Module 9 · Chapters 10 and 11
Signal Detection and Management · Vaccine Risk Communication
How India finds and acts on vaccine safety signals, and how to communicate risk — routinely, with the media and social media, and in a crisis.
10.1 Safety signals
A vaccine safety signal is information indicating a potential link between a vaccine and a previously unknown or incompletely documented event.
Structured spontaneous AEFI reporting is the basic element of vaccine safety monitoring. Signal evaluation is part of vaccine vigilance and keeps regulators and programmes current on benefits and risks. The benefit–risk balance is dynamic and may change (or appear to change) over time.
10.2 Signal management process
Determines whether there are new risks or whether known risks have changed, with recommendations, decisions, communication and tracking.
Figure 10.1 (text also lists tracking of follow-up activities).
| Term | Meaning |
|---|---|
| Signal detection | Identifying signals using data from any source |
| Signal validation | Evaluating supporting data to verify the documentation is sufficient to confirm a cause-effect relationship |
| Analysis and prioritization | Identifying signals needing immediate management — significant public-health risks or impact on benefit–risk |
| Signal assessment | Evaluation to detect new or changed risks with a causal association and determine any regulatory action |
| Recommendations | Suggestions for further action, if required |
Statistical detection — Signals of Disproportionate Reporting (SDR)
- At the AEFI Secretariat (ITSU) the database is screened regularly for SDRs — present when disproportionality measures or case numbers exceed thresholds.
- Methods applied to the MedDRA-coded AEFI database: Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), Reporting Odds Ratio (ROR) — measuring a relative increase in the proportion of reports of an event for an antigen.
- Statistical signals then get detailed qualitative assessment, incl. data from Marketing Authorization Holders (MAHs); sources: ICSRs, other AEFI databases, pre-clinical and clinical trials, literature.
Figure 10.2 · Process at the AEFI Secretariat
Possible recommendations
- No further evaluation/action beyond routine pharmacovigilance.
- Need more information — manufacturer submits data; addresses the signal in ad-hoc regulatory documents; consult other committees/experts; manufacturer conducts a post-authorisation safety study.
- Regulatory action — update product information and/or risk management plan (RMP); additional risk-minimisation (educational materials, Direct Healthcare Professional Communication).
Benefit–risk for patients and public health is considered throughout. Proving causality needs designed epidemiological studies — case-control, cohort, self-controlled case series (SCCS), case-crossover — and sometimes laboratory (pathological, microbiological, immunological) studies.
10.3 Signal management in India
- A dedicated, structured system was set up step by step with training by international experts; a working group developed the Signal Management Framework for AEFI.
- A national Signal Review Panel (SRP) — an independent body — assesses potential signals from databases for all vaccines. Members: clinical pharmacology, medicine, infectious diseases, paediatrics, neurology, cardiology, regulators, among others; some NAC members.
- SRP meets every two months (or earlier) and reports to the National AEFI Committee and MoHFW; the AEFI Secretariat analyses data, presents it and follows up.
- Regulatory recommendations go to CDSCO, which instructs MAHs — e.g. adding adverse events to the Summary of Product Characteristics (SmPC).
- The SRP has completed assessment of the COVID-19 AEFI database and is assessing other routine vaccines.
Figure 10.3 · Signal management for vaccines in India
| Inputs | Processing | Outputs |
|---|---|---|
| AEFI reporting from the field via CoWIN-SAFEVAC & SAFEVAC (serious events incl. deaths and clusters reported immediately to MO/health authorities); CDSCO pre- and post-licensure safety data; medical literature; other sources — PI, SmPC, PSUR, RMP | Signal management by AEFI Secretariat (ITSU) → Signal Review Panel → recommendations and communication | MoHFW ↔ National AEFI Committee → CDSCO (regulatory) and NTAGI (policy) |
Chapter 10 summary
- A national process: detection, validation, confirmation, analysis, prioritisation, evaluation, recommendations, tracking, communication, risk minimisation.
- Aim: continuous benefit–risk assessment and recommendations to vigilance stakeholders.
