In an exclusive Interview with The Daily Guardian, Dr Shahid Jameel, Virologist and Director of Trivedi School of Biosciences at Ashoka University, talks about how to judge the efficacy of a Covid-19 vaccine, how India needs to plan for the vaccination drive and whether the novel coronavirus is likely to mutate in the near future. Excerpts:
Q. What would you say about the companies claiming the efficacy of their vaccines only through press releases?
A. Press releases are quick ways for companies to make their achievements public, but they are geared more towards shareholders and financial markets. A factual position can only be judged when the scientific details of a trial are published in a peer-reviewed publication. We should wait for those. At this time, the percentage of efficacy is not important and should not be used to compare different vaccines. All this means is that vaccines based on the viral spike protein will work to protect against disease, and sometimes against infection as well.
Q. What kind of a vaccine should be given to the people?
A. A vaccine that has been proven to be safe and has good efficacy. This is the reason why human clinical trials are done in stages – Phase 1 for safety in small numbers of volunteers; Phase 2 for safety and immunogenicity in larger numbers of volunteers; and Phase 3 for safety and efficacy in very large numbers of volunteers with gender, racial and age diversity.
Q. How much efficacy should that vaccine have before being approved for people?
A. It depends upon how infectious a virus is. In this case, the WHO and US FDA have set a benchmark of 70% efficacy before a vaccine candidate will be considered for approval.
Q. Why have there been errors with the AstraZeneca vaccine?
A. I cannot answer that. All I know is what the company has said. Errors happen, but what is important is how transparently they are addressed. I am sure the regulators in all countries that want to license this vaccine will look at the data very carefully.
Q. How does India need to plan ahead for successful vaccination?
A. India’s plan should include the following. Firstly, who should get the vaccine first? The primary aim should be to use the vaccine to protect frontline workers (healthcare, sanitation, essential services), reduce mortality (elderly and those with comorbidities) and control the pandemic.
Secondly, to work out the storage-transfer-delivery logistics down to the last detail. India has a lot of experience with the polio vaccine but that was an oral vaccine not an injectable one. India also has a lot of experience with childhood and maternal vaccines, but we have never delivered such large amounts of a vaccine during a pandemic.
Thirdly, the current capacity is to deliver 1.5 million doses per month, or 18 million doses per year. The Health Minister stated that 250 million Indians would be vaccinated in 2021. That means 500 million doses. At current staff strength, it would take more than two years. Therefore, we must increase trained staff.
Fourthly, should we vaccinate those in high priority groups (e.g. healthcare workers) who have already been infected? This would make little sense and waste precious doses. If we decide not to, then there should be an inexpensive test to find out those who already have antibodies. Today the test costs as much as one vaccine dose. That cost has to be factored in.
Lastly, make the plan available for public scrutiny and comment. This will increase trust in the vaccination programme.
Q. What are the parameters which need to be considered for emergency approval of vaccines?
A. Emergency Use Approval looks primarily at safety in large and diverse populations and also a reasonable level of efficacy.
Q. For how long will these vaccines work?
A. We don’t know the answer to this simply because vaccine trial follow-ups have not been done for long enough. Extrapolating from natural infection, neutralising antibodies wane off in about six months, but that does not mean loss of protection since there are T cells and memory recall responses. Even natural infection has not been followed long enough after recovery to fully answer this question. But, going by other endemic coronaviruses, protection may last up to a year or more.
Q. Do you think this virus can mutate? If it does, what is likely to happen?
A. Every virus mutates and so does this one. RNA viruses mutate faster than DNA viruses. However, compared to other RNA viruses, coronaviruses have the lowest rate of mutation. With over 224,000 SARS-CoV2 genomes sequenced by now, mutations in the spike protein neutralizing domain have not been seen. So, that’s good from the vaccine perspective. But this region has no selection pressure on it to change. Once vaccines are deployed in a big way, such mutations will arise. We would have to watch out for that.
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HEALTH MINISTRY RELEASES GUIDELINES AND ADVISORY FOR CORONA VACCINATION
The Ministry of Health & Family Welfare (MoHFW) has released a set of guidelines and advisory around Covid-19 vaccination.
Essentials: The Covid-19 vaccination is only for people who are 18 years and above. The vaccines will be administered in two shots separated by a time frame of 14 days. Interchangeability of Covid-19 Vaccines is not permitted, the second dose should also be of the same Covid-19 vaccine that was administered as the first dose. People with a history of anaphylactic or allergic reaction to a previous dose of Covid-19 vaccine and those who experience immediate or delayed-onset anaphylaxis or allergic reaction to the vaccine or injectable therapies, pharmaceutical products, food items etc, should not be a part of the vaccination drive. Pregnant and lactating women have not been a part of any vaccine trial so far and thus, Covid-19 vaccine will not be given to them.
Conditions: A temporary prohibition from the vaccination is advised at least for 4-8 weeks after recovery in these conditions: persons who have active symptoms of SARS-CoV-2 infection, SARS-COV-2 patients who have been given anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma, and patients who are acutely unwell and hospitalised.
