Safety and immunogenicity of heterologous boosting with orally aerosolised or intramuscular Ad5-nCoV vaccine and homologous boosting with inactivated vaccines (BBIBP-CorV or CoronaVac) in children and adolescents: a randomised, open-label, parallel-controlled, non-inferiority, single-centre study.

BACKGROUND: Heterologous booster immunisation with orally administered aerosolised Ad5-nCoV vaccine (AAd5) has been shown to be safe and highly immunogenic in adults. Here, we aimed to assess the safety and immunogenicity of heterologous booster immunisation with orally administered AAd5 in children and adolescents aged 6-17 years who had received two doses of inactivated vaccine (BBIBP-CorV or CoronaVac). METHODS: We did a randomised, open-label, parallel-controlled, non-inferiority study to assess the safety and immunogenicity of heterologous booster immunisation with AAd5 (0·1 mL) or intramuscular Ad5-nCoV vaccine (IMAd5; 0·3 mL) and homologous booster immunisation with inactivated vaccine (BBIBP-CorV or CoronaVac; 0·5 mL) in children (aged 6-12 years) and adolescents (aged 13-17 years) who had received two doses of inactivated vaccine at least 3 months earlier in Hunan, China. Children and adolescents who were previously immunised with two-dose BBIBP-CorV or CoronaVac were recruited for eligibility screening at least 3 months after the second dose. A stratified block method was used for randomisation, and participants were stratified by age and randomly assigned (3:1:1) to receive AAd5, IMAd5, or inactivated vaccine. The study staff and participants were not masked to treatment allocation. Laboratory and statistical staff were masked during the study. In this interim analysis, adverse events within 14 days and geometric mean titre (GMT) of serum neutralising antibodies on day 28 after the booster vaccination, based on the per-protocol population, were used as the primary outcomes. The analysis of non-inferiority was based on comparison using a one-sided 97·5% CI with a non-inferiority margin of 0·67. This study was registered at ClinicalTrials.gov, NCT05330871, and is ongoing. FINDINGS: Between April 17 and May 28, 2022, 436 participants were screened and 360 were enrolled: 220 received AAd5, 70 received IMAd5, and 70 received inactivated vaccine. Within 14 days after booster vaccination, vaccine-related adverse reactions were reported: 35 adverse events (in 13 [12%] of 110 children and 22 [20%] of 110 adolescents) in 220 individuals in the AAd5 group, 35 (in 18 [51%] of 35 children and 17 [49%] of 35 adolescents) in 70 individuals in the IMAd5 group, and 13 (in five [14%] of 35 children and eight [23%] of 35 adolescents) in 70 individuals in the inactivated vaccine group. Solicited adverse reactions were also reported: 34 (13 [12%] of 110 children and 21 [10%] of 110 adolescents) in 220 individuals in the AAd5 group, 34 (17 [49%] of 35 children and 17 [49%] of 35 adolescents) in 70 individuals in the IMAd5 group, and 12 (five [14%] of 35 children and seven [20%] of 35 adolescents) in 70 individuals in the inactivated vaccine group. The GMTs of neutralising antibodies against ancestral SARS-CoV-2 Wuhan-Hu-1 (Pango lineage B) in the AAd5 group were significantly higher than the GMTs in the inactivated vaccine group (adjusted GMT ratio 10·2 [95% CI 8·0-13·1]; p<0·0001). INTERPRETATION: Our study shows that a heterologous booster with AAd5 is safe and highly immunogenic against ancestral SARS-CoV-2 Wuhan-Hu-1 in children and adolescents. FUNDING: National Key R&D Program of China.

Acceptability of COVID-19 vaccination in Chinese children aged 3-7 years with bronchopulmonary dysplasia.

OBJECTIVES: To describe the status of coronavirus disease 2019 (COVID-19) vaccination with inactivated vaccines BBIBP-CorV and CoronaVac in Chinese children aged 3-7 years with bronchopulmonary dysplasia (BPD), and explore factors influencing vaccination and reasons for nonvaccination. METHODS: This cross-sectional study involving parents of 397 BPD children aged 3-7 years was conducted through WeChat or follow-up telephone interviews using a standardized questionnaire form. Factors influencing COVID-19 vaccination were explored by using modified Poisson regression models. RESULTS: The overall COVID-19 vaccination rate was 69.0% (95% confidence interval: 64.3%-73.4%). COVID-19 vaccination was less likely to be accepted in children whose mothers had a relatively high educational background (university and above), who lived in urban areas and had a low birth weight (<1 kg), a history of hospitalization for lung diseases in the past 12 months, and intellectual disability. Conversely, kindergarten students and children from families with an annual income of >300,000 CNY ( ≈ $\approx $ 41,400 USD) were more likely to accept vaccination. Adverse reactions occurred in 13/274 children (4.7%) within 10 days after vaccination. With respect to reasons of not accepting COVID-19 vaccination, 95 parents (77.2%) worried about the adverse reactions, and 17 parents (13.8%) refused vaccination on the excuse of not being convenient to go to the vaccination station or not knowing where to get the vaccines. CONCLUSIONS: The COVID-19 vaccination rate in BPD children aged 3-7 years needs to be further improved in China. Continuous efforts are required to monitor postvaccination adverse reactions in BPD children, and make vaccination more convenient and accessible.

