A diphtheria-tetanus-acellular pertussis-inactivated polio combination vaccine (dTaP-IPV) was offered as part of the UK antenatal vaccination programme from 2012 to July 2024. Prior research established that infants of mothers who received a dTaP-IPV vaccine in pregnancy have significantly reduced poliovirus-specific neutralising antibodies after their primary immunisation series compared with infants of non-dTaP-IPV vaccinated mothers. We investigated whether sufficient poliovirus-specific neutralising antibody titres are achieved in these children following the pre-school dTaP-IPV booster vaccine. Poliovirus-specific neutralising antibody titres were measured, via a microneutralisation assay, prior to and following receipt of the pre-school booster vaccine in blood samples taken during an observational, cohort, multi-centre, open label phase IV extension study. Prior to the pre-school boost, children of mothers who received dTaP-IPV vaccines in pregnancy had lower geometric mean titres (GMT) of antibodies than children of unvaccinated mothers (4.3 vs 54.7, p = 0.0001). However, following administration of the pre-school booster all children, regardless of maternal vaccination status achieved protective antibody titres (≥ 8), although children of vaccinated mothers still had lower GMTs (988 vs 2964, p = 0.009). Administration of the preschool booster overcomes the polio virus immunity gap that develops following the primary vaccination series in children whose mothers received an antenatal dTaP-IPV vaccine versus unvaccinated mothers. Residual differences in post-booster titres warrant continued surveillance to assess their clinical relevance. Clinical trials registry:NCT03578120.
BACKGROUND:Throughout the SARS-CoV-2 pandemic, several vaccines have been rolled out and distinct variants with different severity and immune profiles emerged in England. Using data from enhanced surveillance of COVID-19 in vaccine eligible individuals we investigated the antibody response following SARS-CoV-2 infection according to vaccination status and variant. METHODS:SARS-CoV-2 PCR-positive eligible individuals were identified from community PCR testing data in England between February 2021 and April 2022 and contacted by nurses to complete questionnaires at recruitment and 21 days post recruitment. Individuals were sent self-sampling kits and self-sampled nasal/oropharyngeal swabs were taken day 1, day 3 and day 7 post-recruitment as well as acute (day 1), convalescent (follow-up) serum and oral fluid samples. Regression analyses were used to investigate how N antibody seroconversion differs by vaccine status, and to investigate how N and S antibody levels differ by vaccine status overall and stratified by variants. Interval-censored analyses and regression analyses were used to investigate the effect of acute S antibody levels on the duration of positivity, the cycle threshold values, the self-reported symptom severity and the number of symptoms reported. RESULTS:A total of 1497 PCR positive individuals were included. A total of 369 (24.7%) individuals were unvaccinated, 359 (24.0%) participants were infected with Alpha, 762 (50.9%) with Delta and 376 (25.2%) with Omicron. The median age of participants was 49 years old (IQR 39-57). Convalescent anti-N antibody levels were lower in vaccinated individuals and convalescent anti-S antibody levels were higher in vaccinated individuals and increased with the number of doses received. Acute anti-S antibody level increased with the number of doses received. Higher acute anti-S antibody levels were associated with a shorter duration of positivity (overall and for the Delta variant). Higher acute anti-S antibody levels were also associated with higher Ct values (overall and for the Alpha and Delta variants). There was no association between the acute anti-S antibody level and self-reported symptom severity. Individuals with higher acute anti-S antibody level were less likely to report six or more symptoms (overall and for Delta variant). CONCLUSION:Understanding the characteristics of the antibody response, its dynamics over time and the immunity it confers is important to inform future vaccination strategies and policies. Our findings suggest that vaccination is associated with high acute anti-S antibody level but reduced convalescent anti-N antibody level. High anti-S antibody level is associated with reduced duration of infection, reduced infectiousness and may also be associated with reduced symptoms severity and number of symptoms.
