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serum institute of india

Serum Institute Ships First Set of Malaria Vaccine to Africa

by Dr. Shruthi R May 21, 2024

written by Dr. Shruthi R

The Serum Institute of India has shipped its first batch of R21/Matrix-M malaria vaccines to Africa, marking a major milestone in the global fight against malaria. This collaboration with Oxford University and Novavax aims to deliver affordable and effective vaccines to malaria-endemic regions, potentially saving hundreds of thousands of lives annually.

Pune-based Serum Institute of India (SII) has announced the shipment of its first batch of R21/Matrix-M malaria vaccines to Africa. This significant step marks a major milestone in the fight against malaria, particularly in malaria-endemic regions.

The initial shipment is destined for the Central African Republic (CAR), with subsequent deliveries planned for South Sudan and the Democratic Republic of Congo. The CAR region will receive a total of 1,63,800 doses, of which 43,200 doses are being dispatched today from SII’s facility.

The R21/Matrix-M vaccine was developed through a collaboration between the Jenner Institute at Oxford University, SII, and Novavax. It leverages Novavax’s saponin-based adjuvant technology and received support from several prestigious organizations, including the European and Developing Countries Clinical Trials Partnership (EDCTP), the Wellcome Trust, and the European Investment Bank (EIB).

To date, SII has manufactured 25 million doses of the vaccine, with plans to scale up to 100 million doses annually. This effort aims to address the substantial malaria burden, particularly in the WHO Africa region, which accounted for 94% of global malaria cases and 95% of malaria deaths in 2022.

The vaccine has received WHO recommendation for use in children, demonstrating high efficacy in its Phase 3 trials. John C. Jacobs, President and CEO of Novavax, emphasized the importance of this vaccine in mitigating the devastating health and economic impacts of malaria, which claims the lives of 1,300 children daily.

Eric Garcetti, US Ambassador to India, highlighted the innovative collaboration between the US and India, which has led to the development of quality, affordable vaccines. Umesh Shaligram, executive director of R&D at SII, praised the dedicated workforce at SII and the partnership with Novavax and Oxford University. This collaboration underscores the importance of innovation, affordability, and accessibility in tackling global health challenges.

The shipment of the R21/Matrix-M malaria vaccine is a testament to the power of global collaboration and a significant step towards a world free from the burden of malaria. The vaccine’s deployment is expected to save hundreds of thousands of lives annually, making a profound impact on global health.

May 21, 2024 0 comment

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Serum Institute of India launches first made-in-India HPV vaccine for cervical cancer

by Medically Speaking Team January 25, 2023

written by Medically Speaking Team

Adar Poonawalla, CEO of Serum Institute of India (SII), announced the launch of the first made-in-India Human Papillomavirus (HPV) “CERVAVAC” vaccine for the prevention of cervical cancer on Tuesday. The event was attended by Home Minister Amit Shah, Adar Poonawalla, and Prakash K Singh, Director of Government & Regulatory Affairs at Serum Institute of India.

“On the occasion of India’s National Girl Child Day and Cervical Cancer Awareness Month, @SerumInstIndia is pleased to launch the first made-in-India HPV vaccine by the hands of our Hon’ble Home Minister Shri @AmitShah Ji. @PrakashKsingh7,” tweeted Adar Poonawalla.

‘CERVAVAC’ is an outcome of a partnership of DBT and BIRAC with the Bill and Melinda Gates Foundation, supported by Serum Institute of India Private Limited for the indigenous development of quadrivalent vaccine through its partnership programme ‘Grand Challenges India’.

Earlier in December last, Dr NK Arora, chairman of the Covid working group, National Technical Advisory Group on Immunisation (NTAGI) had said that it is expected India to get the HPV vaccine, by April at one-tenth cost.

Speaking to ANI, Dr Arora said, “There are two or three companies which are in the process (of manufacturing the vaccine in India) but the Serum Institute of India (SII) has already got the regulators’ clearance and the vaccine should be available for our patients by April or May 2023.”

“The vaccine should be available soon. I don’t know the exact cost yet but am given to understand that the cost of the vaccine will be one-tenth of the internationally-branded vaccine currently available,” he added.

Dr Arora further informed that almost 80,000 cases of cervical cancer occur in India every year.
“During the last 24 hours, our country lost 95-100 women due to cervical cancer. India accounts for the bulk of deaths from cervical cancer in the world. Almost 80,000 cases are reportedly worldwide every year. What is important to note here is that cervical cancer is entirely preventable through vaccination. The Human Papilloma Virus or HPV causes cervical cancer and a vaccine is available which can prevent it,” he added.

He said the Union government will be able to roll out the HPV vaccine as part of its national health programme for girls aged between 9 and 14 years.

January 25, 2023 0 comment

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DCGI nod to SII to make COVID vaccine against Omicron for test, analysis

by Medically Speaking Team February 8, 2022

written by Medically Speaking Team

Official sources claimed on Monday that the Drugs Controller General of India (DCGI) has accepted Serum Institute of India’s application to create a vaccine against the Omicron type of coronavirus for investigation, testing, and analysis.

