Vaccine Development and Human Trials

"Based on the strength of the preclinical data we  have seen so far and interactions with the regulatory authorities, we have been able to further accelerate the clinical development [of the company's vaccine candidate]."

[The company] is working hard to bring it [vaccine efficacy trial results] back to the end of the year." 

"If you have an incidence of one percent a year versus four percent a year, it's totally different. And that's where these trials are so unpredictable."

"[If the incidence is low], we will complement that with international sites to make sure that we reach enough end points quickly to prove the vaccine works."

Paul Stoffels, Chief Scientific Officer, Johnson & Johnson

Healthy study volunteers aged 18 to 55 years will take part in Johnson & Johnson's study for a total of 1,045 participants -- including those aged 65 and older. The trial is set to take place both in the United States and in Belgium. The company hopes to be in possession of vaccine efficacy trial results by the first quarter of 2021. 

No U.S.-approved treatments or vaccines for the SARS-CoV-2 virus that causes COVID-19 currently exist. There is, however general consensus that the global pandemic will come to an end only when a vaccine becomes available. The pandemic has up to the present infected over 7.2 million people worldwide, and killed in excess of 412,000 on a global scale, not to mention shattering the world's economy.

At the announcement by the company that it has moved the start of human clinical trials forward by two months for its experimental vaccine, its stock market shares leaped close to 2 percent, to $200 a share. The accelerated date gives the company the opportunity to join massive clinical trials planned by the U.S. government, with an aim to achieving an effective vaccine by the end of this year.

Johnson & Johnson signed an agreement with the U.S. government back in March, to design and commit to enough manufacturing capacity for the production of over a billion doses of its vaccine through 2021. And that, before it has evidence that its vaccine is safe and effective. Originally the expectation was that safety trials would commence in September; they've been bumped forward two months.

The study is meant to test the vaccine for the required qualities of safety and signs of efficacy. The company is engaged in discussions with the National Institute of Allergy and Infectious Diseases to begin larger, late-stage trials ahead of schedule, and that would depend on the results of the early studies and subsequent regulatory approval.

A handful of coronavirus vaccine candidates in trials will be tested under the federal program, that expects to enroll up to 30,000 subjects, its purpose to acquire a positive result on efficacy as swiftly as conceivably possible. According to Dr.Francis Collins, director of the National Institute of Health, those companies that are involved with the federal program will be required to complete safety trials by summer's end, to qualify for inclusion in those studies.

As far as Johnson & Johnson is concerned, its plans are to test its vaccine in high-transmission areas inside the United States. And should by that time the incidents of COVID-19 have plunged in numbers, they are prepared to add international sites with  high COVID cases in gathering proof of effcacy against COVID-19.

This undated electron microscope image made available by the U.S. National Institutes of Health in February 2020 shows the Novel Coronavirus SARS-CoV-2. Also known as 2019-nCoV, the virus causes COVID-19. The sample was isolated from a patient in the U.S. (NIAID-RML via AP)