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Monitoring the safety,
efficacy, and take-up of
Covid-19 vaccines: the UK
experience
Professor Azeem Majeed
Imperial College London
Global number of Covid-19 cases
Options for control of Covid-19
• Non-Pharmaceutical Interventions
• Medical Interventions
• Vaccines
Pfizer Vaccine:
Clinical Trial
Results
o A total of 43,548 participants were
included in phase 2/3 clinical trials:
o 21,720 received BNT162b2
o 21,728 received placebo.
o The trials took place in six
countries: US, Germany, Brazil,
Argentina, South Africa and Turkey
o Efficacy:
o BNT162b2 was 95% effective in
preventing Covid-19 (95% credible
interval, 90.3 to 97.6).
o Similar vaccine efficacy (generally 90
to 100%) was observed across
subgroups defined by age, sex, race,
ethnicity, baseline body-mass index,
and the presence of coexisting
conditions
Figure 1:
Above - Efficacy of BNT162b2 against Covid-19 after the First Dose.
Below - Covid-19 occurrence at least 7 days after the second dose in participants without evidence of infection
(NEJM: Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine)
Issues to be addressed
• How long does immunity last after vaccination?
• How effective are current vaccines against new variants?
• Will booster doses be needed and, if so, how frequently?
• What are the longer term outcomes after vaccination?
• How to identify serious but rare side effects?
• How to improve confidence in Covid-19 vaccines and
overcome vaccine hesitancy?
Vaccine hesitancy
“A delay in acceptance or refusal of safe vaccines despite availability of vaccine services.” World
Health Organization (WHO)
WHO has named vaccine hesitancy as one of the top 10 threats to global health
“Vaccines only work if people receive them”
Proportion of UK adults likely to have a Covid-19 vaccine
Top reasons for vaccine hesitancy
I am worried about the side effects 44%
I am worried about the long term effects on my health 43%
I would wait to see how well the vaccine works 40%
I do not think it will be safe 24%
I do not feel COVID-19 is a personal risk 17%
I do not think it will work 12%
I am worried about the effect on an existing health condition 11%
I am against vaccines in general 8%
I am pregnant or trying to get pregnant and afraid of the effects on my baby 6%
I do not think I need the vaccine as I have tested positive for COVID-19 5%
I am worried it might be painful 3%
I am worried the vaccine will give me COVID-19 3%
The UK National Health Service
• Free healthcare at the point of access, funded by taxation
• Provides primary care, specialist and prevention services
• Collects data on healthcare use from all provider settings
• First point of access is generally primary care (general
practices), which can arrange investigations and specialist
referrals
• Primary care also responsible for issuing most drug
prescriptions and administering vaccines
Data for monitoring efficacy, safety and take-up of
Covid-19 vaccines
• Primary medical care data
• Hospital admissions data
• Cancer diagnoses
• Mortality records
• Vaccination records
• Covid-19 testing & genotyping data
Primary medical care data
• Collected by clinical staff (doctors, nurses, pharmacists,
healthcare assistants) working in primary care
• Data has been stored using electronic medical records for over
20 years in most primary care (general) practices
• 100% current use of electronic medical records
• Data is population-based, from “cradle to grave”
• For Covid-19 research, primary care data has been linked to
other records – hospital, mortality, testing, vaccination
• Linkage of data is possible through use of a unique 10 digit
personal identifier, NHS Number
Concerns about safety can undermine vaccine
confidence and increase vaccine hesitancy
Factors in vaccine hesitancy in minority groups
Summary of evidence on vaccine effectiveness
against different outcomes in England
Vaccine effectiveness against symptomatic disease
for VOC-20DEC-01 (B.1.1.7) and VOC21-APR-02
(B.1.617.2) by dose
Take-up of Covid-19 vaccination lower in ethnic
minority groups
Cumulative weekly Covid-19 vaccine uptake by age
Daily updates on vaccine doses administered in UK
Monitoring safety of vaccines
• Adverse events are reported to the UK Medicines and
Healthcare Products Regulatory Agency (MHRA)
• MHRA issues alerts and guidance to health professionals
• Advice issued to use Pfizer and Moderna vaccines in people
under 40 years because of concerns about clotting disorders
with AstraZeneca vaccine
• In longer-term, linked data sets will be used to look in more
detail at adverse events
Future developments in data availability
• General Practice Data for Planning and Research (GPDPR)
• Was due to start in July 2021, covering 56M people in England
but start now delayed
• GPDPR will provide access to near-real-time data from general
practice electronic medical records for planning and research
• GPDPR will end the need for ad-hoc data collections
• Proposals have generated complaints from the public because
of distrust of government and lack of consultation
Conclusions
• Vaccines offer the best method for controlling the global
Covid-19 pandemic
• Vaccine hesitancy is a key issue globally, particularly among
marginalised groups, minorities and the poor
• Collecting data on the long-term safety, efficacy and take-up of
Covid-19 vaccines is a public health priority
• Provides data for planning vaccination services and for
improving public confidence in vaccines
• Essential to obtain public trust for medical data collection and
linkage of health records
Acknowledgements
• UK Office for National Statistics
• Public Health England
• World Health Organization
• Our World in Data
• Twitter @Azeem_Majeed