BACKGROUND:Asplenia and splenic dysfunction is associated with an increased risk of severe and fatal infections, especially due to encapsulated bacteria including Streptococcus pneumoniae, Haemophilus influenzae serotype b (Hib) and Neisseria meningitidis. People with sickle cell disease (SCD) develop recurrent splenic infarcts rendering them functionally asplenic. Consequently, additional vaccination against these three pathogens is recommended. There is robust evidence of an increased risk for invasive pneumococcal (IPD) and Hib disease, in people with SCD, but for not invasive meningococcal disease (IMD). METHODS:We conducted a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) recommendations. Studies published in any language before June 2024 and including people with SCD of all ages and from all geographical locations were included. Studies were included if they documented bacterial culture and/or PCR in patients with SCD with suspected infection. The primary outcome was to estimate IMD risk in people with SCD. Secondary outcomes included estimating the risk of IMD and Hib disease in people with SCD. FINDINGS:We identified 3804 publications and included 86 in the final analyses. Among 74 cohort studies published during 1971-2023, there were three IMD cases among 26,404 persons with SCD compared with 570 IPD and 113 Hib cases. Eight case-control studies published during 1983-2022 reported one IMD case among 932 people with SCD (0.1%) compared to 118 IMD cases among 7143 people without SCD (1.65%). In contrast, there were 126 IPD cases (126/932, 13.5%) in people with SCD compared to 588 (588/7143, 8.2%) in those without SCD. For Hib, the rates were 32/932 (3.4%) and 316/7143 (4.4%), respectively. After including all published studies, we identified five IMD cases in people with SCD across studies published worldwide during 1965-1995 and all five survived their infection. INTERPRETATION:We found no evidence of any increased risk of IMD in people with SCD. This has important implications for policymakers in countries and organisations that currently recommend meningococcal vaccination for people with SCD.
BACKGROUND:Heterologous schedules of booster vaccines for COVID-19 following initial doses of mRNA or adenoviral vector vaccines have been shown to be safe and immunogenic. There are few data on booster doses following initial doses of protein nanoparticle vaccines. METHODS:Participants of the phase 3 clinical trial of the COVID-19 vaccine NVX-CoV2373 (EudraCT 2020-004123-16) enroled between September 28 and November 28, 2020, who received 2 doses of NVX-CoV2373 administered 21 days apart were invited to receive a third dose booster vaccine of BNT162b2 (wild type mRNA vaccine) as a sub-study of the COV-BOOST clinical trial, and were followed up for assessment of safety, reactogenicity and immunogenicity to day 242 post-booster. RESULTS:The BNT162b2 booster following two doses of NVX-COV2373 was well-tolerated. Most adverse events were mild to moderate, with no serious vaccine-related adverse events reported. Immunogenicity analysis showed a significant increase in spike IgG titres and T-cell responses post-third dose booster. Specifically, IgG levels peaked at day 14 with a geometric mean concentration (GMC) of 216,255 ELISA laboratory units (ELU)/mL (95% CI 191,083-244,743). The geometric mean fold increase from baseline to day 28 post-boost was 168.6 (95% CI 117.5-241.8). Spike IgG titres were sustained above baseline levels at day 242 with a GMC of 58,686 ELU/mL (95% CI 48,954-74,652), with significant decay between days 28 and 84 (geometric mean ratio 0.58, 95% CI 0.53-0.63). T-cell responses also demonstrated enhancement post-booster, with a geometric mean fold increase of 5.1 (95% CI 2.9-9.0) at day 14 in fresh samples and 3.0 (95% CI 1.8-4.9) in frozen samples as measured by ELISpot. In an exploratory analysis, participants who received BNT162b2 after two doses of NVX-COV2373 exhibited higher anti-spike IgG at Day 28 than those who received homologous three doses of BNT162b2, with a GMR of 5.02 (95% CI: 3.17-7.94). This trend remained consistent across all time points, indicating a similar decay rate between the two schedules. CONCLUSIONS:A BNT162b2 third dose booster dose in individuals primed with two doses of NVX-COV2373 is safe and induces strong and durable immunogenic responses, higher than seen in other comparable studies. These findings support the use and investigation of heterologous booster strategies and early investigation of heterologous vaccine technology schedules should be a priority in the development of vaccines against new pathogens.