- Vaccine–event pairs are screened quantitatively and qualitatively — a continuous process.
- Independent SRP recommends regulatory actions, shared with NAC and MoHFW, then manufacturers.
- Operationalised by the AEFI Secretariat, MoHFW.
Chapter 11 · Vaccine risk communication
An RI communication plan must address both short-term crises (e.g. an AEFI) and long-term support for the programme; the crisis plan is an integral part of the overall RI plan.
11.1 Communication for vaccine safety
- Community cooperation follows when benefits are communicated — like people in malaria areas accepting bed nets despite heat.
- Vaccines are given to healthy people (mostly infants) against future disease → much lower tolerance for side effects; repeated, painful injections; real, perceived or coincidental AEs. As diseases decline, acceptance should be natural but often isn’t — ignorance, misinformation, poor communication/advocacy.
- Behaviour change communication must be proactive (inform, educate) and reactive (AEFIs). Well-informed people make AEFIs easier to handle. Treat the media as a partner, not an adversary.
- Strategic communication: evidence-based, result-oriented, done in consultation with participant groups.
11.1.1 Media in India
~200 publications in 1947 → >1.46 lakh today; ~17,000 newspapers (largest anywhere). RNI circulation per publishing day: 38,64,82,373 (2020–21) → 39,17,12,282 (2021–22).
Television
>1,000 channels, >400 news channels (24×7, many languages). TV viewership >90% but news-channel share in single digits; during COVID-19 it rose from 7% to 21%.
Online
833 million internet users (July 2022, 59% of population) — second largest after China; most newspapers/channels online.
Radio
Reach ~99%; news only on All India Radio; listenership falling with mobile phones.
News media — the “Fourth Estate” — shapes public opinion; tends to prioritise bad news (its “watchdog” role). Ownership: corporate, political, individual; except AIR and Doordarshan News, all news channels are private; print and online are entirely private. Governments run large PR set-ups for outreach and damage control of non-factual reporting.
11.2 Regular routine immunization communication
Prepared once a year with an approved budget around planned RI activities — also the time to prepare crisis plans (resource-intensive; needs grassroots understanding and media skills).
11.2.1 An ideal RI communication plan
- Generates awareness — importance of immunization, where/when vaccines are given free, at what ages.
- Addresses demand barriers — hesitancy to return after discomfort (vaccine risk communication).
- Engages community and media in any crisis affecting trust.
Figure 11.1 — three components: generating awareness about vaccines/programme; risk communication on the risk of not vaccinating versus minimal side effects; communication during crisis. Also identify hesitant groups and address them systematically. Prepare for crises when there is no crisis.
Table 11.1 · Intensity of media by objective
| Objective | Advocacy meetings | Outdoor media | Social mobilization | Media (print, TV) | Social media | Interpersonal communication |
|---|---|---|---|---|---|---|
| Awareness and information | +++ | ++++ | +++ | ++ | ++++ | ++ |
| Vaccine risk communication | + | ++ | + | ++ | ++ | +++ |
| Crisis communication | – | – | – | ++ | – | ++++ |
Plans are made yearly at district and state by the State/District Mass Education and Information Officer (DMEIO)/IEC officer or consultant, supported by the DIO, using the template (Annexure 18):
- Situation analysis and review of current plan
- Objectives based on evidence
- Target audience (primary and secondary)
- Media mix — IPC via advocacy/social mobilisation, mass media for awareness, outdoor as reminder, social media for buzz and youth
- Pre-testing messages
- Campaign seasonality
- Evaluation and feedback
- Budget split by reach, access and impact
11.2.2 Vaccine risk communication
- Discomfort after vaccination is a major cause of drop-outs. Mild fever, local pain/swelling, irritability, reduced feeding are expected and disappear in 2–3 days even untreated; syrup paracetamol and cold compresses help.
- Myths (e.g. that vaccination causes impotency) may not be voiced for fear of offending workers.
- Interpersonal communication by health workers, ASHAs and AWWs is one of the most effective ways to convey that minor side-effect risk is far lower than the risk of disease, hospitalisation, disability and death.
