Vaccine-surveillance-report-week-13.pdf

COVID-19 vaccine surveillance report Week 13 31 March 2022

COVID-19 vaccine surveillance report – week 13

Contents Executive summary ...................................................................................................................... 3 Vaccine effectiveness ............................................................................................................... 3 Population impact ..................................................................................................................... 3 Vaccine effectiveness .................................................................................................................. 4 Effectiveness against symptomatic disease ............................................................................. 4 Effectiveness against hospitalisation ........................................................................................ 8 Effectiveness against mortality ............................................................................................... 10 Effectiveness against infection ............................................................................................... 10 Effectiveness against transmission ........................................................................................ 10 Effectiveness against Omicron variant BA.2 ...........................................................................

12 Population impact ...................................................................................................................... 16 Vaccine coverage ................................................................................................................... 16 Vaccination in immunosuppressed individuals ....................................................................... 20 Vaccination in pregnancy ....................................................................................................... 21 Vaccination status in cases, deaths and hospitalisations ....................................................... 37 Vaccine impact on proportion of population with antibodies to COVID-19.............................. 46 Direct impact on hospitalisations ............................................................................................ 53 References................................................................................................................................. 55

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COVID-19 vaccine surveillance report – week 13

Executive summary Four coronavirus (COVID-19) vaccines have now been approved for use in the UK. Rigorous clinical trials have been undertaken to understand the immune response, safety profile and efficacy of these vaccines as part of the regulatory process. Ongoing monitoring of the vaccines as they are rolled out in the population is important to continually ensure that clinical and public health guidance on the vaccination programme is built upon the best available evidence. UK Health Security Agency (UKHSA), formerly Public Health England (PHE), works closely with the Medicines and Healthcare Regulatory Agency (MHRA), NHS England, and other government, devolved administration and academic partners to monitor the COVID-19 vaccination programme. Details of the vaccine surveillance strategy are set on the page COVID-19: vaccine surveillance strategy (1). As with all vaccines, the safety of COVID-19 vaccines is continuously being monitored by the MHRA. They conclude that overall, the benefits of COVID-19 vaccines outweigh any potential risks (2). Please note that from next week, data on COVID-19 cases by vaccination status will no longer be presented in this report. For more information please see below and on page 37.

Vaccine effectiveness Several studies of vaccine effectiveness (VE) have been conducted in the UK against different COVID-19 variants. Vaccine effectiveness against symptomatic disease with the Omicron variant is substantially lower than against the Delta variant, with rapid waning. However, protection against hospitalisation remains high, particularly after 3 doses.

Population impact The impact of the vaccination programme on the population is assessed by taking into account vaccine coverage, evidence on vaccine effectiveness and the latest COVID-19 disease surveillance indicators. Vaccine coverage tells us about the proportion of the population that have received one, 2 and 3 doses of COVID-19 vaccines. By 27 March 2022, the overall vaccine uptake in England for dose 1 was 69.5% and for dose 2 was 65.3%. Overall vaccine uptake in England in people with at least 3 doses was 50.9%. In line with the programme rollout, coverage is highest in the oldest age groups. We present data on COVID-19 cases, hospitalisations and deaths by vaccination status. This raw data should not be used to estimate vaccine effectiveness as the data does not take into account inherent biases present such as differences in risk, behaviour and testing in the vaccinated and unvaccinated populations.

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COVID-19 vaccine surveillance report – week 13

From 1 April 2022, the UK Government will no longer provide free universal COVID-19 testing for the general public in England, as set out in the plan for living with COVID-19. Such changes in testing policies affect the ability to robustly monitor COVID-19 cases by vaccination status, therefore, from the week 14 report onwards this section of the report will no longer be published. Vaccine effectiveness is measured in other ways as detailed in the vaccine effectiveness section below. Based on antibody testing of blood donors, 99.3% of the adult population have antibodies to COVID-19 from either infection or vaccination compared to 36.0% that have antibodies from infection alone.

Vaccine effectiveness Large clinical trials have been undertaken for each of the COVID-19 vaccines approved in the UK which found that they are highly efficacious at preventing symptomatic disease in the populations that were studied. The clinical trials have been designed to be able to assess the efficacy of the vaccine against laboratory confirmed symptomatic disease with a relatively short follow up period so that effective vaccines can be introduced as rapidly as possible. Post implementation real world vaccine effectiveness studies are needed to understand vaccine effectiveness against different outcomes (such as severe disease and onwards transmission), effectiveness in different subgroups of the population and against different variants as well as to understand the duration of protection.Vaccine effectiveness is estimated by comparing rates of disease in vaccinated individuals to rates in unvaccinated individuals. Below we outline the latest real-world evidence on vaccine effectiveness from studies in UK populations. Where available we focus on data related to the Omicron variant which is currently dominant in the UK. Please note that vaccine effectiveness data will be updated in this report as it becomes available. Last update was published on 31 March 2022.

Effectiveness against symptomatic disease Vaccine effectiveness against symptomatic COVID-19 has been assessed in England based on community testing data linked to vaccination data from the National Immunisation Management System (NIMS), cohort studies such as the COVID Infection Survey and GP electronic health record data. After 2 doses of the AstraZeneca vaccine, vaccine effectiveness against the Omicron variant starts at 45 to 50% then drops to almost no effect from 25 weeks after the second dose. With 2 doses of Pfizer or Moderna effectiveness dropped from around 65 to 70% down to around 15% by 25 weeks after the second dose. Two to 4 weeks after a booster dose of either the Pfizer or Moderna vaccine, effectiveness ranges from around 60 to 75%, dropping to 25 to 40% from 15+ weeks after the booster. Vaccine effectiveness estimates for the booster dose are very similar, irrespective of the primary course received (3). Vaccine effectiveness is generally slightly higher in younger compared to older age groups. 4

COVID-19 vaccine surveillance report – week 13

Figure 1. Vaccine effectiveness against symptomatic disease by period after the second and booster doses for Delta (black squares) and Omicron (grey circles) for a) recipients of 2 doses of Astrazeneca (ChAdOx1-S) vaccine as the primary course and Pfizer (BNT162b2) or Moderna (mRNA-1273) as a booster; b) recipients of 2 doses of Pfizer vaccine as the primary course and Pfizer or Moderna as a booster, and c) 2 doses of Moderna as a primary course and Pfizer or Moderna as a booster a)

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COVID-19 vaccine surveillance report – week 13

b)

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COVID-19 vaccine surveillance report – week 13

c)

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COVID-19 vaccine surveillance report – week 13

Data (based primarily on the Alpha and Delta variants) suggests that in most clinical risk groups, immune response to vaccination is maintained and high levels of VE are seen with both the Pfizer and AstraZeneca vaccines. Reduced antibody response and vaccine effectiveness were seen after 1 dose of vaccine among the immunosuppressed group, however, after a second dose the reduction in vaccine effectiveness is smaller (4). Analyses by dosing interval suggest that immune response to vaccination and vaccine effectiveness against symptomatic disease improves with a longer (greater than 6 week interval) compared to a shorter interval of 3 to 4 weeks (5).