Precautions: The vaccine will be administered carefully to patients who have a history of any blood clotting, coagulation disorder or platelet problem.
NEET EXAM DATE ANNOUNCED, ELIGIBLE CANDIDATES CAN APPLY
The National Board of Examinations (NBE) has released the date of the NEET exam. NBE has announced that NEET PG 2021 exam will be held on 18 April. Earlier National Medical Commission recommended that NEET should be conducted in March or April. Following directions from the Ministry as well as the NMC, the NBE has announced the exam date. Those who are applying for the exams can visit www.nedu.in and www.natboard.edu.in and can ask queries by contacting NBE at 011-45593000. The applicants can also write at its communication web portal.
DELHI WILL HAVE 75 COVID-19 VACCINATION SITES
The Delhi government has designated 75 hospitals for vaccination drive which will start from 16 January onwards. A total of 38 private and 37 government hospitals have been finalised for inoculation. The 75 vaccination sites will have the lowest number of centres in North-East Delhi and East Delhi for inoculation which is 11 centres. There will be 7-8 people at each vaccination site that includes nurses, doctors, security, and paramedical staff. Three rooms will be at each site: waiting room, inoculation room, and observation room post-vaccination. The reception room will be there at the centre where all the details about the beneficiary will be updated in Co-WIN app.
ALL YOU NEED TO KNOW ABOUT INFECTIVE SINUSITIS
The nose is the entry route for airborne infections. The nose is divided into two half by nasal septum. The nasal septum is naturally found off midline in the majority of patients without causing any functional issue. The nose is connected with the spaces found within the facial bone. The spaces are called sinuses. Rhinitis is the inflammation of nasal mucosa and sinusitis is the inflammation of lining epithelium of sinuses. Majority of infections involves mucosa of both spaces so it is called Rhinosinusitis (RS).
The presence of poorly controlled chronic medical illnesses such as diabetes, kidney diseases, cancer, obesity and advanced age are the risk factors for harbouring and development of a worse form of RS. Infective sinusitis can be divided into acute and chronic type based on the duration of symptoms. It is mostly caused by viral, bacterial and fungal infection. Common cold and coronavirus infection are common viruses causing RS. The chances of viral infection are increased by manifolds when a healthy person comes in close contact with an infected person (less than two meters), accidental inoculation of infected fluid into the nose or oral cavity (eating without hand washing, cleaning the nose). The development of symptoms and severity of infection is based on the patient’s health and received viral load from the infected person. Viral Rhinosinusitis (VRS) are mostly asymptomatic. The symptoms of RS are facial pain/pressure, anosmia or hyposmia, clear to whitish nasal discharge and blockage, headache, and fever. The symptoms are more severe and nasal discharge is mostly purulent in bacterial sinusitis. The bacterial infection is generally superimposed on viral infection. The presence of anatomical variation such as deviated nasal septum can worsen the symptoms. VRS generally responds well to symptom-based oral medications for 7-10 days. The commonly prescribed medications are analgesic, nasal decongestant, antihistaminic with steam inhalation, and nasal douches. Bacterial rhinosinusitis needs additional oral antibiotic therapy for a similar duration. Non-responder and complicated RS (extension of infection in the eye or brain) needs hospital-based care.
Fungal sinusitis can be broadly divided into invasive and non-invasive form. Surgical removal of infected tissue with disease-specific medical management is the treatment for non-invasive fungal sinusitis. Invasive fungal sinusitis is seen in immunocompromised individuals. Uncontrolled diabetes, chronic kidney disease, and transplant patients are the most common type of patients who can have invasive fungal sinusitis. The infection can rapidly extend into the orbit and intracranial part. Delayed presentation to the hospital has high chances of mortality. Debridement of infected tissue and prolong intravenous antifungal therapy is the line of management.
The writer is Associate Professor, Department of ENT, AIIMS, New Delhi.
BLOOD PRESSURE DIFFERENCE BETWEEN ARMS: IS IT HARMFUL?
Normally we would expect the blood pressure measured at both right and left arms to be equal or mean difference≤ 5 mm Hg and 4 mm Hg for systolic and diastolic blood pressure, respectively. However, about 20% of patients visiting their doctors have a difference ≥10 mm Hg and 4% have a difference of 20 mm Hg or more. This kind of difference is unlikely to be normal and could be seen in congenital heart disease, aortic dissection, peripheral vascular disease, and unilateral neuromuscular abnormalities. However, in small number of cases no obvious cause could be found and it is considered normal. However, this condition may not be completely normal; rather it could be a marker of atherosclerosis, particularly peripheral vascular disease. Moreover, extensive data shows an association between peripheral vascular disease of the lower extremities and both all cause mortality and mortality from cardiovascular disease. Thus, existence of peripheral vascular disease of lower extremity could be a double whammy for the patient.
WHAT ABOUT BLOOD PRESSURE DIFFERENCE IN UPPER EXTREMITY?
