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AstraZeneca Covid-19 vaccine will be the first vaccine for rollout in India: Dr. Gagandeep Kang
Dr Gagandeep Kang, one of India’s most eminent medical scientists who played a critical role in the development of the indigenous rotavirus vaccine, says that things are within control right now, and will continue to be so till people follow the usual safety protocols and institutions invest in research. She also said about a new variant that some strains spread fast and some spread slowly. This one seems to spread a bit faster.
Q. How worried we should be about this new UK strain?
A. I think the biggest thing we need to do is to make sure that we have sequencing of the strain. This is being done for a few thousand isolates in India, but given that we have done more than 10 million, that’s not efficient. We should be trying to sequence while distributions happen on a regular basis, especially for travellers. That will give us a better answer about whether the strain is already here.
Q. Do you think that this virus spreads very quickly?
A. Some strains spread fast and some spread slowly. This one seems to spread a bit faster. It is circulating widely around the world. These things will happen in the future also. The principles for control are exactly the same still: wearing a mask, social distancing, and making sure that you don’t pass this infection to others.
Q. Do you think this can impact the line of treatment? Do we have tools to control ?
A. We are managing quite well now without vaccines. We will have better control once we have the vaccine available, but we shouldn’t think it’s an all-in-one solution. In the future, other strains might emerge where vaccines might not work. So, we should be prepared for a situation where we can make vaccines in six months, if needed. New strains don’t emerge in a day. They take time. All strains are vaccine-susceptible, but tomorrow they may not be. We have new technology but we need to do better on surveillance, tracking, vaccines, etc. But we have the tools for control now, we should be aware of that. We must be careful and continue to invest in science and in research and development. If we do that, we have nothing to worry about. But, if we ignore the threats, things can spiral out of control.
Q. The Imperial College of London says that according to data, this new strain tends to impact children and adults both. What would you say about this?
A. I think what they are referring to is that, in terms of impact, we are seeing the virus in children a little more than others. That is a factor of its infectiousness, not that it is more dangerous for children. Children are less affected by the virus in terms of the severity of the illness and the ability to spread among younger children. So, I don’t think that is changing at all. It’s just that because this virus seems to replicate at a higher level than other viruses, it may have an easier way to get inside the cells that will contribute to a higher viral load and its ability to spread more easily. I don’t think there is anything to worry about this being more dangerous for children—we have no evidence of that.
Q. Does this impact India›s vaccine roll-out in any way?
A. We don’t know that at the moment. There is no evidence to show that vaccines will not work. So, until we know that, why are we worrying about theoretical problems? 2-4 weeks is the time it will take for people to understand what the biological significance of this strain is. At that time, we will know. Based on the mutation, it doesn’t look likely that vaccines won’t work.
Q. When do we expect the vaccine roll-out to start in India?
A. I think a lot depends on the MHRA in the UK. If they licensed AstraZeneca vaccines, it might happen in the next week. If it does, then we will be looking at having vaccines in India shortly after. I don’t expect the regulator will take a long time to review the data because no Phase 3 efficacy study has been done in India so far. The Covaxin study is ongoing and we don’t have results. So, we must rely on other regulators to review the data from Phase 3 studies, and once they approve the vaccines, our regulator can look at their determination as well as evidence in India and take it from there.
Q. Which vaccine will India get first?
A. It will be the AstraZeneca vaccine because that is the one which has the most complete data package. Phase 1 and Phase 2 trials for safety and immunogenicity have been done in India. Phase 3 has been done outside India. Linking them together, we have enough information to tell us that we have a vaccine.
Q. Do you think that this virus can jump to other species?
A. Of course, it can. We have ample evidence of that happening among dogs, cats, tigers, mink and other kinds of animals. It can also come back into humans. We have evidence of that from the mink studies, where another variant cluster of five variants was seen when it went from humans to minks and back again.
What is in the placebo? Is the recipient of a placebo aware of it? Can a person who has volunteered for the placebo get the Covid vaccine? These are some important questions which are on everyone’s minds as people in certain corners of the world start to receive the Covid vaccine and others hope to do so soon.But now people are in fear to volunteer for a vaccine trials because of hidden doubts in their minds. Dr.Satyajit Rath , Immunologist , IISER,Pune responds to all these anwers.
