In March, the Janssen Pharmaceutical Cos. subsidiary of the iconic New Brunswick-based drugmaker Johnson & Johnson, announced the expansion of a partnership between Janssen and the Biomedical Advanced Research and Development Authority (BARDA) with the goal of developing a vaccine to combat COVID-19.

BARDA and Johnson & Johnson have committed more than $1 billion to co-fund vaccine research, development and clinical testing.

In an exclusive interview with NJBIZ Paul Burton, Janssen’s chief medical officer, discussed the company’s vaccine development strategy and the multi-stage approach of bringing a vaccine from development to market.

The Janssen team, said Burton, started mobilizing in January. “We understood that this was going to be extremely important, it is an unprecedented crisis.”

Burton explained that a vaccine is a way of giving the body immunity to a particular infectious disease, in a safe and controlled way.

“The vaccine candidate we are working on involves taking a piece of the coronavirus DNA – specifically, one that codes for the ‘spike’ protein that latches on to human cells – and placing it inside a dead adenovirus,” he said. “The adenovirus is basically a safe common cold virus – which are good for transporting things into humans – but they lack the DNA needed to replicate. So, the vaccine can’t cause a cold and the protein it produces can’t cause harm either.”

Introducing the spike protein to the human body, said Burton, mobilizes the immune system so that an individual will start making antibodies and get white blood cells revved-up, identifying that protein and then spring into action.

Burton said that the company is confident about its platform because it has been tried and tested in more than 45,000 patients with other diseases. “The lead vaccine candidate we are working on makes use of our AdVac and PER.C6 technologies.”

It has been proven to be effective at making a vaccine in people with the Zika and Ebola viruses. “We are confident in the technology and we can scale it up and we can produce large amounts.”

While it typically takes five to seven years to make a vaccine, Burton said that with this vaccine the company is doing both the development work around making the vaccine and manufacturing rather than in sequence.

“We are doing it all in parallel so that we can be testing this. We have great technology that has been tested in 45,000 people previously.”

By doing the testing and manufacturing together the company expects to meet its goal to begin testing in a Phase 1 trial in September of this year.

By the end of the year Janssen hopes to have 300 million doses of vaccine available for frontline health care workers and patients.

The company is committed to making one billion vaccine doses and more as needed. With its current manufacturing capacity, it would be able to develop 600 million vaccines by the end of the year. But Janssen is investing in new production facilities to increase that number and anticipates reaching one billion doses in early 2021.

“We have the platform that we’ve tried and tested – we are doing all of the laboratory work right now – we will then begin our Phase 1 testing in September we will move quickly forward manufacturing at the same time. We are confident that by the end of the year we should have those initial doses available,” said Burton.

Burton said Janssen is working closely with the U.S. Food and Drug Administration and other health authorities around the world.

Unusual problems

From a public health perspective, Burton said COVID-19 presents a unique set of challenges. For example, its highly contagious nature and people who are asymptomatic can spread the virus.

“One of the big issues is unlike some of these other members of this class like SARS – people can be infectious without having symptoms,” Burton explained. “The good news is that it is a virus that a vaccine can be formed against – that while there are changes to the protein, it is not unduly changing all the time it is not mutating too quickly. So that is another big advantage.”

We understood that this was going to be extremely important, it is an unprecedented crisis.
– Paul Burton

Burton cited Johnson & Johnson’s legacy as a reason for optimism. “J&J was built for times like this and has the expertise and resources to help respond to a health crisis like this,” Burton said.

“We stepped in early with a multi-pronged response to the coronavirus, mobilizing employees around the world, including colleagues based here in New Jersey. We feel very confident that we will be able to produce this vaccine and make it available, pending the outcome of clinical research and regulatory approval.”

Burton added: “We are putting a great deal of effort and resources into this work, which forms part of our contribution to this unprecedented crisis.”

He said that when it is ready, the vaccine will be made available on a not-for-profit basis for emergency use. “It is a matter of us being able to bring the might of J&J to a really important global public health issue and to do it quickly.”