What You Need to Know about Vaccine Hesitancy
You may have read the reports of parts of the UK population choosing not to have the vaccine when invited to do so. You may have also passively watched the row between the AstraZeneca/Oxford vaccine team and the EU play out in public. You are all too aware of the cumulative death toll.
Perhaps you share my response to the daily update on the bad news. I mentally file the information into COVID-19 virus stuff and get on with my lockdown day. However a few weeks ago, *Jay, an elderly friend, sent me a text saying: ‘Just had my first vaccination. Not a single member of BAME community being vaccinated, which seems odd. It was like being back in the 60s.’
The 1960s was before my time. However, I understood the sentiment this white male in his 70s was trying to relay in a politically sensitive way. It was a vaccination event with 100 per cent white recipients (and several non-white practitioners giving the jabs). If you are wondering, BAME is short for Black, Asian and Minority Ethnic.
By text, I rehashed some factors that could explain his observation: religious beliefs, the lived and historical experiences of some communities, persistent poor uptake of flu vaccinations, concerns about historical practices of pharmaceuticals in some countries of origin, lack of trust in government, systematically ‘ignored’ and put at risk even in their workplaces ... The list could go on!
In the end, I hypothesised that it could either be the way the cookie crumbled on the day of his appointment or a reflection of the population in his immediate vicinity. Unconvinced, we went on to share an avocado cake recipe and the Transport for London Awareness Test — the one with the basketball players and the bear. It’s the way text chats go.
Vaccine hesitancy was expected
A November 2020 poll by the UK Household Longitudinal Study with approximately 12,000 respondents found that, at 82 per cent, there was an overall high level of willingness to be vaccinated. However, vaccine scepticism among BAME groups in the UK was high: 72 per cent of Black people said they were unlikely or very unlikely to be vaccinated; with the comparative figures for Pakistani and Bangladeshi groups at 42% and Other White (including Eastern European) groups at 26%. Women, younger people and those with lower levels of education were also more hesitant than others to have the COVID jab.
A further smaller online poll of 2,076 UK adults in December 2020 commissioned by the Royal Society for Public Health (RSPH) found that three in four (76%) of the UK public would take a COVID-19 vaccine if advised to do so by their GP or health professional, with just 8% stating they would be very unlikely to do so. However, the poll also found that that 57% of respondents from BAME backgrounds (199 respondents) were likely to accept a COVID-19 vaccine, compared to 79% of White respondents. Confidence was lowest among respondents of Asian ethnicity, with only 55% indicating they were likely to say yes.
The identified hesitancy has translated into the reported poor uptake amongst BAME groups. Dr Varney, Birmingham’s public health director highlighted that in some parts of the city with the largest Black and Asian populations, 50 per cent of people offered the vaccine said they did not want to take it.
Within the December 2020 SAGE response to the polls of hesitance and its exploration of factors influencing COVID-19 vaccine uptake among minority ethnic groups, trust was identified as a key factor, stating:
‘Trust is particularly important for Black communities that have low trust in healthcare organisations and research findings due to historical issues of unethical healthcare research.’
‘Trust is also undermined by structural and institutional racism and discrimination. Minority ethnic groups have historically been underrepresented within health research, including vaccines trials, which can influence trust in a particular vaccine being perceived as appropriate and safe, and concerns that immunisation research is not ethnically heterogenous.’
Further barriers to vaccine uptake identified included perception of risk, low confidence in the vaccine, access barriers, inconvenience, socio-demographic context, lack of endorsement, lack of vaccine offer or lack of communication from trusted providers and community leaders.
Many people will find the hesitancy puzzling given the evidence that minority ethnic groups have been disproportionately affected by the COVID-19 pandemic, experiencing higher morbidity and mortality.
Within the SAGE report are clues that things have not always been this way with a reference to the H1N1 epidemic of 2009–10 in the UK in which there was comparably higher vaccine uptake by minority ethnic groups attributed to higher levels of illness and death and thus increased awareness among minority ethnic populations. In some ways a comparable situation to the current pandemic that leaves one asking, what changed?
Trust is a huge part of the story
The lessons learned from historical practices of pharmaceutical companies working in conjunction with government cannot be too easily forgotten.
