Vaccine 40 (2022) 521–523

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Vaccine
journal homepage: www.elsevier.com/locate/vaccine

Adverse event of Sinovac Coronavirus vaccine: Deafness

a r t i c l e i n f o a b s t r a c t

Article history: COVID-19 has spread worldwide and is one of the most threatening infectious diseases in the world.
Received 20 July 2021 Vaccination is known as an effective method to protect susceptible populations against such diseases.
Received in revised form 16 November 2021 The Coronavirus vaccine developed by Sinovac has been shown to have a high protective effect, but it also
Accepted 29 November 2021
has potential adverse events. For example, our department saw two patients with reported cases of deaf-
Available online 9 December 2021
ness that occurred after inoculation with the Sinovac Coronavirus vaccine. While deafness is only a rare
adverse event from the Coronavirus vaccine, whether other vaccination centers, hospitals, and centers for
Keywords:
disease control (CDCs) have encountered similar cases still needs to be investigated, reported, and
Coronavirus vaccine
Adverse events
analyzed.
Deafness Ó 2021 Elsevier Ltd. All rights reserved.

The WHO named the New Coronavirus as 2019-nCoV officially At present, progress has been made in the manufacturing and
and stated the virus as the cause of the pneumonia epidemic in production of Coronavirus vaccines. Eighty-three vaccines world-
Wuhan, Hubei, China. In addition, the International Committee wide have entered clinical trials using five technical approaches
on Taxonomy of Viruses announced that 2019-nCoV was officially to vaccine production, including inactivated, adenovirus vector,
classified as severe acute respiratory syndrome Coronavirus2 recombinant subunit, nucleic acid, and attenuated influenza virus
(SARS-CoV-2) [1]. COVID-19 has spread to nearly every country vector [2]. This article focuses on COVID-19 inactivated vaccine,
and has become one of the most threatening infectious diseases which uses African green monkey kidney (vero) cells for viral cul-
globally. According to the Johns Hopkins Center for Systems ture amplification and via b propylene ester inactivated virus to
Science and Engineering University, the total number of known retain the antigen component and induce an immune response in
Coronavirus infections worldwide exceeds 200 million, while the humans.
deaths have reached 4.2 million worldwide. At present, there is The phase I / II clinical trial of the Coronavirus inactivated vac-
no effective antiviral treatment for COVID-19, and the focus cine developed by Beijing Kexing Zhongwei Biotechnology Co., Ltd.
remains on the development of Coronavirus vaccines. (sinovac), a subsidiary of Kexing Biology, started on April 16, 2020,
Vaccines are one of the most effective methods of protection and was released on June 13, 2020. The results showed that the
against disease in susceptible populations. The use of vaccines positive rate of neutralizing antibody was more than 90% [3]. Fur-
should undergo clinical trial and be proven to be safe and effective thermore, the detailed results of phase III clinical trials conducted
before it is applied to large-scale populations. Randomized, con- by Brazilian medical workers showed that two doses of the Sinovac
trolled, double-blind phase III clinical trials evaluated vaccine Coronavirus vaccine protected 50.7% of symptomatic patients with
safety and efficacy by comparing the incidence of adverse events COVID-19 and 100% for moderate and severe cases [4].
between the vaccinated and the placebo groups. Consequently, At present, all provinces and cities in China are actively popu-
safety and effectiveness usually take a long time to demonstrate, larizing the new vaccine, advocating that citizens receive inocula-
creating an unfortunate time strain on introducing possible life- tion as soon as possible. The Coronavirus vaccine in China has been
saving vaccines. The rapid development of global COVID-19 has approved and administered to individuals from 18 years to over
placed considerable pressure on the requirements for the develop- 100 years of age with a total of 2.2 billion doses of the Coronavirus
ment and safety of vaccines. vaccine administered nationwide, and 1.04 billion people have
received a complete cycle of the vaccination. Among multiple vac-
cines, the Sinovac Coronavirus vaccine has been seen to have a
⇑ Corresponding author at: Department of Otolaryngology Head and neck wide coverage rate, and attention has also been given to the anal-
surgery, Qingdao Municipal Hospital, Qingdao 266000, China.
ysis of possible adverse events. Based on the existing clinical
E-mail addresses: [email protected] (H. Zhao), [email protected] (Y. Li),
[email protected] (Z. Wang).
research results, the main adverse events caused by Coronavirus

https://doi.org/10.1016/j.vaccine.2021.11.091
0264-410X/Ó 2021 Elsevier Ltd. All rights reserved.
H. Zhao, Y. Li and Z. Wang Vaccine 40 (2022) 521–523