Effectiveness against hospitalisation Several studies have estimated vaccine effectiveness against hospitalisation in older ages, all of which indicate higher levels of protection against hospitalisation with all vaccines against the Alpha and Delta variants (6, 7, 8, 9). Vaccine effectiveness against a range of hospitalisation outcomes with the Omicron variant has been estimated using a test-negative case control study design (Table 1, 10). Among 18 to 64 year olds using all Covid-19 cases admitted via emergency care VE after a booster peaked at 82.4% and dropped to 53.6% by 15+ weeks after the booster; using all admissions for >-= 2 days with a respiratory code in the primary diagnostic field VE ranged from 90.9% down to 67.4%; further restricting to those on oxygen/ventilated/on intensive care VE ranged from 97.1% down to 75.9%. Among 65+ year olds the equivalent VE estimates were 92.4% down to 76.9%; 91.3% down to 85.3% and 95.8% down to 86.8%. Given that Omicron generally causes milder disease than previous variants, in particular among younger individuals, and that all individuals who are hospitalised for any reason in the UK are tested for COVID-19, an increasing proportion of individuals hospitalised with a positive COVID19 test are likely to have COVID-19 as an incidental finding rather than the primary reason for admission.

This can be seen in the vaccine effectiveness estimates against hospitalisation, whereby outcomes using broad definitions for hospitalisation give lower estimates that are likely more reflective of vaccine effectiveness against infection. Whereas definitions of hospitalisation that are more specific to severe respiratory disease give higher vaccine effectiveness estimates with less evidence of waning. This is also likely to explain the higher vaccine effectiveness against hospitalisation in 65+ year olds compared to 18 to 64 year olds. There appears to be little variation in vaccine effectiveness against hospitalisation after a booster dose according to the type of vaccine used for priming or boost (10).

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COVID-19 vaccine surveillance report – week 13

Table 1. vaccine effectiveness against hospitalisation using different definintions of hospitalisations in a) 18 to 64 year olds and b) 65 year olds and over

ECDS symptomatic with onset date

SUS at least 2 days with ARI code in primary field

SUS at least 2 days and either oxygen, ventilation or ICU with ARI code in primary field

18 to 64 Interval

VE

VE

48.5 (12.3 to 69.7)

36.2 (-33.9 to 69.6)

48.7 (32.8 to 60.8)

44.1 (25.6 to 58)

39.6 (-31.5 to 72.2)

88.9 (58.4 to 97)

14 to 174

54.7 (45.3 to 62.4)

69 (58.1 to 77)

86.7 (63.6 to 95.1)

175+

34.6 (21.7 to 45.4)

56.1 (46.4 to 64)

82.3 (67.7 to 90.3)

Booste 0 to 6 r 7 to 13

63.9 (52.2 to 72.8)

74.3 (55.9 to 85)

90.7 (56 to 98.1)

80.1 (73.5 to 85.1)

90.9 (83.2 to 95.1)

14 to 34

82.4 (78.6 to 85.6)

88.6 (84.9 to 91.5)

97.1 (92.2 to 98.9)

35 to 69

72.7 (67.2 to 77.2)

85.8 (82.4 to 88.5)

94.3 (88.9 to 97.1)

70 to 104

66.9 (59.1 to 73.3)

80.2 (74.9 to 84.4)

89.9 (78.3 to 95.3)

105+

53.6 (36.9 to 65.9)

67.4 (53.1 to 77.4)

75.9 (15.8 to 93.1)

Dose 1 0 to 27 28+ Dose 2 0 to 13

VE 75 (42.4 to 89.1)

65+ Interval

VE

Dose 1 0 to 27

VE

VE

43.9 (-41 to 77.7)

28+

53.4 (36.3 to 65.9)

78.3 (43.7 to 91.7)

Dose 2 0 to 13 14 to 174

77.8 (45 to 91)

82.3 (74.3 to 87.8)

90.9 (72.6 to 97)

175+

66.7 (43.4 to 80.4)

57.7 (49.6 to 64.4)

73.4 (55.1 to 84.3)

85.8 (61.5 to 94.7)

77.9 (65.3 to 85.9)

89.2 (63.1 to 96.8)

92.3 (76.3 to 97.5)

84.7 (76 to 90.2)

94.7 (71.6 to 99)

14 to 34

92.4 (86 to 95.8)

91.3 (89.1 to 93.1)

95.8 (91.3 to 97.9)

35 to 69

87 (79.2 to 91.8)

89.3 (87.3 to 90.9)

92.8 (88.4 to 95.6)

70 to 104

84 (74.6 to 89.9)

88.1 (86.1 to 89.9)

92.5 (88.1 to 95.2)

105+

76.9 (60.6 to 86.4)

85.3 (82.4 to 87.6)

86.8 (77.1 to 92.3)

Booste 0 to 6 r 7 to 13

ECDS = Emergency Care Dataset (this analysis includes all admissions with a positive COVID-19 test via emergency care except for those coded as injuries); SUS = Secondary Users Service (this analysis includes all admissions to secondary care for >=2 days with a respiratory code in the first diagnostic field) (10).

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COVID-19 vaccine surveillance report – week 13

Effectiveness against mortality High levels of protection (over 90%) are also seen against mortality with all 3 vaccines and against both the Alpha and Delta variants with relatively limited waning (6, 11, 12). Vaccine effectiveness against mortality with the Omicron variant has been estimated for those aged 50 years and older by combining the risk of becoming a symptomatic case with the risk of death among symptomatic cases in vaccinated (all vaccines combined) compared to unvaccinated individuals (Table 2). At 25-plus weeks following the second dose, vaccine effectiveness was around 60% while at 2 or more weeks following a booster vaccine effectiveness was 95% against mortality. Table 2. Hazard ratios and vaccine effectiveness against mortality (all vaccine brands combined). OR = odds ratio, HR = hazards ratio, VE = vaccine effectiveness Dose

Interval after dose

OR versus symptomatic disease

HR versus mortality

VE versus mortality

2

25+ weeks

0.93 (0.9 to 0.96)

0.45 (0.19 to 1.03)

59% (4 to 82)

3

2+ weeks

0.41 (0.39 to 0.42)

0.12 (0.06 to 0.24)

95% (90 to 98)

Effectiveness against infection Although individuals may not develop symptoms of COVID-19 after vaccination, it is possible that they could still be infected with the virus and could transmit to others. Understanding how effective vaccines are at preventing infection is therefore important to predict the likely impact of the vaccination programme on the wider population. In order to estimate vaccine effectiveness against infection, repeat asymptomatic testing of a defined cohort of individuals is required. Studies have now reported on vaccine effectiveness against infection in healthcare workers, care home residents and the general population with the Alpha and Delta variants (13, 14, 15, 16). Generally estimates are similar to or slightly lower than vaccine effectiveness estimates against symptomatic disease and there is evidence of significant waning in protection against infection over time. Estimates for vaccine effectiveness against infection with the Omicron variant are not yet available.

