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The Serum Institute of India (SII) has announced the launch of India’s first indigenously developed vaccine PNEUMOSIL that has been developed in collaboration among Serum Institute of India Pvt Ltd , PATH and Bill and Melinda Gates foundation.

“The composition of the WHO pre-qualified vaccine is specially tailored as per the prevalence of the Top 10 serotypes of S. pneumoniae in India and other regions of the world, which is the unique feature of this conjugate vaccine.” Say’s statement given by Serum Institute of India

The vaccine will provide effective and long-lasting protection for children against pneumococcal diseases.

 “It is a great moment of pride to witness Serum Institute take forward the ‘Make in India’ legacy, with the launch of India’s first indigenously developed Pneumococcal Conjugate Vaccine. It is a significant milestone for the country’s public health care which will ensure that children are protected better against Pneumococcal disease with an affordable and high-quality vaccine.  I am sure, Serum Institute of India will continue their endeavour to develop many more life saving vaccines in future also on the lines of clarion call of our Hon’ble Prime Minister “VOCAL FOR LOCAL” and fulfill our Hon’ble Prime Minister’s dream “ATMANIRBHAR BHARAT””, say’s  Dr. Harsh Vardhan, Union Minister, Ministry of Health & Family Welfare 

 “Over the years our constant endeavor has been to provide high quality vaccines with regular supplies which ensures excellent immunization coverage to children and families worldwide. With that thought we have developed this PCV with a unique composition based on the serotype prevalence in India. This makes our PCV an ideal choice for protecting our children from pneumococcal disease. While the vaccine itself is of the highest quality and grade available, vaccine accessibility is of utmost importance as well, and to ensure ease of access by making it available at an affordable price. With the best PCV, we hope to bring down the mortality rate significantly while also making our country self-sufficient with a robust public health care system.” shared Adar Poonawalla, CEO of Serum Institute of India.

The drug regulatory body of India, DCGI is waiting for the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approval to AstraZeneca & Oxford’s COVID19 Vaccine, before giving a nod for Emergency Use Authorisation to its Indian counterpart developed by Serum Institute of India (SII) . It’s expected for British- Sweden giant drugmaker AstraZeneca in the UK to get authorization at any time, Sources to The Medically Speaking team

This is the first time when in four months Delhi records the lowest cases in 24 hours,Delhi records 655 fresh COVID-19 cases and 23 deaths in last 24 hours.

The total cases recorded in Delhi from the time of the outbreak is 6,22,094. Total recoveries recorded are 6,04,746and total deaths are 10,437.The positive rate is 0.98%, the total number of tests conducted in last 24 hours is 67,115 .

The total number of containment zones in Delhi are 4975.

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.

The indigenous vaccine of India has drawn global attention says ICMR that the Indian vaccine against #Covid-19, Covaxin, has drawn global attention.

“India’s indigenous vaccine against Covid19 Covaxine – a product of ICMR-Bharat Biotech collaboration, achieves the remarkable feat. Data generated from within India underlines impressive safety and immunogenicity profile of Covaxine and sparks Lancet’s interest in publishing them.” Tweets ICMR

The ICMR also said,” Encouraging Phase 1 and Phase 2 Covaxin trial results have paved the path for Phase 3 clinical trials in India, which is currently ongoing at 22 sites.”

The Government of India is going to start the dry run for COVID -.19 vaccine on Dec 28-29, this information has been given by the State Info & Public Relations Department of Punjab.

According to the information “Government of India has chosen Punjab to conduct the dry run for COVID19 vaccine on Dec 28-29 at five sites each in Ludhiana & Shaheed Bhagat Singh Nagar districts.

The central govt, , state govt’s and Union territories has done most of the preparations for vaccination at war level, but which vaccine is going to be given has n’t yet decided.

