Associations of BMI with COVID-19 vaccine uptake, vaccine effectiveness, and risk of severe COVID-19 outcomes after vaccination in England: a population-based cohort study
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Abstract
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<h5 class="section-title" id="d3071346e249">Background</h5>
<p id="d3071346e251">A high BMI has been associated with a reduced immune response
to vaccination against
influenza. We aimed to investigate the association between BMI and COVID-19 vaccine
uptake, vaccine effectiveness, and risk of severe COVID-19 outcomes after vaccination
by using a large, representative population-based cohort from England.
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<h5 class="section-title" id="d3071346e254">Methods</h5>
<p id="d3071346e256">In this population-based cohort study, we used the QResearch
database of general practice
records and included patients aged 18 years or older who were registered at a practice
that was part of the database in England between Dec 8, 2020 (date of the first vaccination
in the UK), to Nov 17, 2021, with available data on BMI. Uptake was calculated as
the proportion of people with zero, one, two, or three doses of the vaccine across
BMI categories. Effectiveness was assessed through a nested matched case-control design
to estimate odds ratios (OR) for severe COVID-19 outcomes (ie, admission to hospital
or death) in people who had been vaccinated versus those who had not, considering
vaccine dose and time periods since vaccination. Vaccine effectiveness against infection
with SARS-CoV-2 was also investigated. Multivariable Cox proportional hazard models
estimated the risk of severe COVID-19 outcomes associated with BMI (reference BMI
23 kg/m
<sup>2</sup>) after vaccination.
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<h5 class="section-title" id="d3071346e262">Findings</h5>
<p id="d3071346e264">Among 9 171 524 participants (mean age 52 [SD 19] years; BMI
26·7 [5·6] kg/m
<sup>2</sup>), 566 461 tested positive for SARS-CoV-2 during follow-up, of whom 32 808
were admitted
to hospital and 14 389 died. Of the total study sample, 19·2% (1 758 689) were unvaccinated,
3·1% (287 246) had one vaccine dose, 52·6% (4 828 327) had two doses, and 25·0% (2 297 262)
had three doses. In people aged 40 years and older, uptake of two or three vaccine
doses was more than 80% among people with overweight or obesity, which was slightly
lower in people with underweight (70–83%). Although significant heterogeneity was
found across BMI groups, protection against severe COVID-19 disease (comparing people
who were vaccinated
<i>vs</i> those who were not) was high after 14 days or more from the second dose
for hospital
admission (underweight: OR 0·51 [95% CI 0·41–0·63]; healthy weight: 0·34 [0·32–0·36];
overweight: 0·32 [0·30–0·34]; and obesity: 0·32 [0·30–0·34]) and death (underweight:
0·60 [0·36–0·98]; healthy weight: 0·39 [0·33–0·47]; overweight: 0·30 [0·25–0·35];
and obesity: 0·26 [0·22–0·30]). In the vaccinated cohort, there were significant linear
associations between BMI and COVID-19 hospitalisation and death after the first dose,
and J-shaped associations after the second dose.
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<h5 class="section-title" id="d3071346e273">Interpretation</h5>
<p id="d3071346e275">Using BMI categories, there is evidence of protection against
severe COVID-19 in people
with overweight or obesity who have been vaccinated, which was of a similar magnitude
to that of people of healthy weight. Vaccine effectiveness was slightly lower in people
with underweight, in whom vaccine uptake was also the lowest for all ages. In the
vaccinated cohort, there were increased risks of severe COVID-19 outcomes for people
with underweight or obesity compared with the vaccinated population with a healthy
weight. These results suggest the need for targeted efforts to increase uptake in
people with low BMI (<18·5 kg/m
<sup>2</sup>), in whom uptake is lower and vaccine effectiveness seems to be reduced.
Strategies
to achieve and maintain a healthy weight should be prioritised at the population level,
which could help reduce the burden of COVID-19 disease.
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<h5 class="section-title" id="d3071346e281">Funding</h5>
<p id="d3071346e283">UK Research and Innovation and National Institute for Health
Research Oxford Biomedical
Research Centre.
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Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
Abstract Background Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle–encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19. Methods This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2. Results The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups. Conclusions The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.)
COVID-19 has rapidly impacted on mortality worldwide. 1 There is unprecedented urgency to understand who is most at risk of severe outcomes, requiring new approaches for timely analysis of large datasets. Working on behalf of NHS England we created OpenSAFELY: a secure health analytics platform covering 40% of all patients in England, holding patient data within the existing data centre of a major primary care electronic health records vendor. Primary care records of 17,278,392 adults were pseudonymously linked to 10,926 COVID-19 related deaths. COVID-19 related death was associated with: being male (hazard ratio 1.59, 95%CI 1.53-1.65); older age and deprivation (both with a strong gradient); diabetes; severe asthma; and various other medical conditions. Compared to people with white ethnicity, black and South Asian people were at higher risk even after adjustment for other factors (HR 1.48, 1.29-1.69 and 1.45, 1.32-1.58 respectively). We have quantified a range of clinical risk factors for COVID-19 related death in the largest cohort study conducted by any country to date. OpenSAFELY is rapidly adding further patients’ records; we will update and extend results regularly.
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