Even as the union government is considering granting emergency approval for COVID-19 vaccines, the Maharashtra chapter of the Indian Medical Association (IMA) has urged the government to test the vaccines widely before giving its approval. The association has pointed out that emergency approval has more disadvantages than advantages.
“Safety of the COVID-19 vaccine has to be tested widely with a large number of volunteers across the globe with different categories like age groups, sex, race, continents, and climate conditions. Any vaccine which is not tested fully with such third stage clinical trials is not safe,” stated Dr Avinash Bhondwe, President, IMA Maharashtra. He stated that the vaccine should be distributed only after it is proved safe in wider trials.
Dr Bhondwe pointed out that vaccine manufacturers sought emergency approval for the vaccines after the second phase of human trials. “The first two stages of human trials involve a very low number of volunteers. The efficacy is not measured properly, as the number of volunteers tested is not very high. The side effects are not assessed properly. You may develop side effects which
are not seen in the first two stages,” he said.
According to him, the side effects may range from simple rashes to severe and fatal anaphylactic reactions. The government is taking all precautions, he pointed out, but if something untoward happens, it can be really dangerous.
Many other doctors have also been raising similar concerns. If anything unexpected happens, the whole vaccination campaign has to be discontinued, they point out.
Need for more testing
Dr R V Asokan, General Secretary, IMA, has also emphasized that safety is of paramount importance. “Though [the need for] vaccines is an emergency, safety is also important. If there are any difficulties, it will be on a massive scale. The vaccines can be given permission only after following the protocols. They have to be tested on a larger number of volunteers,” said Dr Asokan. He added that the government can give approval only after completing the trials. “The government has not said that the trials will be cut short. It has just cut short red tape and office procedures,” he further added.
Dr Bhondwe further stated that the efficacy of the vaccine claimed by the pharma companies has to be verified by scientific research authorities and matched with national and international standards. The authorities have the power to accept or reject any research that doesn’t keep up with the required standards. “We are not opposing the vaccines. We are just saying that the vaccines should be safe,” he clarified.
The association observed that a detailed and transparent declaration of facts through a campaign could mitigate the wave of anxiety among Indian citizens, who are looking forward to the vaccine as a panacea for their recent troubles.
Meanwhile, Dr Shivkumar Utture, President, Maharashtra Medical Council, said that the association would have raised its objections when there were reports of reactions after taking the vaccination. However, it was later clarified that the reactions were not due to the vaccines, he said.
The association has also highlighted the lack of adequate infrastructure for storing and transporting vaccines. “Even if the vaccine is given emergency approval by a national body like ICMR, we would like to draw attention to the fact that COVID-19 vaccine needs a cold chain throughout, from the manufacturing site to the vaccination centre. Any disruption in the cold chain would make the vaccine ineffective,” pointed out Dr Bhondwe.
He observed that some types of mRNA vaccines need to be maintained at temperatures of minus 25 degrees to minus 70 degrees. India will have to make transport vehicles incorporating such facilities. The government does not have such vehicles now and may need to source them, which will take some time.
Government hospitals, primary health centres and sub-centres will also have to install such cold stores. “At present, we don’t have these facilities at many places in India. State governments are planning to install it and that will also take a minimum of 2-3 months. Deep-freezing machinery runs on electricity and it is a well-known fact in India, barring some cities like Mumbai, the electricity supply is never without disruption,” the association stated. It advocated for making adequate arrangements for ensuring uninterrupted power supply for the proper storage of the vaccines.
“The necessary infrastructure should be made available and enough vaccinators should be recruited,” said Dr Bhondwe. “We should think about vaccination only after that.”