BACKGROUND:The incidence of invasive pneumococcal disease (IPD) increases rapidly with age. In the UK, adults aged 65 years are eligible for the 23-valent pneumococcal polysaccharide vaccine (PPV23) as part of the national immunisation programme, and a 20-valent pneumococcal conjugate vaccine (PCV20) was recently licensed for adults. Residents of care homes for older adults have a higher risk of IPD and death than the general population. We estimated the potential effect of an additional dose of PPV23 or PCV20 for new residents entering older adult care homes. METHODS:In this observational surveillance study, we used national IPD surveillance and care home resident data from England. Care homes for older adults were defined as residential care and nursing homes registered with the Care Quality Commission for adults aged 65 years and older. IPD in adults aged 65 years and older in England was assessed in the 2022-23 epidemiological year (July 1, 2022, to June 30, 2023) by sex and 5-year age bands using data obtained from UK Health Security Agency national IPD surveillance. We calculated the number needed to vaccinate (NNV) with PPV23 or PCV20 in the population of new care home residents to prevent one vaccine-type IPD case and one death compared with adults aged 65 years who were vaccinated as part of the national immunisation programme in England. FINDINGS:In 2022-23, there were 2574 IPD cases among 10 629 867 people aged 65 years and older in England. Of these, 603 109 were aged 65 years. Of the 2574 cases, 69·4% (1787 of 2574) were due to PPV23 serotypes and 60·8% (1566 of 2574) were due to PCV20 serotypes. Under the assumption of 36% vaccine effectiveness against PPV23-type IPD and 18% vaccine effectiveness against death, PPV23, when offered to all 603 109 adults aged 65 years in the general population, could prevent 163 (36%) of 452 cases (NNV 3700) and 31 (47%) of 66 PPV23-type IPD associated deaths over 5 years (NNV 19 455). However, vaccinating 121 587 new care home residents with PPV23 could prevent 177 (36%) of 492 lifetime cases (NNV 687) and 111 (48%) of 233 deaths (NNV 1095). In all adults aged 65 years in the general population, PCV20 could prevent 303 (75%) of 404 cases (NNV 1990) and 43 (80%) of 54 PCV20-type IPD deaths (NNV 14 026), assuming 75% vaccine effectiveness against PCV20-type IPD and 18% against death. However, vaccinating 121 587 new care home residents with PCV20 could prevent 317 (75%) of 422 cases (NNV 384) and 157 (80%) of 197 deaths (NNV 774). INTERPRETATION:Pneumococcal vaccination for new care home residents could prevent substantially more cases and deaths per dose and would require only 20% more doses than the current national PPV23 programme for adults aged 65 years. PCV20 is likely to have a greater impact against IPD and death than PPV23. FUNDING:None.
Influenza A(H3N2) subclade K (J.2.4.1) has dominated the 2025/26 season start in England. Post-infection ferret antisera raised against northern hemisphere 2025/26 vaccine strains showed reduced reactivity to subclade K viruses in England, aligning with World Health Organization reports. Nevertheless, early post-vaccination, vaccine effectiveness against influenza-related emergency department attendances and hospital admissions remained within typical ranges, at 72–75% in children and adolescents (< 18 years) and 32–39% in adults. Hence, vaccination remains effective against clinical disease caused by influenza A(H3N2) viruses.