Extracorporeal membrane oxygenation (ECMO): does it have a role in the treatment of severe COVID-19? (Coronavirus (COVID-19) collection.)

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged since December 2019 in Wuhan city, and has quickly spread throughout China and other countries. To date, no specific treatment has been proven to be effective for SARS-CoV-2 infection. According to World Health Organization (WHO), management of coronavirus disease 19 (COVID-19) has mainly focused on infection prevention, case detection and monitoring, and supportive care. Given to the previous experience, extracorporeal membrane oxygenation (ECMO) has been proven to be an effective therapy in the treatment of respiratory failure or acute respiratory distress syndrome (ARDS). On the basis of similar principle, ECMO may be also an effective therapy in the treatment of severe COVID-19. In this study, we described and discussed the clinical outcomes of ECMO for ARDS patients, ECMO use for severe COVID-19 in China, the indications of ECMO use, and some important issues associated with ECMO.

Extracorporeal membrane oxygenation (ECMO) for critically ill patients with coronavirus disease 2019 (COVID-19): A retrospective cohort study.

PURPOSE: The role of extracorporeal membrane oxygenatio (ECMO) for rescue therapy of respiratory failure in critically ill coronavirus disease 2019 (COVID-19) patients remains controversial. We aimed to evaluate the clinical outcomes of ECMO in the treatment of COVID-19 compared with conventional ventilation support. METHODS: In this retrospective cohort study, data were collected on extremely critical patients with COVID-19 from January 2020 to March 2020 in intensive care unit of a hospital in charge by national rescue team in Wuhan, China, the epicenter of pandemic. Patients were classified into the ECMO group and the conventional ventilation non-ECMO group. Clinical characteristics, technical characteristics, laboratory results, mortality, and complications of the two groups were analyzed. RESULTS: 88 patients with extremely critical COVID-19 were screened; 34 received ECMO support and 31 received conventional ventilation support. Both groups had comparable characteristics at baseline in terms of age, gender, and comorbidities. Before ECMO or conventional therapy, patients in the two groups had sever acute respiratory distress syndrome with a mean partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2 /FiO2 ) ratio of 69.6 and 75.4, respectively. At the time of reporting, patients in the ECMO had significantly lower in-hospital mortality compared with the control group (58.8 vs. 93.5%, p = .001). CONCLUSION: ECMO is shown to decrease the mortality of extremely critical ill COVID-19 patients compared with the conventional treatment. Although complications occurred frequently, ECMO could still be a rescue therapy for the treatment of COVID-19 during the pandemic.

Mesenchymal Stem Cell-Based Therapy for COVID-19: Possibility and Potential.

A novel coronavirus, named severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) has emerged in Wuhan, China since the end of December 2019 and has quickly spread all over the world in a matter of two months. To date, no specific treatment has been proven to be effective for coronavirus (COVID-19). With the rapid increase of infected patients and deaths, it is vital to explore an effective treatment for COVID-19. Current studies suggest that there exists cytokine storm in SARS-CoV-2-infected patients; some of the them will develop acute respiratory distress syndrome (ARDS) and multiple organ dysfunction, and even death. Mesenchymal stem cells (MSCs) possess the property of immunomodulation. Given the previous preclinical and clinical studies, MSCs therapy has shown safety and efficacy in the treatment of respiratory failure or ARDS. Based on similar principles, MSCs therapy may also be an effective therapy in the treatment of COVID-19. In this study, we summarized the clinical outcomes of MSCs for ARDS patients in some preclinical and clinical studies and discussed the application of MSCs for patients with COVID-19 in China and the related important issues with MSCs used during the outbreak.

Breastfeeding in Neonates During the Coronavirus Disease 2019 Pandemic in China: A Cross-Sectional Survey (preprint)

ObjectiveTo elucidate the current situation of breastfeeding in neonates in China and to investigate whether SARS-CoV-2 is transmitted through the mother’s milk.DesignA nationwide cross-sectional surveySettingThree hundred and forty-four member hospitals of the Chinese Neonatologist Association network from 31 provinces in China.SampleNine hundred and fourteen neonatologistsMain outcome measuresThese included (1) breastfeeding practices in the obstetrics ward; (2) breastfeeding implementation for neonates admitted to neonatal intensive care unit (NICU); (3) presence of SARS-CoV-2 in the breast milk of COVID-19 positive mothers based on the real-time reverse transcriptase-polymerase chain reaction (RT-PCT) test results.ResultsBreastfeeding was undermined during the COVID-19  pandemic. Of the 344 hospitals, 153 (44.48%) centers received breast milk from milk banks to feed babies in NICU. Eight (2.33%) Level III centers performed SARS-CoV-2 PCR tests on breast milk from 15 mothers with COVID-19 and found no SARS-CoV-2 RNA presence in breast milk. Moreover, none of the mothers engaged in breastfeeding. Further, only 52 (5.69%) neonatologists supported breastfeeding in mothers with COVID-19.ConclusionsBased on the available evidence, the benefits of breastfeeding for both infants and mothers outweigh the potential risk of SARS-CoV-2 transmission through breast milk. Amidst the COVID-19 pandemic, medical staff should encourage breastfeeding, in keeping with normal infant feeding guidelines, and provide skilled support to all mothers who choose to breastfeed.