Johnson & Johnson Coronavirus Vaccine Will be Tested in 60,000 People

The Johnson & Johnson coronavirus vaccine candidate has entered third phase of clinical trials where the vaccine will be tested on nearly 60000 subjects to see its effectiveness and safety. The trial will be conducted in the United States and is one of its kind as it is only administered through one shot.

This will be the fourth vaccine to enter large phase 3 trial in the country. The company’s chief scientific officer, Paul Stoffels, says that the data from this trial will be enough to provide with a conclusive result by the end of the year. He also shared the company plan to manufacture 1 billion doses by next year.

This vaccine candidate being manufactured by Janssen Pharmaceutical Companies, a division of J&J, will be superior to the other three as this vaccine will be easier to administer and distribute. Other vaccines began testing earlier and have a head start but all of them require two doses of the vaccine to be administered to be effective. Those vaccines will require people to back to the doctor’s office three to four weeks after the first one to trigger a protective immune response.

Johnson & Johnson vaccine can also be stored in liquid form in a refrigerator for up to three months. For two other vaccines, the cold chain has to be maintained and they have to be kept frozen or at extremely cold temperature for long term storage. If cold chain is broken the vaccine becomes useless.

The Trump administration has invested billions of American taxpayer dollars in vaccine development after the pandemic of which nearly $1.5 billion was promised to J&J for their coronavirus vaccine. The government has also placed an advance order of 100 million dollars for this particular vaccine.

The J&J vaccine uses a viral vector approach for its design strategy. The company scientists took a virus which was not harmful for humans and inserted it into a gene that contains the blueprint for a distinctive part of the novel coronavirus.

In a previously published paper where the researchers tested this vaccine in animals, it was shown that the vaccine produced an immune response against the real coronavirus. The monkeys which were exposed to the real virus remained healthy.

Other data from early studies in humans has also shown that the vaccine did produce an immune response and the side effects were mild, including fever which only lasted for two or three days.

The company has also promised to publish the full protocol for its vaccine trial which will include data on how scientists determined whether the vaccine is safe or not. This step was taken by several companies in an effort to ensure that their vaccines are safe for public use. These companies also promised in a statement that they will not seek an approval for their vaccine if it is not proven safe. J&J will also get their data and trial monitored by an independent committee periodically, to see if their vaccine is a failure or a success.

Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, also stated that once there will be 154 cases of coronavirus patients in the trial, it will be possible for the scientists to tell whether the vaccine is effective or not.

This particular phase 3 trial is double the size of other phase 3 trials in the United States that are being conducted for coronavirus. However, it is important to note that Pfizer trial has also expanded to include 44,000 participants. Among the 60000 people in J&J trial, half will receive a placebo and other half will get a vaccine.

This trial will also have an advantage over the others when it comes to diversity. Clinical trials for vaccines need to recruit people of different ethnicity to see if the vaccine works for everyone. While other vaccine candidates have suffered from problems of not enough diversity in their trials, this trial is being conducted all over the world which means no such issue will arise here.

“The vaccine trials need to have participation that reflect the diversity of our nation,” said Michelle Andrasik, director of community engagement for the Covid-19 Prevention Network, the federal network partnering with companies to run trials. “We need everyone involved to ensure that we find a vaccine that is effective for everyone.”

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