By Dr Lalit Kant

Healthcare workers are at the top  of the priority list of groups to receive the Covid-19 vaccine. Vaccines have started to be rolled out in some countries while others like India, are giving final touches to their plans. Vaccines that are or would be rolled out are being done after receiving emergency use authorization (EUA) from each country’s regulatory agency. According to the WHO about 70% of healthcare workers, who are the beating hearts of every healthcare system, are women. And a large proportion of them are in the reproductive age group.  It is estimated that in US over 3 lakh  health workers will be pregnant or breastfeeding as initial doses of vaccine(s) are being rolled out. In India, we have roughly 13 lakhs Anganwadi workers, 9 lakhs ASHAs, and 2 lakhs Auxiliary Nurse Midwives – all women; about 90% of over 30 lakh nurses are women. There are about 1 million MBBS doctors of which 13-15% may be women. A significant number are likely to be pregnant or breastfeeding when the vaccine(s) start  to be distributed. Will they or won’t they get an emergency use authorized vaccine?

The fact is that vaccine(s) that have received EUA (like the Pfizer-BioNtech) or are in the pipeline (like the Moderna, AsraZaneca), have not been tested for safety and efficacy in pregnant and lactating women. The traditional sequential approach in a typical clinical trial is to conduct the efficacy trials in non-pregnant women. Vaccine trials do not enrol pregnant and/or breastfeeding mothers until the vaccine has been found to be safely tolerated in non-pregnant women. After a woman enrols in a vaccine trial and becomes pregnant subsequently, they are under intensive follow-up for pregnancy outcomes. Once a vaccine has been found to be effective and safe, a bridging study is usually performed enrolling pregnant women as volunteers. The major advantage of this approach is that pregnant women and the child they carry are protected from the potential risk of the candidate vaccine under trial.  The down side is that it delays the vaccine being approved for pregnant women. And also, that a large number of frontline healthcare workers and first responders and essential services may remain unvaccinated.  So, following this sequence, the pregnant and lactating women have been excluded from the Covid-19 vaccine trials.  And there is no data on safety and efficacy among this group.

Let’s take a step back and see if SARS-CoV-2, the virus causing Covidv-19 disease, affects pregnant women differently than non-pregnant women.

Results of a surveillance being carried out by the US CDC provide information on over 23,400 pregnant women between 15 and 44 years with laboratory confirmed infection with SARS-CoV-2 virus. Even after taking into consideration age, ethnicity, and underlying health conditions, pregnant women were about three times higher risk of requiring admission in ICU (intensive care unit), or ventilator support or heart-lung by-pass machine compared to women who were not pregnant. Deaths were also more likely among pregnant women. The study did not include pregnant women who tested positive but had no symptoms. A report from Sweden shows that the risk of being admitted to ICU may be higher in laboratory confirmed pregnant women than non-pregnant women. In the UK information about outcome of over 400 pregnant women indicate that one in ten required intensive care. According to the WHO pregnant women or recently pregnant women who are  older, overweight, and have pre-existing medical conditions such as obesity, hypertension and diabetes seem to have an increased  risk of developing severe COVID-19.

Given that pregnant women are at a higher risk of developing severe Covid-19 disease as compared to non-pregnant women, how have regulatory agencies addressed this issue while giving EUA for Covid-19 vaccines?

The first COVID-19 vaccine to receive the EMU was Pfizer-BioNTech vaccine known as BNT162b2. Pfizer/BioNTech vaccine is an mRNA vaccine. The active ingredient is messenger RNA that carries instructions for making the virus’s spike protein. The mRNA is synthetic, not extracted from actual virus. It is delivered in a tiny sphere of inert fatty material called a lipid nanoparticle.

The UK government was the first to accord EUA to the Pfizer-BioNTech vaccine – an mRNA vaccine on 2^nd December 2020, but has not recommended the vaccine for pregnant and those breastfeeding. Its Medicines and Healthcare products Regulatory Agency (MHRA) has advised that the Pfizer-BioNTech COVID-19 vaccine has not yet been assessed in pregnancy, until more information is available, those who are pregnant should not have this vaccine.

In the US, the FDA and the CDC have left the door open for the healthcare workers to decide for themselves.  The FDA notes that while there have been no specific studies in these groups, there is no contraindication to receipt of the vaccine for pregnant or breastfeeding women.   People who are pregnant and part of a group recommended to receive the COVID-19 vaccine, such as healthcare personnel, may choose to be vaccinated. They are advised to discuss potential benefits and risks of vaccination with their healthcare provider. In essence, the vaccine should not be withheld from pregnant individuals who meet the criteria for vaccination.

