Last Updated : Oct 13, 2020 07:59 AM IST | Source: Moneycontrol.com

COVID-19 vaccine: Johnson & Johnson pauses trials due to unexplained illness in participant

COVID-19 vaccine trial paused: Johnson & Johnson said the participant's illness is being reviewed and evaluated by an independent data and safety monitoring board, and its own clinical and safety physicians.

Representative image
Representative image

Johnson & Johnson said on October 12 it has temporarily paused clinical trials of its COVID-19 vaccine candidate due to an unexplained illness in a study participant.

In a statement, the company said that the participant's illness is being reviewed and evaluated by an independent data and safety monitoring board, and its own clinical and safety physicians.

J&J did not reveal details about the participant’s illness citing privacy. The company also said that they were “learning more” and it is “important to have all the facts before we share additional information.”

A serious adverse event, or SAE, is not uncommon in clinical trials, J&J said in its statement. “The number of SAEs can reasonably be expected to increase in trials involving large numbers of participants. Further, as many trials are placebo-controlled, it is not always immediately apparent whether a participant received a study treatment or a placebo.”

COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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Earlier in the day, Stat News had reported the pause citing a document sent to external researchers running the clinical trial, which stated that a "pausing rule" had been met, the online system used to enrol patients in the study had been closed and the data and safety monitoring board would be convened.

In September, AstraZeneca had paused several global trials of its own COVID-19 vaccine candidate, AZD1222, after an unexplained illness in a study participant. Most of these trials resumed earlier this month.

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First Published on Oct 13, 2020 07:59 am