Covid-19 antidote: J&J says its vaccine shows ‘robust protection’ in primates

Our Bureau Mumbai | Updated on July 30, 2020

Human trials commence, late stage trials set for September

Johnson & Johnson has said that its lead vaccine candidate protected against infection with SARS-CoV-2, the virus that causes Covid-19, in pre-clinical studies on primates.

Based on the strength of data, J&J has started Phase I/ IIa, first-in-human clinical trial of the vaccine candidate (Ad26.COV2.S) in healthy volunteers, in the US and Belgium. Late stage Phase III trials are expected to start in September, the company said.

According to data published in Nature, J&J’s investigational adenovirus serotype 26 (Ad26) vector-based vaccine elicited a robust immune response as demonstrated by ‘neutralising antibodies,’ successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates (NHPs) in the pre-clinical study.

The development comes even as other vaccine candidates from the Oxford AstraZeneca combine, Moderna, Pfizer-BioNtech, Sinovac etc undertake advanced stage human trials. Parallelly, Russia has said it already has a ready vaccine.

Phase III in September

“We are excited to see these pre-clinical data because they show our SARS-CoV-2 vaccine candidate generated a strong antibody response and provided protection with a single dose. The findings give us confidence as we progress our vaccine development and upscale manufacturing in parallel, having initiated a Phase 1/2a trial in July with the intention to move into a Phase 3 trial in September,” said Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.

The robust Janssen Covid-19 clinical trial programme, including the Phase 1/2a clinical trial and the Phase 3 clinical trial programme, will evaluate both one- and two-dose regimens of Ad26.COV2.S in parallel studies. The Phase 1/2a trial will evaluate the safety, reactogenicity (expected reactions to vaccination, such as swelling or soreness) and immunogenicity of Ad26.COV2.S in over 1,000 healthy adults aged 18 to 55 years, as well as adults aged 65 years and older. Planning also is under way for a Phase 2a study in the Netherlands, Spain and Germany and a Phase 1 study in Japan, J&J said.

As J&J plans its Covid-19 Phase 3 clinical development program, discussions are under way with partners with the objective to start a pivotal Phase 3 clinical trial of the single vaccine dose versus placebo in September, pending the interim data of the Phase 1 and 2 trials and approval of regulators. Simultaneously, the company also is planning to start a parallel Phase 3 clinical trial of a two-dose regimen versus placebo, it said.

Significantly, J&J said, it will emphasise representation of populations that have been disproportionately impacted by the pandemic as it designs and implements its Covid-19 Phase 3 trial programme. In the US, this would include significant representation of Blacks, Hispanic/Latinx and participants over 65 years of age.

As J&J progresses the clinical development of SARS-CoV-2, the company continues to increase manufacturing capacity and is in active discussions with global strategic partners to support worldwide access, it said. J&J aims to meet its goal to supply more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective, it added.

Published on July 30, 2020

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