Johnson & Johnson pauses COVID-19 vaccine trial

Pharmaceutical giant Johnson & Johnson has been conducting Covid-19 vaccine clinical trials. With 60000 patients, the participants were enrolled online. An independent committee has been overseeing the data and monitoring the safety of the participants in the clinical trial. They have temporarily paused the study as one of the participants has taken ill. No details about the patient’s unexplained illness were disclosed.

The DSMB (Data and Safety Monitoring Board) has been reviewing the sick case to check if the person received a placebo or a trial treatment. The committee is monitoring and reviewing the participant’s illness. The J&J Phase 3 trial is being conducted in the U.S, Mexico, Peru, South Africa, Chile, and Brazil.

In a similar incident, the clinical study being conducted by Oxford University and AstraZeneca was also paused. One of the patients AZD1222 in the study was suspected to have faced an adverse reaction. The study was resumed in other countries but still on hold in the United States. The patient with the adverse reaction was suffering from spinal cord inflammation – transverse myelitis.

Any clinical study has its fair share of adverse events and accidents. Clinical trials are often paused for a couple of days. This pause has come in for more scrutiny as the world is eagerly awaiting a vaccine against the SARS-CoV-2, the Covid-19 –causing virus. The Study by Johnson & Johnson was in an advanced stage – Phase 3 ENSEMBLE trial. With more than a million lives being lost and several million affected worldwide, all eyes are trained on these clinical studies for a ray of hope in the form of a vaccine.

Under Operation Warp Speed, Johnson & Johnson has received funding of about $1.45 billion for vaccine development. The company is the tenth one in the race towards Phase 3 trials for a vaccine against Covid-19. 3 other American companies are also in the process. There has been testing before the clinical trial on rhesus macaque monkeys. The study established near-complete protection against Coronavirus infection in the nose and lungs. The Ebola vaccine technology has been put to use for creating a single-dose vaccine to prevent symptomatic Covid-19.

The vaccines from competitors such as AstraZeneca, Pfizer Inc., Novavax, and Moderna Inc. are two-shot vaccines that have to be administered with a gap of several weeks. A single-shot vaccine is easier to administer.

Pfizer is slated to announce the results of the clinical test and vaccine in November. Right now, the Pfizer-BioNTech vaccine study has an advantage and has received funding to the tune of $1.95 billion from the U.S. government. The study conducted by Moderna Inc. is in its third phase with about 30000 patients. Novavax has also commenced its phase 3 trial study. This biotechnology firm is working on a vaccine that can be handled as a liquid formulation in an unfrozen state. Requiring a storage temperature ranging from 2-8 degree Celsius, it will be easier to distribute.