In a recent meta-analysis published in British Medical Journal Clark and colleagues found that a between arm blood pressure difference of ≥15 mm Hg was associated with peripheral vascular disease and with cerebrovascular disease but not with coronary artery disease. On the other hand, a difference of 10 mm Hg or more was associated only with peripheral vascular disease. Another prospective study of 1872 subjects in United States revealed that a between arm systolic blood pressure difference of ≥15 mm Hg not only suggested presence of peripheral vascular disease but was also associated with a modest increase in all cause mortality and mortality from cardiovascular disease in those diagnosed with peripheral vascular disease. Furthermore, a linked study on 230 adults with hypertension conducted United Kingdom found that a difference of ≥15 mm Hg was increased all cause mortality by 60% and mortality from cardiovascular disease by 70%.
TAKE HOME MESSAGES FROM THESE STUDIES
1. As recommended by current hypertension guidelines, bilateral blood pressure measurements should be done routinely to avoid delayed diagnosis or under-treatment of hypertension. On the basis of available evidence and practicality, a sequential measurement, followed by confirmation with at least two simultaneous measurements using two automatic devices seems to be a reasonable approach.
2. If the difference is ≥10 mm Hg on repeated simultaneous measurements, the possibility of peripheral vascular disease of the upper extremities is high and further diagnostic evaluation is necessary, especially in people with risk factors for cardiovascular disease. Subsequently blood pressure monitoring should be performed in the arm with the higher readings.
3. If, however, no cause can be found for the blood pressure difference, these patients should be treated as normal.
The writer works in the Department of Cardiology, AIIMS, New Delhi.
Covaxin Phase 3 trial results to be out by March: Bharat Biotech JMD
‘All the trial processes will be completed in February and efficacy data is expected to come by March this year. We expect more than 60 percent efficacy,’ says Bharat Biotech Joint Managing Director Suchitra Ella.
As Bharat Biotech completes clinical trials with volunteers for 10,000 double doses of its vaccine, Joint Managing Director of the firm and one of the brains behind the ‘swadeshi’ vaccine, Suchitra Ella, joins The Daily Guardian for an exclusive interview.
Q: How difficult was it to develop a vaccine in such a short duration of time?
A: It has been unbelievable, unimaginable and unthinkable because such a scenario doesn’t arise normally. This was the first time for us in the last 25 years that we have had to go through such a rushed timeline. This has happened once before, but maybe the severity was not this much. In 2009, when we were asked to make the flu vaccine for H1N1, in 12 months of time, we could make the vaccine. But this time was unprecedented. During the pandemic and the lockdown, when everything was shut down, we were working continuously. We never had a lockdown for a single day. It was about staff organisation, bringing them all together, keeping them confident. We had to practice safety also and it was an extremely difficult situation. Everything happened in real time. We also had a family where everyone was infected, involving children and old people. But we took it in our stride and continued the progress.
Q: How does Covaxin work better than the other vaccine?
A: This vaccine is built on a whole-virion inactivated platform. The technology is virion cell technology. The whole-cell virion vaccine is probably one of the safest vaccine technologies in the world. We aren’t using spike protein or mRNA. We actually asked the ICMR and they consented to give us the live virus from NIV in Pune, because at that point in April, NIV was the only lab that had the actual virus. We had to get the virus in its original form from the NIV lab. We had to bring it by road because during those days there was no availability of transportation. Our scientists went to the lab by road, physically brought it in coolers and we transported the live virus to Hyderabad from Pune. It was difficult to handle the live virus. Then we initiated a process that’s called inactivation from this virus, which means literally killing it to ensure that it shouldn’t multiply or contaminate people or cause infection to the people who are going to be handling it on a daily basis. After that, the killed virus was formulated in a liquid form, adding one or two adjuvants, which is a kind of liquid substance, so that the killed virus is present in that liquid substance. Then that was formulated and called the vaccine candidate.
Q: When will we be able to give this vaccine to children?
A: Not at this point of time. We can’t give them the vaccine, we can give it only to those who are above the age of 18. We are taking permission from the Drug Controller for trials. But at this point in time, we can’t give it.
Q: When will efficacy results be out?
A: The process of the clinical trials is very, very long. This was, of course, unprecedented. But everything was fast-tracked without cutting short the steps and the procedure as per the guidelines under the Drug Act of India which is normally given to us for all vaccines. The same steps have been followed. We first cleared Phase 1 trials, data came in July, we completed that after safety was proven, which was done in 12 medical hospitals. Phase 2 trials were done to prove the immunogenicity of the vaccine to show many antibodies were formed in a person who had been given the vaccine. This was also done on 400 people. In November, we were permitted for Phase 3 trials, the largest trial, in order to ensure that it was working among the largest group of people. All the trials were conducted on 26,000 people and nobody was forced to go through the trials. Now we have completed the two-dose vaccine and we have cleared 10,000 trials till now. All the trial processes will be completed in February and efficacy data is expected to come by March this year. We expect more than 60 percent efficacy.
Q: Do you think a nasal vaccine is better than an intramuscular vaccine?
A: There is scientific progress right now with an intramuscular vaccine that will be injected into the upper arm. We are working with another technology where they have shown enough animal data for something which goes into the nose of the animals. We are hoping to start the clinical trials in February. We will also have another route of vaccination which will be very useful with the largest population, because it is a single dose and easier to administer.
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