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September 13, 2021

Coronavirus company news summary – FDA lays out approach to Covid-19 vaccine safety in children – AzurRX activates Indian sites in Phase II trial of niclosamide

By Chris Lo

The US Food and Drug Administration (FDA) plans to “follow the science” on Covid-19 vaccines for children aged below 12 years. Vaccine trials involving children are currently underway, vaccine manufacturers including Pfizer/BioNTech and Moderna have reported. To ensure safety in this young population, the FDA will require a minimum of two months of follow-up safety data for at least 50% of clinical trial participants after receiving vaccine doses. The agency said it intends to carry out a thorough review of data submitted by manufacturers seeking Emergency Use Authorization or approval for Covid-19 vaccines in this population.

China-based Sinovac Biotech has begun inoculation of children and adolescents in South Africa as part of the global Phase III trials of its Covid-19 vaccine for individuals aged between six months and 17 years. Being conducted in alliance with domestic company Numolux Group, the trial will involve 2,000 subjects in South Africa, while an additional 12,000 participants will be enrolled in Kenya, the Philippines, Chile and Malaysia. The primary objective of the trial is the safety, efficacy and immunogenicity of two doses of the CoronaVac vaccine.

AzurRx BioPharma has activated seven more sites in India for its Phase II RESERVOIR clinical trial being performed to test niclosamide (FW-1022) for treating Covid-19-related gastrointestinal (GI) infections. These new sites are in addition to 11 sites in the US and five sites in Ukraine. The trial will mainly validate the safety of the treatment and assess its efficacy in clearing SARS-CoV-2 from the GI tract. Top-line data are expected in the first quarter of 2022.

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