Introduction COVID-19 disease has been associated with severe illness, hospitalisation and death, however, widespread vaccination coverage in England has resulted in reduced disease severity. From 2022, the national vaccination programme has been run twice per year, prioritising older age groups or those classified as clinically vulnerable. Here we assess the trends in COVID-19 outcomes between September 2023 and April 2024, using national-level data held by the UK Health Security Agency (UKHSA). Methods Data linkage of national-level COVID-19 episode data, NHS emergency and hospital attendance data, and death registrations were used to analyse COVID-19 outcomes. Outcomes were defined as COVID-19 associated A&E attendances, hospital admissions, severe hospitalisations, and deaths The number and rate of each COVID-19 outcome category between September 2023 and April 2024 was calculated, stratified by clinical risk status and age and sex. Results The most common COVID-19 outcomes during this time-period were A&E attendance and hospital admission, with the rates highest among those aged 75 and over. Among this age group, all outcomes disproportionately affect those who have been identified as at clinical risk and those who were immunosuppressed. High rates of A&E attendance and hospital admission were also observed among infants (under 6 months old) but were lower for more severe outcomes. Discussion Groups that were most affected by COVID-19 outcomes were currently prioritised for COVID-19 vaccination in England, which will help protect against more severe outcomes including admission to intensive care and death. Routine national levels surveillance of COVID-19 outcomes is essential to monitor populations most of severe disease and informing vaccination policy. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was performed as part of UKHSA routine work to monitor COVID-19. No external funding received. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: UKHSA has legal permission, provided by Regulation 3 of The Health Service (Control of Patient Information) Regulations 2002 to process confidential patient information under Section 3(i) (a)–(c), 3(i)(d) (i) and (ii) and 3(iii) as part of its outbreak response activities. This study falls within the research activities approved by the UKHSA Research Ethics and Governance Group. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data produced in the present study are available through formal collaboration with UKHSA. Proposals for collaboration will be considered by the UKHSA Immunisation and Vaccine Preventable Diseases team to evaluate the scientific quality and feasibility of the proposal.
ObjectiveTo estimate real world vaccine effectiveness against symptomatic disease and hospital admission with the delta and omicron variants of the SARS-CoV-2 virus in pregnant individuals, and to estimate the protection conferred by previous infection and maternal vaccination in their infants.DesignTest negative case-control study.SettingCommunity and hospital testing for covid-19, in England, 26 April 2021 to 9 January 2022 (delta variant period) and 29 November 2021 to 31 March 2022 (omicron variant period). Testing data were linked to Hospital Episode Statistics and Maternal Services Data Set (for data on pregnant individuals and infants), National Immunisation Management System (for covid-19 vaccinations), and Secondary Uses Service (for hospital admissions).Participants35 206 negative and 16 693 positive eligible test results in the delta variant period from pregnant individuals with symptoms of infection, aged 16-55 years, whose pregnancy ended in 2021, and 5974 negative and 4715 positive eligible test results in the omicron variant period. For infants born in 2021, 23 053 negative and 2924 positive eligible test results in the delta variant period and 13 908 negative and 5669 positive test results from infants in the omicron period.Main outcome measuresVaccine effectiveness against symptomatic disease and hospital admission with the delta and omicron variants of the SARS-CoV-2 virus in pregnant women. Also, effectiveness of maternal vaccination and the protection conferred by previous infection in mothers in preventing symptomatic disease and hospital admission in their infants in the first six months of life. Symptomatic SARS-CoV-2 infection was confirmed by a positive polymerase chain reaction test result.ResultsVaccine effectiveness against symptomatic disease (delta and omicron infection) and against hospital admission (delta infection only) in pregnant individuals was high, as seen in the general population. A booster dose of vaccine gave sustained protection, with no evidence of waning up to 15 weeks after vaccination. Vaccine effectiveness against symptomatic disease peaked at 98.4% (95% confidence interval (CI) 88.4% to 99.8%) and 80.1% (73.8% to 84.9%) against the delta and omicron variants, respectively, after the booster dose of vaccine. Vaccine effectiveness after a two dose primary schedule against hospital admission with delta infection peaked at 92.7% (95% CI 79.9% to 97.4%) in pregnant individuals. Maternal vaccination during and after pregnancy also provided sustained protection from symptomatic disease and hospital admission after delta and omicron infection in infants aged up to six months, with the highest protection seen when maternal vaccination occurred during later pregnancy. The effectiveness of two maternal doses when the last dose was given in the third trimester was 86.5% (95% CI 81.9% to 90.0%) and 56.6% (46.7% to 64.6%) against symptomatic disease with delta and omicron infection, respectively, in infants, and effectiveness against hospital admission was 94.7% (78.2% to 98.7%) and 78.7% (58.2% to 89.1%), respectively. Previous infection with wild-type, alpha, and delta variants of the SARS-CoV-2 virus in pregnant individuals was more protective against mild and severe delta infection than omicron infection in their infants.ConclusionsThe results of this study indicated that maternal vaccination prevented mild and severe disease in pregnant individuals and their infants for up to six months after birth. The findings support the promotion of both primary and booster vaccination for pregnant individuals to protect themselves and their infants.
