Serological responses and vaccine effectiveness for extended COVID-19 vaccine schedules in England
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Abstract
The UK prioritised delivery of the first dose of BNT162b2 (Pfizer/BioNTech) and AZD1222 (AstraZeneca) vaccines by extending the interval between doses up to 12 weeks. In 750 participants aged 50–89 years, we here compare serological responses after BNT162b2 and AZD1222 vaccination with varying dose intervals, and evaluate these against real-world national vaccine effectiveness (VE) estimates against COVID-19 in England. We show that antibody levels 14–35 days after dose two are higher in BNT162b2 recipients with an extended vaccine interval (65–84 days) compared with those vaccinated with a standard (19–29 days) interval. Following the extended schedule, antibody levels were 6-fold higher at 14–35 days post dose 2 for BNT162b2 than AZD1222. For both vaccines, VE was higher across all age-groups from 14 days after dose two compared to one dose, but the magnitude varied with dose interval. Higher dose two VE was observed with >6 week interval between BNT162b2 doses compared to the standard schedule. Our findings suggest higher effectiveness against infection using an extended vaccine schedule. Given global vaccine constraints these results are relevant to policymakers.
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SciScore for 10.1101/2021.07.26.21261140: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Serological Testing: Serum samples were tested for nucleoprotein (N) antibodies as a marker of previous SARS-CoV-2 infection (Anti-SARS-CoV-2 total antibody assay, Roche Diagnostics, Basel, Switzerland) and spike (S) protein antibodies, which could be infection- or vaccine-derived (Elecsys Anti-SARS-CoV-2 S total antibody assay, Roche Diagnostics: positive ≥ 0.8 arbitrary units (au)/mL to assess vaccine response).(9, 10) Assessment of Vaccine Effectiveness: A test negative case-control design was used to estimate odds … SciScore for 10.1101/2021.07.26.21261140: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics not detected. Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Table 2: Resources
Antibodies Sentences Resources Serological Testing: Serum samples were tested for nucleoprotein (N) antibodies as a marker of previous SARS-CoV-2 infection (Anti-SARS-CoV-2 total antibody assay, Roche Diagnostics, Basel, Switzerland) and spike (S) protein antibodies, which could be infection- or vaccine-derived (Elecsys Anti-SARS-CoV-2 S total antibody assay, Roche Diagnostics: positive ≥ 0.8 arbitrary units (au)/mL to assess vaccine response).(9, 10) Assessment of Vaccine Effectiveness: A test negative case-control design was used to estimate odds ratios for testing SARS-CoV-2 positive to in vaccinated compared with unvaccinated people with COVID-19 compatible symptoms who were tested using polymerase chain reaction (PCR), as described previously.(8) Data sources: Outcome assessment: All healthy adults aged ≥50 years in England were eligible for inclusion. Anti-SARS-CoV-2 total antibody assay, Roche Diagnostics, Basel, Switzerland) and spike (S) proteinsuggested: NoneSoftware and Algorithms Sentences Resources Statistical analyses were performed using STATA v.14.2. STATAsuggested: (Stata, RRID:SCR_012763)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:(19, 20) Notwithstanding this, it is important to emphasise that a single dose of either vaccine remains highly effective against severe endpoints, which is the primary aim of the vaccination programme, with 75-85% protection against hospitalisation in the oldest cohorts.(8) As of 28/06/2021, the vaccination programme is estimated to have prevented nearly 8 million infections and 27,000 deaths in England alone.(21, 22) Strengths and Limitations: The strength of this study is the combination of sero-surveillance with real-world national VE data for two different vaccines in different age groups, including older adults who were excluded from initial clinical trials, with variable, real-world dosing intervals. Serological assessments provide an objective measure of vaccine responses which are important for comparing vaccines and schedules, but interpretation of serological data is limited as the way in which it correlates with protection is unknown and the recognition that neutralising activity of antibodies and cellular immunity also play an important role in protection. As with any observational study, there are limitations to VE analysis. There may be confounding factors that could increase the risk of COVID-19 in vaccinated individuals, for example, if vaccinated individuals adopted riskier behaviours after vaccination or unvaccinated individuals isolated themselves to reduce their risk of viral exposures. In addition, VE could be attenuated if there are high levels of prote...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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