An Australian consumer survey on COVID-19 vaccination and pregnancy

Pregnant women are more than twice as likely to require intensive care admission and invasive ventilation due to COVID-19 than non-pregnant women of childbearing age, and are a priority vaccination group. The Immunisation Coalition regularly undertakes surveys of the Australian population, to understand attitudes around immunisation, by engaging a private market research company, APMI Partners. A limited report is loaded on the Immunisation Coalition website. The aim was to examine the views of pregnant and recently pregnant women in Australia on COVID-19 vaccination during pregnancy, by conducting detailed analyses on the Immunisation Coalition’s survey data. Pregnant and recently pregnant women across Australia were surveyed in November/December 2021 by AMPI Partners, on behalf of the Immunisation Coalition. Pregnant and recently pregnant (had a baby after 17 May 2021) women were eligible for inclusion. The online survey was offered in multiple languages. Descriptive statistics were undertaken. Ethics approval was obtained to conduct detailed analyses on these data. Written consent was obtained from participants. The online survey was completed by 526 women. All states and territories were represented and the demographics were representative. Age ranged from 20-43 years, with a mean of 30.4 years. The survey was completed in a language other than English by 56 (8.6%) women. Overall, 393 (74.7%) women received a COVID-19 vaccination. Reasons for not receiving the vaccine included concerns about: the long-term effect on my baby (n=40);the vaccine was developed too quickly (n=39);the side effects of the vaccine on the baby (n=35);and my partner did not want me to (n=21). Midwives were the most trusted source of information for 31 women, with 26 (83.9%) of these women receiving the vaccine. Most women were aware that COVID-19 vaccination was recommended during pregnancy and could access the vaccine if desired. Targeted communication addressing concerns could improve uptake.

Improving outcomes among young adults with type 1 diabetes: the D1 Now pilot cluster randomised controlled trial.

BACKGROUND: The D1 Now intervention is designed to improve outcomes in young adults living with type 1 diabetes. It consists of three components: an agenda-setting tool, an interactive messaging system and a support worker. The aim of the D1 Now pilot cluster randomised controlled trial (RCT) was to gather and analyse acceptability and feasibility data to allow (1) further refinement of the D1 Now intervention, and (2) determination of the feasibility of evaluating the D1 Now intervention in a future definitive RCT. METHODS: A pilot cluster RCT with two intervention arms and a control arm was conducted over 12 months. Quantitative data collection was based on a core outcome set and took place at baseline and 12 months. Semi-structured interviews with participants took place at 6, 9 and 12 months. Fidelity and health economic costings were also assessed. RESULTS: Four diabetes centres and 57 young adults living with type 1 diabetes took part. 50% of eligible young adults were recruited and total loss to follow-up was 12%. Fidelity, as measured on a study delivery checklist, was good but there were three minor processes that were not delivered as intended in the protocol. Overall, the qualitative data demonstrated that the intervention was considered acceptable and feasible, though this differed across intervention components. The agenda-setting tool and support worker intervention components were acceptable to both young adults and staff, but views on the interactive messaging system were mixed. CONCLUSIONS: Some modifications are required to the D1 Now intervention components and research processes but with these in place progression to a definitive RCT is considered feasible. TRIAL REGISTRATION: ISRCTN (ref: ISRCTN74114336 ).

mRNA-1273 or mRNA-Omicron boost in vaccinated macaques elicits similar B cell expansion, neutralizing responses, and protection from Omicron.

SARS-CoV-2 Omicron is highly transmissible and has substantial resistance to neutralization following immunization with ancestral spike-matched vaccines. It is unclear whether boosting with Omicron-matched vaccines would enhance protection. Here, nonhuman primates that received mRNA-1273 at weeks 0 and 4 were boosted at week 41 with mRNA-1273 or mRNA-Omicron. Neutralizing titers against D614G were 4,760 and 270 reciprocal ID50 at week 6 (peak) and week 41 (preboost), respectively, and 320 and 110 for Omicron. 2 weeks after the boost, titers against D614G and Omicron increased to 5,360 and 2,980 for mRNA-1273 boost and 2,670 and 1,930 for mRNA-Omicron, respectively. Similar increases against BA.2 were observed. Following either boost, 70%-80% of spike-specific B cells were cross-reactive against WA1 and Omicron. Equivalent control of virus replication in lower airways was observed following Omicron challenge 1 month after either boost. These data show that mRNA-1273 and mRNA-Omicron elicit comparable immunity and protection shortly after the boost.

Protection from SARS-CoV-2 Delta one year after mRNA-1273 vaccination in rhesus macaques coincides with anamnestic antibody response in the lung.

mRNA-1273 vaccine efficacy against SARS-CoV-2 Delta wanes over time; however, there are limited data on the impact of durability of immune responses on protection. Here, we immunized rhesus macaques and assessed immune responses over 1 year in blood and upper and lower airways. Serum neutralizing titers to Delta were 280 and 34 reciprocal ID50 at weeks 6 (peak) and 48 (challenge), respectively. Antibody-binding titers also decreased in bronchoalveolar lavage (BAL). Four days after Delta challenge, the virus was unculturable in BAL, and subgenomic RNA declined by ∼3-log10 compared with control animals. In nasal swabs, sgRNA was reduced by 1-log10, and the virus remained culturable. Anamnestic antibodies (590-fold increased titer) but not T cell responses were detected in BAL by day 4 post-challenge. mRNA-1273-mediated protection in the lungs is durable but delayed and potentially dependent on anamnestic antibody responses. Rapid and sustained protection in upper and lower airways may eventually require a boost.

Protective antibodies elicited by SARS-CoV-2 spike protein vaccination are boosted in the lung after challenge in nonhuman primates.

Adjuvanted soluble protein vaccines have been used extensively in humans for protection against various viral infections based on their robust induction of antibody responses. Here, soluble prefusion-stabilized spike protein trimers (preS dTM) from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were formulated with the adjuvant AS03 and administered twice to nonhuman primates (NHPs). Binding and functional neutralization assays and systems serology revealed that the vaccinated NHP developed AS03-dependent multifunctional humoral responses that targeted distinct domains of the spike protein and bound to a variety of Fc receptors mediating immune cell effector functions in vitro. The neutralizing 50% inhibitory concentration titers for pseudovirus and live SARS-CoV-2 were higher than titers for a panel of human convalescent serum samples. NHPs were challenged intranasally and intratracheally with a high dose (3 × 106 plaque forming units) of SARS-CoV-2 (USA-WA1/2020 isolate). Two days after challenge, vaccinated NHPs showed rapid control of viral replication in both the upper and lower airways. Vaccinated NHPs also had increased spike protein-specific immunoglobulin G (IgG) antibody responses in the lung as early as 2 days after challenge. Moreover, passive transfer of vaccine-induced IgG to hamsters mediated protection from subsequent SARS-CoV-2 challenge. These data show that antibodies induced by the AS03-adjuvanted preS dTM vaccine were sufficient to mediate protection against SARS-CoV-2 in NHPs and that rapid anamnestic antibody responses in the lung may be a key mechanism for protection.