Dr Moulay Tahar University of Saïda Faculty of Natural and Life Sciences Guided Worksheet No. 2

Chapter 2.

Around a week after she received her first dose of Covishield, the Indian version of AstraZeneca’s COVID- 19 vaccine, 20-year-old Rijuta developed a blinding headache. On 2 June 2021, she was admitted to a large corporate hospital in Bhopal city, Madhya Pradesh. Imaging and blood tests revealed a clot in her brain, says her friend Ajay, while her platelet counts dropped precipitously. Concerned, the family approached a

reputable neurosurgeon for a second opinion. The neurosurgeon told the family that Rijuta’s symptoms were consistent with thrombosis with thrombocytopenia syndrome (TTS), the infrequent adverse event that occurs between 0.5 and 6.8 times for every 100,000 jabs. “But she said that no one could confirm it,” Ajay

told TheBMJ. When the family raised the possibility of Rijuta’s illness being linked to the vaccine with the doctors treating her, they dismissed the idea. Rijuta, who was studying for her bachelor’s degree in arts, died on 20 June. Despite the strong evidence that the AstraZeneca vaccine could cause TTS by then, the Bhopal hospital didn’t report Rijuta’s case to India’s COVID-19 vaccine safety surveillance system. Ajay says

Rijuta’s family couldn’t do so either because they didn’t know how to report it. Rijuta’s case highlights just two of the many gaps that plague India’s COVID-19 vaccine safety system: hospitals are failing to report

adverse events following immunization (AEFI), while patients and their families don’t know how to do it. But the system is also constrained by other problems, including the slow pace at which officials are investigating whether reported adverse events are due to vaccines and the non-communication of their

findings with patients.

Families left in the dark In July 2021, Tamil Nadu-based entrepreneur Venugopalan Govindan lost his 20- year-old daughter, Karunya after she became ill following her first Covishield jab. Karunya, who was studying for a master's degree in data science, was diagnosed with multisystem inflammatory syndrome, a condition that appears on the World Health Organization’s list of adverse events of special interest for COVID-19 vaccines. These events are so-called because there is a theoretical possibility that they may occur after covid vaccination, although no evidence exists yet. For this reason, W.H.O advises that such events be monitored carefully.When Karunya was admitted to hospital, Govindan suspected a link with the vaccine, but did not know where to report it. In desperation, he contacted the Serum Institute of India, the manufacturer of Covishield. The institute says it reported this information to a pharmacovigilance program for manufacturers, which is supposed to forward the information to the covid vaccine safety system. Aneja said that government policy was to communicate the results of causality analysis for all serious adverse

events to recipients. Yet several state officials told The BMJ they were not aware of any such policy. “We only communicate the results to the district committee. There is no policy to tell patients,”Vinay Kumar,

state immunization officer for Tamil Nadu said. In any case, Govindan says he didn’t receive any updates on the information he submitted to the Serum Institute of India. Frustrated, he has taken to social media to

publicize his daughter’s story. His appeals were then heard by a senior official associated with the safety system, who collected Karunya’s medical records again. Eventually, on 29 October 2021, the official informed Govindan that the committee had classified the link between his daughter’s death and the vaccine as “indeterminate”—a term used when an adverse event occurs soon after vaccination, but there isn’t enough evidence to arrive at a causal link. For other families, who didn’t go public with their stories, getting the

results of causality analyses has proved harder, if not impossible. Govindan says “No one knows that a reporting system exists. Even when someone knows, they have to be extremely persistent to get deaths

registered.” Once reported, the system is “a black hole,” he adds, with no assurance that a case will be dealt with in a time-bound manner. Also, India doesn’t currently have any countrywide compensation programme for vaccine-related injury.For Govindan, the entire situation is especially grating because Indian government officials have frequently miscommunicated the risk from COVID-19 vaccines in the last year. In their

eagerness to promote vaccination, government officials often claimed that COVID-19 vaccines were completely safe, even though this statement isn’t true of any vaccine. The entire experience has left Govindan and many of his family unwilling to take their second doses of the vaccine. “Myself and my wife, who are single jabbed, are staying away from that poison. And so also my brother and his wife, ” he says.

BMJ 2022

• Give a title to the text
• Choose 4 keywords in the text
• Cite the various undesirable side effects of vaccination against COVID-19.
• Give a summary of the text in Arabic or French in four (4) sentences maximum.
• Do you think vaccination against COVID-19 is safe? Argue your answer.