State, districts prepare for post-vaccine vigilance
Following recent orders from the ministry of health and family welfare, the state health department has started taking steps to monitor “adverse events”, which may be experienced by recipients of the expected Covid-19 vaccine. As per the Centre’s instruction, the Post Graduate Institute of Medical Sciences, Rohtak, has been appointed as the nodal authority for adverse event following immunisation (AEFI) surveillance in Haryana. Officials also confirmed that AEFI committees at the state and district level will be revamped to include appropriate experts, including physicians and pharmacologists.
The World Health Organisation defines an adverse event following immunization (AEFI) as “any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.” These may range from minor adverse events (AEs), such as fever, dizziness and muscle pain, which are recorded side effects of vaccines already in use, to moderate or severe AEs that may require hospitalisation, such as seizures or death. The latter, officials and experts pointed out, are extremely rare — and even more rarely associated with vaccine use, given the stringent safety guidelines that govern vaccine trials.
“Nevertheless, AEs are to be expected with any medicine or vaccine. Even if a patient experiences redness or swelling where the injection is administered, it is counted as an AE. The task of an AEFI committee, which already exists in Haryana at both state and district level, is to track these occurrences and determine their causal relationship with the vaccine. Usually, minor events are assessed at a district level while moderate and severe events are assessed at a state level every three months, as part of the Universal Immunisation Programme for children and pregnant mothers. However, for Covid-19, district-level committees will be trained to assess moderate and severe AEs locally as well,” said Dr Virender Ahlawat, the National Health Mission’s deputy director for immunisation in Haryana.
Given that a large volume of people is likely to receive a Covid-19 vaccine, the number of ensuing AEs is also likely to be higher than in existing immunisation programmes, which are targeted to a much smaller portion of the population. The state AEFI committee typically conducts causality assessments for moderate and severe AEs every three months. However, Ahlawat added that a Covid-19 immunisation campaign would require such cases to be assessed more frequently.
“We do not really have a sense yet of what events may be reported after a Covid vaccine is introduced. We have to be more vigilant than usual and will conduct causality assessments monthly. At a district level, task forces have already been created and told to set up AEFI management centres, where vaccine recipients will be able to report any untoward symptoms,” Ahlawat said.
Officials also said that AEFI committees in Haryana will be revamped in coming weeks to include appropriate experts. “At the moment, since the UIP is targeted mainly toward children, pharmacovigilance committees feature experts in maternal and child health. Physicians and public health experts who have a broader experience in pharmacovigilance will have to be appointed to these committees. PGIMS, Rohtak, will soon nominate an expert member to the state AEFI committee, following which we will begin training officials in districts,” Ahlawat said.
At PGIMS Rohtak, investigators are already carrying out AEFI surveillance among at least 370 people who have received doses of Bharat Biotech’s Covaxin, currently in Phase III of vaccine trials. “There are three aspects to such vigilance. The first is we keep the patient under observation after administering the shot. The second is that we monitor them remotely through follow ups. Now, in Phase III, we have also asked the patients to maintain a daily diary in which they log their physical conditions. This is then shared with the data safety management board for scrutiny,” said Dr Dhruv Chaudhry, state nodal officer for Covid-19 management and co-principal investigator on the Covaxin trials at PGIMS Rohtak. He said that so far, among trial participants at PGIMS, no moderate or severe AEs have yet been reported.
AEFI surveillance data from the trial will be shared with the pharmacovigilance cell at PGIMS Rohtak, which will appoint an appropriate expert to the state AEFI committee. “Our learnings will be shared with the state health department and we will advise them on creating an AEFI protocol for Covid-19. The finer details will ultimately rest on which vaccine is administered to the public at large,” said Chaudhury.
A senior official in the state health, member of Haryana’s AEFI committee, said on the condition of anonymity, “Adverse event surveillance will be a huge challenge. In Haryana, for example, the state AEFI committee is usually running on a backlog of a few months at the least. A lot more manpower will be required to sift through the data when a vaccine for Covid-19 is finally rolled out. It is a positive step that these measures are being taken months before the campaign begins, so that AEFI surveillance can be strengthened to a good degree by then.”
Addressing the issue of vaccine distribution, officials said that they will be able to fine-tune protocols for AEFI surveillance on the basis of high-risk groups who will receive the vaccine first, including frontline workers and elderly individuals with comorbidities.
As reported on November 28, the district health department has identified at least 24,971 frontline healthcare workers in the district for priority vaccination against Covid-19. With vaccine delivery expected to commence early next year, officials said they are preparing for a scenario in which demand is going to outstrip supply. “It is still too early to say when a vaccine will be readily available for all,” said Dr Naresh Garg, district immunisation officer, Gurugram.