ISE18/20-21

• While massive vaccination is conceived to be most effective way to tackle the health crisis posed by the Coronavirus Disease 2019 ("COVID-19"), there are widespread concerns across the globe whether the fast-track development of vaccines in just eight months for emergency use is safe and have the intended protective power. Recent allegations of deaths and complications after jabs, as well as emergence of variant virus also deepen the worry.^{1Legend symbol denoting So far, vaccine for COVID-19 sets a record in terms of time taken in development, even faster than that of four years for mumps in 1967. See World Economic Forum (2020).} In face of this vaccine hesitancy, just 30%-50% of surveyed respondents in advanced places (including Hong Kong) indicated that they were willing to take the shots in January 2021.^{2Legend symbol denoting University of Oxford (2021), Chinese University of Hong Kong (2021) and South China Morning Post (2021).}
• In Hong Kong, the vaccination programme is likely to start in March 2021 at the earliest, upon scheduled arrival of the first batch of one million doses of the vaccine developed by the Fosun Pharma/BioNTech in late February.^{3Legend symbol denoting The Standard (2021).} To address risk concerns, the Government is planning to set up an indemnity fund to offer financial assistance to those "who may experience serious complications" after the COVID-19 vaccination, in the light of overseas practice and upon approval of the Finance Committee of the Legislative Council ("LegCo").^{4Legend symbol denoting GovHK (2020a and 2021).} However, apart from stating that "indemnities ultimately determined by the court or arbitration", details of this fund have not been released to the public at this juncture.
• Globally, vaccination indemnity fund so far is not a common practice. According to the World Health Organization ("WHO"), only 25 places have established vaccine injury compensation schemes ("VICS") by now.^{5Legend symbol denoting Mungwira et al (2020).} Amongst them, the United Kingdom ("UK") is a pioneer in extending the VICS coverage to COVID-19 vaccine. Coupled with its simpler mechanism and four-decade long implementation history, the UK experience appears to be a good case for local reference. This issue of Essentials discusses the VICS in the UK, after a brief summary of global and local concerns over COVID-19 vaccine.

Global practice on vaccine injury compensation schemes

• Social benefits of mass vaccinations: WHO recommends that vaccination is effective to stop the spread of some infectious diseases, saving over 2.5 million lives across the globe in 2008. Mass vaccination can contribute to herd immunity. Successful examples include global eradication of smallpox and the elimination of certain infectious diseases (e.g. measles and polio) in many regions. Yet vaccination is not entirely risk-free for individuals, with a modest probability of getting serious vaccine injury (e.g. every one million doses of vaccine against measles might give rise to 1.0-3.5 cases of anaphylaxis and the respective probability figure for influenza vaccine is 0.7 case).^{6Legend symbol denoting World Health Organization (2018 and 2020).} There is a case to balance social benefits against individual risks.
• Recent hesitancy on COVID-19 vaccination: Although COVID-19 has already caused more than 2.3 million deaths amidst over 100 million infections across the globe by early February 2021, there is strong public hesitancy in taking up the vaccination. First, hasty development of an entirely new vaccine in just eight months is conceivably too short, as compared with the usual practice of five to ten years to develop a safe and proven vaccine. Secondly, the potential side-effects of the new vaccines are not fully known yet, with very limited clinical trials so far. Also aggravating the concerns is the indemnity granted to vaccine makers for emergency use. Thirdly, a handful of severe adverse events after jabs (e.g. anaphylaxis and deaths) reported in some places (e.g. Israel and Norway) intensifies public scepticism, though there is no concrete clinical evidences linking the events to vaccinations so far.^{7Legend symbol denoting South China Morning Post (2020).} Fourthly, it is not entirely certain that the new vaccines can tackle the emerging variants of COVID-19 seen in the UK and South Africa. In face of these concerns, only 35%-50% of surveyed respondents in Asia-Pacific (e.g. Australia, Japan and Singapore) are willing to take the shots, making the policy target of herd community rather remote at present.^{8Legend symbol denoting World Economic Forum (2020) and University of Oxford (2021).}
• Policy objectives of VICS: Since the 1960s, about 25 places have set up VICS, including the United States ("US"), the UK, Germany, Japan and South Korea. In short, VICS is intended to offset the small risks of injury and incentivize individuals to take up vaccines for herd community. Relative to civil litigation, VICS provides a faster, more timely and equitable access to vaccine injury compensation, with lower administrative cost and without a need to prove the negligence of vaccine makers. On the supply side, drug makers are more willing to devote huge investment to conduct research for development of new vaccines and supply them to the public as and when the liability is partially shouldered by governments.^{9Legend symbol denoting Most VICS established in the 1970s were due to increasing reports of side-effects associated with the pertussis vaccine. See Mungwira et al (2020).}
• General features of VICS: There is a wide variation in implementation details of VICS across the 25 places. On administration, almost all the schemes are run by the governments on the back of necessary legislation. On funding, most schemes are funded by governments through treasury expenditure (e.g. the UK and Germany), albeit not necessarily in the form of dedicated funds. While some countries financed it by specific taxes (e.g. a vaccine tax of US$0.75 (HK$5.82) per injection charged to the drug makers in the US), others by mandatory contributions from insurance and pharmaceutical companies (e.g. Sweden and Finland). On vaccine coverage, some places cover only mandatory or recommended vaccines, but others include all licensed ones. On eligibility of claimants, it is a usual practice to limit the compensation to those victims with significant injury above pre-scribed threshold (e.g. disability), but very few places also cover mild injuries (e.g. South Korea and New Zealand).
• On vetting of claims, independent medical experts will judge whether there is a causal link between vaccination and the reported injury, and these decisions can be appealed by the claimants.^{10Legend symbol denoting For vetting claims of VICS, most places adopt the "balance of probabilities" approach assuming that it is "more likely than not" the vaccine caused the injury considering its nature, the consistency of time interval from vaccination, and the existing medical evidence. By contrast, civil litigation requires the establishment of fault by at least one party "beyond reasonable doubt" prior to compensation.} On the amount of compensation, successful claimants are compensated with either a lump-sum of money or variable compensation calculated based on medical costs, loss of earnings or other criteria (e.g. emotional distress). As a reference, total compensation for the 735 successful claims on routine vaccinations in the US amounted to US$187 million (HK$1.5 billion) in 2020 excluding legal fees. The average compensation was thus US$254,500 (HK$1.97 million) per claim. On litigation rights of claimants, most places allow claimants to seek either (a) damages through the courts; or (b) compensation from VICS, but not both. For those places allow both (e.g. Denmark and the UK), the compensation payments of VICS are adjusted if damages have been received through the courts.

