PRAC meeting 5 August 2021: COVID-19 vaccine safety issues

BACKGROUND Traditional monitoring for Adverse Events Following Immunisation (AEFI) relies on various established reporting systems, where there is inevitably a lag between an AEFI occurring and its potential reporting, and subsequent processing of reports. AEFI safety signal detection strives to detect AEFI as early as possible, ideally close to real-time. Monitoring social media data holds promise as a resource for this. OBJECTIVE 1) To investigate the utility of monitoring social media for gaining early insights into vaccine safety issues, by extracting vaccine adverse event mentions (VAEM) from Twitter using natural language processing (NLP) techniques. 2) To document the NLP processes used and identify the most effective of them for successively identifying tweets that contain VAEM, with a view to defining an approach that might be applicable to other similar social media surveillance tasks. METHODS A VAEM-Mine method was developed that combines topic modelling with classification techniques to extract maximal VAEM posts from a vaccine-related Twitter stream, with a high degree of confidence. The approach does not require a targeted search for specific vaccine reactions, but instead identifies any VAEM post within many unrelated posts. RESULTS The VAEM-Mine method successively isolates vaccine adverse event mentions from the massive amount of other vaccine-related Twitter posts, achieving an F1-Score of 0.91 in the classification phase. CONCLUSIONS Social media can assist with detection of vaccine safety signals as a valuable complementary source for monitoring mentions of vaccine adverse events. A social media based VAEM data stream can be assessed for changes to detect possible emerging vaccine safety signals, helping to address the well-recognised limitations of passive reporting systems, including timeliness and under-reporting.

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COVID-19 Vaccination Acceptance Among Healthcare Workers and Non-healthcare Workers in China: A Survey

Frontiers in Public Health ◽

10.3389/fpubh.2021.709056 ◽

2021 ◽

Vol 9 ◽

Author(s):

Ming-Wei Wang ◽

Wen Wen ◽

Nan Wang ◽

Meng-Yun Zhou ◽

Chun-yi Wang ◽

...

Keyword(s):

Healthcare Workers ◽

Vaccine Development ◽

Vaccine Coverage ◽

Multinomial Logistic Regression ◽

Vaccine Safety ◽

Public Acceptance ◽

Safety Issues ◽

The Public ◽

Current Vaccine ◽

Vaccination Acceptance

Background: The coronavirus pneumonia is still spreading around the world. Much progress has been made in vaccine development, and vaccination will become an inevitable trend in the fight against this pandemic. However, the public acceptance of COVID-19 vaccination still remains uncertain.Methods: An anonymous questionnaire was used in Wen Juan Xing survey platform. All the respondents were divided into healthcare workers and non-healthcare workers. Multinomial logistic regression analyses were performed to identify the key sociodemographic, cognitive, and attitude associations among the samples of healthcare workers and non-healthcare workers.Results: A total of 2,580 respondents completed the questionnaire, including 1,329 healthcare workers and 1,251 non-healthcare workers. This study showed that 76.98% of healthcare workers accepted the COVID-19 vaccine, 18.28% workers were hesitant, and 4.74% workers were resistant. Among the non-healthcare workers, 56.19% workers received the COVID-19 vaccine, 37.57% workers were hesitant, and 6.24% workers were resistant. Among the healthcare workers, compared with vaccine recipients, vaccine-hesitant individuals were more likely to be female (AOR = 1.52, 95% CI: 1.12–2.07); vaccine-resistant individuals were more likely to live in the suburbs (AOR = 2.81, 95% CI: 1.44–3.99) with an income of 10,000 RMB or greater (AOR = 2.00, 95% CI: 1.03–3.90). Among the non-healthcare workers, vaccine-hesitant individuals were more likely to be female (AOR = 1.66, 95% CI: 1.31–2.11); vaccine-resistant individuals were also more likely to be female (AOR = 1.87, 95% CI: 1.16–3.02) and older than 65 years (AOR = 4.96, 95% CI: 1.40–7.62). There are great differences between healthcare workers and non-healthcare workers in their cognition and attitude toward vaccines.Conclusions: Our study shows that healthcare workers are more willing to be vaccinated than non-healthcare workers. Current vaccine safety issues continue to be a major factor affecting public acceptance, and to expand vaccine coverage in response to the COVID-19 pandemic, appropriate vaccination strategies and immunization programs are essential, especially for non-healthcare workers.