FLWs must themselves trust vaccination — consult them on their concerns and knowledge gaps. In non-crisis periods build their capacity: technical knowledge of vaccines, common minor AEFIs and VPDs; BRIDGE training (Boosting Routine Immunization Demand Generation) — listening, empathising, counselling, group communication, negotiation.
Essentials of risk communication with hesitant caregivers
- Listen to the caregiver.
- Understand local perceptions of the disease, injections and vaccine.
- Keep key messages in mind; use the right one.
- Communicate the benefits of vaccination.
- Avoid technical terms and long words.
- Anticipate counterpoints; prepare responses.
- Give the big picture on vaccine safety.
Engaging media, social media and radio (non-crisis)
Engaging with media
- Build rapport when there is no crisis — keep an updated list of health/development reporters.
- Understand their needs; supply regular news; push positive stories (immunization, nutrition, maternal health).
- A media corner on the government website with press releases and videos — a key source in crises.
- Explain how the programme works; give district/state/national RI fact sheets; workshops and field visits to session sites and cold-chain points.
- Monitor media; train spokespersons; ensure evidence-based reportage and follow-up stories.
- Engage regional/language media trusted by marginalised and minority communities — a communication vacuum fills with misinformation.
- Ensure multiple sources are cited (not just parents — also CMO, independent experts); evidence-based reporting; follow-up reports.
Social media messaging
- Spread positive messages; rigorous monitoring and tracking of rumours, myths and rumour-mongers; alert the focal point through established chains.
- Use Facebook pages, WhatsApp groups and official Twitter accounts of state/district health departments; messages, GIFs and videos best created at state level and shared with districts; each district names a focal person.
- Seek media support for dos and don’ts (e.g. not vaccinating during fever); avoid scary caricatures; avoid sensationalism; avoid religious undertones.
Dos
- Messages, GIFs, videos carefully crafted and pre-approved
- Factual, not speculative
- Photos show ideal vaccination practice
- Simple, non-technical language
- Written permission before posting personal photos
Don’ts
- Unverifiable information
- Targeting a community, class or race
- Offensive or defamatory language
- Naming a vaccine brand or manufacturer
- Personal information without permission
Radio — main entertainment for marginalised groups; used for RI, Mission Indradhanush and MR campaigns; radio jockeys (RJs) are particularly effective in allaying parents’ fears about AEFIs. Media capacity building — online courses such as Critical Appraisal Skills (CAS); a media rating tool for balanced reporting is in Annexure 19.
11.2.3 & 11.3 Preparing for and planning crisis communication
A crisis in immunization is an emergency from an unexpected series of events that risks the integrity or reputation of the programme, services or vaccines — usually triggered by negative media/community attention: adverse events, legal disputes, accidents, man-made disasters attributed (rightly or wrongly) to the programme. Often avoidable through foresight, care and training; well managed, a crisis can strengthen the programme.
The plan is prepared and managed by a communication crisis management group led by the DIO and the DMEIO/consultant; may include the District Public Relations Officer and DAC members. The team: (1) develops the plan — lists potential crises, grades them by impact on vaccine trust, defines activities per level, responsibilities and tools; (2) identifies triggers and acts per plan; (3) assesses impact and reviews the plan.
Figure 11.2 · Communication management framework (8-step cycle)
Key messages (district-specific, with supporting messages) are translated into the regional language and shared with stakeholders likely to be contacted. A monitoring mechanism tracks daily news (print, TV, social media) and alerts the designated decision-maker; review successes and failures after the crisis.
11.3.1 Types of crises and calibrated actions
State/national: controversy over a new vaccine or schedule change; critical public, media or scientific debate; viral rumours. District: most commonly an AEFI in RI or a campaign. Actions are calibrated to impact — informing early can prevent escalation, but over-communicating minor or unrelated events can needlessly damage confidence.