Vaccination in Hong Kong

• Vaccination programme in Hong Kong: Mass vaccination programme in Hong Kong began with free vaccines for children in the 1950s, with a high coverage rate at 97%-99% for school children during 1998-2019. Since the 2010s, the Government has extended the programme to high-risk adults against emerging epidemics (e.g. seasonal flu and pneumococcal). Most infectious diseases (e.g. measles, tetanus and polio) are under control, as seen in a 99% drop in reported caseload over the past 40 years.^{11Legend symbol denoting Department of Health (various years) and Census and Statistics Department (various years).}
• Regulation of vaccine safety: Under Pharmacy and Poisons Regulations (Cap. 138A), registered vaccines must conform to the criteria on safety, efficacy and quality before sale in the market. As there is no VICS in Hong Kong, vaccine injurers can only pursue civil litigation for compensation. Some LegCo Members suggested in December 2008 and July 2009 to set up similar "misadventure fund" to compensate victims of vaccine injuries.^{12Legend symbol denoting Minutes of meeting of the Panel on Health Services (2008 and 2009).}
• Reported injury after vaccination: Based on limited data in the public domain, over 2.1 million doses of vaccines had been administered in 2019. The injury rate appears to be on the low side, with a reaction rate of seasonal flu vaccine estimated at one case per 2.59 million vaccinations during 2016-2021. On average, 54 annual cases of Guillain-Barré Syndrome (a rare symptom allegedly associated with vaccination) were reported during 2000-2020.^{13Legend symbol denoting The Government indicated some reported adverse events may occur by chance during the post-vaccination period and are unrelated to vaccination. See Centre for Health Protection (2021) and GovHK (2020b).}

Vaccine injury payment scheme in the United Kingdom

• Origins of the VDPS in the 1970s: The national vaccination programme in the UK was voluntary. In the 1970s, medical studies revealed that the pertussis vaccine might cause brain damage to children, undermining public confidence in such programme. As the vaccination rate of pertussis plummeted by three-fifths to only 30% during 1974-1978, the UK government asked the Royal Commission on Civil Liability and Compensation for Personal Injury to review the case.^{14Legend symbol denoting Centers for Disease Control and Prevention (1982) and Millward (2019).} In March 1978, the Commission recommended "paying compensation for vaccine damage where vaccination is undertaken to protect the community." In face of strong public pressure, the UK government quickly enacted the Vaccine Injury Payments Act ("Act") in March 1979, establishing the Vaccine Injury Payments Scheme ("VDPS") which met no opposition in Parliament.
• Key features of VDPS: The Act has been in place for more than 40 years, with several minor legislative amendments. At its present form, Department of Work and Pensions ("DWP") is tasked with administration of payments under VDPS, while Department of Health and Social Care is responsible for advising the diseases to be covered by the Act. Here are the salient features of VDPS:
  
  

