The race to develop a vaccine against the new strain of corona virus (SARS-CoV-2) has just got a new potential candidate. Johnson & Johnson announced that it had invested US $ 1 billion in US efforts to stop COVID-19.
Through a US military research agency, the government provided $ 456 million to Johnson & Johnson’s Janssen division. The corporation will also invest an equivalent amount to bring a COVID-19 vaccine study to the finish line.
The Janssen vaccine will be based on an adenovirus 26 (Ad26) version of the virus that causes the common cold, but has been genetically modified to lose the ability to infect. The scientists plan to transplant the surface protein genes of SARS-CoV-2 virus into “middlemen“Ad26 and use this hybrid virus to study vaccines.
The goal is to make the human immune system recognize the surface protein on SARS-CoV-2, not necessarily its core is Ad26 or corona, the human immune system will also launch an attack to destroy them. . This strategy has previously been used by Janssen in vaccines against HIV, Ebola, Zika and respiratory syncytial virus.
Speaking of potential, Johnson & Johnson’s pharmaceutical segment last year brought in revenues of up to $ 42 billion, making it the sixth largest pharmaceutical company in the world. Among the top 10 largest pharmaceutical companies in the world, only Sanofi is currently involved in the COVID-19 vaccine research race.
Paul Stoffels, scientific director of Johnson & Johnson and a veteran HIV drug developer, spoke to Science magazine from his home in Belgium, where Stoffels is practicing social isolation and at home. to protect myself and others from the spread of the new corona virus.
Stoffels shared that Johnson & Johnson’s COVID-19 vaccine project was implemented on a non-profit basis. They plan to produce and distribute 1 billion doses of vaccine worldwide. This is the greatest effort of Johnson & Johnson in the history of the corporation, Stoffels said.
Here is an interview of Paul Stoffels with Science reporter:
Reporter: What is the strategy for the same type of vaccine that you are aiming for?
Paul Stoffels: Have in hand “middlemen“Ad26, we have created 10 structures [virus chỉnh sửa gen] Various and tested all on mice. Through this process, we found the structure with the best immune activation.
In parallel, we also considered upgrading the cell line, which allowed us to grow cells at very high densities, resulting in very large yields. That gives us the capacity to produce up to 300 million doses of vaccine per year in each 2,000 liter biological tank.
Paul Stoffels, scientific director of Johnson & Johnson
We learned from the Zika vaccine development process, that intermediates [Ad26] is appropriate, we can get very significant immunity from this vaccine.
[Trong đại dịch COVID-19] we need good protection against a less lethal disease that happens on a large scale. So even though we could do it with a dose [vắc-xin duy nhất], but we will give a two-dose clinical trial.
In a crisis situation, perhaps we could deploy one injection first, then give one booster a year later to boost our immunity.
Please share your vaccine production capacity with the world?
We can produce 300 million doses of vaccine per year, in a 2,000 liter biological tank. We now have a fully operational facility with a 2,000-liter bio-tank and we begin setting up the second facility in the United States, which will be ready for production by the end of this year.
We have also talked to vaccine companies in other countries around the world, companies with similar capabilities to see which companies we can partner with, or we can still see. consider building new factories there yourself.
We think the world will need 1 billion doses of the COVID-19 vaccine, so we need 4 factories. And if the world needs more than that, we will adjust to get more vaccines in each biological tank.
Have you already tested the COVID-19 vaccine on monkeys and are you trying to infect the virus on them to test for protection?
Now, that is the next step we will take. We are working with Dan Barouch at Harvard, and while we are talking here, three primate have been vaccinated.
Why do you need September to be able to launch Phase I human clinical trials, while other competitors have come to this step faster?
With a strategy of producing vaccines using intermediaries like Ad26, you need to get seeds [bản sao của virus được thiết kế] to [gieo vào các bể chứa] biological production. It will take time to make sure we choose the right replicas and develop them consistently.
We grow them to achieve great yields, and so we will have seeds for the next few years, to produce hundreds of thousands of vaccine lots.
If you start testing Phase I in September, what is the plan after that?
Because we have a lot of data proving the safety [của trung gian Ad26 và sau cả thử nghiệm lâm sàng giai đoạn I], we can speed up the process from phase I [thử nghiệm phản ứng an toàn và miễn dịch] to proof-of-concept research.
We are experienced and accustomed to recruiting volunteers. This process can take place extremely quickly. We can experiment with 250 or 500 people in a single day. And just wait 1 month later, add 3 days when taking their blood tests, and we can know the test results.
So do you want to carry out an effective phase II study on 500 people as a proof-of-concept test?
To have a Phase II clinical trial large enough in real life, you need thousands of people who are in an emergency situation. That can be done very quickly, but you need to be in an epidemic area, and currently do not know if there will still be an epidemic somewhere late.
It is highly likely that the world still has such areas.
How long will it take you to get Phase I data to allow this phase II research start?
We worked like crazy to get to this point, 10 weeks after the vaccine project started. We have 4,000 clinical research participants worldwide, and we are capable of recruiting a huge study in a short time. Six weeks.
If this SARS-CoV-2 virus becomes a seasonal outbreak, and it will return to temperate countries in the Northern Hemisphere in autumn, early winter and next year, you may have the vaccine available. Ready a big test within that time frame?
In ideal condition we would have.
Assuming the vaccine is effective. What about accessibility? If you produce 1 billion doses, how do you distribute it to people all over the world, both in rich and poor countries, who will get the vaccine first?
First of all, our goal of getting 1 billion doses is to try to avoid a vaccine war. The whole world will have enough vaccine in that case. But we will need to work with the health authorities.
This project is implemented on a non-profit basis. This is the only time in history we can really do something for the world, it has a very powerful impact. And then every other company can partner with us because we’re ready to welcome them.
That is why I hope we can accelerate the process of expanding the scale of vaccine production further, by working with governments around the world. I am almost certain that things will accelerate within 6 months because we are doing it for no profit.
This is one of the greatest, if not the greatest, initiatives in Johnson & Johnson history to try to make a difference that will help the world.