During the H1N1 epidemic, similarly as we have now vaccines were fast-tracked. Six million people in Britain, and more across Europe, were given the Pandemrix vaccine made by GlaxoSmithKline during the 2009–10 swine flu pandemic, but the jab was withdrawn after doctors noticed a sharp rise in narcolepsy among those receiving it. GSK had been given an indemnity from any liability by the UK Government.
Pfizer was embroiled in litigation as a result of a clinical trial conducted in 1996 in Kano, Nigeria during an epidemic of meningococcal meningitis. To test its new antibiotic, trovafloxacin (Trovan), Pfizer gave 100 children trovafloxacin, while another 100 received the gold-standard anti-meningitis treatment, ceftriaxone. Pfizer gave the children a substantially reduced dose of the gold standard relative to that described on approved prescribing information. The allegation is that this was done to skew the test in favour of Pfizer’s drug. In February 2009, Pfizer decided to settle its legal case with the 200 plaintiffs.
There are more examples of such questionable practices across the globe. These imprints of broken trust remain, resulting in lower trust and confidence in vaccine efficacy and safety.
Many, including those with country of births in other regions of the world, have lived through epidemics or have relatives who have. These include MERS, SARS and Ebola. Rarely have countries mass medicated their path out. Even within this pandemic are countries like New Zealand and Taiwan that have opted for elimination. Within several Asian countries, face masks were already the norm so many from those regions would have found it strange watching UK politicians argue about the merits of the public health messages of face masks, social distancing and hand-washing as the infection spread.
There may be a silent questioning of and unease about the need for such wide population immunisation intervention when it is feasible that behavioural changes and proactive policies by the government could have made a difference and prevented the spread of the virus, illness and death.
Mistrust to intense distrust
If there had been unease about the government, it is likely this would have shifted to one of concrete distrust with the handling of the situation in care homes and the health services where BAME communities are over-represented in frontline roles and the sectors.
Around 1.3 million people were employed by the NHS at the end of March 2020 of which 77.9% of NHS staff were White (where ethnicity was known), and 22.1% were from all other ethnic groups combined. Asians make up 10.7% of NHS staff but make up 7.2% of working age population; and for staff identifying as Black they reportedly make up 6.5% of NHS workforce but 3.4% of working age population. There is a higher percentage of junior doctors than senior doctors were from the Black, Chinese and Mixed ethnic groups. Furthermore among non-medical staff, there was a higher percentage of people from Asian, Black, Mixed and Other ethnic backgrounds in ‘support’ and ‘middle’ grades compared with ‘senior’ and ‘very senior manager’ grades.
In the last decade, many in the care sector and NHS have seen the austerity measures of the government enacted that altered and intensified their working patterns and shifts, stretched resources and took advantage of their good will. Many care and health service staff often work unpaid hours beyond the end of their shifts. Many have seen suitably qualified colleagues, themselves or know relatives side lined, possibly for less capable colleagues of a different background to move up the career ladder, and away from frontline roles. Unfair treatment is highly unlikely to induce trust.
The vaccination effort may be regarded not as a means to primarily save lives but one to stop the NHS buckling after consecutive years of disinvestment and under funding. The NHS is again a political tool.
With insufficient and sometimes out of date PPE, having been reassured by their Trusts and the government that their PPE had passed stringent tests that demonstrated they were safe, many frontline workers were put at risk. This inevitably contributed to further erosion of trust and questions raised about how much their lives were valued at the start of the pandemic. The likelihood is that a person of BAME background may work in care or have a direct relationship with someone who works in care, the NHS or other frontline roles.
When compared to previous years, a Public Health England report of August 2020 found a particularly high increase in all cause deaths among those born outside the UK and Ireland; those in a range of caring occupations including social care and nursing auxiliaries and assistants; those who drive passengers in road vehicles for a living including taxi and minicab drivers and chauffeurs; those working as security guards and related occupations; and those in care homes.
Filipino healthcare workers were disproportionately affected such that the high death rate among Filipino nurses in the UK became a concern discussed at an international level. Two key contributory factors were identified: the availability of PPE and the likelihood these nurses were being placed in higher risk environments.