Effectiveness against transmission As described above, several studies have provided evidence that vaccines are effective at preventing infection. Uninfected individuals cannot transmit; therefore, the vaccines also provide some protection against transmission. There may be additional benefit, beyond that due to prevention of infection, if some of those individuals who become infected despite vaccination are also at a reduced risk of transmitting (for example, because of reduced duration or level of viral shedding). Several studies have provided evidence of reduced risk of household transmission from vaccinated cases compared to unvaccinated cases (17, 18, 19, 21). 10

COVID-19 vaccine surveillance report – week 13

Consensus vaccine effectiveness estimates Table 3 summarises consensus estimates of vaccine effectiveness against different outcomes that have been reached by the UK Vaccine Effectiveness Expert Panel. These take into account estimates from UK studies by public health agencies and academic groups as well as international data. Table 3. Consensus estimates of vaccine effectiveness against the Omicron variant Vaccine product for primary course

AstraZeneca

Moderna

Pfizer

Outcome

Second dose: 0 to 3 months

Second dose: 4 to 6 months

Second dose: 6+ months

Booster dose: All Periods

Booster dose: 0 to 3 months

Booster dose: 4 to 6 months

Booster dose: 6+ months

All Infection

30% (10 to 50%)

0 to 35% (range only)

Insufficient data

See individual periods

50% (40 to 60%)

30% (20 to 40%)

Insufficient data

Symptomatic

40% (30 to 50%)

20% (5 to 30%)

5% (0 to 5%)

See individual periods

60% (50 to 70%)

40% (30 to 50%)

Insufficient data

Hospitalisation 85% (60 to 90%)

70% (50 to 75%)

65% (45 to 85%) See individual periods

90% (85 to 95%)

85% (85 to 95%)

Insufficient data

Mortality

Insufficient data

Insufficient data

Insufficient data

See individual periods

90% (85 to 98%)

Insufficient data

Insufficient data

Transmission

Insufficient data

Insufficient data

Insufficient data

Insufficient data

Insufficient data

Insufficient data

Insufficient data

All Infection

30% (20 to 40%)

Insufficient data

Insufficient data

See individual periods

50% (40 to 60%)

30% (20 to 40%)

Insufficient data

Symptomatic

55% (35 to 75%)

30% (15 to 35%)

15% (10 to 20%) See individual periods

65% (55 to 75%)

Insufficient data

Insufficient data

Hospitalisation 85 to 95% (range only)

75 to 85% (range only)

55 to 90% (range only)

See individual periods

85 to 95% (range only)

Insufficient data

Insufficient data

Mortality

Insufficient data

Insufficient data

Insufficient data

Insufficient data

Insufficient data

Insufficient data

Insufficient data

Transmission

Insufficient data

Insufficient data

Insufficient data

Insufficient data

Insufficient data

Insufficient data

Insufficient data

All Infection

30% (20 to 40%)

Insufficient data

Insufficient data

See individual periods

50% (40 to 60%)

30% (20 to 40%)

Insufficient data

Symptomatic

50% (30 to 65%)

20% (15 to 30%)

15% (10 to 15%) See individual periods

65% (55 to 75%)

45% (35 to 55%)

Insufficient data

Hospitalisation 90% (85 to 95%)

80% (75 to 85%)

70% (55 to 90%) See individual periods

90% (85 to 95%)

85% (85 to 95%)

Insufficient data

Mortality

Insufficient data

Insufficient data

Insufficient data

See individual periods

90% (85 to 98%)

Insufficient data

Insufficient data

Transmission

Insufficient data

Insufficient data

Insufficient data

0 to 25% (range only)

Insufficient data

Insufficient data

Insufficient data

Booster data is based on use of the Moderna or Pfizer vaccines as a booster. This table provides overall estimates but there may be variation by age group or other clinical or demographic factors. High Evidence from multiple studies which is consistent Confidence and comprehensive Medium Evidence is emerging from a limited number of Confidence studies or with a moderately level of uncertainty Low Little evidence is available at present and results are Confidence inconclusive

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COVID-19 vaccine surveillance report – week 13

Effectiveness against Omicron variant BA.2 The Omicron variant sub-lineage known as BA.2 was designated VUI-22JAN-01 on 19 January 2022. An increase in the number of sequences of the Omicron sub-lineage BA.2 was noted in the UK in the week starting the 3 January 2022. Vaccine effectiveness against symptomatic disease following BA.2 infection was analysed in a test-negative case control design, as compared to the Omicron BA.1 sub-lineage. Vaccine effectiveness against both symptomatic disease (Figure 2) and hospitalisation (Table 4) was similar for BA.1 and BA.2 (20). Note, in this analysis all admissions via emergency care (excluding injuries) are included – this may underestimate VE against hospitalisation as discussed in the vaccine effectiveness against hospitalisation section above. Figure 2. Vaccine effectiveness against symptomatic disease after 2 doses or a booster dose

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COVID-19 vaccine surveillance report – week 13

Table 4. vaccine effectiveness against hospitalisation using the Emergency Care Dataset Dose

Interval (days)

Vaccine effectiveness (95% CI) BA.1

BA.2

24.2 (-12.5 to 48.9)

38.1 (-52.5 to 74.9)

14 to 174

63.3 (47.2 to 74.6)

68.7 (26.6 to 86.6)

175+

32.4 (11 to 48.7)

49.9 (6.5 to 73.2)

Unvaccinated 1

0 to 27 28+

2

3

0 to 13

0 to 6 7 to 13

91.6 (65.8 to 97.9)

14 to 34

83.2 (75.4 to 88.5)

87.3 (57.2 to 96.2)

35 to 69

80.5 (74.8 to 84.9)

83.3 (70.7 to 90.5)

70+

72.5 (64.5 to 78.7)

70 (49.3 to 82.2)

Vaccine effectiveness publications UKHSA and collaborators have published a significant amount of research into vaccine effectiveness, which is summarised on pages 4 to 13. The publications listed in table 5 provide further results and details on the methods used. Table 5. UKHSA publications on the effectiveness of COVID-19 vaccination Publication

Subject

COVID-19 Vaccine Effectiveness against the Omicron BA.2 variant in England

This study estimates the effectiveness of booster vaccination against symptomatic disease caused by the BA.2 sub-lineage of the Omicron (B.1.1.529) variant.

Vaccine effectiveness against hospitalisation with the Omicron variant

This study estimates vaccine effectiveness against hospitalisation with the Omicron variant and investigates the impact of using different hospitalisation outcome definitions

Effectiveness of COVID-19 vaccines against hospitalisation with the Omicron variant in adults aged 75 years and older

This study reports on vaccine effectiveness against hospitalisation with the Omicron variant in adults aged 75 years and older.

Effectiveness of BNT162b2 and ChAdOx1 against SARS-CoV-2 household transmission: a prospective cohort study in England

This study reports on vaccine effectiveness against transmission of COVID-19 with the Alpha and Delta variants.

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COVID-19 vaccine surveillance report – week 13

Publication

Subject

Effectiveness of 3 doses of COVID-19 vaccines against symptomatic COVID-19 and hospitalisation in adults aged 65 years and older

Updated analysis on the effectiveness of 3 doses of COVID-19 vaccines against symptomatic COVID-19 and hospitalisation in adults aged 65 years and older.

Effectiveness of BNT162b2 COVID-19 booster vaccine against COVID-19 related symptoms and hospitalization in England

This study provides real world evidence of significant increased protection from the booster vaccine dose against symptomatic disease and hospitalisation irrespective of the primary course.

