The Colombian government signed a memorandum of understanding with the US biotech company on Wednesday Inovio that lays the foundation for mass production in the country of INO-4800, its covid-19 vaccine. The agreement comes a few days after the Invima gave authorization to this company to begin phase 3 of its clinical trials among nationals.
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In an interview with EL TIEMPO, Joseph Kim, CEO of the company, spoke of the advantages of its biological over others that are already on the market and the potential that exists in Colombia to become an arsenal of vaccines for the region. Kim also gave his perspective on the future of the pandemic and explained why vaccines are the most effective tool in the world’s battle against the deadly disease.
Invima recently gave the green light for phase 3 clinical trials. When do you plan to start and how many people do you expect to be volunteers?
ASAP. We are in the process of importing the equipment and starting up. It could happen in a week or two. We expect about 1,000 people to participate. The total number worldwide are 10,000 or more.
And when do you think you will have definitive results to begin your application?
We expect to see final results in about four to six months, that is, we are aiming for spring, and we will continue to monitor participants for safety for a year. Our goal is to apply for emergency use as soon as phase 3 is completed, not only in Colombia but in the other countries that are participating such as Brazil, the Philippines and Mexico.
If all goes well, when do you expect to start the official production and distribution of the vaccine?
We’re going as fast as we can, and we expect the emergency clearance to come out by the summer of 2022.
Vaccines such as Pfizer, Moderna and others have been on the market for some time and are expanding their production capacity. Why then is another vaccine like yours necessary, which also starts with that disadvantage?
Is right. The first wave of vaccines has been very effective and important. But we are leaders in a second wave of vaccines because they are still so much needed locally. Our goal is to direct it to where it is needed most, low- and middle-income countries outside the US and Europe, where there is less access to COVID-19 vaccines.
But INO-4800 has many potential advantages over what is available. Our vaccine does not have to be frozen for storage or distribution, as it is stable at room temperature and can last up to a year under those conditions. With normal refrigeration its useful life is five years. That is a tremendous advantage. Also, it is more tolerable. We have not seen side effects, such as fever or chills, that are common in the others. In a scenario where it will be necessary to give boosters, a vaccine that is safe, durable and without complications is required.
In terms of results, how does the INO-4800 compare to the others already available?
What we have seen is that INO-4800 develops a strong immune reaction that is at the level of the others. But in addition to that, it generates a very good T-cell response. And that is very good because the T cells are the ones that guarantee protection as time passes and on which the reaction against covid variants depends. In our clinical trials 1 and 2, T cells were 100 percent against variants such as alpha, beta, and delta. INO-4800 not only provides high levels of protection at the start but its protection is longer and more durable.
Why did you choose Colombia for phase 3 of the tests?
Colombia is not only an attractive market to carry out the tests but to distribute them. The country has a solid regulatory agency (Invima) and a government that cares about its people and that from the beginning showed interest in working with Inovio, not only for clinical trials but also for the transfer of technology that allows the production of the vaccine in Colombia. For use among Colombians and so that perhaps Colombia is an exporter of the vaccine to other countries in the region. And that is the reason for this trip. We came to sign a memorandum of understanding (MOU) with the government of President Iván Duque.
What was agreed in the MOU?
Work together to develop the dependencies that will produce INO-4800 and potentially other vaccines in which we have been working. It’s very important.
How do Colombians and the country’s pharmaceutical industry benefit?
Colombians benefit because as we establish that production chain, they will have a vaccine available for now and for the future. It’s about safety in health. Likewise, they will be able to produce for other countries.
In other words, will Colombians have priority when it comes to distribution?
Of course. By establishing production in Colombia, Colombians will have priority access, but they also benefit by becoming producers for other markets.
How safe is your booster vaccine if we consider that many Colombians have already been inoculated with other types of biologics previously?
Our vaccine has shown the best indicators of both safety and durability not only as a primary source of vaccines but as a booster. In our statistics we have seen that our booster vaccine provides great levels of additional protection.
Give us your projections on the pandemic. Are we coming to the end now that vaccines are available and other medicines are being developed to control your symptoms?
Vaccines have been very successful and as we reach 70 or 80 percent of the vaccinated population we will be in a better place. I believe that the pandemic as such will end by the end of 2022 but then it will become an endemic disease like influenza, something that will have to be faced every year, perhaps by applying reinforcements or through monitoring or both. But the covid-19, as we have seen, is going to go through mutations, new variants, and that is going to cause outbreaks, in some serious cases such as in the case of delta and more may come.
Unfortunately, we will have to battle with the covid for many more years. But my hope is that the pandemic will end and we will soon enter its endemic phase. And that is why INO-4800 is important because we will continue to need safe vaccines in the future.
But if the covid is going to mutate, what guarantees that INO-4800 or other vaccines will be effective against these new variants?
Our vaccine is ready to face the endemic phase of the disease and will be an arsenal against it. But additionally we are already developing a new generation of ‘pancovid’ vaccines that we call INO-4802 and we will begin phase 1 of clinical trials at the end of this year. This new generation vaccine will help us to protect ourselves even more against the variants of the virus that may arise.
And, finally, what do you think about the mandates or mandatory nature of the vaccine, an issue that sparks intense controversy in the US and other countries?
People are free to decide to a certain extent. But vaccines have proven over the years to be one of the most important medical advances for our society. And we continue to use vaccines to protect our children from infections, to protect adults from diseases that can cause cancer, and covid vaccines are no exception.
We have lost millions of people in the last 20 months to COVID-19 and vaccines are overwhelmingly efficient at providing protection and very safe. And having the option of being able to protect ourselves and our families is very important. And it is the responsibility of governments to offer as much protection as they can to their citizens. I support the mandates, but I understand that it is a complex issue. I have no doubt that the benefits of the vaccine far outweigh the risks or concerns.
SERGIO GÓMEZ MASERI
EL TIEMPO correspondent
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