Publications

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

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, […]

Live-Attenuated Respiratory Syncytial Virus Vaccine With M2-2 Deletion and With Small Hydrophobic Noncoding Region Is Highly Immunogenic in Children

A promising attenuation strategy involves deletion of most of the open reading frame (ORF) encoding the RNA synthesis regulatory protein M2-2. The RSV M2-2 protein is a small, nonabundant protein encoded by the second, downstream ORF in the M2 messenger RNA, which slightly overlaps the 5’ proximal, upstream M2-1 ORF

In the race for coronavirus vaccines, don’t leave pregnant women behind

As the world rushes to develop new vaccines against Covid-19, there is a real risk that pregnant women and their babies will not be among those who are able to benefit from them.

Does respiratory syncytial virus lower respiratory illness in early life cause recurrent wheeze of early childhood and asthma? Critical review of the evidence and guidance for future studies from a World Health Organization-sponsored meeting

A long-standing question is whether RSV LRTI in early life causes subsequent recurrent wheeze of early childhood (RWEC) and asthma. The current evidence supporting a causal association between RSV and RWEC/asthma is mixed. To shed light on this important question, the World Health Organization (WHO) undertook three activities. The first comprised an analysis of the sample size required to estimate the potential impact of RSV prevention by vaccines or mAbs on the subsequent development of RWEC in RCTs. The second was a systematic review and meta-analysis that will be reported separately. Third was a convening of subject matter experts on February 12–13, 2019 in Geneva, Switzerland.

Consensus Report on Shigella Controlled Human Infection Model: Conduct of Studies

Shigella CHIMs are useful for evaluating potential therapeutics and vaccines. As this organism is increasingly recognized as a cause of morbidity and mortality, a vaccine is now a global health priority. The Shigella CHIM allows for rapid evaluation of vaccine efficacy for up- or down-selection of vaccine candidates. Opportunities have arisen to validate the model as a predictor for vaccine efficacy in the field.

Harmonization of Zika neutralization assays by using the WHO International Standard for anti-Zika virus antibody

During outbreaks of emerging viruses, such as the Zika outbreak in 2015–2016, speed and accuracy in detection of infection are critical factors to control the spread of the disease; often serological and diagnostic methods for emerging viruses are not well developed and validated. Thus, vaccines and treatments are difficult to evaluate due to the lack of comparable methods. In this study, we show how the 1st WHO International Standard for anti-Zika antibody was able to harmonize the neutralization titres of a panel of serological Zika-positive samples from laboratories worldwide.

Safety and Immunogenicity of the Respiratory Syncytial Virus Vaccine RSV/ΔNS2/Δ1313/I1314L in RSV-Seronegative Children

Respiratory syncytial virus (RSV) is the most important cause of severe acute lower respiratory illness (LRI) in infants and children worldwide, and the relative importance of RSV has increased as the burden of bacterial pneumonia has declined with vaccine implementation. According to global estimates, RSV caused approximately 33 million cases of LRI and approximately 118 000 deaths in children <5 years of age in 2015.

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