Effectiveness of COVID-19 vaccines against the Omicron (B.1.1.529) variant of concern

This study reports on the vaccine effectiveness against symptomatic disease with 2 dose courses of BNT1622 and ChAdOx1-S as well as booster doses of BNT162b2 following a primary course of either BNT1622 or ChAdOx1-S.

Effectiveness of BNT162b2 (Comirnaty, PfizerBioNTech) COVID-19 booster vaccine against COVID-19 related symptoms in England: test negative case-control study

Results from the first UK real-world study by UKHSA show significantly increased protection against symptomatic disease from a booster dose of the Pfizer-BioNTech vaccine in those aged 50 years and older.

Duration of Protection against Mild and Severe Disease by COVID-19 Vaccines

This study reports on the vaccine effectiveness and duration of protection of Comirnaty, Vaxzevria and Spikevax against mild and severe COVID-19 in the UK.

Serological responses and vaccine effectiveness for extended COVID-19 vaccine schedules in England

This study investigates the impact of different dosing schedules on immune response and vaccine effectiveness.

Pfizer-BioNTech and Oxford AstraZeneca COVID-19 vaccine effectiveness and immune response among individuals in clinical risk groups

This study reports on the immune response and clinical effectiveness of COVID-19 vaccine among individuals in clinical risk groups. A supplementary appendix is also available to download.

Effectiveness of COVID-19 vaccines against hospital admission with the Delta (B.1.617.2) variant

This study reports on the effectiveness of COVID-19 vaccines on hospitalisation disease with the Delta variant. A supplementary appendix is also available to download.

Effectiveness of COVID-19 Vaccines against the B.1.617.2 (Delta) Variant

This study reports on the effectiveness of COVID-19 vaccines on symptomatic disease with the Delta variant. 14

COVID-19 vaccine surveillance report – week 13

Publication

Subject

Effectiveness of BNT162b2 mRNA and ChAdOx1 adenovirus vector COVID-19 vaccines on risk of hospitalisation among older adults in England: an observational study using surveillance data

A study using the SARI watch surveillance system of COVID-19 hospitalisations found high levels of protection against hospitalisation after both a single dose and 2 doses of COVID-19 vaccines.

Effectiveness of BNT162b2 mRNA vaccine and A study on deaths with COVID-19 indicates ChAdOx1 adenovirus vector vaccine on that COVID-19 vaccines offer high levels of mortality following COVID-19 protection against mortality. Effect of Vaccination on Household Transmission of SARS-CoV-2 in England

Impact of vaccination on household transmission of SARS-COV-2 in England is an analysis to determine whether individuals who have received vaccine, but still become infected with SARS-COV-2 up to 60 days after the first dose, are less likely than unvaccinated cases to transmit to their unvaccinated household contacts.

Vaccine effectiveness of the first dose of ChAdOx1 nCoV-19 and BNT162b2 against SARS-CoV-2 infection in residents of LongTerm Care Facilities (VIVALDI study)

The VIVALDI study found evidence that COVID-19 vaccines were associated with a substantially reduced risk of infection in care home residents.

Effectiveness of BNT162b2 and ChAdOx1 nCoV-19 COVID-19 vaccination at preventing hospitalisations in people aged at least 80 years: a test-negative, case-control study

The Avon CAP study, conducted in 2 hospitals in Bristol, found evidence of high levels of protection against hospitalisation in 80+ year olds with a single dose of either vaccine.

COVID-19 vaccine coverage in health-care workers in England and effectiveness of BNT162b2 mRNA vaccine against infection (SIREN): a prospective, multicentre, cohort study

Early data from UKHSA’s SIREN study shows a promising impact on infection in healthcare workers aged under 65. Healthcare workers in the study are tested for COVID-19 every 2 weeks – whether or not they have symptoms.

Effectiveness of the Pfizer-BioNTech and Oxford-AstraZeneca vaccines on COVID-19 related symptoms, hospital admissions, and mortality in older adults in England: test negative case-control study

Early data from routine COVID-19 testing in older adults shows that vaccines are effective at preventing COVID-19 disease and severe outcomes.

Impact of COVID-19 vaccination programme on Report on the impact of COVID-19 seroprevalence in blood donors in England, vaccination programme on seroprevalence 2021 in blood donors in England, 2021.

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COVID-19 vaccine surveillance report – week 13

Population impact Vaccines typically have both direct effects on those who are vaccinated and indirect effects on the wider population due to a reduced probability that people will come into contact with an infected individual. The overall impact of the vaccination programme may therefore extend beyond that estimated through vaccine effectiveness analysis. Estimating the impact of a vaccination programme is challenging as there is no completely unaffected control group. Furthermore, the effects of the vaccination programme need to be differentiated from that of other interventions (for example, lockdowns or outbreak control measures), changes in behaviour and any seasonal variation in COVID-19 activity. UKHSA and other government and academic partners monitor the impact of the of the vaccination programme on levels of COVID-19 antibodies in the population and different disease indicators, including hospitalisations and mortality. This is done through populationbased testing and through modelling which combines vaccine coverage rates in different populations, estimates of vaccine effectiveness and disease surveillance indicators.

Vaccine coverage The data in this week’s report covers the period from 8 December 2020 to 27 March 2022 (week 12) (Figure 3). It shows the provisional number and percentage of living people in England who have had received one, 2 or 3 doses of a COVID-19 vaccination by age group and week since the start of the programme. Further data on vaccine uptake by age in England can be found in the national flu and COVID-19 surveillance reports. Age is calculated as age on the 31 August 2021, that is, academic cohort for all ages.

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0.0 2020-50 2020-51 2020-52 2020-53 2021-01 2021-02 2021-03 2021-04 2021-05 2021-06 2021-07 2021-08 2021-09 2021-10 2021-11 2021-12 2021-13 2021-14 2021-15 2021-16 2021-17 2021-18 2021-19 2021-20 2021-21 2021-22 2021-23 2021-24 2021-25 2021-26 2021-27 2021-28 2021-29 2021-30 2021-31 2021-32 2021-33 2021-34 2021-35 2021-36 2021-37 2021-38 2021-39 2021-40 2021-41 2021-42 2021-43 2021-44 2021-45 2021-46 2021-47 2021-48 2021-49 2021-50 2021-51 2021-52 2022-01 2022-02 2022-03 2022-04 2022-05 2022-06 2022-07 2022-08 2022-09 2022-10 2022-11 2022-12

% vaccine uptake

COVID-19 vaccine surveillance report – week 13

Figure 3. Cumulative weekly vaccine uptake by age

a) Dose 1 Over 80 75 to under 80 70 to under 75 65 to under 70 60 to under 65 55 to under 60 50 to under 55 45 to under 50

35 to under 40 30 to under 35 25 to under 30 20 to under 25 18 to under 20 16 to under 18 12 to under 16 Under 12