We estimated the risk of death from coronavirus disease 2019 in vaccinated compared with unvaccinated patients. The risk of death was reduced 44% after 1 dose of the Pfizer-BioNTech BNT162b2 vaccine, 55% after 1 dose of the Oxford-Astrazeneca ChAdOx1 vaccine, and 69% after 2 doses of the BNT162b2 vaccine. This is above the protection provided against infection.
Estimates of chronic hepatitis B virus (HBV) prevalence and critically the amount of infection that is undiagnosed or unlinked to care are uncertain-even in countries like UK where vertical transmission and overall prevalence are very low. In the absence of country of birth data, we aim to estimate HBV prevalence through combining public health surveillance data on antenatally screened women by ethnic group and multipliers generated from non-antenatally screened populations by ethnic group with English population denominators. Of 714,287 women aged 16-49 years with ethnic group data tested as part of antenatal care between 2015 and 2021, 4174 (0.6%) were HBsAg-positive; 94% in people of ethnic groups other than White British. Of 1,447,467 people tested for HBsAg with ethnic group data from other testing sources (primary and secondary care excluding occupational health and renal services), 27,628 (1.9%) were HBsAg-positive; 87% in people of ethnic groups other than White British. We estimate that the overall number and prevalence of people with chronic hepatitis B in England is 268,767 (95% CI: 227,896-314,044) and 0.58% (95% CI: 0.50-0.68). Approximately two-thirds were male, one-third female, and 68% were aged under 50. We estimate that over 83% of HBV infections are in people of ethnic groups other than White British, with 23% in people from Black ethnic groups, 21% from other White ethnic groups and 19% in Asian ethnic groups. These estimates are the first step towards establishing whether England can meet World Health Organisation targets to eliminate HBV as a public health problem-using methods that can also be used by other countries.
The meningococcal group B vaccine, 4CMenB, is a broad-spectrum, recombinant protein vaccine that is licensed for protection against meningococcal group B disease in children and adults. Over the past decade, several observational studies supported by laboratory studies have reported protection by 4CMenB against gonorrhoea, a sexually transmitted infection caused by Neisseria gonorrhoeae. Gonorrhoea is a major global public health problem, with rising numbers of diagnoses and increasing resistance to multiple antibiotics. In England, more than 82 000 cases of gonorrhoea were diagnosed in 2022, with nearly half of the cases diagnosed among gay, bisexual, and other men who have sex with men. There are currently no licensed vaccines against gonorrhoea but 4CMenB is estimated to provide 33-47% protection against gonorrhoea. On Nov 10, 2023, the UK Joint Scientific Committee on Vaccination and Immunisation agreed that a targeted programme should be initiated using 4CMenB to prevent gonorrhoea among individuals at higher risk of infection attending sexual health services in the UK. This decision was made after reviewing evidence from retrospective and prospective observational studies, laboratory and clinical data, national surveillance reports, and health economic analyses. In this Review, we summarise the epidemiology of invasive meningococcal disease and gonorrhoea in England, the evidence supporting the use of 4CMenB for protection against gonorrhoea, and the data needed to inform long-term programme planning and extension to the wider population.