inactivated vaccine are pain and swelling at the injection site, and malities found in CT, and MRI evaluation of the brain or brain
less severe reactions such as fever or allergic reaction [5]. The most functional imaging, temporal bone CT, internal auditory canal
common adverse event in the phase I and II clinical trials of Coron- MRI and cervical vascular ultrasound, and organic lesions in
avirus vaccine was pain at the injection site, with a severity rating brain and inner ear were excluded. Similarly, other systemic dis-
of one recovered within 48 h post vaccine [6,7]. At present, there is eases were excluded along with genetic and psychological factors
no report on other adverse events from receiving the Sinovac such as stress from work, life, or emotional instability. Treatment
Coronavirus vaccine. plan for the patient included intravenous glucocorticoid (methyl-
Deafness is the condition of lack of hearing or impaired hearing prednisone), Ginkgo biloba extract, Mecobalamin neurotrophic
[8]. In our hospital, we found that two instances where patients drugs, including batroxobin, with an initial dose of 10 IU, after
experienced extreme sensorineural deafness after receiving the which a dose of 5 IU was administered the next day for treat-
Sinovac vaccination. Following is a description of their medical his- ment. To assess for treatment effect, the patient received pure
tory and the reported incidence of deafness post-vaccination. tone audiometry on May 30, June 2 and June 6, respectively,
Patient 1 and the average hearing threshold improvement of the damaged
A 30-year-old male patient was admitted to the hospital on May frequency of the left ear was less than 10 dB, which was judged
2, 2021, due to ‘‘hearing loss in the right ear accompanied with as ineffective treatment.
dizziness lasting four days”. His condition was characterized by Through these two cases, we believe that the Coronavirus inac-
hearing loss in the right ear with tinnitus and dizziness four days tivated vaccine developed by Beijing Kexing Zhongwei Biological
after receiving a single dose of the Sinovac Coronavirus vaccine. Technology Co., Ltd. may have potential adverse events that
The initial symptom was dizziness, which lasted for several hours include deafness, which is total frequency profound hearing loss,
and did not alleviate when changing his physical position. Cur- accompanied by tinnitus, with or without vertigo. Treatment for
rently, the patient has expressed a significant reduction in dizzi- these cases also proved to be ineffective. Moreover, deafness was
ness than before, with only occasional dizziness attacks; unrelated primary disease and psychological condition and
however, hearing loss has had no noticeable improvement. The occurred without inducement. Therefore, we suggest that patients
patient was admitted to our hospital department for pure tone that have experienced unilateral sensorineural hearing loss in the
audiometry. The results showed that the right ear experienced sev- past should see a doctor immediately following vaccination with
ere sensorineural hearing loss. Dix Hallpike test (-), roll test (-). the Coronavirus vaccine if they experience sensorineural hearing
Conferring to the results, he was diagnosed with ‘‘sudden hearing loss in the contralateral ear as to receive treatment and avoid irre-
loss with vertigo” per diagnostic criteria and guidelines for diagno- versible damage.
sis and treatment of sudden hearing loss (2015) [9]. Described as in For deafness that onsets post-inoculation with the Coronavirus
good health previous to diagnosis, physical examination after vaccine, it also warns us to consider the possible adverse events of
admission discovered the external auditory canal was smooth the inactivated vaccine. Currently deafness is only a rare adverse
and that the tympanic membrane was intact. Supplementary event following the Coronavirus inactivated vaccine. However,
examination, including hematological examination, was normal, whether other vaccination centers, hospitals and Centers for Dis-
and all other abnormalities of the brain, temporal bone, and inter- ease Control (CDCs) have encountered similar instances still needs
nal auditory canal were ruled out using CT and MRI of the brain, to be reported and analyzed. Although there are few adverse
brain function imaging, temporal bone CT, internal auditory canal events in clinical trials and no reports on deafness, long-term
MRI and cervical vascular ultrasound. Organic lesions in brain and extensive safety monitoring of vaccine safety and efficiency
and inner ear were excluded, and other systemic diseases and is still needed. This also warms us that those who experience dis-
genetic factors were as well. Psychological factors such as stress comfort following vaccination should seek healthcare as soon as
from work or life and emotional instability were also excluded. possible. For the healthcare professionals, better data collection
A treatment plan was given to address hearing loss that and monitoring after receiving the vaccination should be
included intravenous glucocorticoid (methylprednisone), Ginkgo implemented.
biloba extract, Mecobalamin neurotrophic drugs including batrox-
obin at an initial dose of 10 IU for the first treatment, followed by Declaration of Competing Interest
5 IU the following next day, fibrinogen determination before use
[10]. To test for the effectiveness of treatment, the patient received The authors declare that they have no known competing finan-
pure tone audiometry on May 7 and May 10, respectively, and it cial interests or personal relationships that could have appeared
was discovered that the average hearing threshold of the damaged to influence the work reported in this paper.
frequency of the right ear was improved by less than 10 dB, which
was judged as an ineffective treatment.
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H. Zhao, Y. Li and Z. Wang Vaccine 40 (2022) 521–523

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