Johnson & Johnson moved up the start of human clinical trials for its experimental vaccine against the highly contagious coronavirus by two months to the second half of July, as the drugmaker rushes to develop a prevention for COVID-19, the company said on Wednesday. The acceleration should allow J&J to take part in the massive clinical trials program planned by the U.S. government, which aims to have an effective vaccine by year end.
Last March, J&J signed deals with the U.S. government to create enough manufacturing capacity to produce more than 1 billion doses of its vaccine through 2021, even before it has evidence that it works. There are currently no U.S. approved treatments or vaccines for the virus. A vaccine is seen as essential to ending the pandemic that has infected more than 7.2 million people and killed over 412,000 globally, while battering economies worldwide.
J&J initially expected safety trials to start in September. Chief Scientific Officer Paul Stoffels told Reuters the company has been working closely with its U.S. government partners to accelerate that timeline. J&J’s study will test the vaccine for safety and early signs of efficacy in 1,045 healthy volunteers aged 18 to 55 years, and in those aged 65 and older. The trial will take place in the United States and Belgium. The company is also in talks with the National Institutes of Allergy and Infectious Diseases(NIAID) to start larger, late-stage trials ahead of schedule, depending on results of the early studies and regulatory approval.
The United States is planning to test a handful of coronavirus vaccine candidates in trials that will enroll up to 30,000 subjects with the aim of getting an answer on efficacy as quickly as possible. National Institutes of Health Director Dr. Francis Collins told Reuters that companies will need to complete their safety trials by the end of summer to be included in those studies.The company plans to test the vaccine in high-transmission regions within the United States.
There are about 10 coronavirus vaccines in human testing. Experts have said a safe and effective vaccine could take at least 12 to 18 months from the start of development, which would shave several years off the typical vaccine development timeline.
Source: Reuters
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