  (a)	Funding and a uniform compensation amount of £120,000: VDPS is directly funded by the Treasury. There is only one uniform lump-sum and tax-free payment to eligible claimants on a case-by-case basis, at £120,000 (HK$1.27 million) in 2021. This amount was first pitched at £10,000 (HK$105,800) in 1979, but was adjusted periodically to reflect rising medical costs. Since the launch of VDPS, a total of £74.7 million (HK$790 million) was compensated to 941 successful claims till April 2019. The success rate was only 15%, mainly attributable to stringent medical eligibility thresholds to be discussed later;15Legend symbol denoting Department of Work and Pensions (2019).
  (b)	Coverage of vaccines: Only designated diseases targeted by routine vaccination programme and specific pandemics are covered by VDPS. There are 17 of such diseases (e.g. COVID-19 added at end-2020) right now, compared with just eight in 1979. Only citizens aged 2-21 for vaccine injury from routine childhood vaccinations or persons vaccinated within six years against a specific pandemic in the UK are eligible for VDPS;16Legend symbol denoting GovUK (2021).
  (c)	Stringent requirement of 60% disability: VDPS does not consider minor injuries. It provides compensation to those who suffer from serious vaccine injury with at least 60% of disability (e.g. equivalent to loss of a hand) only, with reference to the injury scale of the Industrial Injuries Disablement Benefit Scheme. It covers both physical and mental injury;
  (d)	Vetting process: Independent medical advisers formed by doctors will consider available evidence for each claim. It is assessed on a relative basis and considers whether "it is more likely than not that vaccination caused the disability", instead of an absolute and proven causation approach. Such decisions are regularly audited;17Legend symbol denoting House of Commons (2015). and
  (e)	Appeal and litigation rights: Claimants may appeal to DWP or an independent tribunal to review the assessment decision. Moreover, VDPS claimants still have the litigation rights to pursue compensation against a vaccine manufacturer. In practice, any successful litigation would have the award of VDPS deducted from the final settlement.18Legend symbol denoting Department of Health and Social Care (2020).

• Swine flu pandemic in 2009-2010 as an example: The outbreak of swine flu could be a good reference case for COVID-19. When swine flu vaccine was added to VDPS for emergency use in October 2009, it had not completed usual clinical trials.^{19Legend symbol denoting The pandemic of swine flu during 2009-2010 had swept across 171 countries. Over half a million people are thought to have died during the pandemic, with over 450 deaths in the UK.} After 10 months of implementation, it was removed from both the vaccination programme and VDPS in August 2010, upon increasing reports of narcolepsy on vaccinated children in the UK and Nordic countries. During the pandemic, the UK government estimated that there was about one narcolepsy in every 52 750 jabs. Yet it rejected most of the submitted claims because they did not meet the "severe" injury threshold.^{20Legend symbol denoting Some six million people in the UK administered the swine flu vaccine called Pandemrix. Following suggestions of a possible association with narcolepsy, it was suspended in the UK in March 2011 as advised by the European Medicines Agency. See House of Commons (2016 and 2017).} By end-2020, just six out of 189 claims were successful (with a success rate of only 3%), and each of the persons injured by the vaccine was awarded £120,000 (HK$1.27 million) in accordance with the Act.^{21Legend symbol denoting Narcolepsy UK (2021) and Department of Work and Pensions (2020).} For those rejected cases, one claimant won a judicial appeal in 2017.
• Effectiveness of VDPS: VDPS seems to have boosted public confidence of vaccinations in the UK. For example, the vaccination rate of pertussis had recovered to pre-crisis level in the 1980s, hitting a high of 93% in 2019. Moreover, the coverage rates of recommended vaccines stayed at a high level of 87%-97% in 2019. Partly due to this public trust, the vaccination rate against COVID-19 in the UK hit 17% by early February 2021, one of the highest globally.^{22Legend symbol denoting University of Oxford (2021).}
• Issues of concerns: Yet there are concerns that both the amount of compensation and success rate of claiming VDPS in the UK is lower than other places (e.g. the US).^{23Legend symbol denoting Success rate in the US were 49% for claims on routine vaccination programme and 8% for those on global pandemics (e.g. swine flu and COVID-19), while those in New Zealand and Taiwan were 54% and 49% overall. All these schemes are funded by taxes, except that for global pandemics in the US funded by appropriation.} The UK government reiterates that VDPS is just an ex-gratia payment (rather than compensation) on the one hand, and the victims have litigation rights against the vaccine manufacturers on the other.^{24Legend symbol denoting Some suggested enhancing VDPS payments to cover lifetime medical costs of victims, while loosening the stringent threshold of 60% disability level. See Vaccine Justice (2011) and House of Commons (2015 and 2019).} Also, there are public concerns that COVID-19 vaccine may follow the footsteps of swine flu vaccine in 2009-2010 under an unfavourable scenario of emerging clinical cases of adverse effects associated with vaccination.

Prepared by LEUNG Chi-kit
Research Office
Information Services Division
Legislative Council Secretariat
10 February 2021