 Let's talk about COVID-19 vaccines. Some of the latest news on this front has come from the United States where the Food and Drug Administration has said that it is willing to fast track the approval process for a vaccine if there are more benefits than risks. Last week, the financial times that reported at the US administration was considering fast-tracking the process for the vaccine candidate developed by Oxford University in AstraZeneca. Phase three trials for this vaccine have begun in the US. The third phase of trials are conducted on the maximum number of people and are vital to declaring the vaccine both safe and effective. Now the date being mentioned is the first week of November which is suspiciously close to the US presidential elections. It does look like Donald Trump is planning to use the vaccine to boost his electoral prospects which currently don't look that good. But he's not alone. Politicians everywhere including in India have been hoping that the vaccine gets credited to their name and gives them some political capital. But what happens when medical procedure is bypassed in this rush for political gains? I mean all these Dr. Satyajit Rath talks to Newskirt Prabir Purkhayas on this issue. Satyajit, today's discussion let's start with the vaccine issue. Now it seems that the vaccine is also becoming an electoral ploy in the US elections and Trump wants to sanction use of vaccine before the election campaign really starts. Do you think that is a possibility and what are the implications of that if that happens? Well, let's look at it this way. There was a ploy to declare a vaccine on the 15th of August 2020 and that clearly did not work. This is your talk of the Indian vaccine that Modi would announce from the ramparts of the red port vaccine. Thankfully that did not pan out. Proper procedures are being followed so far. But certainly following on from that as well as following on from their own previous efforts at short circuiting due approval processes, the US administration has now declared the 3rd of November to be a potential target date and it's a little bit further away than the 15th of August. Phase 3 trials have already started. So is it within the bounds of possibility that the data might come in time for a rapid but proper procedure to certify a vaccine? There is an outside chance. It's not a very good chance. But the US FDA and its political masters, as it turns out, have now begun apparently making noises about preparing ground for a short circuit of due process. Okay. So a new process is already being discussed. So that's exactly what an emergency authorization, use authorization is, which is apparently what is being discussed. Okay. The whole point about having an emergency use authorization, is that due process of efficacy for approval has not been gone through in its entire. This is the hydrochloroquine authorization or the therapy of authorization as well. Correct. So the hydroxychloroquine was a, so it's interesting that you bring it up because it's instructive for us to compare and contrast what's going on. So hydroxychloroquine was authorized on two grounds. One, that it was safe because it's already in the market and being used. And two, with no data whatsoever of any rigorous kind, meaning no clinical trial data, that there were anecdotal stories that it might be useful. The emergency use authorization therefore depended on saying, hey, it's safe and it might work. Okay. So at least it satisfied the safety requirement, if not the efficacy requirement. Right. Now that's precisely what is apparently being discussed as the basis for an emergency use authorization for what I keep calling candidate vaccines. Okay. Again, it is said, they've already been shown to be safe because they've finished phase one and phase two trials. Those trial results have been published and therefore they're safe. Okay. Whether they work or not, they likely work because they generate neutralizing antibody responses. We'll get a little bit of phase three data that begins to show some differences that should be enough for an emergency use authorization. So it's been argued that it is safe and therefore there is not so much of a risk. This is the argument. This is the basis. I haven't heard the actual FDA personnel being reported as having said anything in this much detail. Simply the more more opaque noises about we are looking at possibilities. But this is likely to be the basis. What's interesting is for us to look at the difference between a drug and a vaccine in the context of emergency use authorization. Okay. You give drugs to sick people. That the drug has a long history of being safe. You're giving it to sick people. You're hoping that it'll make a difference. If it doesn't make a difference, you're hoping based on its safety profile that it will do no harm. It will have no adverse consequences. Now, at least the safety has been proven. Therefore, risk to sick people is one issue. But here you are giving safety based on phase one and phase two trials to healthy people and that to a much larger number. So it's a little, you're right, but it's a little more complicated than that. And here's the complication. Remember what we said about the drug. We said that if it doesn't work, it won't do any harm. It will have no adverse consequences. So let us ask, is that true of a vaccine that doesn't quite work? Now, this is not simply a matter of safety, because let us admit that phase one, phase two trials have been done and therefore the candidate vaccine is safe. In terms of the adverse effects, I take the