England, like other countries that experienced a large outbreak of emergent mpox in 2022, continued to record cases during 2023 at a low but steady frequency. Comprehensive national surveillance shows that cases continue to occur primarily among gay, bisexual and other men who have sex with men mostly in London. Of 137 cases in 2023, around half were acquired overseas, half were vaccinated, and one case of reinfection was reported. Eleven people required hospital care. High vaccination uptake, during 2022, has provided good coverage of those at higher risk of mpox. Using the screening method, vaccine effectiveness of one dose was estimated at 84%. None of the vaccinated cases in 2023 were hospitalised.### Competing Interest StatementThe authors have declared no competing interest.### Funding StatementThis study did not receive any funding### Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesI confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.YesAll data produced in the present work are contained in the manuscript
Background The Sanofi/GSK AS03-adjuvanted (VidPrevtyn Beta) vaccine and the Pfizer-BioNTech mRNA (Comirnaty Original/Omicron BA.4-5) bivalent vaccine were offered to adults aged 75 years and over in England from 3rd April 2023. This is the first time an adjuvanted COVID-19 vaccine has been administered as part of a UK COVID-19 vaccination programme. In clinical trials, antibody levels generated were comparable with mRNA vaccines but there are no real-world data on the effectiveness or duration of protection. Methods We used a test-negative case–control study design to estimate the incremental vaccine effectiveness of the Sanofi/GSK and Pfizer bivalent BA.4-5 boosters against hospitalisation amongst those aged 75 years and older in England. Cases (those testing positive) and controls (those testing negative) were identified from the national COVID-19 PCR testing data undertaken in hospital settings. The study period included tests from 3rd April 2023 to 27th August 2023. Tests were linked to the COVID-19 vaccination register and to the national hospital admission database, restricting to those with an acute respiratory infection coded in the primary diagnosis field. Vaccine effectiveness was estimated using multivariable logistic regression amongst those who had last received an autumn 2022 booster given at least 3 months prior. The test result was the outcome and vaccination status the exposure. Analyses were adjusted for week of test, gender, age, clinical risk group status, care home resident status, region, index of multiple deprivation, ethnicity, influenza vaccination status and recent COVID-19 positivity. Findings There were 14,169 eligible tests from hospitalised individuals aged 75 years and older; 3005 cases (positive tests) and 11,164 controls (negative tests). Effectiveness was highest in the period 9–13 days post vaccination for both manufacturers at about 50%; 43.7% (95% CI, 20.1–60.3%) and 56.1% (95% CI, 25.2–74.2%) for Sanofi/GSK and Pfizer BA.4-5, respectively. There was evidence of waning with a reduction to about 30% for both manufacturers after 5–9 weeks. The longest time interval post vaccination for which we were able to estimate effectiveness was 10+ weeks post vaccination, at which point vaccine effectiveness was 17.6% (95% CI, −3.6 to 34.5%) and 37.9% (95% CI, 13.2–55.5%) for the Sanofi/GSK and Pfizer BA.4-5 boosters, respectively. Interpretation Both boosters provided good protection against hospitalisation amongst older adults. The finding that the adjuvanted vaccine targeting the distant Beta strain had similar effectiveness to the bivalent mRNA vaccine targeting more closely matched Omicron sub-lineages is notable and highlights the need for further real-world studies into the effectiveness of vaccines from different vaccine platforms and formulations in the presence of matched and unmatched strains. Funding No external funding.
Invasive meningococcal disease (IMD), caused by infection with the bacterium Neisseria meningitidis, usually manifests as meningitis or septicemia and can be severe and life-threatening (1). Six serogroups (A, B, C, W, X, and Y) account for most cases (2). N. meningitidis is transmitted person-to-person via respiratory droplets and oropharyngeal secretions. Asymptomatic persons can carry N. meningitidis and transmit the bacteria to others, potentially causing illness among susceptible persons. Outbreaks can occur in conjunction with large gatherings (3,4). Vaccines are available to prevent meningococcal disease. Antibiotic prophylaxis for close contacts of infected persons is critical to preventing secondary cases (2).
