Eli Lilly pauses trial for promising COVID-19 treatment, shortly after Johnson & Johnson halted own vaccine trial

Although we are headquartered in Washington D.C. USA, our reporters and editors are working around the globe to cover what you care about. We invite you to donate to our fundraiser to help us keep our quality news free and available to all.  

A trial for a promising treatment for COVID-19 was halted on Tuesday, shortly after Johnson & Johnson paused its vaccine trial as well for the same disease.

American drugmaker Eli Lilly said it had paused a trial of a combination antibody treatment for COVID-19 for safety reasons.

The company did not say whether a volunteer had suffered a side effect, the most common reason for halting clinical trials.

[read_more id="2" more="Read full article" less="Read less"]

Lilly is testing a combination of two lab-engineered immune system proteins called monoclonal antibodies to treat severely ill patients with COVID-19.

Eli Lilly and Company is an American global pharmaceutical company with headquarters located in Indianapolis, Indiana, in the United States. The company also has offices in Puerto Rico and 17 other countries. Their products are sold in approximately 125 countries. The company was founded in 1876 by Col. Eli Lilly, a pharmaceutical chemist and veteran of the American Civil War, after whom the company was named.
Eli Lilly and Company is an American global pharmaceutical company with headquarters located in Indianapolis, Indiana, in the United States. The company also has offices in Puerto Rico and 17 other countries. Their products are sold in approximately 125 countries. The company was founded in 1876 by Col. Eli Lilly, a pharmaceutical chemist and veteran of the American Civil War, after whom the company was named.

It is similar to the treatment received by President Donald Trump early in the month.

The company said the trial’s data Safety Monitoring Board (DSMB), an independent group of medical experts in the United States who monitor clinical trials, recommended the pause.

“The trial, evaluating Lilly’s investigational neutralizing antibody as a treatment for COVID-19 in hospitalized patients, is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study,” the company said in a statement.

On Monday night, Johnson & Johnson confirmed it had paused its COVID-19 vaccine study because one of its participants was taken ill.

Alex Gorsky
Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson

While Eli Lilly is pursing a treatment, Johnson & Johnson is developing a vaccine.

Its vaccine trial is taking place in three continents, including in Sub-Saharan Africa.

Johnson & Johnson said the study was on hold because of “an unexplained illness in a study participant.”

“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” the company said in a statement.

“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.

“Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies. Based on our strong commitment to safety, all clinical studies conducted by the Janssen Pharmaceutical Companies of Johnson & Johnson have prespecified guidelines. These ensure our studies may be paused if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study.

“We must respect this participant’s privacy. We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.

“SAEs are not uncommon in clinical trials, and the number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo,” the company said.

“Last month, one of the three major worldwide coronavirus vaccine trials was paused in Phase 3 after a participant had a suspected adverse reaction. The trials for that vaccine, being developed by Oxford University and manufactured by AstraZeneca, were resumed a few days later, after a monitoring committee determined that it was safe to resume the trial,” noted the Daily News.

Last month Johnson & Johnson announced it had started a 60,000 person clinical trial of its single-dose COVID-19 vaccine on three continents, including in Sub-Saharan Africa, and that it could learn key results from the trial by early next year. The vaccine is being developed by Janssen Pharmaceutical Companies.

The final-stage trial will include 60,000 adult volunteers, those with and without comorbidities associated with an increased risk for progression to severe COVID-19, and will aim to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States.

With more than 16,000 COVID-19 related deaths and over 660,000 cases, South Africa currently has the highest death toll and number of infections in Africa, according to the latest data released on Wednesday by the Africa CDC, and Johnson & Johnson intends to carry out trials in places with high incidence of COVID-19.

The New Brunswick, New Jersey-based company said in order to evaluate the effectiveness of Janssen’s COVID-19 vaccine, countries and clinical trial sites which have a high incidence of COVID-19 and the ability to achieve a rapid initiation will be activated.

With the announcement, Johnson & Johnson has become the fourth experimental coronavirus shot to enter final-testing in the United States.

The company said it will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles.

“The Company is committed to transparency and sharing information related to the Phase 3 ENSEMBLE study – including the study protocol,” J & J said in a statement.

“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson.

Alex Gorsky
Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson

“As the world’s largest healthcare company, we are bringing to bear our best scientific minds, and rigorous standards of safety, in collaboration with regulators, to accelerate the fight against this pandemic. This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”

According to Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, the company remains “fully focused on developing an urgently needed, safe and effective COVID-19 vaccine for people around the world.”

