In the midst of the race to develop a possible vaccine against the new coronavirus, pharmaceutical giant Johnson & Johnson has started phase three global trials of its single-dose Covid-19 vaccine with up to 60,000 volunteers from the US, South Africa, Argentina. , Brazil, Chile and Colombia. , Mexico and Peru.
The Covid-19 vaccine is being developed by its pharmaceutical companies Janssen.
“Johnson & Johnson will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles,” the company said in a statement.
The dosage marks the first major test in the United States of an inoculation that can work after a single injection.
Some other vaccines in the US, including injections by Moderna Inc. and Pfizer Inc., and others in other countries are already in the final stage of testing.
If enrollment goes as expected, the test could yield results as early as the end of the year, allowing the company to seek an emergency clearance early next year, if effective, Johnson’s chief scientific officer said Tuesday. & Johnson, Paul Stoffels. “We remain fully focused on developing a safe and effective COVID-19 vaccine that is urgently needed for people around the world,” he added.
“We are convinced that the single dose could be very effective,” he said in a press call, citing promising results from previous research, Bloomberg reported.
The study will compare the vaccine to a placebo injection, with the aim of showing whether it reduces Covid-19 cases from moderate to severe. J&J will publish detailed test plans on Wednesday, Stoffels said. Leaders Pfizer Inc., Moderna Inc. and AstraZeneca Plc have already done the same.
“The ENSEMBLE Phase 3 study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single dose of vaccine versus placebo in up to 60,000 adults 18 years and older, including a significant representation of those over 60, “the company said in a statement.
The company also agreed in principle to collaborate with the United Kingdom and Northern Ireland (the UK government) on a separate phase 3 clinical trial in several countries to explore a two-dose regimen of the Janssen vaccine candidate.
“Multiple Covid-19 vaccine regimens are likely to be required to meet the global need,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a statement, according to Bloomberg reports. The J&J vaccine “may be especially helpful in controlling the pandemic if it is shown to be protective after just one dose,” he added.
The US FDA has said that a coronavirus vaccine must be shown to be at least 50 percent more effective than a placebo in a large-scale trial to be considered for approval. However, a smaller sample of infections in a clinical trial changes the estimate of how that standard is met, according to the researchers.
J & J’s vaccine is made with slightly different technology than others in the later stages of testing, modeled after an Ebola vaccine created by the company. Unlike the other three vaccines that began late-stage testing in the US, it only requires one injection, not two.
Earlier, US President Donald Trump suggested Monday that Pfizer Inc could secure the first US approval of a COVID-19 vaccine in the coming weeks, and said a Johnson & Johnson contender could come later.
When asked which pharmacist could be approved, Trump told Fox News in an interview: “Pfizer is doing great,” adding that “Johnson & Johnson … will probably be a little later. He also cited the efforts of Moderna Inc and AstraZeneca Plc.
Meanwhile, testing for another experimental vaccine, made by AstraZeneca, remains on hold in the US As officials examine a safety issue, even though studies have resumed in other countries. However, AstraZeneca established its first interim analysis when around 40 coronavirus infections were reported among the participants.
As for the other vaccine-producing companies, Moderna previously said it was on track to produce 20 million doses of its experimental coronavirus vaccine by the end of the year, while maintaining its goal of preparing between 500 million and 1 billion doses in 2021.
Moderna has a vaccine supply agreement with the US for 100 million doses and has finalized advanced talks with the European Union for the vaccine.
Vaccines and treatments are considered essential to control the COVID-19 pandemic which has shown no signs of slowing down and killed more than 970,000 people worldwide.
With contributions from the agency
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