Week number

17

40 to under 45

100.0

90.0

80.0

70.0

60.0

50.0

40.0

30.0

20.0

10.0

0.0 2020-50 2020-51 2020-52 2020-53 2021-01 2021-02 2021-03 2021-04 2021-05 2021-06 2021-07 2021-08 2021-09 2021-10 2021-11 2021-12 2021-13 2021-14 2021-15 2021-16 2021-17 2021-18 2021-19 2021-20 2021-21 2021-22 2021-23 2021-24 2021-25 2021-26 2021-27 2021-28 2021-29 2021-30 2021-31 2021-32 2021-33 2021-34 2021-35 2021-36 2021-37 2021-38 2021-39 2021-40 2021-41 2021-42 2021-43 2021-44 2021-45 2021-46 2021-47 2021-48 2021-49 2021-50 2021-51 2021-52 2022-01 2022-02 2022-03 2022-04 2022-05 2022-06 2022-07 2022-08 2022-09 2022-10 2022-11 2022-12

% vaccine uptake

COVID-19 vaccine surveillance report – week 13

b) Dose 2 Over 80 75 to under 80 70 to under 75 65 to under 70 60 to under 65 55 to under 60 50 to under 55 45 to under 50

35 to under 40 30 to under 35 25 to under 30 20 to under 25 18 to under 20 16 to under 18 12 to under 16 Under 12

Week number

18

40 to under 45

100.0

90.0

80.0

70.0

60.0

50.0

40.0

30.0

20.0

10.0

COVID-19 vaccine surveillance report – week 13

c) Dose 3. Please note the data for this graph is shown from week 35 (week ending 5 September 2021) Over 80 D3

75 to under 80 D3

70 to under 75 D3

65 to under 70 D3

60 to under 65 D3

55 to under 60

50 to under 55

45 to under 50

40 to under 45

35 to under 40

30 to under 35

25 to under 30

20 to under 25

18 to under 20

16 to under 18

12 to under 16

Under 12

100.0

90.0

80.0

% vaccine uptake

70.0

60.0

50.0

40.0

30.0

20.0

10.0

0.0

Week number

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COVID-19 vaccine surveillance report – week 13

Vaccination in immunosuppressed individuals Provisional vaccine uptake data in living and resident people identified as immunosuppressed in England to the end of week 12 can be found in Table 6. This shows that vaccine uptake in the 524,413 people identified as immunosuppressed was 95.7% for at least dose 1, 94.4% for at least 2 doses and 87.8% for at least 3 doses. Additional data on vaccine uptake in people with at least 3 doses by age in England can be found in the National flu and COVID-19 surveillance reports. Table 6. Vaccine uptake in people identified as immunosuppressed in England Immunosuppression

People in NIMs Cohort

Numbers vaccinated with at least 1 dose

Percentage vaccine uptake with at least 1 dose

Numbers vaccinated with at least 2 doses

England

524,413

501,669

95.7

495,028

Percentage Numbers Percentage vaccine vaccinated vaccine uptake with at with at least uptake with at least 2 doses 3 doses least 3 doses 94.4

460,472

Detailed information on the characterisation of the immunosuppressed group by NHS Digital is available online.

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87.8

COVID-19 vaccine surveillance report – week 13

Vaccination in pregnancy Vaccination of pregnant women alongside their peers is recommended in the UK and other countries as an important way to protect pregnant women and their unborn children against COVID-19 disease. Vaccination of pregnant women is strongly recommended by the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives. Increased severity of COVID-19 disease in pregnant and recently pregnant women has been reported after the first SARS-CoV-2 wave in England (22, 23) and in Scotland (24, 25). Pregnant women who develop severe disease have increased rates of admission to ICU, need for invasive ventilation and pre-term delivery. Data from the US Centers for Disease Control and Prevention (CDC) found that pregnant women were around 3 times more likely to be admitted to ICU and nearly 3 times more likely to require invasive ventilation compared to non-pregnant women with COVID-19 disease and 25% more likely to die (26). From 16 April 2021, the Joint Committee on Vaccination and Immunisation (JCVI) advised that pregnant women be offered COVID-19 vaccines at the same time as people of the same age or risk group (27). Therefore, any pregnant women not in a high-risk group would likely have received their first dose from mid-April 2021 as part of the general adult population programme in those aged under 50 years.

This was offered by decreasing age group (27). As part of the ongoing review of the programme, the JCVI met on 2 December 2021 and considered further data on severity of SARS-CoV-2 infection in pregnant women and their pregnancies together with data on vaccine safety; as a result pregnant women were added to the UK's priority COVID-19 vaccine list (28). Prior to 16 April 2021, COVID-19 vaccine was delivered to priority groups, based on clinical risk and risk of exposure, and delivered in order of priority. On 22 December 2020, JCVI advised that vaccine could be offered to pregnant and breast-feeding women who were in these risk categories The Pfizer vaccine was rolled out from early December 2020, AstraZeneca vaccine was used from 4 January 2021 and the Moderna vaccine became available from April 2021. From 17 April 2021 pregnant women have been offered the Pfizer-BioNTech or Moderna (mRNA) vaccines where available for their first dose (29). There is evidence of high levels of protection against SARS-CoV-2 infection in pregnant women after COVID-19 vaccination (30 to 32) and evidence that vaccination induces higher antibody levels than after disease (32). There is also evidence from a recent US study that 2-doses of mRNA COVID-19 vaccination during pregnancy might help prevent COVID-19 hospitalisations in young infants under 6 months of age (33).

Between February and September 2021, 0.4% of 1,714 pregnant women with COVID-19 symptoms who required hospital treatment in the UK had received 2 doses of COVID-19 vaccine and, of 235 pregnant women who were admitted to intensive care with COVID-19 disease in that period, none had received 2 doses of vaccine (35). Similar findings have been reported from Scotland (25, 35) with the most recent study reporting that 90.9% (748 out of 823; 95% CI 88.7−92.7) of SARS-CoV-2 associated with hospital admission, 98% (102 out of 104; 95% CI 92.5−99.7) of SARS-CoV-2 associated with 21

COVID-19 vaccine surveillance report – week 13

critical care admission and all baby deaths, occurred in pregnant women who were unvaccinated at the time of their COVID-19 diagnosis (24). The researchers also found high extended perinatal mortality rate for women who gave birth within 28 days of a COVID-19 diagnosis compared to rates across the pandemic period and in women vaccinated and going on to give birth within 28 days. COVID-19 vaccines used in the UK programme do not contain live SARS-CoV-2 virus and therefore cannot infect a pregnant woman or her unborn child with the virus. Whilst, as is commonly the case in trials of medicinal products, pregnant women were excluded from the original COVID-19 vaccine trials, there is accumulating experience and evidence of the safe and effective use of mRNA vaccines (such as the Pfizer-BioNTech or Moderna) in pregnant women. In Scotland COVID-19 vaccine had been administered to more than 28,000 pregnant women to the end of January 2021 (24) and over 6,000 women in Wales had received their first dose of vaccine before they gave birth (between 1 January 2021 and 31 January 2022) (36). In the USA more than 200,000 women have indicated they were pregnant at the time they received COVID19 vaccination to 14 March 2022 (37). No safety concerns relating to COVID-19 vaccination of pregnant women have been found in published studies to date (38 to 41).

The rate of vaccine side-effects appears to be similar in pregnant and non-pregnant populations (38). This report presents data on vaccine coverage and outcomes for women delivering up to the end of December 2021 and updates the early data on COVID-19 vaccination in pregnant women published in the COVID-19 vaccine surveillance report – weeks 47 of 2021, 4 of 2022 and 8 of 2022. Findings continue to be considered preliminary.

