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J&J Plans to Start Testing COVID-19 Vaccine in Humans in July

Johnson & Johnson announced its early-stage human trial for a potential COVID-19 vaccine will begin in the second half of July.

Previously, J&J had said the goal was to enter human trials in September. The company has previously pledged to distribute its vaccine on a not-for-profit basis for emergency pandemic use.

Chief Scientific Officer Paul Stoffels told Reuters the company has been working closely with its U.S. government partners to accelerate that timeline.

“Based on the strength of the preclinical data we have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development,” Stoffels said in a statement.

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 the results of the early studies and regulatory approval.

Stoffels said last week that J&J hopes to have results of its vaccine efficacy trials in the first quarter of 2021. He added that the company is “working hard to bring it back to the end of the year.”

A lot will depend on how much virus is circulating at that time, he said.

“If you have an incidence of 1% a year versus 4% a year, it’s totally different. And that’s where these trials are so unpredictable,” he said referring to the percentage of new cases occurring in the population at the time.

The company plans to test the vaccine in high-transmission regions within the United States. If the incidence is low, “we will complement that with international sites to make sure that we reach enough endpoints quickly to prove the vaccine works,” Stoffels said.

There are at least 124 Covid-19 vaccines under development as of June 2, according to the World Health Organization. At least 10 of those are already in clinical trials.