Covid-19: What you need to know today
Oct 14, 2020
Covid-19: What you need to know today

Johnson & Johnson has paused the trial of its vaccine candidate for the coronavirus after an unexplained illness in one of the participants, although it wasn’t immediately clear whether the person was part of the test (or experimental group) which receives the shot, or the control group which doesn’t (people in this group usually receive a placebo).

The news was broken by Stat News, which also broke the news of the pause in the AstraZeneca-Oxford vaccine trial back in September.

What now?

The Data Safety Monitoring Board (DSMB), an independent panel comprising at least three external experts who have no financial links with either the study or the company conducting it — it is considered good practice to, apart from medical experts, have someone who specialises in the ethics of medical trials, and a person who understands data, as part of this board — will now have to look at the case, and decide what to do next. In any trial, the DSMB is responsible for the safety of participants.

Stat News, citing J&J, made the distinction between a pause and a hold.

“J&J emphasised... the difference between a study pause and a clinical hold, which is a formal regulatory action that can last much longer. The vaccine study is not currently under a clinical hold. J&J said that while it normally communicates clinical holds to the public, it does not usually inform the public of study pauses.”

The AstraZeneca study restarted a few days after it was paused.

Such pauses, and even holds, are common in the vaccine development process. But this isn’t just any ordinary vaccine. It is a vaccine for the coronavirus disease, which has infected 38 million and killed almost 1.1 million people around the world since the beginning of the year. There are 8.35 million active cases of Covid-19 as this column is being written, and at the current fatality rate of closed cases, at least 300,000 of them can be expected to succumb to the viral disease. All of this has made the process of finding a vaccine for Covid-19 a very public one, with unprecedented attention being paid to every small development. Most newsrooms, including Hindustan Times, have a vaccine tracker (both – a piece of content, and a very real person keeping an eye on all vaccines). HT’s for instance, shows that there are 29 vaccine candidates in early or Phase 1 trials, another 14 in Phase 2 trials, and 11 in large Phase 3 trials. It also shows that five have been approved for emergency, limited, or early use. The J&J vaccine was in a Phase 3 trial involving 60,000 participants.

Interestingly, most companies, including J&J, have released to the public extensive details of their clinical testing protocol — another unprecedented move in the history of vaccine development. J&J is also one of nine companies whose CEOs have signed a pledge to ensure they will “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals” — a promise that came amidst fears that the political establishment in several countries could arm-twist companies into rushing vaccines into the market or for regulatory approval before their safety was established beyond doubt (and in vaccines, safety is even more important than efficacy).

J&J was matter-of-fact about the pause, as it should be. “Adverse effects — illnesses, accidents, etc — even those that are serious, are an expected part of any clinical study, especially large studies,” it said in a statement. It is likely that the company will release more information about the patient’s illness over the next few days.

J&J was matter-of-fact about the pause, as it should be. “Adverse effects — illnesses, accidents, etc — even those that are serious, are an expected part of any clinical study, especially large studies,” it said in a statement. It is likely that the company will release more information about the patient’s illness over the next few days.



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