Start of phase 3 trial is the result of positive results from the company’s phase 1and 2 clinical trials that showed safety profile as well as immune response against the vaccine, the company said.
With this bump of the trial, a vaccine from the company can be available for public by early 2021. In the next phase J&J will enroll up to 60,000 volunteers across three continents and study safety and efficacy of a single vaccine dose versus placebo in preventing Covid-19.
“Johnson & Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year. The Company is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective”, the company said.
In this part of the trial, the company will enroll participants from Argentina, Peru, Brazil, South Africa.
The company though has not announced if India will be part of the trial (no Asian countries are listed in the phase 3 trial) it has an agreement with India’s Bio E where the company has transferred the technology and manufacturing rights of its vaccine to the company.
Bio E is expected to manufacture 400 million doses of the vaccine by mid 2021.