Amid the race to develop a potential vaccine against novel coronavirus, pharma giant Johnson & Johnson has begun phase three global trials of its single-dose Covid-19 vaccine with up to 60,000 volunteers from US, South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru.
The Covid-19 vaccine is being developed by its Janssen Pharmaceutical Companies.
“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 dosing up marks the first big US trial of an inoculation that may work after just one shot.
A few other vaccines in the U.S. — including shots made by Moderna Inc. and Pfizer Inc. — and others in other countries are already in final-stage testing.
If enrollment goes as expected, the trial could yield results as soon as year-end, allowing the company to seek emergency authorization early next year, should it prove effective, Johnson & Johnson Chief Scientific Officer Paul Stoffels said Tuesday. “We remain fully focused on developing an urgently needed, safe and effective COVID-19 vaccine for people around the world,” he added.
“We are convinced that the single dose could be very efficacious,” he said on a call with the press, citing promising results from earlier research, reported Bloomberg.
The study will compare the vaccine with a placebo injection, with a goal of showing whether it reduces cases of moderate to severe Covid-19. J&J will publish detailed trial plans Wednesday, Stoffels said. Frontrunners Pfizer Inc., Moderna Inc. and AstraZeneca Plc have already done the same.
“The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single vaccine dose versus placebo in up to 60,000 adults 18 years old and older, including significant representation from those that are over age 60,” the company said in a statement.
The company has also agreed in principle to collaborate with the UK and Northern Ireland (the UK Government) on a separate Phase 3 clinical trial in multiple countries to explore a two-dose regimen of Janssen’s vaccine candidate.
“It is likely that multiple Covid-19 vaccine regimens will be required to meet the global need,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, in a statement, as per Bloomberg reports. J&J’s vaccine “may be especially useful in controlling the pandemic if shown to be protective after a single dose,” he added.
The US FDA has said that a coronavirus vaccine must prove 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 calculation of how that standard is met, according to researchers.
J&J’s vaccine is made with slightly different technology than others in late-stage testing, modelled on an Ebola vaccine the company created. Unlike the other three vaccines that started late-stage testing in the U.S., it requires only one shot, not two.
Earlier, US President Donald Trump on Monday suggested Pfizer Inc could secure the first US approval of a COVID-19 vaccine in coming weeks, saying a contender by Johnson & Johnson could come later.
Asked which drugmaker could be approved, Trump told Fox News in an interview: “Pfizer’s doing really well,” adding “Johnson & Johnson … they’ll probably be a little later.” He also cited efforts by Moderna Inc and AstraZeneca Plc.
Meanwhile, testing of still another experimental vaccine, made by AstraZeneca, remains on hold in the U.S. as officials examine a safety question, even though studies have resumed in other countries. However, AstraZeneca set its first interim analysis when about 40 coronavirus infections are reported among participants.
As for the other vaccine production companies, Moderna said earlier that 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 readying 500 million to 1 billion doses in 2021.
Moderna has a vaccine supply deal in place with the U.S. for 100 million doses, and has finished advanced talks with the European Union for the vaccine.
Vaccines and treatments are seen as essential in controlling the COVID-19 pandemic that has shown no signs of slowing and killed over 970,000 people worldwide.
With agency inputs