Updated: October 14, 2020 9:30:43 pm
Health workers in a Covid-19 ward in New Delhi
The quest to find a quick and effective treatment for Covid-19 suffered two setbacks in a 24-hour span after two major US drug makers, Johnson & Johnson and Eli Lilly and Company, announced were stopping late-stage clinical trials for safety concerns.
Eli Lilly and Company said it was stopping the phase III trial, called ACTIV-3, from its coronavirus antibody drug LY-CoV555 in hospitalized patients without specifying what the safety concerns were. Recently, United States President Donald Trump touted the drug Lilly, along with the Regeneron Pharmaceuticals Inc antibody treatment he received for his COVID-19 treatment, as “a cure” for the disease.
One day before Johnson & Johnson became the second company after AstraZeneca stopped trials of the Covid-19 vaccine. Johnson & Johnson, however, said it was a “study break” and not a “regulatory suspension.” AstraZeneca, which has jointly developed a vaccine with the University of Oxford, has resumed late-stage trials, except in the US, after the adverse event in September.
Interestingly, both J&J and AstraZeneca use a common cold virus known as adenovirus to transport coronavirus proteins into human cells, causing the body to mount an immune defense against SARS-CoV-2. However, experts have said that it is not uncommon to stop drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem.
Covid-19 drugs, vaccines whose trials have been stopped:
Eli Lilly and Company Covid-19 Antibody Treatment
As part of its antibody therapy, the US pharmaceutical company Eli Lilly has developed a drug called LY-CoV555 and applied for emergency use authorization from the US FDA earlier this month. The company, which is jointly developing the treatment with Canadian biotech AbCellera, had started its ACTIV-3 trial in August and aims to recruit 10,000 patients, mainly in the United States.
The ACTIV-3 trial seeks to compare patients receiving their drug LY-CoV555 plus Gilead’s antiviral drug remdesivir to those receiving remdesivir alone.
What is LY-CoV555: The drug LY-CoV555 is basically a manufactured copy of an antibody from a patient who recovered from Covid-19. It is administered intravenously as a drip. Known as monoclonal antibodies, these treatments work by recognizing and blocking foreign invaders to block infection of healthy cells. They are best known for treating certain types of cancer and autoimmune diseases.
Recent Research: Clinical trial data published by Eli Lilly has shown that her therapy can help reduce hospital stays and emergency room visits for Covid-19 patients. While requesting authorization for emergency use, the firm had asked US regulators to administer the drug to higher-risk patients recently diagnosed with mild to moderate Covid-19 symptoms.
Why did it stop?
Without disclosing any information about the adverse event, Lilly said Tuesday that it had stopped its clinical trial for the Covid-19 drug “out of caution” about a possible safety issue. “As a precaution, the independent data security monitoring board ACTIV-3 (DSMB) has recommended a break in enrollment,” Reuters quoted Lilly spokeswoman Molly McCully as saying. “Lilly supports the independent DSMB’s decision to cautiously ensure the safety of the patients participating in this study,” the statement said.
However, Reuters reported that US drug inspectors discovered serious quality control problems at an Eli Lilly pharmaceutical plant that was preparing to manufacture the Covid-19 drug.
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Johnson & Johnson Coronavirus Vaccine
Johnson and Johnson had started a 60,000-person phase III trial of their JNJ-78436735 vaccine last month and said it is likely to present results by the end of the year or early 2021. The antidote stands out from other pioneers like Moderna or Pfizer Inc. as it is the first that could potentially be a single injection vaccine.
What is the JNJ-78436735 vaccine? The vaccine is based on a single dose of an adenovirus, which causes the common cold. The virus has been modified so that it cannot replicate and combines with a part of the coronavirus called a “spike protein” that it uses to penetrate human cells. J&J had used the same technology in its Ebola vaccine.
Recent test results: An early to mid-stage clinical trial showed that a The single dose of the vaccine induced a strong neutralizing antibody response. in almost all participants 18 years of age and older and was generally well tolerated. The 65-year-old participants also showed strong humoral and cellular immune responses.
Why did it stop?
Johnson & Johnson has said it temporarily halted clinical trials of its vaccine due to an “unexplained illness” in a study participant. J&J said it was unclear whether that person received the vaccine or a placebo. “The participant’s illness is being reviewed and evaluated by an independent safety and data monitoring board, as well as the company’s safety and clinical physicians,” the company said in a statement.
AstraZeneca-Oxford coronavirus vaccine
Late-stage trials of the ChAdOx1 vaccine are underway in the UK, India, South Africa and Brazil at the University of Oxford (also named AZD1222 and Covishield in India). However, the trials are suspended in the United States. The vaccine candidate can obtain the necessary clearances for Christmas in the UK, according to a report in The Times.
What is the ChAdOx1 vaccine? Similar to the J&J injection, the vaccine is made from a genetically modified virus that causes the common cold in chimpanzees.
Recent test results: A report on data from an early-stage human trial of the vaccine candidate showed that it had triggered a dual immune response in humans. The vaccine induced neutralizing antibodies that rendered the virus non-infectious in “all participants” who had received a second dose, according to an article published in The Lancet.
Why did it stop?
On September 9, trials of the vaccine were stopped after one of the participants in the UK developed an “unexplained illness” in an adverse event. The participant had reportedly developed a severe spinal inflammatory syndrome called transverse myelitis. The Serum Institute of India, which sponsors mid- and late-stage human clinical trials for the candidate vaccine in India, also halted the trials a day later. However, trials resumed in the UK and India on September 12 and 22, respectively.
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