1. How a volunteer would know whether he has taken a placebo or a vaccine for COVID-19?
No, they will not know. In fact, not even the people giving the injection will know, in all likelihood. That is why these are called ‘blinded’ trials; the people taking the experimental vaccine (or ‘candidate vaccine’) and the people monitoring it will not know who has got the ‘vaccine’ and who has got the ‘dummy vaccine’ or ‘placebo’ (so they are ‘bind’ to that information!). That way, that knowledge will not affect what they do and how they behave, which will reduce the possibility of bias in the study.
2. What is the difference between placebo and Vaccine?
A ‘placebo’ is a ‘dummy vaccine’, in the sense that it looks like the ‘vaccine’, but does not have any of the active ingredients of the ‘vaccine’. So the ‘placebo’ would have no real effect at all. Placebos are used so as to have a group to compare the ‘vaccinated’ group with, in order to see if the vaccine ‘works’. It is, effectively, an ‘unvaccinated’ group, except that group is getting a ‘pretend vaccine’ so as to maintain ‘blinding’ in the trial.
3. Do you think if a person takes a placebo then he/she can’t take a vaccine? if no then why?
No no; of course, people taking placebos in a vaccine trial can, should and will get the actual vaccine if and when the trial is successful and the vaccine is seen to work!
4. What test can be done to know about the safety and effectiveness of a vaccine?
The safety and effectiveness of an experimental vaccine cannot be tested by anyone ‘test’. It is a structured process of first ‘pre-clinical’ testing in experimental animals in which safety and the ability to generate a useful immune response are tested, and then the three phases of trials in humans, in which safety is tested (phase 1), the ability to generate an immune response is tested (phase 2), and then the actual ability to protect against the disease is tested (phase 3). All of these have been and are being done for all COVID-19 vaccine candidates.
Mass Vaccination requires successful supply chain strategies Says, Pawanexh Kohli
In an Exclusive interview, Pawanexh Kohli who is Former Chief Executive and advisor to India’s National Centre for Cold-chain Development(NCCD) , said that the biggest fear is that vaccine may prove ineffective against the future strain of virus.Therefore deployment of the vaccine should be extensive and expansive.
What would be the first step basic step involved to start Mass vaccination?
A mass vaccination exercise will require diligent planning and like all successful supply chain strategies, the basic step must be to first identify the destination points. Thereafter, after terminal inoculation centres are known, the strategy will be able to work backwards to distribution depots, to a regional store or the source manufacturer. The long haul from source to distribution depots will be planned as a bulk movement and from depot to inoculation centres in smaller tertiary shipper boxes. Each shipper box can carry 5 to 10,000 doses so that can be replenished every few days or weekly. The identifying of first recipients is just a diversion and efforts should be applied to identify vaccine givers and inoculation centres. In fact, the vaccine givers should be the first recipients, and they should receive their dose at least 2 weeks before they start inoculating the others in their zone.
How the distribution of a vaccine will be done to make the process smooth?
First concern will be to administer the vaccine in a socially distanced environment. A vaccine taker should not run the risk of picking up COVID19 even while waiting to receive the vaccine. Therefore, existing movie halls, restaurants, schools, convention halls should be designated as vaccination centres. Luckily they are all under occupied or empty, most already have cold rooms which can hold the vaccine at 2-8 °C for a couple of days.
Even railway coaches can be compartmented and quickly converted into inoculation centres, and a vaccine train can be deployed in each region – to service rural areas as it moves from village to village. Similarly, a group of vaccine buses can be used as mobile inoculation centres. The same infrastructure can be used at multiple locations.
A one way flow of people must be maintained and crowding must be avoided. Further, to ensure that a schedule is maintained, a ‘vaccine deposit’ can be refunded if the recipient will abide by the program. Another option is to offer a coronavirus insurance for a year if discipline of schedule is kept. Lastly, the actual distribution of the vaccine should be matched against return logistics of used syringes and vials from each location, to safely manage the medical waste that will be generated and as a double check avoid incorrect reporting.
Each vaccine taker should be marked with indelible ink, like is done after voting, and as a sign of social responsibility. Of course, Aadhaar linked digital records should also be kept.
What is the procedure to be followed for storing a vaccine?
Storage should only be to buffer the supply, with the agenda being to maintain a high throughput of vaccines. After all, the vaccines are not being made to be stored nut to be distributed. Any storage, in-situ or in transport, should be monitored for 3 parameters – for time & location though GPS, for temperature through data loggers, for excursions through thermos-chromic labels. The first would apply to the basic article of carriage, the second to tertiary packaging or individual boxes, and the last to individual vials. This will ensure a very high level of safety in the distribution network and mitigate risks. Usually any vaccine movement is monitored in a similar fashion, and in this case will probably require more close monitoring.
