Coronavirus vaccine: Johnson & Johnson’s Covid-19 vaccine enters Phase-3 trials; When is it expected?

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New Delhi | Updated: Sep 24, 2020 10:46 AM

Coronavirus vaccine latest update: Johnson & Johnson has said that the main purposes of this study were to assess the safety, side-effects if any, and find out If the JNJ-78436735-Ad26.COV2.S vaccine helps prevent or lessen the severity of Coronavirus.

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Coronavirus vaccine latest update: Johnson & Johnson has launched the Phase 3 human trials of its experimental Coronavirus vaccine candidate JNJ-78436735-Ad26.COV2.S. The potential Covid-19 vaccine candidate is being developed by Johnson & Johnson’s Janssen Pharmaceutical Companies. During the large-scale phase 3 clinical trials, 60,000 volunteers would be enrolled across three continents. Countries, where phase 3 human trials of Johnson & Johnson’s Coronavirus vaccine will be taking place, are – Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the US. Johnson & Johnson has stated that the phase 3 clinical study will assess the safety and efficacy of a single vaccine dose versus placebo in preventing Coronavirus. Johnson & Johnson has revealed that it has the “ultimate goal” of supplying “a safe, effective vaccine in 2021”.

Johnson & Johnson’s Coronavirus vaccine candidate JNJ-78436735-Ad26 is an Adenovirus type 26 (Ad26) vector-based adenoviral vaccine.

In July, Johnson & Johnson began testing its investigational vaccine on over 1,000 healthy adults between the age groups of 18 and 55 in the US and Belgium as part of that 1/2a phase. Back then people aged 65 and over were also recruited. “During this phase, we really zero in on establishing safety and finding the correct dose,” Johnson & Johnson stated. These results have been submitted to medRxiv and are due to be published online imminently, the company stated.

More about Johnson & Johnson Covid-19 vaccine

Johnson & Johnson has said that the main purposes of this study were to assess the safety, side-effects if any, and find out If the JNJ-78436735-Ad26.COV2.S vaccine helps prevent or lessen the severity of Coronavirus.

In this study, half of the participants will get a placebo instead of Ad26.COV2.S vaccine. The placebo looks just like the JNJ-78436735-Ad26.COV2.S vaccine and is given the same way: by injection (shot). But the placebo contains no active vaccine. Using a placebo in the study allows researchers to see potential differences between the investigational vaccine and the placebo. The placebo in this study will be sodium chloride, also known as saline (saltwater), Johnson & Johnso said.

Participants, who join the study, will be in it for about 2 years. During the study, staff will collect blood samples, saliva samples, and nasal swabs. If any volunteer becomes COVID-19 positive, the study staff will monitor him/her daily and request that the volunteer provide extra nasal swabs and saliva samples. The study will be conducted in two stages for each age group. The first group consists of 2,000 participants aged 18-59 who do not have other health conditions. After they have received the injection of the study vaccine or placebo and have been observed for 3 days following the injection, all the remaining participants in that age group will be enrolled. The same process will be followed for the group aged 60 and older, Johnson & Johnson stated.

During the Phase 3 human trial of the COVID-19 vaccine candidate, an independent, expert vaccine Safety Advisory Board has been put in place for additional consultation and advice on safety risk management. Furthermore, the safety of the entire clinical study will be overseen by an independent Data and Safety Monitoring Board (DSMB).

Johnson & Johnson said it would also disclose the data on external public registries, such as ClinicalTrials.gov and the EU Clinical Trials Register. Apart from this, Clinical Study Reports and Clinical Trial Participant Data will be made available for sharing with researchers through the Yale University Open Data Access (YODA) Project.

Johnson & Johnson has also agreed in principle to collaborate with the United Kingdom of Great Britain and Northern Ireland (the UK Government) on a separate Phase 3 clinical trial in multiple countries to explore a two-dose regimen of Johnson & Johnson’s vaccine candidate.

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