Background The Sano fi /GSK AS03-adjuvanted (VidPrevtyn Beta) vaccine and the P fi zer-BioNTech mRNA (Comirnaty Original/Omicron BA.4-5) bivalent vaccine were offered to adults aged 75 years and over in England from 3rd April 2023. This is the fi rst time an adjuvanted COVID-19 vaccine has been administered as part of a UK COVID-19 vaccination programme. In clinical trials, antibody levels generated were comparable with mRNA vaccines but there are no real-world data on the effectiveness or duration of protection. Methods We used a test -negative case - control study design to estimate the incremental vaccine effectiveness of the Sano fi /GSK and P fi zer bivalent BA.4-5 boosters against hospitalisation amongst those aged 75 years and older in England. Cases (those testing positive) and controls (those testing negative) were identi fi ed from the national COVID-19 PCR testing data undertaken in hospital settings. The study period included tests from 3rd April 2023 to 27th August 2023. Tests were linked to the COVID-19 vaccination register and to the national hospital admission database, restricting to those with an acute respiratory infection coded in the primary diagnosis fi eld. Vaccine effectiveness was estimated using multivariable logistic regression amongst those who had last received an autumn 2022 booster given at least 3 months prior. The test result was the outcome and vaccination status the exposure. Analyses were adjusted for week of test, gender, age, clinical risk group status, care home resident status, region, index of multiple deprivation, ethnicity, in fl uenza vaccination status and recent COVID19 positivity. Findings There were 14,169 eligible tests from hospitalised individuals aged 75 years and older; 3005 cases (positive tests) and 11,164 controls (negative tests). Effectiveness was highest in the period 9 - 13 days post vaccination for both manufacturers at about 50%; 43.7% (95% CI, 20.1 - 60.3%) and 56.1% (95% CI, 25.2 - 74.2%) for Sano fi /GSK and P fi zer BA.4-5, respectively. There was evidence of waning with a reduction to about 30% for both manufacturers after 5 - 9 weeks. The longest time interval post vaccination for which we were able to estimate effectiveness was 10+ weeks post vaccination, at which point vaccine effectiveness was 17.6% (95% CI, - 3.6 to 34.5%) and 37.9% (95% CI, 13.2 - 55.5%) for the Sano fi /GSK and P fi zer BA.4-5 boosters, respectively. Interpretation Both boosters provided good protection against hospitalisation amongst older adults. The fi nding that the adjuvanted vaccine targeting the distant Beta strain had similar effectiveness to the bivalent mRNA vaccine targeting more closely matched Omicron sub-lineages is notable and highlights the need for further real-world studies into the effectiveness of vaccines from different vaccine platforms and formulations in the presence of matched and unmatched strains.
Sniff nasal inspiratory pressure (SNIP) is used to assess respiratory muscle strength in neuromuscular diseases like amyotrophic lateral sclerosis (ALS). The effect of contralateral nostril occlusion and mouth sealing on SNIP measurement are unclear. 81 participants were included (16 healthy, 39 patients with limb-onset ALS and 26 patients with bulbar-onset ALS). SNIP was obtained with combinations of mouth open/sealed and contralateral nostril open/occluded. Occluding the contralateral nostril (with mouth closed) increased SNIP by 12 cmH2O (95% CI 4, 20; p=0.003) in the healthy participants, by 9 cmH2O (95% CI 5, 12; p<0.001) in the limb-onset cohort and by 10 cmH2O (95% CI 5, 14; p<0.001) in the bulbar-onset cohort. Opening the mouth decreased SNIP by 19 cmH2O (95% CI 5, 34; p<0.009) in healthy participants, by 8 cmH2O (95% CI 4, 13; p<0.001) in the limb-onset cohort and by 13 cmH2O (95% CI 7, 19; p<0.001) in the bulbar-onset cohort. With contralateral nostril occlusion, 11% fewer individuals would have qualified for non-invasive ventilation. In conclusion, contralateral nostril occlusion increased SNIP compared with standard technique, likely reflecting true strength. Opening the mouth reduced SNIP, emphasising the need for good mouth sealing. Documenting SNIP technique is important for longitudinal assessments and clinical decision-making.
Surface electromyography (sEMG) can be used to measure the electrical activity of the respiratory muscles. The possible applications of sEMG span from patients suffering from acute respiratory failure to patients receiving chronic home mechanical ventilation, to evaluate muscle function, titrate ventilatory support and guide treatment. However, sEMG is mainly used as a monitoring tool for research and its use in clinical practice is still limited—in part due to a lack of standardization and transparent reporting. During this round table meeting, recommendations on data acquisition, processing, interpretation, and potential clinical applications of respiratory sEMG were discussed. This paper informs the clinical researcher interested in respiratory muscle monitoring about the current state of the art on sEMG, knowledge gaps and potential future applications for patients with respiratory failure.