Vaccine coverage COVID-19 vaccine coverage in women before they give birth has increased as more women have become eligible for vaccination. In November 2021, 48.6% of women giving birth had received at least one dose of vaccine. This increased to 53.7% of women who gave birth in December 2021. Of women who gave birth in November 2021, 38.3% had received 2 doses of the vaccine increasing to 43.3% of women who gave birth in December 2021 (see Table 7). In the overall period between January and December 2021 a total of 528,362 women gave birth of whom 102,089 had received at least 1 dose of COVID-19 vaccine prior to delivery (68,952 of these women had received at least 2 doses and 4,456 women had received at least 3 doses). There were 11,492 women who had received their first dose prior to pregnancy and went on to conceive and deliver by December 2021. There were 14,895 women who were vaccinated in the first trimester, 37,916 in the second and 45,980 in the third trimester. In addition, 28,994 women were known to have received dose one before giving birth but without enough information to establish which trimester. Of these women, 21,801 were known to have received this dose in pregnancy, and 7,143 were around the start of pregnancy. 22

COVID-19 vaccine surveillance report – week 13

Of all vaccinated women giving birth, 64,109 had received one or more doses of only Pfizer vaccine; 3,857 one or more doses of only Moderna; 4,598 one or more doses of only AstraZeneca and the remaining 29,525 of vaccinated women received a mixture of doses: 19,267 received a combination of Pfizer and Moderna and 10,252 received AstraZeneca with Pfizer or Moderna.

23

COVID-19 vaccine surveillance report – week 13

Table 7. Overall vaccine coverage in women giving birth, by month of delivery1 Month

Women giving birth

One or more doses Two or more doses by time of delivery by time of delivery

Jan-21

41,949

18 (0.0%)

1 (0.0%)

41,773 (99.6%)

32,026 (76.7%)

Feb-21

40,093

82 (0.2%)

0 (0.0%)

39,878 (99.5%)

30,587 (76.7%)

Mar-21

44,589

294 (0.7%)

25 (0.1%)

44,174 (99.1%)

33,630 (76.1%)

Apr-21

42,864

492 (1.1%)

93 (0.2%)

42,217 (98.5%)

31,726 (75.1%)

May-21

44,172

1,252 (2.8%)

306 (0.7%)

42,752 (96.8%)

31,271 (73.1%)

Jun-21

43,815

4,354 (9.9%)

646 (1.5%)

39,321 (89.7%)

27,406 (69.7%)

Jul-21

47,444

7,700 (16.2%)

2,201 (4.6%)

39,561 (83.4%)

26,018 (65.8%)

Aug-21

46,202

10,482 (22.7%)

6,124 (13.3%)

35,536 (76.9%)

21,748 (61.2%)

Sep-21

46,723

15,101 (32.3%)

10,519 (22.5%)

31,441 (67.3%)

17,395 (55.3%)

Oct-21

46,212

19,209 (41.6%)

14,654 (31.7%)

26,808 (58.0%)

13,082 (48.8%)

Nov-21

42,768

20,793 (48.6%)

16,389 (38.3%)

21,811 (51.0%)

8,203 (37.6%)

Dec-21

41,531

22,312 (53.7%)

17,994 (43.3%)

19,029 (45.8%)

4,739 (24.9%)

1

Unvaccinated at Unvaccinated who went on to delivery receive dose(s) after pregnancy to 14 March 2022

1,972 women could not be matched with a NIMS record; their vaccine status is therefore unknown, they are excluded from these figures.

24

COVID-19 vaccine surveillance report – week 13

Table 8. Vaccine coverage by ethnicity, for women giving birth October to December 2021 (latest 3 months)2 Women giving birth One or more doses Two or more doses in October to by time of delivery by time of delivery December 2021

Unvaccinated at Unvaccinated who went on to delivery receive dose(s) after pregnancy to 14 March 2022

Asian

15,927

6,749 (42.4%)

4,983 (31.3%)

9,178 (57.6%)

4,227 (46.1%)

Black

6,042

1,504 (24.9%)

1,014 (16.8%)

4,538 (75.1%)

1,089 (24.0%)

Other

5,105

2,040 (40.0%)

1,658 (32.5%)

3,065 (60.0%)

990 (32.3%)

Mixed

3,111

1,197 (38.5%)

0,947 (30.4%)

1,914 (61.5%)

506 (26.4%)

White

93,595

48,075 (51.4%)

38,267 (40.9%)

45,520 (48.6%)

17,947 (39.4%)

Unknown

6,731

2,749 (40.8%)

2,168 (32.2%)

3,433 (51.0%)

1,265 (36.8%)

Table 9. Vaccine coverage by quintile of deprivation of the small area in which the woman lived, for women giving birth October to December 2021 (latest 3 months)3 Women giving birth in One or more doses October to December by time of delivery 2021

Two or more Unvaccinated at doses by time delivery of delivery

Unvaccinated who went on to receive dose(s) after pregnancy to 14 March 2022

1 - most deprived

31,180

10,208 (32.7%)

6,844 (21.9%)

20,972 (67.3%)

5,962 (28.4%)

2

28,348

11,916 (42.0%)

9,009 (31.8%)

16,432 (58.0%)

5,869 (35.7%)

3

25,051

12,759 (50.9%)

10,205 (40.7%)

12,292 (49.1%)

5,116 (41.6%)

4

23,415

13,424 (57.3%)

11,015 (47.0%)

9,991 (42.7%)

4,848 (48.5%)

5 - least deprived

21,143

13,675 (64.7%)

11,721 (55.4%)

7,468 (35.3%)

4,070 (54.5%)

Unknown

1,374

332 (24.2%)

243 (17.7%)

493 (35.9%)

159 (32.3%)

2 549 women could not be matched with a NIMS record; their vaccine status is therefore unknown, they are excluded from these figures.

3 549 women could not be matched with a NIMS record; their vaccine status is therefore unknown, they are excluded from these figures.

25

COVID-19 vaccine surveillance report – week 13

Table 10. Vaccine coverage by age of mother, for women giving birth October to December 2021 (latest 3 months)4 Age

Women giving One or more doses Two or more doses by birth in October by time of delivery time of delivery to December 2021

Unvaccinated at delivery

Unvaccinated who went on to receive dose(s) after pregnancy to 14 March 2022

Under 20

2,689

499 (18.6%)

255 (9.5%)

2,190 (81.4%)

421 (19.2%)

20 to 24

14,963

4,127 (27.6%)

2,477 (16.6%)

10,836 (72.4%)

3,024 (27.9%)

25 to 29

33,616

12,846 (38.2%)

9,102 (27.1%)

20,770 (61.8%)

7,977 (38.4%)

30 to 34

45,803

24,815 (54.2%)

20,210 (44.1%)

20,988 (45.8%)

9,249 (44.1%)

35 to 39

26,372

16,100 (61.0%)

13,697 (51.9%)

10,272 (39.0%)

4,376 (42.6%)

40 and above

6,507

3,927 (60.4%)

3,296 (50.7%)

2,580 (39.6%)

0,977 (37.9%)

4 549 women could not be matched with a NIMS record; their vaccine status is therefore unknown, they are excluded from these figures.

