The COVID19 pandemic has changed women's experiences of pregnancy in the UK

IntroductionDuring the SARS-CoV-2 pandemic, maternity care has been substantially altered to reduce transmission of the SARS-CoV-2 virus. Many antenatal services are now restricted or delivered online, and visiting has been restricted during labour and in the postnatal period. MethodsWe conducted an online survey from 1st August to 31st December 2020 to investigate the experiences of women who were pregnant or breastfeeding in the UK during the SARS-CoV-2 pandemic. The survey included 55 open and closed questions and required 5 minutes to complete. We publicised the survey using social media. ResultsWe received 96 responses, including 66 currently pregnant women and 22 women who were pregnant during the pandemic. The response rate was 70.1% of survey views. We found mixed experiences of the impact of the pandemic on antenatal and perinatal care, notably with some women feeling visiting restrictions were insufficient and others feeling they were too strict. Twenty-nine women received no information about COVID-19, and 6 women found it very difficult to find information. Thirty-nine women would have liked to have more information about breastfeeding after a pregnancy affected by COVID-19, and 37 women wanted more information about antibody persistence and transfer. DiscussionAdditional support is required for pregnant and lactating women during the current pandemic. Provision of information and support, including via social media, may improve womens experiences of pregnancy in the current environment. SignificanceMaternity services in the UK have been significantly restructured to prevent transmission of the SARS-CoV-2 virus, including restrictions to in-person antenatal care, and perinatal visiting. It is not fully known how these changes are perceived by pregnant and breastfeeding women. Reactions to changes in antenatal care are mixed, including whether restrictions were too lenient or too strict. Most women underwent online antenatal care in addition in-person visits. Some received no information about COVID-19, and a significant proportion of women would have liked more information, particularly regarding antibody transfer and benefits of breastfeeding during the pandemic. Ethical statementThis study was approved by North East - Newcastle & North Tyneside 1 Research Ethics Committee

Safety, Immunogenicity, and Efficacy of a COVID-19 Vaccine (NVX-CoV2373) Co-administered With Seasonal Influenza Vaccines

BackgroundThe safety and immunogenicity profile of COVID-19 vaccines when administered concomitantly with seasonal influenza vaccines has not yet been reported. MethodsA sub-study on influenza vaccine co-administration was conducted as part of the phase 3 randomized trial of the safety and efficacy of NVX-CoV2373. The first [~]400 participants meeting main study entry criteria and with no contraindications to influenza vaccination were invited to join the sub-study. After randomization in a 1:1 ratio to receive NVX-CoV2373 (n=217) or placebo (n=214), sub-study participants received an age-appropriate, licensed, open-label influenza vaccine with dose 1 of NVX-CoV2373. Reactogenicity was evaluated via electronic diary for 7 days post-vaccination in addition to monitoring for unsolicited adverse events (AEs), medically-attended AEs (MAAEs), and serious AEs (SAEs). Influenza haemagglutination inhibition and SARS-CoV-2 anti-spike IgG assays were performed. Vaccine efficacy against PCR-confirmed, symptomatic COVID-19 was assessed. Comparisons were made between sub-study and main study participants. FindingsSub-study participants were younger, more racially diverse, and had fewer comorbid conditions than main study participants. Reactogenicity events more common in the co-administration group included tenderness (70.1% vs 57.6%) or pain (39.7% vs 29.3%) at injection site, fatigue (27.7% vs 19.4%), and muscle pain (28.3% vs 21.4%). Rates of unsolicited AEs, MAAEs, and SAEs were low and balanced between the two groups. Co-administration resulted in no change to influenza vaccine immune response, while a reduction in antibody responses to the NVX-CoV2373 vaccine was noted. Vaccine efficacy in the sub-study was 87.5% (95% CI: -0.2, 98.4) while efficacy in the main study was 89.8% (95% CI: 79.7, 95.5). InterpretationThis is the first study to demonstrate the safety, immunogenicity, and efficacy profile of a COVID-19 vaccine when co-administered with seasonal influenza vaccines. The results suggest concomitant vaccination may be a viable immunisation strategy. FundingThis study was funded by Novavax, Inc. Research in ContextO_ST_ABSEvidence before this studyC_ST_ABSWe searched PubMed for research articles published from December 2019 until 1 April 2021 with no language restrictions for the terms "SARS-CoV-2", "COVID-19", "vaccine", "co-administration", and "immunogenicity". There were no peer-reviewed publications describing the simultaneous use of any SARS-CoV-2 vaccine and another vaccine. Several vaccine manufacturers had recent publications on phase 3 trials results (Pfizer/BioNTech, Moderna, AstraZeneca, Janssen, and the Gamaleya Research Institute of Epidemiology and Microbiology). Neither these publications nor their clinical trials protocols (when publicly available) described co-administration and they often had trial criteria specifically excluding those with recent or planned vaccination with any licenced vaccine near or at the time of any study injection. Added value of this studyImmune interference and safety are always a concern when two vaccines are administered at the same time. This is the first study to demonstrate the safety and immunogenicity profile and clinical vaccine efficacy of a COVID-19 vaccine when co-administered with a seasonal influenza vaccine. Implications of all the available evidenceThis study provides much needed information to help guide national immunisation policy decision making on the critical issue of concomitant use of COVID-19 vaccines with influenza vaccines.