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World Health Organization develops guidance for vaccine safety information on the web

Weekly releases (1997–2007) ◽

10.2807/esw.10.02.02618-en ◽

2005 ◽

Vol 10 (2) ◽

Author(s):

Collective Editorial team

Keyword(s):

World Health Organization ◽

Advisory Committee ◽

Safety Information ◽

Vaccine Safety ◽

Safety Net ◽

World Health ◽

Safety Issues ◽

The World ◽

Health Organization ◽

The Web

The World Health Organization (WHO) Global Advisory Committee on Vaccine Safety was established in 1999 to respond promptly, efficiently, and with scientific rigour to vaccine safety issues of potential global importance. In 2003, GACVS launched the Vaccine Safety Net project.

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Vaccine safety issues at the turn of the 21st century

BMJ Global Health ◽

10.1136/bmjgh-2020-004898 ◽

2021 ◽

Vol 6 (Suppl 2) ◽

pp. e004898

Author(s):

Laura Conklin ◽

Anders Hviid ◽

Walter A Orenstein ◽

Andrew J Pollard ◽

Melinda Wharton ◽

...

Keyword(s):

21St Century ◽

Scientific Evidence ◽

Scientific Information ◽

Vaccine Safety ◽

Live Vaccines ◽

Early 21St Century ◽

Safety Issues ◽

Specific Effects ◽

To Come ◽

The Early 21St Century

Global gains in vaccination coverage during the early 21st century have been threatened by the emergence of antivaccination groups that have questioned the effectiveness of vaccines to generate public distrust of vaccines and immunisation programmes. This manuscript summarises six key topics that have been at the centre of global discussions on vaccine safety during the early 21st century: thiomersal in multi-dose non-live vaccines, aluminium adjuvants used with several non-live vaccines, autism and auto-immune conditions as possible consequences of vaccination, a risk of immune overload with increasing numbers of vaccinations, and detrimental non-specific effects (NSEs) of vaccination. For each topic, we describe the hypothesis behind the public concern, the evidence reviewed by the WHO’s Global Advisory Committee for Vaccine Safety (GACVS) during 1999–2019, and any significant new data that has emerged since GACVS conclusions were made. Although the scientific evidence on these issues overwhelmingly supports the safety of vaccines, communication messages to caregivers and providers need to condense and convey scientific information in an appropriate way to address concerns contributing to vaccine distrust. In addition, there is need for further studies specifically designed to address both positive and negative NSE of vaccination. The role of GACVS will be increasingly important in evaluating the evidence and engaging the global community in promoting and assuring the safety of vaccines in the decades to come as we move into an era in which we use new vaccination platforms, antigens and formulations.

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Willingness to Take COVID-19 Vaccines in Ethiopia: An Instrumental Variable Probit Approach

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18178892 ◽

2021 ◽

Vol 18 (17) ◽

pp. 8892

Author(s):

Abayomi Samuel Oyekale

Keyword(s):

Instrumental Variable ◽

Safety Concern ◽

Vaccine Safety ◽

Probit Regression ◽

Safety Issues ◽

Phone Survey ◽

Region Of Residence ◽

Working Age ◽

Youth Population ◽

Instrumental Variable Probit

This paper analyzed the factors influencing the willingness of Ethiopia’s population to take COVID-19 vaccines. The data included the COVID-19 High Frequency Phone Survey of Households in Ethiopia that were collected in 2021. This paper relied on the 10th round of the survey, which was comprised of 2178 households. The Instrumental Variable Probit regression model was used to analyze the data. The results showed that majority of the respondents (92.33%) would receiveCOVID-19 vaccines, while 6.61% and 1.06% were, respectively, unwilling and unsure. Across the regions of Ethiopia, Southern Nations, Nationalities, and Peoples’ Region (SNNPR) (99.30%), Oromia (97.54%), Tigray (97.04%) and Gambela (95.42%) had the highest proportions of respondents willing to have the vaccine. Vaccine safety concern was the topmost reason for those unwilling to receive the vaccine. The results of the Instrumental Variable Probit regression showed that currently working, age, engagement with non-farm businesses and region of residence significantly influenced the population’s willingness to take the vaccine (p < 0.05). It was concluded that although the willingness be vaccinated was impressive, without everyone being receiving the COVID-19 vaccine, infection risk can still be high; this is due to the persistent mutation of the viral strains. Thus, there is a need to intensify efforts toward addressing the safety issues of COVID-19 vaccines, while efforts to enhance acceptability should focus on the youth population and those who are unemployed.