The Canadian Government has towed the line of its neighbour – the US. It says that though the safety and efficacy of Pfizer BioNTech vaccine in pregnant women has not yet been established, it encourages those who are pregnant and breastfeeding to talk to their doctors, if they are thinking of getting the shot. The vaccine has not been withheld.

It is learnt that Pfizer BioNtech has applied for emergency use authorization in India. Would the DCGI go the UK way or join the US and Canada group. Without the appropriate data, the regulatory agency in India is likely to lean towards the UK’s decision of not recommending the vaccine for healthcare workers who are pregnant or lactating.

It is not difficult to appreciate the dilemma of the regulators. They are dealing with a new virus and a vaccine developed using a new technology without much data specific to pregnancy and lactation. The Pfizer-BioNTech is not a live virus vaccine, and therefore there’s no reason to believe that it would put an expectant mother or her unborn child at risk, nor that it would cause any harm to breastfed babies. But evidence is needed.

Similar situation is likely to emerge when AstaZaneca and Serum Institute of India or Bharat Biotech submit their application for emergency use authorization. Pregnant healthcare personnel will continue to wait till safety and efficacy data emerges. We need far sighted and ethical actions, especially when it comes to such pandemic viral diseases as Covid-19, the precaution should be weighed vis-a-vis the benefits the vaccine would offer.

Generating evidence for Covid-19 in pregnancy and lactation should become a priority. Since the immune responses to vaccination in pregnant women cannot be assumed from that of non-pregnant women and because the assessment of safety of vaccination in pregnancy is unique, pregnant women should be included in appropriately designed vaccine trials. The vaccine developers/ manufacturers should ensure that at least some of the candidate vaccines prioritised for development should use platforms and adjuvants that have been found safe and effective in vaccines developed earlier for other infections.

At the global level the public health and medical establishments must move forward with the responsible and informed inclusion of pregnant women in the design, clinical trials, and implementation of vaccine programs both now and in the future.  Their inclusion will ensure that pregnant and breastfeeding healthcare workers receive the same protection as the non-pregnant colleagues. They too should benefit from vaccines accorded emergency use authorization.

The write is dr Lalit Kant , MD ,Infectious Disease Epidemiologist, Independent Consultant

The British Health Minister Matt Hancock said that AstraZeneca had submitted a full data package about its Covid-19 vaccine to the medical regulator, the journey to approval for use of the vaccine.

“I am delighted that the AstraZeneca vaccine, developed in the UK, has submitted its full data package to the MHRA for approval . This is the next step towards a decision on the deployment of the coronavirus vaccine,” said British Health Minister Matt Hancock

India’s first indigenous COVID-19 vaccine COVAXIN has showed long -term antibody and T – cell memory responses ( 3 months after vaccination ).Based on these results Covaxin can also generate antibodies that may remain for 6-12 months, Bharat BioTech said in a research paper.

According to the paper uploaded on ‘medRrxiv’ , a server that carries preprints server for health sciences and research work before it is peer reviewed .

The two dose has showed no serious adverse events were reported in this study ,”After two doses , local and systemic adverse reactions observed in both vaccine groups  were minimal , and the majority of them resolved within 24 hours of onset.

The results from the phase 2 study show that both humoral and cell-mediated responses were observed. No neutralising antibody differences were observed between sexes and across age groups. BBV152 was well tolerated in both dose groups with no serious adverse events.

In the double-blinded, phase-2 trials, 380 healthy children and adults have received two vaccine formulations, (n=190 each) with 3 µg and 6 µg with Algel-IMDG.

The Serum Institute of India (SII) has submitted the data to DCGI’s Subject Expert Committee (SEC).In previous meeting by SEC Serum Institute of India and bharat biotech was asked to submit more data about clinical trials, reports IANS

The SEC can do a meeting on Serum Institute of India’s emergency authorisation for Covishield vaccine at the end of this week.