Docs raise concern over vaccine safety

February 6, 2021 0 By FM

Indian Medical Association (IMA), the largest body of allopathic practitioners in the country, has come out in support of the government’s COVID-19 vaccination drive and requested all its 3.5 lakhs members to get vaccinated voluntarily. However, apprehensions have been brewing among a section of medical practitioners over the efficacy and safety of these vaccines. They point out that a vaccine should be used for a vaccination program only if it completes all three stages of clinical trials.

In India, Covishield, manufactured by Pune-based Serum Institute of India, and Covaxin, manufactured by Hyderabad-based Bharat Biotech, are being used for the vaccination programme.

The apprehension is mainly over Covaxin, which was granted emergency approval before the completion of phase 3 clinical trials. Resident doctors at Dr Ram Manohar Lohia Hospital even refused to take Covaxin, citing incomplete clinical trials. In a letter addressed to the medical superintendent, the resident doctors’ association said: “The residents (doctors) are a bit apprehensive about the lack of a complete trial in case of Covaxin and might not participate in large numbers, thus defeating the purpose of vaccination.” They have also requested to vaccinate them with Covishield, which has completed all stages of the trial before its rollout. “There should have been the choice of Covishield and most of the countries have been using it for vaccination. Without providing a choice, the authorities are actually denying us vaccination. Also, if there was an alternative, people would have shown more enthusiasm in the vaccination drive,” said a source within the resident doctors association at Dr Ram Manohar Lohia Hospital.

Hasty approval: ADEH

Even though the association in its letter asked authorities to vaccinate them with Covishield, they feel that approvals for both Covishield and Covaxin were given in haste. “We are not batting for a single vaccine and feel that approvals for both vaccines were rushed. Both the vaccines were given approval on the belief that they will provide better results in the future. The approval should have been given based on data, which is paramount,” said a source within the association.

The Alliance of Doctors for Ethical Healthcare, a pan-India network of doctors standing for ethical and rational practice, also observed that the vaccines were given approval in haste. “It is very premature and scientifically incorrect to give approval for vaccines before the completion of the clinical trial. Bharat Biotech has neither submitted the data nor is it in the public domain. The government should have waited till the completion of the trial for giving approval. After the third phase of clinical trials, we may get a very good result and it may come out in flying colours. But we have unnecessarily spoiled the chance. It’s very unfortunate India has joined the club of a few countries which are not transparent about their clinical trials,” said Dr. Arun Gadre, Member, Alliance of Doctors for Ethical Healthcare.

The body has also pointed out that the people who received Covaxin will be under the impression that they are taking a vaccine that has proved its efficacy. “If the vaccine does not meet the minimum efficacy criteria, people who took the vaccine have less chances of developing antibodies after a month and will be exposed to the virus,” said Dr Gadre.

Will vouch for vaccine safety: IMA

IMA, in a press statement, said that after an extensive review of scientific data, indexed articles, expert panel reports and in discussion with experts within IMA, ICMR and WHO, decided to actively take part in the mission of COVID vaccination programme rolled out by the government of India. It appreciated and congratulated the hard work of Indian scientists, modern medicine doctors and the government for bringing out two Indian vaccines against SARS-CoV-2. “Bharat Biotech has developed a whole-virion inactivated vaccine (COVAXIN) and Serum Institute of India [has licensed] a recombinant chimpanzee adenovirus vector vaccine (COVISHIELD). Good protective levels of antibodies have been found to develop with Indian vaccines against the current strain and the new, mutated strains. These vaccines are practically easy to store and use in Indian conditions,” stated IMA.

IMA observed that India is heading towards becoming a superpower with research and development in the field of modern medicine. “All the infrastructure facilities of IMA branches across the country will be available voluntarily for this vaccination programme and all our members will voluntarily provide technical and supportive manpower. IMA believes that getting vaccinated is not only to protect the individual but also to bring herd immunity to the community, thereby raising the hope of controlling the coronavirus pandemic,” stated IMA.

It further stated that IMA stands with scientists to endorse the safety and efficacy of both these vaccines, so public awareness and countering the myths on the vaccines percolating on social media shall be its priority. “Our modern medicine doctors will vouch for safety, quality and professionalism in these difficult times and support the emergency approval for the usage of vaccines. However, we appeal to the public that even after vaccination, they should adhere to COVID appropriate behaviour like [wearing] masks, physical distancing, hand hygiene and respiratory hygiene,” said IMA.

IMA has also constituted a Pharmacovigilance Centre at its headquarters in New Delhi for monitoring post-vaccination reactions and rendering appropriate support. The body stated that it is looking forward to having a smooth, hassle-free and effective vaccination delivery system.

‘Vaccines will improve’

Defending its decision to support the government in the vaccination drive and asking its members to voluntarily come forward to take the vaccine, Dr Jayesh M Lele, Secretary-General, IMA, said: “We supported the government’s vaccination programme as vaccination is the most important thing [in fighting the pandemic]. Unless the vaccines are tested, clarity will not be there. If nobody takes the vaccine, how will you know whether there are any reactions or it is working or not working? [The vaccines] will improve gradually. If any allergies are there, they will be sorted out.”

He added that the pharmacovigilance centre at IMA headquarters will take up any issues that arise.

Meanwhile, the Maharashtra chapter of the Indian Medical Association, which had earlier urged the government to grant approvals for the vaccines only after conducting trials widely, also came out in support of the vaccines. “Absolutely no serious side effects were seen in the second phase trials and the vaccines are compatible and effective. Indians always oppose new things and opposition was there even against polio vaccination. Apprehensions over COVID-19 vaccines are only among a section of doctors and scientists. In India, vaccination is given only to healthcare workers. The government may consider completion of the third phase trials only after completing the vaccination of healthcare workers,” said Dr Avinash Bhondwe, President, IMA Maharashtra. He added that the government may give approval for vaccination of the public after completing the vaccination of the healthcare workers.



Healthcare workers are compelled to take Covaxin: KARD

Following the footsteps of the resident doctors at Dr Ram Manohar Lohia Hospital, Karnataka Association of Resident Doctors (KARD) has also raised their concerns over administering Covaxin, manufactured by Bharath Biotech, as it is still in phase III of clinical trials. The association demanded that the healthcare workers should be given the right to choose the vaccine to be administered to them.

Dr Dayanand Sagar, President, KARD said, “The government of India has approved Covishield and Covaxin. Covishield has got at least an interim analysis report. However, Covaxin is being used in the healthcare workers for phase III trials. We strongly condemn the experiment that is being done on the healthcare workers.” He termed the undertaking that is being taken as very suspicious. “The consent form is very suspicious which mentions that the efficacy of Covaxin is not proven yet. It needs to be studied and we are part of the studies. It also mentions that compensation will be given in case of any adverse effects,” said Dr Sagar.

The association alleged that in several medical colleges in Karnataka, healthcare workers are compelled to take Covaxin. “The healthcare workers should be given the choice. The government should provide a vaccine which has got at least an interim analysis report of phase III trials,” he added.