It will be imperative that the temperatures are maintained within the set parameters. Either within the range of 2 to 8 °C, or below -20 and/or below –70 °C depending on the vaccine. We must also keep in mind, that in cold climates, such as J&K these days, space may need to be heated to keep the temperature. So, it is not always refrigeration for cooling, but could also require heating. Data loggers will be important so that out-of-range parameters is flagged off and that batch can be discarded.
Another option is to store the vaccine in thermal shippers with passive cooling, and inside actively refrigerated space (like cold rooms and reefer trucks). A far higher level of redundancy will be in-built in case of cooling failure. This is not too dissimilar to ice-lined refrigerators, where the refrigeration system is buffered with the passive cooling system.
COVISHIELD is expected to be available by January 2021 : Adar Poonawala , CEO, Serum Institute
In an Exclusive interview with Medically Speaking Adar Poonawala, Ceo, Serum Institute says if it’s proven immunogenic and efficacious then it’s expected to get the vaccine by January 2021.
According to the reports it’s expected that India may get vaccine by January 2021 but it depends many important developments that includes trials success , immunogenic and efficacy.
“The UK trials are on the verge of completion, and our Indian trials are also running smoothly. It is too early to comment on when India can get a vaccine.Based on the trial’s success in India and the UK, and if approvals from regulatory bodies are in place in time, then we can expect the vaccine to be available in India by January 2021 (only if it’s proven immunogenic and efficacious).” Said Adar Poonawala, Ceo, Serum Institute.
The cost of Vaccine is yet to be decided and Serum Institute is also in conversation with the government “We are in conversation with the government regarding the cost of the vaccine and it is too soon to confirm. But it will certainly be affordable.” Said Adar Poonawala, Ceo , Serum Institute
The Serum Institute has done a huge investment till now in terms of production , technology and production “Currently, we have invested around $200mn for the COVID vaccine candidates in terms of optimizing our production of the facility, technology, and resources to ensure smooth production. Additionally, as part of our alliance with GAVI and Gates Foundation we have received $300mn to manufacture billions of vaccines for GAVI nations and India.”Says Adar Poonawala,Ceo, Serum Institute
However manufacturing capacity of Serum Institute is billions doses “Presently, we have an annual capacity of over 1.5 billion doses. Once the new facility is ready, our capacity will be around 1.95bn doses. Following the urgency of the situation, we have dedicated two of our facilities in India to produce millions of doses of COVID-19 vaccine. So far, we have produced small batches for testing and trial purposes only. Under an at-risk manufacturing and stockpiling license from DCGI, we will soon be manufacturing 60-70 million doses, and aim to scale manufacturing further up to 100mn doses of the vaccine per month. However, we will progress to mass production only after it is proven efficacious and immunogenic for mass use.” Ceo , Serum Institute Adds
Presently, Serum Institute is conducting trials on 1,600 volunteers and 15 different locations.
Intranasal vaccine can be more efficient: Bharat Biotech Executive director
Intranasal vaccine can be more efficient in terms of ease of formation, manufacturing and distribution. Bharat Biotech is soon going to start Phase-3 trials for ‘COVAXIN’ with an investment of Rs 150 crore that will include 26,000 participants. Talking exclusively to Medically Speaking .Sai Prasad, the Executive Director of Bharat Biotech International Ltd, spoke at length about COVAXIN results, preparation for supply chain and planning to start trials in other countries also. Excerpts:
Q. What would be the age group? How many sites will be involved? On how many people are you going to start phase 3 trials?
A. The phase 3 trial for COVAXIN includes approximately 26,000 participants in around 25 sites, pan India. The age group will be 18 years and above.
Q. When it’s expected to launch COVAXIN?
A. . If the trial progresses with the data being permissible and appropriate regulatory approvals in place, we look forward to launching the vaccine in Q2 of 2021.Our phase 1 and 2 immunogenicity data showed excellent results and we are optimistic as we move on to the phase 3 clinical trials.
Q. What would be the route intramuscular or intradermal for giving a vaccine?
A. The current phase III trial will be through the intramuscular route. We are simultaneously conducting phase I/II trials for an intradermal formulation, which is ongoing.
Q. What would be the procurement strategy you are going to follow? Any discussion with Government of India?
A. We don’t have the full details of this right now. Talks are ongoing with the Government of India in regards to volumes and manufacturing timelines.