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Vaccine safety in the next decade: why we need new modes of trust building

BMJ Global Health ◽

10.1136/bmjgh-2020-003908 ◽

2021 ◽

Vol 6 (Suppl 2) ◽

pp. e003908

Author(s):

Heidi J. Larson ◽

Isabelle Sahinovic ◽

Madhava Ram Balakrishnan ◽

Clarissa Simas

Keyword(s):

Social Media ◽

New Technologies ◽

Vaccine Safety ◽

Safety Net ◽

Global Network ◽

Public Confidence ◽

Media Campaigns ◽

Safety Issues ◽

Safety Concerns ◽

The World

Among the realm of highly varied vaccine perceptions and concerns expressed by publics around the world, vaccine safety is the most frequently cited. While many of the safety questions raised have substantial evidence to address the concerns, vaccines do have small risks, and need vigilant and responsive systems to address them. With more and more new vaccines, combinations of vaccines and new technologies to develop and deliver them, new safety concerns will arise that need attention. Adding to this landscape is the dramatic impact which digital communication has had on how fast rumours and vaccine concerns can spread, making the task of the public health and scientific community even more pressing. One of the more recently characterised vaccine safety issues, now named ‘immunisation stress-related-response,’ has gained particularly high visibility given these highly globally connected social media networks. To better anticipate and address these rapidly shared vaccine safety concerns, a number of global efforts and local responses are being made. Co-created social media campaigns engaging parents and adolescents have been effective, while the WHO’s Vaccine Safety Net (VSN) initiative has grown its global network to increase awareness about vaccines and contribute to building confidence in vaccines. The VSN reviews websites around the world to assess their quality and accuracy to ensure and promote access to trustworthy and science-based information on vaccine safety for internet users. These and the efforts of the multiple network partners are more crucial than ever to sustain public confidence in this evolving vaccine safety landscape.

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Impact of Media Coverage on Influenza Vaccine Coverage in Elderly Individuals from 2020 to 2021 in the Republic of Korea

Vaccines ◽

10.3390/vaccines9040367 ◽

2021 ◽

Vol 9 (4) ◽

pp. 367

Author(s):

Yunhyung Kwon ◽

Young June Choe ◽

Jae-Won Yun ◽

Hee Kyoung Kim ◽

Sungnam Kim ◽

...

Keyword(s):

Influenza Vaccine ◽

Vaccination Coverage ◽

Media Coverage ◽

Vaccine Coverage ◽

Vaccine Safety ◽

Coverage Rate ◽

Vaccination Programs ◽

Safety Issues ◽

Vaccination Coverage Rate ◽

Rate Ratios

Increased awareness of adverse events following immunization (AEFI) can disrupt vaccination programs. In South Korea, a report of alleged influenza vaccine-related deaths attracted significant media attention in 2020. We retrieved the vaccination coverage and AEFI data to determine their association with media coverage. Between 2015 and 2019, the vaccination coverage rate ranged between 80.5% and 83.3%; however, the vaccination coverage rate declined significantly from 2020 to 2021 to 73.6% (p < 0.0001). During the 43rd week of 2020, following a large amount of media coverage on vaccine safety issues, the number of cases with AEFI reached 60. Between 2015 and 2020, the mortality rate ratios for influenza vaccines and non-vaccines ranged between 0.1296 (95% confidence interval (CI), 0.1262–0.1331, p < 0.0001) and 0.1608 (95% CI, 0.1572–0.1644, p < 0.0001). Vaccine safety surveillance should be continued in conjunction with investigation and transparent risk communication to maintain public trust in vaccines and vaccinations.

