Two Covid-19 drug trials interrupted due to safety concerns

0
20


Safety concerns have prompted two major US pharmaceutical companies to halt trials of investigational Covid-19 drugs, dealing a blow to hopes of a medical intervention to stop the pandemic.

Eli Lilly said on Tuesday he was halting recruitment for his antibody treatment, similar to the one taken by US President Donald Trump this month. Johnson & Johnson has said it is suspending all trials of its investigational Covid-19 vaccine after a participant developed an “adverse reaction”.

J&J said the cause of the reaction in the participant was not immediately clear, nor if it was related to the vaccine. Neither company has given more details on the security concerns.

J&J is the second company to halt Covid-19 vaccine trials in recent months. AstraZeneca stopped its trial in September when at least one participant developed unexplained neurological symptoms.

AstraZeneca, which works with the University of Oxford, has since resumed testing everywhere except the United States. J&J and AstraZeneca both use an adenovirus – a common virus that causes coughs and fever – to deliver the immune protein into the body.

J & J’s vaccine is one of many vaccines in development, as governments and the pharmaceutical industry battle to find a way to slow a pandemic that has killed more than a million people. It is the first leading drug maker to test a single dose Covid-19 vaccine in Phase 3 trials. Like its UK competitor AstraZeneca, J&J has said it will not look to cash in on its vaccine during the pandemic.

In a statement on the decision to stay the trials, released late Monday, J&J said: “It is important to have all the facts before sharing additional information. He added that it was not always immediately clear whether a participant received the vaccine or a placebo.

The participant’s adverse reaction was under review by an independent data security oversight committee and company doctors, the New Jersey-based drugmaker said. He added that serious adverse events were not uncommon in clinical trials, and their frequency is expected to increase as the size of the trials increased.

Mathai Mammen, global head of research and development at J&J, said on Tuesday that further details would not be available for at least “a few days.”

J&J is currently investigating its vaccine candidate using one and two dose schedules. It is not known which trial the participant was enrolled in.

The company said a pause in a study was different from when a regulator, such as the U.S. Food and Drug Administration, requires the trial to be suspended for a generally longer period. J&J said he generally does not communicate study breaks to the public, although he does notify all investigators.

Separately on Tuesday, J&J released its quarterly financial results. The drugmaker said third-quarter sales rose 1.7% from the same period in 2019 to $ 21.1 billion, supported by its pharmaceutical division. Adjusted earnings per share increased 3.8% to $ 2.20.

Its New York-listed shares, largely flat after the company revealed it had halted vaccine trials, fell 2.3% on Tuesday.

Eli Lilly’s shares, meanwhile, fell 2.9% after announcing the suspension of a trial of his antibody treatment for hospital patients.

The treatment, which uses synthetically produced anti-coronavirus antibodies, is similar to that of Regeneron, which the US president took to fight his own case of the virus, and which he has since called a “cure.”

Data from Regeneron suggests that its treatment works for patients at an early stage of the disease, but has little effect in those whose body has started to develop its own immune response. Eli Lilly and Regeneron have both requested emergency clearance for their treatments.

Video: Coronavirus: the global vaccine race | Interview with FT

LEAVE A REPLY

Please enter your comment!
Please enter your name here