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What do we know about whether Stevens-Johnson Syndrome has been associated with the COVID-19 disease or COVID-19 vaccines?

Update

The COVID-19 vaccines to date have been safe and effective in the populations that they have been studied and deployed in, and there is currently no evidence to suggest that COVID-19 vaccines are associated with Stevens-Johnson Syndrome (SJS). There have been a very small number of documented cases of SJS after other vaccines— such as influenza, smallpox, polio, hepatitis B, DTP (diphtheria, tetanus, and pertussis), and MMR (measles, mumps, and rubella), but these associations have not be proven to be causal in scientific studies. Like other vaccines, COVID-19 vaccines are being carefully monitored for any such rare adverse reactions. The available evidence suggests that receiving the COVID-19 vaccine is much safer overall than the potential of being infected with COVID-19, which can result in negative skin conditions.

This article was published on
March 18, 2021

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What our experts say

Stevens-Johnson syndrome (SJS) is a very rare, severe disorder of membranes in skin and mucous. It's typically a reaction that starts with flu-like symptoms, followed by a painful rash that commonly spreads, blisters, and sheds. A more severe form of SJS is toxic epidermal necrolysis (TEN), which involves reactions on more than 30% of the skin surface and extensive damage to the mucous membranes.

Infections like pneumonia are the most common cause of SJS in children, whereas medications are the most common cause in adults. There is currently no evidence to suggest that the main COVID-19 vaccines (Pfizer-BioNTech, Moderna, Johnson & Johnson, and AstraZeneca) are associated with SJS or TEN. Receiving a vaccine is safer overall than potentially being infected with COVID-19. In fact, COVID-19 infection has been associated with negative skin conditions.

Approximately 1 in 5 individuals will develop a skin rash associated with COVID-19 illness. These rashes are generally either hives, rashes caused by injured or inflamed blood capillaries (such as erythema) or “COVID fingers or toes” (known as chilblains) that present with reddish or purplish bumps on the fingers or toes. Erythema multiforme (EM), a skin disease typically set off by a viral infection (most commonly Herpes simplex virus, but also COVID-19) can be difficult to discern from SJS/TEN, but is characterized by a more typical rash with bullseye-shaped lesions. These rashes can still result in significant debilitation and hospitalization. There is currently no evidence, however, that SJS is specifically a side effect of the COVID-19 disease or the COVID-19 vaccines. Data indicate that receiving a COVID-19 vaccine is safer all around than risking natural infection and the potential negative skin reactions that could emerge as a result of infection. 

Some misinformation has been spreading about the risks of SJS from the COVID-19 vaccines without evidence. Some of these claims may stem from the fact that there have been a small number of case reports on COVID-19 patients, who may have developed SJS after certain vaccinations (for example, the flu vaccine) without known exposure to other medications that are associated with SJS.

In a systematic review examining a potential association between SJS and vaccination, no significant association was found. Though SJS may be a possible rare adverse reaction to certain vaccines, vaccination is widely considered safe and important for saving lives. A licensed physician can help patients understand if they are in the rare group that should be medically exempt from getting a particular vaccine.

For a patient who has recently experienced SJS/TEN or is survivor of SJS/TEN, the general recommendation is that it is safer to get a COVID-19 vaccine than to risk getting infected. This is because the COVID-19 vaccines induce a predictable, controlled immune response against the COVID-19 spike protein, which prevents an extreme inflammatory response that is seen in some patients who have severe COVID-19. As a result, receiving a COVID-19 vaccine is likely safer overall for current or past SJS/TEN patients than going through acute COVID-19 infection, which is less predictable in terms of immune response.

The Stevens Johnson Syndrome Foundation states that genetic factors predisposing one to SJS/TEN are specific to a specific drug or chemical, leaving no reason to believe that someone who has had SJS would be at increased risk of an adverse reaction to a COVID-19 vaccine. However, individuals who fall in this category should consult with a care provider, particularly as the immune response to COVID-19 vaccines has not yet been widely studied in immunocompromised individuals or those on high doses of steroid medications.

Context and background

Scientific and clinical studies are continuing to understand the risks associated with COVID-19 vaccines (including rare allergic regions and the unlikely risk of SJS/TEN). The COVID-19 vaccines that have been approved by regulatory agencies are widely considered safe for adults over the age of 18 and are important for saving lives. Approved COVID-19 vaccines have been rigorously tested in clinical trials for safety, with recognition that the participants in these studies are less diverse than in the general population. Currently, with millions of diverse people receiving COVID-19 vaccines around the world, there are programs in place to carefully monitor adverse effects including rare allergic reactions. Clinical trials have also begun to test the safety of COVID-19 vaccines in children under 18, such as Moderna’s kidCOVE study which began dosing participants between the ages of 6 months to 12 years of age in March 2021.

Resources

  1. Stevens-Johnson Syndrome (Cleveland Clinic)
  2. CDC Science Clips on the rare but severe cutaneous reactions Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) (U.S. Centers for Disease Control and Prevention)
  3. Two False Negative Test Results in a Symptomatic Patient with a Confirmed Case of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Suspected Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) (Cureus Journal of Medical Science)
  4. Erythema multiforme-like eruption in patients with COVID-19 infection: clinical and histological findings (Clinical and Experimental Dermatology)
  5. Cutaneous eruption in COVID-19-infected patients in Thailand: An observational descriptive study (The Journal of Dermatology)
  6. Stevens-Johnson Syndrome After Immunization With Smallpox, Anthrax, and Tetanus Vaccines (Mayo Clinic Proceedings)
  7. Stevens-Johnson Syndrome Due to Influenza Vaccination (Cureus Journal of Medical Science)
  8. Erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrolysis reported after vaccination, 1999-2017 (Elsevier Vaccine Journal)
  9. Stevens-Johnson syndrome and toxic epidermal necrolysis after vaccination: reports to the vaccine adverse event reporting system (Pediatric Infectious Disease Journal)
  10. Is there an association between Stevens-Johnson Syndrome and vaccination? A systematic review (Annali di igiene)
  11. COVID-19 Vaccination information (Stevens Johnson Syndrome Foundation)
  12. Moderna Announces First Participants Dosed in Phase 2/3 Study of COVID-19 Vaccine Candidate in Pediatric Population (Moderna Press Release)

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