vaccine for the next 15 days or three weeks. I'm healthy and I have had apart from a little local pain, apart from a little fever, I have had no ill effects. Is that going to change if it is given under an emergency use authorization? Not likely. But remember what a vaccine does. A vaccine generates an immune response. The immune response we hope will last for a substantial period of time. This is very unlike a drug. You want the drug to have an effect while the drug is in the body. That's it. The vaccine is designed to create a long-term downstream effect over time. Now, in this context, consider what might happen. Supposing, just supposing that all is well, the vaccine offers some measure of protection and that will say that the gamble has worked. But suppose alternatives. Number one, the one alternative is that there will be an immune response. The phase two trial has said that there will be immune responses. So when it's given under an emergency use authorization, there will be an immune response. But that immune response won't protect. Now, it's caused no harm because you say the people who are vaccinated with this emergency authorized vaccine are no worse off than people who are not vaccinated. Not quite. And that's where the difference becomes prominent. In the first place, we know, for example, in India, we are very familiar with the idea that a preexisting immune response to dengue virus can actually enhance these caused by dengue virus. This is not at all to say that I think that's what's going to happen. This is simply to point out that in the immortal phrase, stuff happens. I mean, there's a stronger word than that, but we'll leave it out. But if that is a possibility, then what we would be dealing with is an adverse effect that is generated by an emergency authorized vaccine use in healthy people over a reasonably long term. Now, let's also break it down a bit. What you're saying is I get the vaccine and it doesn't really give me protection against the infection. I get the infection. Now the reaction of the body actually makes the infection far worse. This is what seems to happen in the second dengue infection. This is what happens. The second one becomes much more. What is thought to happen in the dengue example? Kind of a cytokine reaction? Well, let's not even get into how it happens, because in all likelihood, how it happens in dengue is not going to be exactly how it happens in other instances. But the fact is, is this a possibility? Yes. Has it been ruled out? No. What would rule it out? Has such a case happened in the past with the vaccines, for instance? Not to my knowledge, but that's because in the past, no vaccine has been authorized through a short circuit. Remember, we said if there's protection, well and good. If there is just no protection, then it's okay. It's no worse. Whereas in the unlikely event that there is exacerbated disease, we're being troubled. But that's unlikely. You say the most likely thing is that it won't protect after all. But that's not all. Even though it doesn't protect, it will have generated an immune response. Now, my body is experienced with a SARS-CoV-2 vaccine and has generated a response in a direction that is apparently not protected. This might make me resistant to the effect of an actual vaccine. Okay. So now that I have my body has experienced with some components of a candidate vaccine and has for whatever reason ended up making a response that's not protected, that's background. Now, on top of this, I get a vaccine, even a vaccine that actually works. But my body may have very different ideas about how to respond in the light of its own previous experience. So it will react in that direction much more strongly and therefore the actual protective reaction may not take place. And while we do not have really apart from Dengue too many examples of exacerbated infection, do we have examples of redirected immune responses based on previous experience in truck loops, in experimental systems, in human systems? There are any number of examples where a previous experience with an infection modifies the direction of response to a subsequent immunization. So let me summarize it for our viewers. So one risk we carry is a Dengue-like response where the second infection in this case, not from the vaccine, but from the virus itself, could provide a much more serious reaction in the body. So that is one. That's a risk, but you are saying maybe it's not such a big risk, but certainly the more known and established risk is that instead of the body's immune system reacting, which it would normally do, because of the vaccine it may direct itself in a different way and that may actually make me more open to infections than would have occurred otherwise. Have I summarized this for my viewers? Yes, except that it's more that a vaccine that works may not work in these people. In fact, in added to that, the vaccine that works in other people will not work in this. May not work in these people. You have actually removed the protection, possible future protection by giving a not properly tested vaccine. Our next segment is about the challenges faced by health workers in Palestine, both due to the COVID-19 pandemic and Israeli occupation. Shada Odeh of the Palestinian Health Workers Health Work Committees talks about some of these challenges. So in a larger level, how has the health system been affected, especially when it comes to personal and equipment, when it comes to doctors, healthcare personnel in terms of their training, in terms of the psychological situation they're in, what is