On 28th January 2021, the Health Service Journal highlighted that Guy’s and St Thomas’ Foundation Trust, the largest hospital trust in England, had had 80 per cent of its staff vaccinated. However, the rate was about a quarter among Black-African and Black-Caribbean staff, and lower for Filipino staff and among Asian staff groups, Bangladeshi employees were least vaccinated.
The Trust chair of Guy’s and St Thomas’ Foundation Trust, Sir Hugh Taylor is quoted to have said there were “hard to reach” staff groups who were “hesitant about the vaccine for a number of reasons”. Such language to describe staff who are likely to be physically deployed within the organisation’s buildings and easy to reach to cover shifts cannot be helpful in breeding trust. The Foundation Trust will be conducting a survey to try to find out why staff had not taken the vaccine.
Representation in the vaccine trials is just as crucial
From time to time, I catch up with old clinician friends — practising and retired. All, I thought, had had the Pfizer vaccine, irrespective of background. However in late January, I stumbled on one who had not.
*Afia had not been asked and if she was, was unsure if she would have it. For her the data, particularly with respect to the AstraZeneca vaccine and ethnic minorities, just wasn’t there. This matters as diverse racial and ethnic representation in trials is important because drugs and vaccines can affect groups differently, reflecting variation in underlying experiences and environmental exposure.
As Afia was doing her consultations through a computer screen, she did not have to think much about it. If circumstances changed and she were put back into the frontline seeing patients in real life, the calculations which change. She had weighed up the risks. Afia encouraged me to look at the data for myself and so I did.
Given that about 20 years ago, prior to a consulting career, I had the job title of Formulary and Drug Use Pharmacist. I reviewed new drugs and requests for medicines and other interventions, and made recommendations on whether a drug would be made available for patients in our health community, so I was relatively comfortable delving into the published trial data.
I was stunned with the relatively low number of participants, the merging of results for different dose regimens and the small numbers of ethnic minorities and findings (or lack of) presented in relation to various sub-groups (not surprising given the numbers that would make findings less than statistically significant):
- The study had 11,636 participants (7548 in the UK, 4088 in Brazil) included in the interim primary efficacy analysis. The majority of participants were aged 18 to 55 years old (10281, 87.8%); white (9625, 82.7%) and female (7045, 60.6%).
- There were two dose regimens: some participants received two standard doses and the others, a low dose followed by a standard dose. Each dosing regimen had a control group.
- In participants who received two standard doses, the vaccine was found to be 62·1% efficacious as 27 of 4440 who received the regimen developed symptoms and tested positive compared to 71 of 4455 in the control group. In participants who received a low dose followed by a standard dose, efficacy was 90·0% as three of 1367 developed symptoms and tested positive compared to 30 out of 1374.
- The data from both groups were then merged to give a 70·4% overall vaccine efficacy across both groups was (30 of 5807 vs 101 of 5829).
Specifically, in relation to ethnic minorities, there were 2,013 non-White participants. Of these, 1365 were in the Brazil arm of the trial of which the majority (796) were identified as mixed. The Brazil arm of the study all received the two standard doses. Across the entire study, in both the UK and Brazil arms, there were a total of 519 Asian participants.
There are critiques of the Pfizer and Moderna studies and their reported efficacy of 95%, with alternative suggestions of vaccine efficacy as low as 19% and 29% against an endpoint of COVID-19 symptoms, with or without a positive test result. There has been a call, including that from Peter Doshi, for sharing of the raw clinical trial data.
The Pfizer study had 44,820 participants screened of which 37,706 were included in its analysis (18,860 vaccine, 18,846 placebo). The loss of participants from the initial 44,820, then to the 37,706 prior to the subgroup of 36,523 used in the vaccine efficacy analysis has also been questioned.
With respect to ethnicity data, among its 37,706 participants, 31,266 (83%) were white, 3492 (9%) Black or African American, 1608 (4.3%) Asian, 855 (2.3%) multiracial and 485 in other groups or not reported . There were 19,075 (50.6%) male and 18,631 (49.4%) female participants. The majority of participants (57.8%) were aged 16 to 55 (21,785) and those aged over 55 totalled 15,921 (42.2%), greater in number than the entire study size included in the AstraZeneca preliminary analysis.
