Johnson & Johnson Candidate Enters Phase 3 Trials

Large banners hang in an atrium at Johnson & Johnson headquarters in New Brunswick, NJ (AP Photo / Mel Evans, File)

Coronavirus Vaccine Tracker: A coronavirus vaccine being developed by Johnson & Johnson began phase 3 clinical trials in the United States on Wednesday, becoming the fourth company to reach this stage. AstraZeneca, Pfizer and Moderna candidate vaccines are already undergoing phase 3 trials in the US, although there is a pause in AstraZeneca trials for now.

There is additional excitement regarding the Johnson & Johnson candidate, as he is the first that a single shot vaccine could be. All other leading contenders right now would require double or multiple doses to remain effective. The Johnson & Johnson candidate has developed a single dose vaccine, but only the results of phase 3 trials could establish whether it is effective as a single dose vaccine or not.

Single-dose vaccines have obvious advantages, especially in today’s emergency situation. Twice as many people can be vaccinated compared to other candidates, leading to faster implementation and reduced costs.

The Johnson & Johnson tests are also expected to be the biggest yet. The company plans to register 60,000 participants for the tests. Pfizer is testing its vaccine on 44,000 participants, while Moderna and AstraZeneca have enrolled about 30,000 each.

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Johnson & Johnson said it expected to know by December if its vaccine was effective or not. That’s more or less in line with the schedules posted by Modern and AstraZeneca as well. Pfizer, on the other hand, has said it expected to get the effectiveness data by the end of October. If the results are satisfactory, you intend to immediately request emergency authorization. The Food and Drug Administration, the regulatory body in the United States, has said it was open to granting emergency use authorization even before the completion of phase 3 trials, if the benefits outweigh the risks.

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Johnson & Johnson is developing a single-dose Covid-19 vaccine. (Cheryl Gerber / Courtesy of Johnson & Johnson via AP)

Bharat Biotech will produce a nasal coronavirus vaccine being developed by the US University.

Hyderabad-based Bharat Biotech will manufacture and distribute 1 billion doses of a nasal coronavirus vaccine being developed by the University of Washington School of Medicine in the United States.

Clinical trials for this candidate vaccine have not yet started, the Indian company has obtained exclusive rights to manufacture and distribute the vaccine in all markets except the United States, Europe and Japan.

Bharat Biotech is also developing its own coronavirus vaccine, called Covaxin. That candidate is in phase 2 testing right now.

The vaccine being developed by the University of Washington School of Medicine is expected to require a single dose. Bharat Biotech CMD Krishna She said that a nasal vaccine was not only easier to administer, but it also reduces the use of other medical consumables such as needles and syringes, significantly reducing costs.

In Search of a Coronavirus Vaccine: The Story So Far

• 187 candidate vaccines in clinical or preclinical trials
• 38 of them in clinical trials
• Nine in the final stages, phase III of human trials
• At least eight candidate vaccines are under development in India. Two of them have entered phase II trials after completing phase I.

The most commented:

* AstraZeneca / University of Oxford
* Modern
* Pfizer / BioNTech
* Johnson and Johnson
* Sanofi / GlaxoSmithKline
* Novavax
* Russian vaccine, developed by Gamaleya Insttiute in Moscow
* Three Chinese vaccines that have been approved for use in China without the completion of phase 3 trials. One of them has received authorization for emergency use in the UAE.

(As of Sept 23; source: WHO Coronavirus Vaccine Overview Sept 22, 2020)

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