26

COVID-19 vaccine surveillance report – week 13

In the most recent 3-month period, there were 130,511 women whose vaccination record was linked and who gave birth, of whom 62,314 (47.7%) were vaccinated. These women accounted for 61.0% of all vaccinated women giving birth since January. There were differences in vaccine coverage by both ethnicity (Table 8) and by quintile of deprivation (Table 9). Overall, 38.5% of women who were unvaccinated when they gave birth in the most recent 3-month period (October-December 2021) went on to be vaccinated post-partum. This included 24.0% of Black women and 46.1% of Asian women, lower than the proportions of unvaccinated women of these ethnicities who were immunised post-partum between September and November 2021 (33.0% and 54.5% respectively). Whilst increases in coverage were observed in all groups, women of black ethnicity (in whom one dose coverage increased from 20.5% to 24.9%) and women living in the most deprived areas in England (in whom one dose coverage increased from 25.5% to 32.7%) continue to be least likely to have been vaccinated with one or 2 doses of COVID-19 vaccine before they gave birth. Coverage increased as levels of deprivation decreased (Table 9).

Vaccine coverage increased with increasing age group to those aged 35 to 39 years in whom uptake was 61.0% for one dose and 51.9% for 2 doses (Table 10), with similar coverage in women who were aged 40 years or over when they gave birth.

Methods Data on COVID-19 vaccination status together with details of each vaccine administered are recorded in a central data set called the National Immunisation Management Service (NIMS) 5. In addition, NHS Digital manages the Hospital Episode Statistics (HES) data sets, containing information about hospital activity in England. Records of women giving birth (‘delivery records’) in the months since 1 January 2021 were identified in HES. De-duplication of delivery records resulted in a data set of women who had given birth with 1 record per woman, identified by her NHS Number, and the latest ‘delivery episode’ associated with her. An ‘earliest’ and ‘latest’ likely pregnancy start date were assigned to each woman’s record, using the known delivery date and further information from her record, where available: 1. Where a valid gestational age was recorded (GESTAT_1 between 24 and 42), the woman’s earliest pregnancy start date was calculated by taking the number of weeks away from the delivery date, and then calculating an additional earlier week, to account for GESTAT_1 recording completed weeks of pregnancy. In a similar way, latest pregnancy start date was calculated by taking the number of weeks of GESTAT_1 away from the delivery date. 2.

Where no valid GESTAT_1 was available, the first 12 diagnoses codes were examined to identify any with a code suggesting delivery at term (O60.2). In this case the gestational age at delivery was assumed to be between 37 and 42 completed weeks of pregnancy, and a similar method was used to establish earliest and latest pregnancy start dates. 5 NIMS Data controllers are NHSEI and NHSD. The NIMS IT software is commissioned by NHSEI via South

Central West CSU and is provided by the System C and Graphnet Care Alliance.

27

COVID-19 vaccine surveillance report – week 13

3. Where no valid GESTAT_1 was available and there were no codes suggesting term delivery, the first 12 diagnoses codes were examined to identify any suggesting preterm delivery (O60.1 or O60.3). In this case the gestational age at delivery was assumed to be between 24 and 36 completed weeks of pregnancy, and these values were used to establish earliest and latest pregnancy start dates. 4. In the absence of any additional information in the woman’s record (or in conflicting cases where diagnoses codes suggesting both term and pre-term delivery appeared in the same record), the gestational age at delivery was assumed to be between 24 and 42 completed weeks of pregnancy, and these values were used to establish earliest and latest pregnancy start dates. Earliest and latest dates for the start of each trimester were established in a similar way, using the windows of trimester 1: day 0 to day 97 (where day 0 is the earliest or latest pregnancy start date, as established using the method above), trimester 2: day 98 to day 195 and trimester 3: day 196 to delivery. Each woman’s delivery record was linked to her record(s) in the NIMS using the NHS Number, establishing her vaccine status as either having had one or more doses before delivery (including any prior to becoming pregnant) or not having had any doses of the vaccine prior to delivery, using the NIMS vaccine records.

For each vaccine dose (this analysis considered doses one to 4) the woman was known to have received, the following information was ascertained: Dose administered prepregnancy

Dose administered before the earliest pregnancy start date

Dose administered in pregnancy

Dose administered after the latest pregnancy start date and before the delivery date

Dose administered postpregnancy

Dose administered on or after the delivery date based on NIMS records extracted on 14 March 2022

Dose in pregnancy: unknown

Dose administered around the start or pregnancy: after the earliest pregnancy start date and before the latest pregnancy start date

Unvaccinated

No vaccine records exist for the woman, based on NHS number

And the following information about trimester. Dose administered pre-pregnancy

Dose administered before the earliest pregnancy start date

Dose administered in trimester 1

Dose administered after the latest pregnancy start date and before the earliest pregnancy start date +97 days

Dose administered in trimester 2

Dose administered after the latest pregnancy start date +98 days and before the earliest pregnancy start date +195 days 28

COVID-19 vaccine surveillance report – week 13

Dose administered in trimester 3

Dose administered after the latest pregnancy start date + 196 days and before the delivery date

Dose administered post-pregnancy

Dose administered on or after the delivery date based on NIMS records extracted on 14 March 2022

Dose in trimester unknown

Dose administered in the ‘gap’ between trimesters, because of inaccuracy in establishing pregnancy start date

Unvaccinated

No vaccine records exist for the woman, based on NHS number

The ethnicity, residence and age information used to generate Tables 8 to 10 was taken from the NIMS record. The analysis within this section was carried out on 14 March 2022. The latest HES data available were for December 2021, and all HES data since April 2021 is considered provisional.

Pregnancy outcomes The following figures present rates of women in England who: 1. Gave birth to one or more live-born babies at term without low birthweight; that is, they experienced none of the following adverse outcomes considered (outcomes 2 to 4), according to their delivery record. 2. Gave birth to a stillborn baby (based on recorded diagnoses). 3. Gave birth to a baby with low birthweight (less than 2,500g) or a very low birthweight (less than 1,500g). The babies with a very low birthweight are therefore a subset of the low birthweight babies. 4. Gave birth prematurely (less than 37 weeks gestation), very prematurely (less than 32 weeks gestation) and extremely prematurely (less than 28 weeks gestation). The very premature and extremely premature are therefore a subset of women who gave birth prematurely. These analyses assess whether rates were different in women giving birth between January and December 2021, who received one or more COVID-19 vaccination doses during their pregnancy compared with those who did not (either because they were unvaccinated or had only received vaccine doses prior to pregnancy). The analyses do not take other factors that might affect these outcomes into account, such as age (except for outcome 1 above) and whether the woman was categorised as clinically at risk.

