We Dont Have the Chance to Wait for COVID Vaccine for YearsDirector of the Infectious and Immunological Diseases Research Center and the Division of Pediatric Infectious Diseases at Cedars-Sinai Medical Center, Moshe Arditi, MD, told us how the world of science went out of their way to be victorious in the COVID vaccine race. Professor Arditi shared the details of the BCG vaccine experiments he is directing, which also made the headlines in Turkey concerning the struggle with COVID-19. The professor with Cerrahpaşa Medical University background also cleared the wrong association of the Kawasaki illness hes an expert in, with COVID-19.
Translation by Janet MITRANI
I would like to start with a very basic question. How is vaccine produced?
Vaccines are designed to imitate the immune response a person would naturally develop when infected. The vaccine teaches the immune system to recognize the pathogen so that the next time it confronts the pathogen, the body can get rid of it. In the beginning, the ideas are tested in the laboratory and on animals. Then it is tried, in the first phase, on a group of 30-40 volunteers, and in the second phase on hundreds of people of different age groups. In the third phase, during the infection season, it is determined how many of the thousands of volunteers have caught the disease. In each phase it is examined whether the required immunity has surfaced, and whether negative side effects have occurred. In the fourth phase the vaccine is launched in control of the healthcare authorities, continuing the security and efficiency checks.
Among pharmaceuticals, vaccines are monitored longest because the vaccine is given to healthy people. A person’s health cannot be risked. It is very hard to shorten the duration of these phases. On the other hand, when we consider the epidemic speed of COVID-19, we don’t have the chance to wait for the vaccine for years.
Then, the question everyone is wondering, when do you think the COVID-19 vaccine will be ready?
I think we can develop a secure and effective COVID-19 vaccine in 12 to 18 months. Dr. Anthony Fauci, the coronavirus consultant of the White House is hoping that an effective and harmless vaccine will be able to be developed in February-March 2021, considering that the vaccine studies in humans have started in March. Until now our record for producing a vaccine was as short as 4 years. Our possibility of cutting back the duration to 12-18 months is like a miracle. However, there’s a difference between the vaccine that works in small experiments and the vaccine that will be performed on billions of people.
Dr. Moshe Arditi together with Dr. Anthony Fauci
Dr. John Bell in Oxford said that the vaccine will be ready mid-June. Also, Dr. Martin Bachmann from Bern University in Switzerland stated that the vaccine they are developing may be used on the Swiss. Can we trust these claims?
In my opinion, no one can give such a date for the vaccine. You should promise less, deliver more; instead of promising more and delivering less. We still don’t know how protective immunity develops. Our biggest concern is the case of ‘enhanced immune response’ where the immune system overreacts. Rather than protecting against the virus, when the vaccinated person confronts the virus, he/she experiences a worse case of the illness. So, we cannot shortcut skipping the security issue. Countries should work not separately but together as they did in the ‘Manhattan Project’, and develop a universal vaccine, treatment, and knowledge for COVID-19.
What are the scientists doing to speed up the vaccine discovery process?
100 vaccine studies and 80 drug studies are being executed globally right now. Many new procedures are being recommended for the vaccines to produce quicker results: ‘Challenge Test’ is one of these. In this, after the tested vaccine is injected to the volunteers, it is waited for their bodies to produce antibodies, and to see quickly whether the vaccine works, coronavirus is directly injected to the same volunteers.
This issue is morally controversial. People trying to legalize this in the U.S. Congress, say that this is a case of war. Just like soldiers are given tough assignments during the war, injecting young people with the vaccine and then the virus should be accepted ethically. This is a procedure that speeds up the vaccine experiments and could help us.
A second method is instead of testing on tens of thousands of people, the vaccine is tested on much fewer people; if the results are positive, the vaccine may be injected to, for example, only to the healthcare providers. In short, the vaccine can be ‘emergency used’ on limited groups. Only this way we can reduce the process to 12 months. The coronavirus epidemic that resembles nothing we have encountered until now including MERS, SARS, and H1N1, will change how scientific researches are made globally forever. In the coming decades infection disease researches will be prioritized.
Vaccine studies for SARS had been conducted, too. However, when SARS disappeared by itself, these were laid aside. Can something like that happen with COVID-19?
No, even if COVID disappears, we will see through the vaccine studies. As opposed to SARS, it is very hard for COVID-19 to disappear by itself. COVID was able to turn into a pandemic because it can easily be transmitted by respiration. We learned a lot from SARS. We have blood samples of people who had SARS in 2003; we saw that the antibodies in the blood can kill COVID-19. If only the funding had continued, thus SARS vaccine studies could have gone on.