Q. Do you think we have enough cold storage? What is your cold chain and manufacturing strategy?
A. The Cold storage is in place and the government is taking the necessary steps to augment. Bharat Biotech is ready for both manufacturing and cold chain requirements.The immunisation and vaccine distribution in India is a very good one with extensive distribution to the furthest corners of India.
Q. Are you going to start clinical trials in other countries also?
A. We are in preliminary talks with a few countries. A phase 3 efficacy trial of such a size, 26,000 participants, will hopefully be enough to get robust data in understanding the vaccine.
Q. How much a single dose of nasal vaccine is efficient?
A. An intranasal vaccine may be more efficient in terms of ease of formulation, manufacturing and distribution but we are still in the early stages. Intranasal vaccines will be in the second wave of Covid vaccines.
Q. How much investment you have already made on Covaxin? How much capacity you are planning to scale up?
A. The company is spending around Rs 150 crore on phase 3 trial and additionally Rs 200 crore in setting up a new facility that will be operational by December to increase the capacity. We have access to large-scale facilities outside Hyderabad too, and we are looking to scale up our capacity to approximately 500 million doses per annum.
Q. Any discussion with government on nasal vaccine? How and when you are going to start clinical trials?
A. We have a licensing agreement with Washington University School of Medicine in St Louis for a novel chimp-adenovirus, single-dose intranasal vaccine for Covid-19. Bharat Biotech owns the right to distribute the vaccine in all markets except the US, Japan, and Europe. While the phase I trials will take place in Saint Louis University’s Vaccine & Treatment Evaluation Unit, Bharat Biotech, upon obtaining the required regulatory approval, will pursue further stages of clinical trials in India and will undertake large-scale manufacture of the vaccine at our GMP facility located in Genome Valley, Hyderabad.
Vaccine storage and distribution is the biggest challenge for India
Once the vaccine will come and received approval from regulatory then the real challenge for both developing and developed countries will start for storage, transportation, and distribution of vaccine. As India is the second-most populous country in the world, delivering the vaccine to hospitals, pharmacies, and mass immunisation is going to form the biggest challenge.
The Medically Speaking spoke to some top experts in the field, World Health Organization (WHO) Southeast Asia Regional Director Dr. Poonam Khetrapal Singh, Satyajit Rath from New Delhi’s National Institute of Immunology (NII) and Raghavan Varadarajan, Professor at the Indian Institute of Science (IISc) in Bengaluru, to find out if India is prepared to handle cold chains and other important challenges regarding the storage, transportation, and distribution of the vaccine.
What is the role of cold chains ?
The purpose of the cold chain is a transportation and storage of a vaccine at a particular temperature that comes under WHO guidelines. A cold chain is a system of storage and transporting vaccines at recommended temperatures from the point of manufacturing to the point of use. According to WHO, it is an essential requirement for a vaccine and needs to be followed. Without the proper cold chain facilities, the vaccine will face the risk of being exposed to temperatures against the recommended temperature, which can result in the wastage of the vaccine.
According to Dr Poonam Khetrapal Singh, “The role of cold storage is to safeguard the potency of the vaccines. Each vaccine has to be stored, transported and handled at a particular temperature to avoid loss of its effectiveness. Different vaccines require different temperatures at which they must be stored and handled. The recommended temperature requirements for vaccines are specified for all vaccines. Failure to adhere to these requirements can lead to a loss of vaccine potency, leading to an inadequate immunity in the recipient of the vaccine. The cold storage facilities help to adhere to these temperature requirements.”
How does cold storage work?
Besides cold chains, cold storage is also an important matter. Vaccine must be stored properly from the time it’s manufactured until they are administered. Vaccines exposed to the temperature outside the recommended ranges can have reduced potency and protection.
“Vaccines are mostly biological material. This kind of material is heat-sensitive and can degenerate quite rapidly without cold storage. Therefore, cold storage is needed for most vaccines,” said Satyajit Rath from New Delhi’s NII.
Do you think India is prepared for a cold chain for the vaccine?
The experts said that a real problem will arise regarding distribution and the capacity of cold storages. “Since India’s childhood immunisation programmes, including the polio vaccination campaigns, have needed cold storage, there is certainly some capacity for cold storage in the country for a vaccination campaign. However, there are likely to be two difficulties. One is that the scale of available cold storage is likely to be inadequate for the scale of the Covid-19 vaccination which will be needed. Thus it will need to be expanded a lot, both in quantity and in distribution across the country. The second problem is that India’s current cold storage facilities, adequate or not, are mainly refrigeration-level, but not freezing level, let alone ultra-cold level. Some of the Covid-19 vaccine candidates which are being tested for efficacy require these kinds of cold storage temperatures. That will compound India’s cold storage problem. In fact, ultra-cold temperatures are quite likely to be unachievable for India in a mass vaccination campaign,” said Satyajit Rath.
