Johnson & Johnson announced on Wednesday that the Phase 3 trial of the potential coronavirus vaccine has begun.
J&J is the fourth drug company to be supported by the Trump administration's Operation Warp Speed Covid-19 vaccination program to conduct late-stage testing. The others are Moderna, Pfizer, and AstraZeneca.
According to the National Institute of Allergy and Infectious Diseases, the study will enroll up to 60,000 adult volunteers in 215 locations in the US and other countries. Participants will be selected at random to receive a dose of the potential vaccine or a placebo according to the details of the study, which will determine whether the vaccine is safe and effective.
"Four COVID-19 vaccine candidates are in the US a little more than eight months after the identification of SARS-CoV-2 in phase 3 clinical tests," said institute director Dr. Anthony Fauci in a statement.
"This is an unprecedented achievement for the scientific community, made possible by decades of advances in vaccine technology and a coordinated strategic approach between government, industry and academia," he said. "It is likely that multiple COVID-19 vaccination schedules will be required to meet global needs. The Janssen candidate has shown promise in early-stage testing and may be particularly useful in fighting the pandemic if it is found that it has a protective effect after a single dose. " ""
J&J, whose Janssen subsidiary is based in Belgium, has stated that it uses the same technologies that it used to develop its experimental Ebola vaccine. Genetic material from the coronavirus is combed with a modified adenovirus, which is known to cause colds in humans.
Preclinical studies have shown that J & J's potential Covid-19 vaccine can produce a promising response in non-human primates and hamsters.
J & J's chief scientist Paul Stoffels told reporters on a conference call Tuesday that data from early-stage studies that will be released "immediately" show that human immune responses are "comparable to protected animals." He also said the vaccine appeared to be well tolerated and symptoms such as fever went away within 48 hours.
He said it will likely take six weeks to two months to reach 60,000 participants, allowing J&J to recruit a diverse cohort. The study will include those with and without other ailments associated with an increased risk of progression to severe Covid-19 and is expected to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States.
"There are many so-called standby cohorts where we have identified the specific populations we want to target in high-risk areas," he said. "The data teams have been working hard to figure out where in the US and other parts of the world we can get access to the people and parts of the population at high risk and diversity that we need in clinical trials."
The development comes when President Donald Trump says the US could find a safe and effective vaccine by the end of October and have enough vaccine doses to vaccinate every American by April.
When asked which drug company could be the first to receive US approval, Trump told Fox News on Monday that Pfizer, Moderna and AstraZeneca are making good progress. He added that J & J's vaccine "will likely be a little later".
The U.S. Department of Health announced on August 5 that it had signed a contract with Janssen for 100 million doses of its vaccine, valued at approximately $ 1 billion. The deal gives the federal government the opportunity to order another 200 million cans, according to the announcement.
The phase 3 study is jointly funded by J&J, the National Institutes of Health and NIAID, Stoffels said Tuesday.
J&J had previously announced that it was anticipating potential vaccine batches for a potential emergency approval, which will be available in early 2021. The company announced that it has continued to expand its manufacturing capacity and remains on track to meet its goal of delivering one billion doses of a vaccine per year.
Public health officials and infectious disease experts say world leaders will need a range of drugs and vaccines to fight the virus, which emerged less than 10 months ago.