happening right now? Okay, yes, of course, when there is the lockdown, all the medical, all the healthcare system, they are not in lockdown, all the healthcare professionals, they should be ready in the first line. So, yes, of course, in the earlier time of COVID-19, like I'm talking about March time, most of the organization, even the NGOs and the private and even the Ministry of Health, they have been supporting the availability of all the COVID-19 precautions, like the gowns, the mask, the fields, the gloves, the hygiene kits, and all the disinfectants. But now, but because of WHO and other international they started to have it in to be available. And the private sector, they start also to to bring this kind of equipment, but it was very expensive. It was 10, let's say 10 time more their price. For example, we couldn't buy for our staff, but at least now time, the situation is much better. Now, most of the protective devices and equipments is available for the medical staff. Of course, the medical staff from nurses and doctors, as a health system, they suffer from shortage of nurses and doctors. And, you know, some doctors and nurses and technicians, lab technician, for example, they have their only problems that, for example, she's pregnant or they have some chronic disease they should stay, according to the criteria, they should be staying at home. And this is what happened in the Ministry of Health and in our organization that we asked them to stay at home because they have medical, other medical problems. When the team of nurses and doctors go to work in the quarantine areas, they should stay there for 14 days. After 14 days, they should go back. So this means that medical staff, they are isolated from their social network. They are isolated from their families, from their children, whether I'm talking about men or women, if she is mother and she will not see her child or take care of her child, yes, this is a very difficult situation. And also, yes, psychologically, it's very dramatic for the medical and professional, they were worried that they would be a victim of COVID because of working with the people who are having this kind of virus. Yeah, and there is a number, let's say, of nurses and doctors and technicians, they were infected by COVID-19 and they were in quarantine for, and they will have some complications and they have been in the ICU bed and under ventilator, but they're lucky still we don't have any case. I guess, yes, I guess, maybe one or two cases, they died from COVID, which is, let's say, something good for for medical staff because we feel that losing one medical staff or it will be a problem for our health care system. And then, of dealing with this kind of virus, there were a plan at the national level to train our doctors and nurses how to protect themselves, how to deal with the Ministry of Health and the NGOs. We do a lot of self-supported group ventilation to do healing for their psychology because, yes, it's very burning for them and for their emotions and for their logical afraid from having the COVID feeling isolated from their networks and families and friends. The stigmatization also is very important for the medical staff and for the people they afraid and they don't want to be other people and their neighbors to know that they have COVID, you know, this is the situation of stigmatization is very difficult. So, yes, there is a lot of, let's say, psychological intervention provided by the psychologist, provided by a team working inside organization, like our organization we did for our healthy professionals. We did also psychological support through helplines for the women, for people with disability, for elderly people, for also people inside the quarantine. We have a hotline and the numbers and there's another organization also they give support through telephone or WhatsApp or Skype because also as an organization and as a health care system also they deal with the victim of violence so we continue to provide them support through the phone. Many services provided face-to-face through phone call. For example, in our organization unless we prepare, tell we prepare our centers as a primary health care centers with a tent and a screening area. We were calling our clients like the pregnant woman through the phone call telling them what to do and so on. So, yes, we try to find alternative. We use as a medical staff to work during the emergency, during this conflict, to always we will find alternative and the beauty of the work that we have a national health committee run by Ministry of Health, all the health sectors set and they talk about the plan, the protocol, what to do, how we can divide the work, who can take care of the psychological support, who can go for home visits or do mobile clinic because we continue to do mobile clinic, reach the people in marginalized area, do home visits with all the precautions needed, provide the sanitation material for the people for the poor area and the marginalized area, provide medication for the people with chronic disease because there is an interruption in the system in the protocol for elderly people, for the people with disability, for chronic disease people, for all cancer people. So, we try to as a healthcare system and organization and as a health act to focus and reach those groups and provide them with at least primary healthcare services unless the thing go back to the normal life hopefully. That's all we have time for today. We'll be back tomorrow with more news from the country and the world. Until then, keep watching NewsClick.