However, women who gave birth on or after 17 April 2021 without the reported complications (outcome 1 above), were also reviewed with vaccinations given from 16 April onwards. This is a more homogenous group of pregnant women who were eligible for vaccination based solely on age and not because they were considered at high risk of exposure or severe disease. Therefore, data are also presented for women giving birth between 17 April and 31 December 2021 for comparison. 29

COVID-19 vaccine surveillance report – week 13

Figure 4. Women giving birth January to December 2021 to live-born babies at term without low birthweight

Figure 5. Women giving birth January to December 2021 to live-born babies at term without low birthweight, by age

30

COVID-19 vaccine surveillance report – week 13

Figure 6. Women giving birth April to December 2021 to live-born babies at term without low birthweight

Figure 7. Women giving birth April to December 2021 to live-born babies at term without low birthweight, by age

31

COVID-19 vaccine surveillance report – week 13

Figure 8. Stillbirths experienced by women giving birth January to December 2021

Figure 9. Low birthweight babies to women giving birth January to December 2021

32

COVID-19 vaccine surveillance report – week 13

Figure 10. Women giving birth prematurely January to December 2021

The proportion of women giving birth between January and December 2021 to live-born babies at term without low birthweight (that is, with no specified adverse outcomes) having received one or more doses in pregnancy (91.8% 95%CI 91.7 to 92.0) is similar to the proportion in women who did not receive any doses in pregnancy (91.5% 95%CI 91.5 to 91.6) (Figure 4). These positive outcomes were similar across all age groups in vaccinated and unvaccinated women (Figure 5). For the more recent period (women vaccinated from 16 April and delivering from 17 April 2021), when all pregnant women were routinely offered vaccination on the basis of age, women who had received at least one dose of COVID-19 vaccine during their pregnancy were more likely to give birth without any of the reported adverse outcomes than women who had not been vaccinated in pregnancy (92.8% 95%CI 92.6 to 93.0 compared with 91.5% 95%CI 91.4 to 91.6) (Figure 6). This difference was more apparent in those aged 30 years and older (Figure 7). The stillbirth rate for women who gave birth having received one or more doses in pregnancy (3.78 per 1,000, 95%CI 3.41 to 4.19) was similar to the rate for those who had not received any doses in pregnancy (3.90 per 1,000, 95%CI 3.72 to 4.09) giving birth between January and December 2021 (Figure 8).

In the same period, the proportion of women who had received one or more doses in pregnancy giving birth to babies with low birthweight (5.12%, 95%CI 4.98 to 5.26) was lower than those who had not received any doses in pregnancy (5.37%, 95%CI 5.31 to to 5.44) (Figure 6). There was no statistically significant difference between the 0.83% (95%CI 0.78 to 0.89) of women who had received one or more doses in pregnancy and 0.77% (95%CI 0.75 to 0.80) of those who had not, who gave birth to a very low birthweight baby (Figure 9). 33

COVID-19 vaccine surveillance report – week 13

The proportion of women who received one or more doses in pregnancy having premature births was 5.88% (95%CI 5.74 to 6.04), compared with 5.90% (95%CI 5.83 to 5.97) in those who had not (Figure 10). The proportion of women with very premature births was 1.46% (95%CI 1.39 to 1.54) in those who received one or more dose in pregnancy, lower than the 1.77% (95%CI 1.73 to 1.81) with a very premature birth who had not been vaccinated during pregnancy. The proportion of women with extremely premature births was 0.90% (95%CI 0.85 to 0.97) in those who received one or more dose in pregnancy: lower than the 1.26% (95%CI 1.22 to 1.29) in those who had not.

Interpretation and limitations The first women to be offered COVID-19 vaccine were those who were categorised as at risk of severe disease and women of older age who are at increased risk of the 3 adverse outcomes presented here (given the medical conditions that placed them in this category), together with healthcare professionals at higher risk of COVID-19 exposure. Women with underlying conditions that put them at very high risk of serious complications of COVID-19 will thus account for a relatively high proportion of early deliveries in women who had received one or more doses of the vaccine before 16 April 2021. It is therefore very reassuring that women who had received at least one dose of the vaccine in pregnancy were more likely to deliver live born babies at term without low birthweight and had no overall increased risk of any adverse outcome through January to December. These findings support the conclusions on vaccine safety from COVID-19 vaccine surveillance report – week 47 (COVID-19 vaccine weekly surveillance reports (week 39 2021 to week 3 2022). More detailed statistical analyses are planned (see COVID-19 vaccination in pregnancy surveillance protocol. The adverse pregnancy outcomes considered are routinely reported as official statistics annually by ONS, however HES data was used to monitor outcomes more quickly than ONS data allows.

There are recognised limitations of the data sets including the level of completeness of the relevant fields.

Methods The same methods as used to establish coverage figures were used to group records of deliveries into those who had received at least one dose of the vaccine during their pregnancy and those who had not. The definition of this second group includes any women who received dose(s) only prior to pregnancy and those who received their first dose after delivery, as well as those unvaccinated as of 14 March 2022. Outcomes are also presented by age at delivery, using the woman’s date of birth as recorded in NIMS. To identify deliveries where adverse outcomes were experienced; the following criteria were applied. The outcomes are related: for example, babies born prematurely are more likely to be born with low birthweight, and therefore a delivery may have more than one adverse outcome. 34

COVID-19 vaccine surveillance report – week 13

Stillbirths were identified as records where any one or more of the first 12 diagnoses was the following: Z37.1: Single stillbirth; Z37.3 Twins, one liveborn and one stillborn; Z37.4 Twins, both stillborn; Z37.6: Other multiple births, some liveborn; Z37.7: Other multiple births, all stillborn. Low birthweight and very low birthweight deliveries were identified as records where any of the first 4 babies born had a known birthweight between 500g and 2499g (1499g or lower for very low birthweight). Premature deliveries were identified as records where the gestational length was less than 37 weeks (less than 32 weeks for very premature, and less than 28 weeks for extremely premature). Low birthweight is by convention presented as a percentage of all deliveries with known birthweights, and prematurity usually presented as a percentage of all deliveries with known gestational length. However here they are presented as percentages of all deliveries, to reduce the chance of significant findings arising from a change in the overall success of recording these fields during the pandemic. Figures will therefore differ from official statistics and should be considered for surveillance purposes only. Confidence intervals were calculated using the Wilson Score method (42).

A confidence interval is a range of values that is used to quantify the imprecision in the estimate of a particular indicator. Specifically, it quantifies the imprecision that results from random variation in the measurement of the indicator. A wider confidence interval shows that the indicator value presented is likely to be a less precise estimate of the true underlying value.

Main findings COVID-19 vaccination is the safest and most effective way for women to protect themselves and their babies against severe COVID-19 disease. COVID-19 vaccine coverage in pregnant women at delivery has increased as more women have become eligible for vaccination reaching 53.7% for women who gave birth in December 2021 having had one or more dose before their baby was born. This is in line with coverage reported across the UK with 56% of women in Scotland (24) and 57.7% in Wales (36) delivering in December 2021 who had received any dose and their first dose of COVID-19 vaccine respectively prior to delivery. As in the previous report, however, coverage increased with decreasing levels of deprivation and women of black ethnicity had the lowest vaccine coverage. Coverage increased with increasing age group to 35 to 39 years. Whilst coverage has improved since the November coverage presented in the week 8 report, across all groups it continues to highlight inequalities consistent with those seen across the entire COVID-19 vaccination programme. Coverage of at least one dose increased from 5.5% in 35