Coronavirus vaccine update: Johnson & Johnson pauses vaccine trial after unexplained illness in volunteer

US drugmaker Johnson & Johnson has paused clinical trials of its coronavirus vaccine candidate after an “unexplained illness” in a volunteer. Johnson & Johnson is conducting Phase III trials of its coronavirus vaccine candidate.

In a statement issued late on Monday night, Johnson & Johnson has said, “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 has further said, “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.”


Last month, J&J had said its experimental Covid-19 vaccine had produced a strong immune response against the novel coronavirus in an early-to-mid stage clinical trial, following which the pharma giant kicked off a final 60,000-person clinical trial. Results of the coronavirus vaccine trial are expected by the end of this year or early 2021.

Johnson & Johnson has however refused to divulge further details about the illness in the volunteer and said, “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.”

The company has also said that such illnesses in vaccine trial volunteers are a usual phenomenon. Johnson & Johnson has said in its statement, “Adverse events illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies.”

Johnson & Johnson has further clarified that a pause in vaccine trial is however not similar to a “regulatory hold” and that such pauses are a common part of clinical trials.


In September, the coronavirus vaccine being developed by AstraZeneca and Oxford University had suffered a similar setback as Johnson & Johnson which forced the British drugmaker to pause its clinical trials.

A volunteer for the AstraZeneca vaccine trials in UK had developed an unexplained illness, following which the trials were paused in the country and also in India. However, it has again resumed the trials of its Covid-19 vaccine candidate across several countries.

The UK government has said Thailand will also be manufacturing the AstraZeneca coronavirus vaccine. India’s Serum Institute of India (SII) has already been roped in to make the coronavirus vaccine on a large-scale. SII is also conducting clinical trials of the Covid-19 vaccine in India.

Meanwhile, the US government has awarded $486 million to AstraZeneca to develop and secure supplies of up to 100,000 doses of Covid-19 antibody treatment.

The agreement, under the Trump administration’s Operation Warp Speed, is for developing a monoclonal antibody cocktail that can prevent Covid-19, especially in high-risk population like those over 80 years old, the US Department of Health and Human Services said.


Mexico government has said it has joined the WHO-led Covax coronavirus vaccine alliance and made a payment of $159.88 million. The country has made the payment in order to gain access to Covid-19 vaccine doses as part of the Covax programme.

The Covax Facility is a multilateral initiative running trials on several potential vaccines. The payment made to Gavi, The Vaccine Alliance, which administers Covax, will allow Mexico to acquire enough doses of a vaccine to immunize up to a fifth of the country’s population of around 125 million people.

WHO chief scientist Soumya Swaminathan has said that more than 180 countries have joined the vaccine alliance led by the organisation. The Covax programme aims at distributing coronavirus vaccines across the world equally among the rich and poor.

(With inputs from agencies)

Source link

Leave a comment

%d bloggers like this: