Kenya Set To Participate In Coronavirus Vaccine Trials

Kenya will participate in final clinical trials for a coronavirus vaccine being developed by AstraZeneca and Oxford University.

It will be the second African country to be involved in the trials that were suspended on Wednesday after a participant had a suspected adverse reaction in the UK.

Already more than 1,000 participants have been enrolled in South Africa for the trials.

At least 400 healthcare workers will take part in the Kenyan trials that will be conducted in two coastal towns of Mombasa and Kilifi.

The two towns were in April classified as coronavirus hotspots by the government.

The AstraZeneca-Oxford University vaccine candidate is among nine other vaccine trials being tried in larger groups globally.

Participants will be given two jabs four weeks apart. They will also be allowed to carry on with their daily schedule. Exposure to the virus will not lead to removal from the trials.

The trials will determine the vaccine’s safety, ability to generate protection and effectiveness. Preliminary results of the findings will be out in November.

Development of the potential COVID-19 vaccine has expanded into a Phase III clinical trial in the US to assess the safety, efficacy and immunogenicity of the potential vaccine for the prevention of COVID-19.1

The trial is funded by US Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca.

The NIAID-supported COVID-19 Prevention Network (CoVPN) will participate in the trial.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “We are proud to be collaborating with NIAID to accelerate the development of the potential vaccine.

Should clinical trials demonstrate the vaccine protects against COVID-19 disease and it is approved for use, we will work hard to make it globally  available in a fair and equitable manner as rapidly as possible.”

Trial centres across the US are recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus.

Centres outside the US are included based on predicted transmission rates of the virus and sites in Peru and Chile are planned to initiate recruitment shortly.

Participants are being randomised to receive two doses of either the potential vaccine or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control.

The trial is assessing efficacy and safety of the potential vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.

Clinical development of the potential vaccine is progressing globally with late-stage Phase II/III trials ongoing in the UK and Brazil, a Phase I/II trial in South Africa and planned trials in Japan and Russia.

These, together with the US Phase III clinical trial will enrol up to 50,000 participants globally. Results from the late-stage trials are anticipated later this year, depending on the rate of infection within the clinical trial communities.

 

 

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