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Immunization Controversy: Understanding and Addressing Public Misconceptions and Concerns

The Journal of School Nursing ◽

10.1177/105984050101700105 ◽

2001 ◽

Vol 17 (1) ◽

pp. 32-37 ◽

Cited By ~ 2

Author(s):

Judy K. Blackford

Keyword(s):

Scientific Evidence ◽

Vaccine Safety ◽

School Nurses ◽

The Internet ◽

Accurate Information ◽

Vaccine Preventable Diseases ◽

Safety Issues ◽

Parental Concerns ◽

Negative Report ◽

The Media

School nurses often meet with parents who are reluctant to immunize their children. This reluctance is based on widely publicized stories about vaccine safety. Illnesses that are preventable by vaccines have become almost nonexistent, and consequently, vaccine safety concerns have increased in prominence. Often a negative report about the risk of a particular vaccine is released by the media and on the Internet before scientific evidence has been obtained. To adequately respond to parental concerns, school nurses should be aware of the historical impact of vaccine safety issues and the vaccine-related fears that are prevalent at the present time. Nurses also need to be provided with scientifically accurate information so that risk-benefit concerns regarding vaccine safety can be effectively communicated to parents. In this way, school nurses can play an important role in ensuring that the student population and the community are protected from vaccine-preventable diseases.

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Novel vaccine safety issues and areas that would benefit from further research

BMJ Global Health ◽

10.1136/bmjgh-2020-003814 ◽

2021 ◽

Vol 6 (Suppl 2) ◽

pp. e003814

Author(s):

Daniel A Salmon ◽

Paul Henri Lambert ◽

Hanna M Nohynek ◽

Julianne Gee ◽

Umesh D Parashar ◽

...

Keyword(s):

Case Studies ◽

Pain Syndrome ◽

Vaccine Safety ◽

Lessons Learned ◽

Postural Orthostatic Tachycardia Syndrome ◽

Human Papillomavirus Vaccine ◽

Dengue Disease ◽

Safety Issues ◽

Potential Safety ◽

Safety Case

Vaccine licensure requires a very high safety standard and vaccines routinely used are very safe. Vaccine safety monitoring prelicensure and postlicensure enables continual assessment to ensure the benefits outweigh the risks and, when safety problems arise, they are quickly identified, characterised and further problems prevented when possible. We review five vaccine safety case studies: (1) dengue vaccine and enhanced dengue disease, (2) pandemic influenza vaccine and narcolepsy, (3) rotavirus vaccine and intussusception, (4) human papillomavirus vaccine and postural orthostatic tachycardia syndrome and complex regional pain syndrome, and (5) RTS,S/adjuvant system 01 malaria vaccine and meningitis, cerebral malaria, female mortality and rebound severe malaria. These case studies were selected because they are recent and varied in the vaccine safety challenges they elucidate. Bringing these case studies together, we develop lessons learned that can be useful for addressing some of the potential safety issues that will inevitably arise with new vaccines.

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Change of Willingness to Accept COVID-19 Vaccine and Reasons of Vaccine Hesitancy of Working People at Different Waves of Local Epidemic in Hong Kong, China: Repeated Cross-Sectional Surveys

Vaccines ◽

10.3390/vaccines9010062 ◽

2021 ◽

Vol 9 (1) ◽

pp. 62

Author(s):

Kailu Wang ◽

Eliza Lai-Yi Wong ◽

Kin-Fai Ho ◽

Annie Wai-Ling Cheung ◽

Peter Sen-Yung Yau ◽

...

Keyword(s):

Vaccine Development ◽

Vaccine Safety ◽

Vaccine Hesitancy ◽

Willingness To Accept ◽

Third Wave ◽

Personal Protection ◽

Cross Sectional ◽

Safety Issues ◽

The Third ◽

High Level

Vaccine hesitancy is among the major threats to the effectiveness of vaccination programmes. This study aimed to report the trend in response to willingness to accept the COVID-19 vaccine between two waves of the local epidemic and examine differences among occupations. Two cross-sectional surveys were conducted online during the first wave (February) and third wave (August to September) of the local epidemic in 2020. Acceptance of the COVID-19 vaccine was measured along with personal protection behaviours and occupations. A total of 2047 participants provided valid responses. The willingness to accept the COVID-19 vaccine among the participants was lower in the third wave (34.8%) than the first wave (44.2%). There were more concerns over vaccine safety in the third wave. Clerical/service/sales workers were less likely to accept the vaccine (adjusted odds ratio: 0.62, 95% confidence interval: 0.43–0.91). A high-level compliance of facemask wearing was found, and more people maintained social distancing and used alcohol hand rub in the third wave. Decreasing willingness to accept the COVID-19 vaccine may be associated with increasing concerns about vaccine safety and growing compliance of personal protection behaviours. The rush of vaccine development with higher risks of safety issues may jeopardize the public’s trust and lower uptake rates. Education and favourable policy should be provided to the general working population for the vaccination, especially for those who are not professional and are frequently exposed to crowds.

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