When you were talking about the risks of the vaccine, you mentioned ‘enhanced immune response’. Even though it’s a small number, we heard that about 100 children globally have been treated with extraneous inflammation in intensive care. They have the symptoms of Kawasaki disease you are an expert of. Rumor is that COVID-19 causes Kawasaki. What do you think?
Dr. Moshe Arditi together with Dr. Tomisaku Kawasaki
These children suffer some of the symptoms of Toxic Shock Syndrome and Kawasaki disease at the same time. However, we cannot call this new syndrome Kawasaki Disease and we shouldn’t. International Pediatric Emergency Care Specialists had a meeting with Kawasaki Disease Specialists and examined these cases. To emphasize that this is a different syndrome than the Kawasaki Disease, they named it ‘COVID-19 Associated Hyper Inflammatory Response Syndrome’.
The most important thing I want to express here is that, families should not panic because of this news that is everywhere, and that this newly explained syndrome related to COVID-19 is very rare. In my opinion, the only good thing about COVID-19 is that it increased the public awareness for Kawasaki Disease globally.
Controlled clinical trials are conducted as to whether BCG (Bacillus Calmette-Guerin) vaccine that is used against tuberculosis, can help the immune system fight COVID-19. You are leading one of the five experiments led in the U.S. What exactly is being done in that study?
In my study 400 healthcare workers volunteered. We will inject half of them with the BCG vaccine and half with placebo. We’ll track them for 6 months. If anyone among them are sick, they will be given COVID, PCR and antibody tests. At the end of the process we’ll check the group performances. All the experiment results from all the U.S. universities will be collected so we can say that we have an experimental group of 1700 people.
Dr. Moshe Arditi & Selin Kandiyoti
Similar studies are being conducted in many countries. Are the countries working in an organized cooperation?
This started in the Netherlands by immunologist Dr. Mihai Netea. We all are using Dr. Mihai Netea’s protocol. They already gave 500 volunteers the BCG vaccine, 500 the placebo, in total to 1000 healthcare workers, and they are waiting for the results. In another study, they did the same trial on a high-risk group of 1800 people aged 65 and above. In Australia they have started a trial on 4000 healthcare workers. The decision to share the data and coordinate the results was made, so that because the test subjects will increase, the trials will be more trustworthy. Germany, India, and Egypt are also starting the trials.
In the case that this benefit is proven, will the BCG vaccine we had when we were babies be enough for us? Will it have to be repeated?
What we know is that BCG’s immunity against tuberculosis lasts for 15-20 years. Yet what we are after is how long the BCG’s benefit except for its specific use, meaning for other illnesses, lasts. We wonder whether its effect duration is the same. We know it lasts for 1 or 2 years, but we don’t know the rest, we haven’t studied. However, we have such charts that, in the countries where the BCG vaccine was made, death rates are way lower when compared to the countries where it wasn’t made.
We cannot regard this and say directly “BCG Vaccine protects us from COVID-19". Nonetheless there is a correlation in-between that we cannot disregard. The data are really impressive. Even if we didn't have this data, BCG's non-specific trained immunity capacity has been scientifically proven, and that is enough reason to go through with this controlled trial. For the proof and a real cause and effect relation, we will check the results of our controlled trials. If it is proven of course the vaccine should be repeated.
Portugal repeats this vaccine every ten years. In this case the trials in the countries where BCG was never made, such as the U.S., Italy, Netherlands, are more important, because the test subjects will be having the vaccine for the first time. Considering that the non-specific effect lasts for 1 or 2 years, this will serve as a bridge between the healthcare workers and other risk groups, for the time it takes to develop the COVID-19 vaccine that is being worked on all around the world.
Data dated April 10th: https://www.jsatonotes.com/
You are a very successful physician who is being consulted on COVID-19 both in the U.S. and here. Could we relate this to the medical education you got in Cerrahpaşa Medical Faculty in Turkey?
Of course, I can. We studied with very important professors in Cerrahpaşa. They all are important in a different way for me. We lost many of our valuable teachers to COVID. I’m very sorry to say that my pathology professor Feride Öz lost her life at the age of 87 because of COVID, beginning of April. I am very sorry. This is very emotional for me. We had studied in one of the best faculties in the world. Especially the Pathology Department of Cerrahpaşa was known all over the world. This department had been founded by Siegfried Oberndorfer and Philip Schwartz who had been running away from the Nazis and thus had been invited by Atatürk from Germany. Feride Öz and my valuable professor Talia Bali Aykan had personally been students of Schwartz himself. I am forever grateful to them.