Paul Stoffels, Vice-Chairman of the Executive Committee; Chief Scientific Officer, Johnson & Johnson, USA, speaking during the session A Decade to Deliver the Global Goals at the World Economic Forum Annual Meeting 2020 in Davos-Klosters, Switzerland, 23rd of January. Congress Centre - in Senada Copyright by World Economic Forum/Jakob Polacsek
Paul Stoffels, Vice-Chairman of the Executive Committee; Chief Scientific Officer, Johnson & Johnson, USA, speaking during the session A Decade to Deliver the Global Goals at the World Economic Forum Annual Meeting 2020 in Davos-Klosters, Switzerland, 23rd of January. Congress Centre – in Senada Copyright by World Economic Forum/Jakob Polacsek

“We greatly value the collaboration and support from our scientific partners and global health authorities as our global team of experts work tirelessly on the development of the vaccine and scaling up our production capacity with a goal to deliver a vaccine for emergency use authorization in early 2021.”

[/read_more]

Simon Ateba
Simon Ateba
Based in Washington, District of Columbia, United States of America, Simon leads a brilliant team of reporters, freelance journalists, analysts, researchers and contributors from around the world to run TODAY NEWS AFRICA as editor-in-chief. Simon Ateba's journalistic experience spans over 10 years and covers many beats, including business and investment, information technology, politics, diplomacy, human rights, science reporting and much more. Write him: simonateba@todaynewsafrica.com

LEAVE A REPLY

Please enter your comment!
Please enter your name here

Trending Now

Damning report finds detainees in Iran were sexually abused and given electric shocks in gruesome post-protest crackdown

Iran’s police, intelligence and security forces, and prison officials have committed, with the complicity of judges and prosecutors, a catalogue of...

Africa shocked U.S. under Trump has worst coronavirus response in the world

President Donald Trump has "failed in his basic duty to protect Americans", world's renowned journalist Bob Woodward told Fox News Sunday...

Nigerian activists sue President over electricity tariff and fuel price hike

Nigeria's Socio-Economic Rights and Accountability Project (SERAP) and 302 concerned Nigerians have filed a lawsuit against President Muhammadu Buhari and the...

Anxiety in Africa as Johnson & Johnson conceals critical details about COVID-19 vaccine illness

Anxiety continued to mount across Sub-Saharan Africa on Monday over COVID-19 vaccine trials by Johnsons & Johnson, as the company continued...

Ethiopia charges prominent opposition figure Jawar Mohammed with terrorism

As human rights organizations continue to warn that Prime Minister Abiy Ahmed is turning Ethiopia into a dictatorship, his administration on...

Maduro’s ally Alex Morán asks West African regional court to halt extradition to U.S.

A Special Envoy to the Government of Venezuela, Alex Nain Saab Morán, has urged the West African regional court, the ECOWAS...

“This is worse than COVID-19”, Ethiopian migrants describe “hell” in Saudi prisons

An investigation by Amnesty International has exposed horrifying new details about the treatment of Ethiopian migrants detained in Saudi Arabia. Since...

AstraZeneca and Oxford COVID-19 vaccine trials resume in US. They had continued in Africa

The Food and Drug Administration on Friday authorized trials of a vaccine being developed by pharmaceutical company AstraZeneca and Oxford University...

Johnson & Johnson resumes COVID-19 vaccine trials without providing information over illness as anxiety remains in Africa

Johnson & Johnson on Friday announced that it was resuming a COVID-19 vaccine trials in the United States without providing enough...

Police in U.S. failing to protect protesters from violence, as volatile elections near

Law enforcement agencies across the United States are failing to facilitate people’s fundamental right to freedom of peaceful assembly, and to...

54.2 million Americans have already voted representing 39.4% of total votes counted in 2016

At least 54.2 million Americans have already voted, according to data compiled by the U.S. Elections Project website, putting the 2020...

U.S. smashes daily COVID-19 record with more than 83,000 new cases

The United States reported 83,010 new coronavirus cases on Friday, according to The COVID Tracking Project, the highest number of infections...

Guinean security forces kill 8 people, including 3 children, during election protests in Conakry

Guinean security forces have killed at least eight people, including three children,  during demonstrations in Guinea’s capital, Conakry. Since presidential elections on October 18,...

What the Joseph Robinette Biden presidency would mean for Africa – Perspectives by Simon Ateba

Joseph Robinette Biden Jr., the 47th vice president of the United States in the Obama administration from 2009 to 2017, is...

AstraZeneca and Oxford COVID-19 vaccine trials resume in US. They had continued in Africa

The Food and Drug Administration on Friday authorized trials of a vaccine being developed by pharmaceutical company AstraZeneca and Oxford University to resume in the United States.AstraZeneca paused its COVID-19 clinical trials around the world early last month after an adverse reaction in a trial participant in the United Kingdom. A week after, trials resumed in the United...

[/read_more]

[read_more id="2" more="Read full article" less="Read less"]

Tweet
Share
WhatsApp
Reddit
Share