The Pfizer vaccine was granted emergency use authorisation by the UK MHRA on 2nd December, with the AstraZeneca vaccine receiving its authorisation on 30th December 2020, and the Moderna vaccine on 8th January 2021.
With the available trial information, although wanting to learn more about its relatively new mRNA technology, Afia indicated she could be persuaded by the Pfizer vaccine. The AstraZeneca COVID-19 vaccine uses a replication deficient chimpanzee adenovirus. However, the likelihood of being given a choice of vaccines on the NHS is slim. Furthermore, on vaccine choice, the Joint Committee on Vaccination and Immunisation (JCVI) highlights that there has been no clinical trials directly comparing the Pfizer-BioNTech and AstraZeneca vaccines.
My conversation with Afia happened before the row between the EU and AstraZeneca erupted; and the subsequent announcement from national regulatory bodies across Europe reaching different decisions from the UK. The UK JCVI had advised that the first priorities for the COVID-19 vaccination programme — using authorised vaccines — should be the prevention of mortality and the maintenance of the health and social care systems. As the risk of mortality from COVID-19 increases with age, priority would be on age starting with residents in a care home for older adults and their carers; all those 80 years of age and over and frontline health and social care workers; and all those 75 years of age and over.
France’s Health Authority recommended on 2 February that the AstraZeneca vaccine should not be used for people over 65, saying more studies were needed before a roll out to older age groups. Germany, Austria, Sweden, Norway, Denmark, Netherlands, Spain and Poland have taken a similar stance. Italy and Belgium recommend it for those under 55. Switzerland’s medical regulator ruled against approving the vaccine for any age group saying there was not enough data yet on safety, effectiveness and quality to do so.
The FDA has not been as quick as the UK and Europe to approve the AstraZeneca vaccine. It is reported to have also expressed concerns about the limited ethnicity data in the trials and the absence of older people at highest risk, as most participants were under 55. There is also the matter of the pause to the AstraZeneca Oxford clinical trials in the autumn which the New York Times suggests may have hurt relationship with regulators and raised doubts about whether its vaccine will stand up to intense public and scientific scrutiny.
Questions about safety, scrutiny and surveillance
Following the emergency use approval of the vaccines in the UK, as at Sunday 7 February 2021 records showed that 12,014,288 people had received the first dose and 511,447, the second dose.
With the large numbers of people vaccinated there is an emerging conversation on safety and surveillance for unwanted effects of the vaccines in these times, where opportunities for physical visits to GPs are limited and four in 10 people not seeking help from their GP, afraid to be a burden on the NHS during the pandemic. We are probably more accustomed to living with symptoms or opting for self-care except in the most urgent and serious of conditions.
The vaccinations started with the elderly population. I wondered whether they knew if, who and where to report side effects; what the chances were of them leaping to see their GP by Zoom; the likelihood they would sign up to a tracking app or think to log onto the drug’s agency surveillance website. Furthermore, I worried that symptoms in older people could be brushed aside as deterioration due to their advanced years or the effects of the long period of confinement and isolation.
So I sought the opinion of Jay, my elderly friend with no medical background. He thought the details of who to report symptoms was somewhere in the extensive notes given as takeaway that he had not read. He wouldn’t bother to report any reactions unless it was extreme (and that would most probably be after it had subsided). He did go back to find his takeaway pamphlet and the information was buried in the depths of page 3. He, like a few other friends, has had no after effects.
On 4th February 2021, researchers from the ZOE COVID app team at King’s College London published their analysis from nearly 40,000 people who received the Pfizer vaccine in December: 23,308 people who had received just one dose, and 12,444 who had both. They found that around one in seven people who received one dose of the vaccine experienced at least one whole body (systemic) effect like fatigue, headache and chills within seven days of their jab. They also found that around four in ten people who received their first dose had at least one after effect in their arm, most commonly pain and swelling in the day or two after the jab.
Because many people have been continually using the ZOE COVID app throughout the pandemic, the researchers compared the effects of vaccination in people who had already had COVID-19 with those who had not. They found that previous exposure to coronavirus makes it more likely that someone will experience systemic effects after vaccination. For communities who may have been disproportionately exposed and infected, this could be an important finding.
