The latest challenge in the vaccination is the approval given to Bharath Biotech on the reliability of the vaccine. People will watch the safety of the vaccine. People have been generally expressing this concern,” said the source to TNM.
The Kerala government has nearly finished the registration process for COVID-19 vaccination - collecting and compiling the data base for the health care workers.The first phase of the vaccination will cover healthcare workers, anganawadi workers and medical students.
An epidemiologist who works with the government told TNM that if there are concerns about the vaccine this must be raised by healthcare workers. However, he added that healthcare workers in Kerala aren’t too hesitant to accept the vaccine. Pointing to the lack of clear definition and processes for Emergency Use authorisation, the epidemiologist said, “The approval given for Covaxin is Emergency Use Authorisation. But what emergency is hasn’t been specified (by the drug regulator). This is different from anywhere else in the world.”
“The approval for Covaxin shouldn’t have been given now. If it was only Covishield, vaccination would have been smoother. Now Covishield has also come under scanner,” he said.
According to Dr Abraham Varghese the IMA has been sensitising healthcare professionals to counter vaccine hesitancy. “We are also collecting data of the healthcare workers who haven’t yet registered with the government for vaccination. Also we will sensitise the public that the vaccine is safe and would have the same side-effects as any other vaccine that has been invented so far.”
In the past, Kerala has seen resistance by some sections to take vaccines. In October 2017, there was a social media campaign against the drive for measles-rubella vaccination. Scores of messages appeared on Facebook and WhatsApp citing the 'hazards' of vaccination. Some of the messgaed even said that the MR vaccine will harm the natural immunization of children and that Measles and Rubella are not severe diseases for children. Following this, Health Minister KK Shailaja clarified that this was false propaganda and warned strict action against those who created panic among people.
The epidemiologist also said that awareness about the COVID-19 vaccines is the need of the hour. “Only when it’s addressed and the healthcare workers get vaccinated, the apprehensions among the general public will be eliminated and we can move to the next phase of vaccination.”
While the Indian Council for Medical Research (ICMR) had earlier stated that it may not be necessary to vaccinate India’s entire population, Dr Abraham said the vaccination drive would yield results only if it covers all categories of people. “The whole vaccination drive will be futile if a section of the population is left out,” Dr Abraham noted.