Reporting ocular adverse events following COVID‐19 vaccination: Communiqué to healthcare professionals

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• Background
• Considerations

Reporting of adverse events following immunization (AEFI) is important to inform vaccine safety surveillance and is mandatory in all provinces and territories (except Newfoundland & Labrador and the Yukon Territory, where there are robust AEFI reporting policies and processes in place). Ocular adverse events following immunization are of special interest and reporting to local public health allows the Public Health Agency of Canada (PHAC) and Health Canada to continually monitor and assess COVID-19 vaccine safety.

While Health Canada and the PHAC have received a small number of reports of ocular adverse events following COVID-19 vaccination in Canada, the small number does not suggest there are safety concerns with these vaccines. However, we are aware that some members of the ophthalmological community have identified a series of ocular events that have occurred following COVID-19 vaccination that they suspect may be associated with vaccination. In particular, internationally, it is suspected that corneal transplant rejection may be occurring at a higher than expected frequency after COVID-19 vaccination.

To enable continued monitoring and assessment of this potential safety issue in Canada, ophthalmological specialists and health care professionals are encouraged to report any ocular adverse events that occur following vaccination. Reports of adverse events following immunization are analyzed by Health Canada and PHAC. To enable the detection of safety concerns, reports from across the country are compiled and analyzed, along with international data, literature reviews, and expert opinions. Information on how to report adverse events following immunization can be found here: Reporting Adverse Events Following Immunization (AEFI) in Canada

If a safety concern is identified, Health Canada will take appropriate regulatory actions in a timely manner. PHAC would relay this information to public health authorities, who could in turn, take action such as modifying their immunization program and providing guidance to health care providers. Health Canada and PHAC also could provide safety information to health care providers and the Canadian public to raise awareness.

Background

As part of ongoing COVID‐19 vaccine safety efforts, the Public Health Agency of Canada and Health Canada are closely monitoring ocular adverse events after COVID‐19 vaccination via passive and active Canadian safety surveillance systems, including the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS), the Canada Vigilance Program (CV), the Canadian National Vaccine Safety Network (CANVAS), and the Canadian Immunization Monitoring Program ACTive (IMPACT).

Ocular adverse events have long been known to occur after vaccination against influenza, yellow fever, hepatitis B, and Neisseria meningitidis.

Very rare reports of ocular adverse events after COVID‐19 vaccination have emerged since the rapid initiation of national vaccination campaigns (see Table 1).

The benefits of the COVID-19 vaccines continue to outweigh their risks in the authorized populations, resulting in reduced deaths and hospitalizations due to COVID‐19 infection.

Considerations

It is important to note that ocular adverse events occurring after vaccination are not necessarily related to the vaccine. No clear causal association has been established between ocular adverse events and COVID‐19 vaccines.

Currently available published studies on the subject include retrospective case series and case reports, which are insufficient to establish a causal association.

Ocular adverse events that occur after COVID‐19 vaccination could resemble ocular manifestations known to occur with SARS-CoV-2 infection itself (see Table 1). Such adverse events following immunization are of special interest and reporting to local public health is encouraged.

Continued reporting of ocular adverse events following COVID-19 vaccination will provide additional information to inform causality assessment at the national level. Federal post-market surveillance enables the detection of adverse events that are rare and therefore unlikely to be detected during clinical trials, by municipality, province, or territory alone.

Table 1: Non-exhaustive list of ocular adverse events occurring with SARS-CoV-2 infection and adverse events following vaccination with COVID-19 vaccines

Occurring with SARS-CoV-2 infection

Rare case reports following COVID-19 vaccination (unknown association)

Eyelid manifestations Anterior and posterior ocular segment manifestations Neuro‐ophthalmic ocular manifestations Conjunctivitis Episcleritis Uveitis Vascular changes in the retina and cotton wool spots Optic neuritis Ocular motility deficits from cranial nerve palsies Transient visual blurring from accommodation deficits

Eyelid swelling, eyelid purpuric lesions Herpes zoster ophthalmicus Corneal graft rejection after corneal transplantation Acute macular neuroretinopathy Multiple evanescent white dot syndrome Central serous retinopathy Retinal detachment Acute anterior uveitis Panuveitis Multifocal choroiditis Acute zonal occult outer retinopathy Reactivation of Vogt‐Koyanagi‐Harada (VKH) disease Optic neuritis Arteritic anterior ischemic optic neuropathy Abducens nerve palsy Superior ophthalmic vein (SOV) thrombosis Cerebral venous sinus thrombosis New‐onset Graves' disease Other reports with only ocular symptoms, without ocular findings, such as visual blurring and eye pain