On 5 February 2021, the MHRA, the medicines regulator, published its first report on suspected side-effects of vaccines administered from 9 December 2020 to 24 January 2021. There were 22,820 reports of suspected side effects, or an overall reporting rate of 3 in 1,000 doses of vaccine. The reporting levels to the yellow card scheme seems quite low in comparison to the ZOE COVID app, suggesting underreporting.
The MHRA has stated it is working to actively promote reporting on COVID-19 vaccines from patients and healthcare professionals to the coronavirus yellow card scheme. The MHRA has also published its safety surveillance strategy for monitoring the safety of all UK-approved COVID-19 vaccines. The UK drugs regulator is noted as stating that the COVID vaccines being given to millions of people in the UK are extremely safe.
Ways forward …
With 112,798 deaths of people who had a positive test result for COVID-19 and died within 28 days of the first positive test as at 8 February 2021, many of us are grieving the loss of our fathers, mothers, children, siblings, uncles, aunts, papis, nanas and friends.
The track and trace system and the vaccines have been touted as a way out of the pandemic. The track and trace system fell mighty short of world beating and did not give the route out. As the implementation of the vaccination programme carries on apace, the cautiously optimistic words of Jeremy Farrar, Director of the Wellcome Trust come to mind:
‘The “first” vaccine, or even the first generation of vaccines, will most likely not be perfect; the first generation of COVID-19 vaccines will probably be only partially effective.
Urgency must not be misunderstood; accelerating vaccine development must not mean compromising safety. Transparent, rigorous assessment by independent regulatory bodies without political interference is non-negotiable.
Trust is our most important tool in public health and we must do everything we can to avoid putting that in doubt. … Truthful, considered public health messaging that does not deal in false expectations.’
That word again, trust. This time it is accompanied with truth telling.
In the search for solutions to vaccine hesitancy and poor uptake in some communities, public relations campaigns have been disseminated featuring actors and politicians, and ‘community leaders’ have been mobilised. It is uncertain what impact these have had — positive or negative. These are probably useful starts though in of themselves may be insufficient for the deep and meaningful work of (re-)building trust.
The BAME respondents to the RSPH commissioned poll who were not willing to be vaccinated were especially receptive to offers of further health information. Over one third (35%) said they would likely change their minds and get the jab if given more information by their GP about how effective it is — almost twice as many as the 18% of White people who were initially unwilling. I suspect many people can be persuaded with good efficacy and safety information that duly takes account of their backgrounds and lived experiences.
With minority ethnic groups disproportionately affected by the COVID-19 pandemic experiencing higher morbidity and mortality, it is reasonable to expect that more should have and is done on demonstrating the effects and side effects of the vaccines in these groups in trials.
We need the data. We need the evidence — over a period of time. We need to have real choice — whether in choosing to get vaccinated or not and what vaccine. Like Afia, it is possible that provided with the data some may move from hesitancy to a preference for one vaccine over another.
Vaccine hesitancy is complex extending beyond BAME groups, and identified in women, younger people and people with lower levels of education. There may be further work to be done on exploring why some eagerly get into queue for the vaccines, whether or not they trust the government and the practices of pharmaceutical companies. There could be push and pull factors at play. Many may be sufficiently fed up with COVID restrictions, and thus are willing to give anything a try for the chance to spend time with their extended family and friends, a return to some adventure, even that summer holiday abroad. For those with no holiday to get away to, no fancy restaurants or bars waiting but the prospect of a life of continued unfair treatment and quashed dreams, the response could be different.
Moving forward requires fairer treatment in our workplaces and society. It means truly valuing people and showing it. It needs the commitment to do the necessary work to move individuals and communities from distrust to trust.
In our daily lives, when our trust is broken. Acknowledgement, apologies and corrective actions are good starting points. When we are hesitant, we need people to listen. We may need space and more information to make sense of our unease.
As the TFL awareness test demonstrates, by focusing too much on certain aspects of situations we may miss the profound developments or perspectives on the periphery. As for the cake, I am still waiting on the avocado to ripen. It may take some time.
*Obviously not their real names.