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Covid 19 vaccination-isop_june_2021

  • 1. Monitoring the safety, efficacy, and take-up of Covid-19 vaccines: the UK experience Professor Azeem Majeed Imperial College London
  • 2. Global number of Covid-19 cases
  • 3. Options for control of Covid-19 • Non-Pharmaceutical Interventions • Medical Interventions • Vaccines
  • 4. Pfizer Vaccine: Clinical Trial Results o A total of 43,548 participants were included in phase 2/3 clinical trials: o 21,720 received BNT162b2 o 21,728 received placebo. o The trials took place in six countries: US, Germany, Brazil, Argentina, South Africa and Turkey o Efficacy: o BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). o Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions Figure 1: Above - Efficacy of BNT162b2 against Covid-19 after the First Dose. Below - Covid-19 occurrence at least 7 days after the second dose in participants without evidence of infection (NEJM: Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine)
  • 5. Issues to be addressed • How long does immunity last after vaccination? • How effective are current vaccines against new variants? • Will booster doses be needed and, if so, how frequently? • What are the longer term outcomes after vaccination? • How to identify serious but rare side effects? • How to improve confidence in Covid-19 vaccines and overcome vaccine hesitancy?
  • 6. Vaccine hesitancy “A delay in acceptance or refusal of safe vaccines despite availability of vaccine services.” World Health Organization (WHO) WHO has named vaccine hesitancy as one of the top 10 threats to global health “Vaccines only work if people receive them”
  • 7. Proportion of UK adults likely to have a Covid-19 vaccine
  • 8. Top reasons for vaccine hesitancy I am worried about the side effects 44% I am worried about the long term effects on my health 43% I would wait to see how well the vaccine works 40% I do not think it will be safe 24% I do not feel COVID-19 is a personal risk 17% I do not think it will work 12% I am worried about the effect on an existing health condition 11% I am against vaccines in general 8% I am pregnant or trying to get pregnant and afraid of the effects on my baby 6% I do not think I need the vaccine as I have tested positive for COVID-19 5% I am worried it might be painful 3% I am worried the vaccine will give me COVID-19 3%
  • 9. The UK National Health Service • Free healthcare at the point of access, funded by taxation • Provides primary care, specialist and prevention services • Collects data on healthcare use from all provider settings • First point of access is generally primary care (general practices), which can arrange investigations and specialist referrals • Primary care also responsible for issuing most drug prescriptions and administering vaccines
  • 10. Data for monitoring efficacy, safety and take-up of Covid-19 vaccines • Primary medical care data • Hospital admissions data • Cancer diagnoses • Mortality records • Vaccination records • Covid-19 testing & genotyping data
  • 11. Primary medical care data • Collected by clinical staff (doctors, nurses, pharmacists, healthcare assistants) working in primary care • Data has been stored using electronic medical records for over 20 years in most primary care (general) practices • 100% current use of electronic medical records • Data is population-based, from “cradle to grave” • For Covid-19 research, primary care data has been linked to other records – hospital, mortality, testing, vaccination • Linkage of data is possible through use of a unique 10 digit personal identifier, NHS Number
  • 12. Concerns about safety can undermine vaccine confidence and increase vaccine hesitancy
  • 13.
  • 14. Factors in vaccine hesitancy in minority groups
  • 15.
  • 16. Summary of evidence on vaccine effectiveness against different outcomes in England
  • 17. Vaccine effectiveness against symptomatic disease for VOC-20DEC-01 (B.1.1.7) and VOC21-APR-02 (B.1.617.2) by dose
  • 18. Take-up of Covid-19 vaccination lower in ethnic minority groups
  • 19. Cumulative weekly Covid-19 vaccine uptake by age
  • 20. Daily updates on vaccine doses administered in UK
  • 21. Monitoring safety of vaccines • Adverse events are reported to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) • MHRA issues alerts and guidance to health professionals • Advice issued to use Pfizer and Moderna vaccines in people under 40 years because of concerns about clotting disorders with AstraZeneca vaccine • In longer-term, linked data sets will be used to look in more detail at adverse events
  • 22. Future developments in data availability • General Practice Data for Planning and Research (GPDPR) • Was due to start in July 2021, covering 56M people in England but start now delayed • GPDPR will provide access to near-real-time data from general practice electronic medical records for planning and research • GPDPR will end the need for ad-hoc data collections • Proposals have generated complaints from the public because of distrust of government and lack of consultation
  • 23.
  • 24. Conclusions • Vaccines offer the best method for controlling the global Covid-19 pandemic • Vaccine hesitancy is a key issue globally, particularly among marginalised groups, minorities and the poor • Collecting data on the long-term safety, efficacy and take-up of Covid-19 vaccines is a public health priority • Provides data for planning vaccination services and for improving public confidence in vaccines • Essential to obtain public trust for medical data collection and linkage of health records
  • 25. Acknowledgements • UK Office for National Statistics • Public Health England • World Health Organization • Our World in Data • Twitter @Azeem_Majeed

Editor's Notes

  1. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine | NEJM