Table 11.2 · Crisis situation — AEFI
| Impact | Example | Action |
|---|---|---|
| Low | A child admitted after vaccination, stable; one newspaper story next day; no TV follow-up; discharged the same evening | Watch closely; have holding statements and trained spokespersons ready in case it worsens (death, more admissions); ensure surveillance is alert for missed related cases; stay in touch with media partners |
| Medium | Three infants hospitalised; one needs care, two observed; a TV channel and local papers report | Do not communicate to a wider audience yet; prepare: gather facts, engage stakeholders incl. spokespersons, develop messages and share with allies who may be contacted |
| High | Two children die and three hospitalised within 24 h in a village; highway blocked demanding compensation; continuous TV coverage; reporters calling; health minister wants a report | Respond immediately: gather key media/social-media influencers; gather facts; understand the problem; liaise with stakeholders and spokespersons; develop and share messages; communicate externally |
11.3.2 First-step actions (within hours)
- Holding statements and key messages; FAQs with answers (vaccine safety, VPDs).
- District AEFI response template (Annexure 20) and district/state RI fact sheets — updated every month.
- A primary spokesperson authorised to talk to media, and secondary spokespersons (third-party experts).
- Media contact lists; key-stakeholder lists; immediate channels (web, social media, email, press release); vaccine reaction background notes.
2. “We have started the investigation of this unfortunate incident and are doing our utmost to know the reasons as soon as possible.”
Also define: decision-making and information-release authority (plan approved by district competent authority for SOPs, tools, finances; who releases what, when, how; expedited verification); roles (incl. a designated spokesperson coordinating with internal/external stakeholders); information sharing routes and media needs (deadlines, transcripts online); monitoring public opinion (social media, hotline); contacts incl. after-hours numbers.
11.4 Preparing key messages
- Well-prepared, accurate and empathetic.
- Shared with all stakeholders so everyone says the same thing.
- Ideally tested on the target audience.
- Use a message map to agree messages, be precise, be consistent and repeat, manage difficult questions, be confident.
Format (Annexure 21): three key messages, each backed by three supporting messages.
Table 11.3 · Example
| Key message 1: Vaccines are safe. | Key message 2: Vaccines prevent diseases. | Key message 3: The risk of a VPD is more than the risk of minor side effects. |
|---|---|---|
| 1a Serious side effects are very rare (examples) | 2a TB, diphtheria, pertussis, measles, polio etc. can cause hospitalisation, disability, death | 3a Rates of fever and local swelling/pain after pentavalent |
| 1b Minor effects (fever, pain, swelling, irritability, crying, reduced feeding) last less than a couple of days | 2b ___ cases of diphtheria and pertussis and ___ deaths every year | 3b Number of diphtheria and pertussis cases and their fatality rates in India |
| 1c Syrup paracetamol relieves fever and pain | 2c Three doses of pentavalent protect against diphtheria, pertussis, tetanus, hepatitis B and Hib pneumonia/meningitis | 3c A couple of days of fever is nothing compared to infection, hospitalisation and death from pertussis/diphtheria |
Other key messages: AEFIs are very rare; most are coincidental; an AEFI does not mean vaccines are unsafe; minor effects are common and resolve in 2–3 days; if a child becomes severely sick, inform the ASHA/AWW/ANM and go to the nearest hospital.
Share with MOs, block extension educators and professional associations to advocate with community “custodians” (panchayat, religious leaders, influencers), in mothers’ and community meetings, media interactions, mid-media (posters, banners, hoardings, leaflets, wall paintings, miking) and social media. Trust built in “good” times makes people receptive in a crisis.
11.5 Communication activities during a crisis
11.5.1 Interpersonal communication
Engage the affected families and community early; nominate a health worker or MO with good communication skills as focal person; enlist local influencers; give consistent, simple messages; arrange treatment, transport, referral and free treatment.
11.5.2 Engaging the media — AEFI media management protocol
Time-bound actions keeping the media informed of facts, the department’s response, the patient’s status and preventive steps — to kill speculation and convey the scientific and programme view. It creates a standard procedure for communicators; tools include AEFI response templates, state RI fact sheets and ready reckoners for uniform messaging, a response timeframe, and partner roles. All state immunization spokespersons are notified immediately of any media report or query.
Table 11.4 · Responding to media queries
| Authority | Actions |
|---|---|
| District Immunization Officer | Proactively gather case details (or get them from the field MO). Share factual, verifiable, non-speculative information that does not trivialise the event — the government is aware, investigating and tracking. If media persist or may misinterpret, issue a written response/press release (Annexure 20) and share it simultaneously with state and national immunization offices. Get back with updates as promised; refer media to trusted non-government experts (IAP, IMA, technical spokespersons); avoid conflicting messages. If a story omits the department’s version, contact the reporter; else mail a statement or put it on the website; for persistently negative stories, write to the editor with facts. Sensitise editors/journalists on AEFI. |
| State Immunization Officer (SEPIO) | Same protocol — gather information (via DIO/MO), share verifiable facts, state that the state is investigating and tracking, respond with a statement (Annexure 20) and verbal answers if needed, follow the response timeline. |
• If queries persist, state spokespersons respond at the earliest
• If a district crisis escalates to state-level media, a press release preferably by the spokesperson at the earliest
REMEMBER — next media query on AEFI
- An authorised, updated government spokesperson
- Factual information
- AEFI response templates
- Adhere to timelines
- Keep higher-ups informed
Ways to reach the media: press statement, press release, press conference, press interview, spokesperson clip on the website (Annexures 22–23).
11.5.3 Social media in a crisis
- Better not to post event-specific information — WhatsApp forwards spread it uncontrollably.
- If an AE is raised on Twitter/Facebook, acknowledge it has been noted and conveyed for medical help, investigation and preventive action.
- Do not engage with negative posts — it gives traction and makes them viral.
- Keep sending positive vaccine-safety messages; contextual messages only after careful vetting.
11.5.4 Figure 11.3 · Identified spokespersons (trained to deliver appropriate messages)
| Level | Primary spokespersons | Secondary spokespersons |
|---|---|---|
| District | DM / CMO / DIO | District AEFI Committee member; district IAP, IMA members |
| State | Health Secretary / MD / SIO | State AEFI Committee member; state medical college members; state IAP, IMA members |
| National | JS / AC | National AEFI Committee member; other experts |
Table 11.5 · Managing an adverse event crisis
| Level | Communication action points |
|---|---|
| Community — health worker | Inform MO/DIO immediately; meet the family and empathise; listen patiently; take village elders/religious leaders along; follow up after 1–2 days; respect privacy; arrange treatment and ambulance; ensure adequate care at the referral hospital |
| PHC/block — MO | Meet the family with a trusted HW; take control and reassure without appearing judgemental; keep family and community informed with facts; if information is scanty, say it is being looked into and facts will be out in a specified time; understand their perspective; verify facts and inform the DIO; ensure treatment; start investigation and report |
| District — DIO | Involve DAC if needed; gauge dip in community confidence; contact supportive opinion leaders; identify positive role models in the community; answer negative media questions positively; do not bombard the family with visits; share investigation progress with community representatives; review media reports for tonality and accuracy |
| State — EPI officer | List state health journalists; identify and orient spokespersons; disseminate consistent key messages; orientation workshops, deliberations and field visits for journalists; involve school teachers to inform parents |
| National — government official / NAC | Track tonality/accuracy; list journalists; identify and orient spokespersons; organise journalist visits; join talk shows to clarify and stop rumours |
Chapter 11 summary
- AEFI crisis communication belongs in routine RI communication plans.
- Train FLWs and PHC MOs in IPC — the most effective medium in a crisis.
- Continuous, planned engagement with print and TV.
- Social media has its own rules — have someone familiar with it handle it.
- Choose media by purpose, message, audience and reach.
- Key and supporting messages are essential for routine and crisis communication.
- Crisis plans are group efforts with impact-graded actions.
- A media response protocol must be in place; everyone knows their role.
- Develop the crisis plan proactively when there is no crisis.
Quick recall
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