In a statement today, the company Johnson & Johnson has announced that it is halting all its coronavirus vaccine trials as one of the study participants has developed an unexpected illness. This announcement has left many worried over how the company will move forward regarding the development of its coronavirus vaccine candidate.
Johnson & Johnson Covid-19 vaccine study paused due to illness.
Again. Nothing to worry. This is the purpose of conducting phase 3 trials on 10s of 1000s of volunteers, to identify rare events.
This is turbulence, not a crash.
— Faheem Younus, MD (@FaheemYounus) October 13, 2020
Before the announcement the company was one of the front runners for a potential COVID-19 vaccine.
However, this is not the first time it has happened. The company AstraZeneca in September had also halted its coronavirus vaccine trials when one of the subjects developed severe neurological symptoms.
Later University of Oxford which is developing the vaccine with AstraZeneca had announced that the trial data was extensively reviewed, and the illness was not linked to the vaccine administration. At the time the subject had developed spine issues, unusual weakness in limbs and an altered state of mind.
AstraZeneca and University of Oxford also consulted reputed scientists and researchers in this regard, and they unanimously decided to continue with the trial study.
A few takeaways: it’s not clear what the issue is, if it will have a meaningful impact on AstraZeneca’s trial, or the trials of other #Covid19 vaccine makers.
(Though stocks are reacting at least in short term as if this is a boon for Moderna, Novavax etc)
— Meg Tirrell (@megtirrell) September 8, 2020
— CNBC Now (@CNBCnow) September 8, 2020
Right now, Johnson and Johnson is not sure what is causing the illness in of their test subjects. The company even does not even know if the illness is linked to the vaccine or even if the subject received the vaccine.
In clinical trials for vaccines, subjects are often randomized into two groups. One receives the placebo and one receives the drug or the vaccine. often doctor and the subject do not know which person received which. This is what makes such clinical data clean of any human error or bias.
Johnson & Johnson started its phase 3 clinical trial last month. They aim to enroll at least 60,000 people in the trial and will test a single shot vaccine.
BREAKING: Johnson & Johnson starts Phase 3 #COVID19 Vaccine trial
-Follows positive interim Phase 1/2a results
-Placebo controlled, double blind study
-Single dose, 60,000 adults 18+ years old pic.twitter.com/w94DlLThys
— Squawk Box (@SquawkCNBC) September 23, 2020
The announcement suggests that an independent data safety monitoring board and the physician at the company will review and monitor the patient’s illness. It was also shared that the company is withholding more information till they have all the facts and to respect the patient’s privacy as well.
The statement further said, “Adverse events – illnesses, accidents, etc. – even those that are serious, are an expected part of any clinical study, especially large studies”.
This is in fact true. All trials for drugs and vaccines are often laden with some kind of side effects. After all the data is collected the scientists and the policy makers weight the total benefit of the vaccine against its possible side effects. That is how a vaccine gets approval for public use.
But there are some serious concerns in the scientific community that a vaccine for coronavirus is being developed at an alarmingly fast pace. If approved within this year or the next, any coronavirus vaccine would be the fastest vaccine in the world to be ever developed. Usually the process of development of a vaccine takes years.
The World Health Organization has also warned against countries taking a nationalistic approach. The international health agency instead is asking for a “collective” effort.
While many companies and countries have promised to share the vaccine with third world countries, President Donald Trump has made no such promise. He is also pushing for a vaccine to be developed before election day on November 3.
I welcome China’s willingness to join #COVAX.
We are all in this together. Multilateralism is key to reaching our #GlobalGoal of access to vaccines everywhere, for everyone who needs them.
We look forward to working with China and other partners on this.
— Ursula von der Leyen (@vonderleyen) October 11, 2020
We are delighted that Mexico 🇲🇽 and Brazil 🇧🇷 have joined the #COVAX Facility 🔬
— CEPI (@CEPIvaccines) September 29, 2020
— Peter Eriksson (@MinisterPeterE) October 1, 2020
Many are also worried that news of such illnesses might erode the trust of the public in the vaccine even when it is approved by the FDA.
An associate professor in epidemiology at La Trobe University in Melbourne, Hassan Vally, thinks that these vaccine trial pauses might even become more commonplace as the time passes.
He explained, “As you vaccinate more people in these trials the chances are that there will be some illnesses in participants. The only difference here is that in the world that we live in right now, the progress of these trials are in the public eye, and so we are riding every bump.”
Johnson & Johnson has already received $1 billion from the federal government as a part of Operation Warp Speed, to develop a coronavirus vaccine.
Many are now waiting as the company evaluates the trial data and its participants to determine the cause of the adverse event.