How much storage, distribution of the vaccine is challenging for India?
According to Raghavan Varadarajan, Professor at IISc, Bengaluru, “A lot of infrastructure is required, for example, the vaccine formulations have to be refrigerated, and sufficient numbers of syringes, needles, swabs and other associated ancillaries are required and will need to be disposed of properly.”
Vaccine candidates like Moderna and Pfizer will require stringent standards for refrigeration, which may become a challenge for India.
“As I pointed out above, the different Covid-19 vaccine candidates being tested apparently need different cold temperatures. Some need about 5ºC above zero, some need about 10ºC below zero, and some need as much as 70ºC below zero. The particular vaccine candidates which will be licensed and be available in India will determine what sort of cold storage conditions will be needed. And since more than one vaccine may be available, different cold storage conditions might also be needed, complicating the issue further,” said Rath.
The bulk of vaccines will be distributed through the Centre’s Universal Immunisation programme (UIP) which has started systems like vaccine logistics and cold chain management and will involve capacity building and system strengthening. This program is supported by more than 27,000 functional cold chain points, out of which, 3% are located at the district level.
It’s important that every facility should have a proper emergency retrievel and storage plan.
CSIR to detect link between Air pollution and COVID-19 Says Dr Shekhar C Mande
According to a study done by the University of Cambridge said that Air Pollution is linked to COVID-19 has higher mortality. During research when samples were taken from region to region it was found that people who are exposed pollution found to be at higher risk of COVID-19. Now in India as Air pollution has worsened the Council of Scientific and Industrial Research (CSIR) has started its own research on the matter at the National Environmental Engineering Research Institute (NEERI), Nagpur. Director General of CSIR, Dr Shekhar C. Mande, speaks on the subject and about other Covid-related developments like the “Feluda test”, in an exclusive interview with Medically Speaking Excerpts:
Q. Is CSIR going to do research on the link between air pollution and Covid-19?
A. Of course, but the research will take some time to accomplish. Our labs are working on it already and the National Environmental Engineering Research Institute (NEERI) in Nagpur has started some work too.
Q. When is CSIR expected to complete its research on whether Covid-19 is air-borne or not?
A. Researchers have started compiling the results of the airborne study. They are conducting this research at two centres in Hyderabad and Chandigarh. Samples for the study have been collected from various places of India, from places like ICUs, hospital corridors, waiting rooms, places where healthcare workers are most at risk, high rise structures, etc. We are detecting how far this virus can travel. We have taken samples multiple times and are still sampling from different locations with different distances from patients, 4ft, 8ft and 12ft. Now, we have to wait for the results which are expected to come in the next ten days.
Q. CSIR has tied-up with the UP government. Which projects are the CSIR going to focus on?
A. We are going to work with the UP government on the types of projects which are required. If they have some ambitious plans on agriculture, the pharma industry or the environment, we will work as a knowledge partner. We are proposing some documents along with the UP government on pharma and we will be doing many other projects too.
Q. When will “Feluda” come to the market? How does it work?
A. It’s almost ready to enter the market. Feluda stands for FnCas9 Editor Linked Uniform Detection Assay. It detects active Covid-19 infection by using a CRISPR CAS 9-based readout on a paper strip. Detection takes place in less than an hour. It doesn’t require a real-time PCR machine, will be cheap, and can be performed at the point of care settings where a simple PCR machine is present. The virus has regenetic material RNA and we need to detect that particular RNA. We first do a reaction called RT-PCR (Reverse Transcription Polymerase Chain Reaction) in which we make DNA from RNA and amplify those copies of DNA. Then there is an enzyme which actually tries to match with the virus. It goes to the correct site and identifies the sequence for Covid. A paper strip is dipped into a solution, and if it is Covid-19 RNA, then you get a band that can be seen. The test gives its results in 45 minutes.
Q. What should be the comprehensive distribution and delivery mechanism for vaccines?
A. The Government of India is coming up with a very comprehensive plan and will take very considered decisions as a high priority. Those plans are pretty much in place and the people who have drawn these plans are technical experts in their area and therefore it’s going to be very robust.
Q. In your opinion, who should get the vaccine first?
A. People who are at high risk should get the vaccine first because they are handling Covid-19 patients every day. They deserve to get the vaccine first.