“With reference to your application, please find herewith the permission to manufacture SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein nanoparticle vaccine (omicron variant) for examination, test and analysis under the provisions of New Drugs and Clinical Trials Rules, 2019 to manufacture the test batches of the drug/drugs mentioned therein,” an approval order issued on February 4 stated.

Director, Government and Regulatory Affairs at the SII, Prakash Kumar Singh had put in an application to the DCGI on January 6 stating the Pune-based firm, in collaboration with Novavax Inc, is working on the development of a vaccine against Omicron, an official source said, adding that the SII has obtained permission and licence to manufacture SARS-CoV-2rS drug substance for examination, test and analysis.

“…the new coronavirus variant ‘Omicron’ has already been reported in more than 60 countries and is spreading very fast worldwide and in our country also. Our CEO, Dr Adar C Poonawalla is very concerned about the protection of citizens of our country and the world at large against coronavirus and its new variants and we are relentlessly working on the development of SARS-CoV-2 rS Protein (COVID-19) Recombinant Spike Nanoparticle Vaccine (Omicron variant).”

“Development of this vaccine shall be another example of vaccine production strength of our country in line with the clarion call of our prime minister ‘Making in India for the World’ and shall further keep our country’s flag flying high globally,” Singh had stated in the application,” the source said.

February 8, 2022 0 comment

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Covishield, Covaxin to be capped at ₹ 275 each post getting marketing approval

by Medically Speaking Team January 27, 2022

written by Medically Speaking Team

Official sources say the price of Covishield and Covaxin, the Covid vaccines that are due to receive normal market approval from India’s medicines regulator soon, will likely be capped at ₹ 275 per dosage plus a 150 service charge.

A report in PTI said a regular market approval is awaited for both the vaccines from India’s drug regulator.

The report, quoting official sources, said the National Pharmaceutical Pricing Authority (NPPA) has already been directed to start working towards capping the price.

According to current rates, each dose of the Bharat Biotech-produced Covaxin is priced at ₹1,200, while Serum Institute’s Covishield costs ₹780 in private facilities. A service charge of 150 is included in the price.

“The NPPA has been asked to work towards capping the price of the vaccines. The price is likely to be capped at ₹275 per dose along with an additional service charge of ₹150,” a source told PTI.

On January 19, a Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation had recommended granting regular market approval to Covishield and Covaxin for use in the adult population subject to certain conditions.

Prakash Kumar Singh, the director (government and regulatory affairs) at Serum Institute of India, had submitted an application to the Drugs Controller General of India on October 25 seeking regular market approval for its Covishield vaccine.

Meanwhile, V Krishna Mohan, the whole-time director at Bharat Biotech, had submitted complete information on the chemistry, manufacturing and controls, along with the pre-clinical and clinical data, while seeking regular market authorisation for Covaxin a few weeks ago.

Both the vaccines have only been authorised for emergency use in the country.

A full market authorisation is granted when a vaccine is deemed safe and effective for most people who are inoculated with it. Such an approval is authorised after submission and review of full data from phase 1, 2 and 3 trials of the jab, as reported by Hindustan Times earlier.

January 27, 2022 0 comment

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Lancet study on Covishield Vaccine Protection Decline is Misquoted: Experts

by Medically Speaking Team December 24, 2021

written by Medically Speaking Team

According to specialists, the Lancet article, which claims that the protection provided by the Oxford AstraZeneca COVID-19 vaccine Covishield diminishes after 3 months, has been misquoted.
Experts think the Lancet study on Covishield diminishing antibodies after 90 days has been misquoted, according to ANI.

Dr JA Jayala, President, IMA, said, “Most of the scientific data that is available says that vaccines provide antibodies and T cell immunity as well. It is based on certain facts. Most of the scientific data is available and the studies which have been conducted wide across the country and abroad have proved that antibody is not just stopping but it is continuing.

“But we are concerned about the T cell immunity or/and cellular immunity which is long lasting by all chances and once you are getting infected with the virus or when you are getting the passive immunity by the Covishield, definitely you will have the effect of that sustaining for a longer time. It will be preventing you and helping you to come out of the severe infection you are getting,” the Indian Medical Association President said.

“Unfortunately, this study has a strange methodology, which none of us, including my peers, had ever seen before… So my point is, without discrediting the study authors, methodologies are very important when we come to understanding conclusions. So my message is that one should never blindly jump to conclusions. This study is based on the author’s conclusions,” he said.

“Always look at the methodology and see the data. And if we don’t understand, run it by somebody who knows it before jumping to a conclusion. Unfortunately, the study has been misquoted. And all over the world, there’s panic among people who’ve taken AstraZeneca vaccine,” said Dr Rajeev Jayadevan, Vice Chairman Research Cell Kerala State IMA.

“Even till today, no decline has been observed as far as the protection offered by both vaccines, Covishield and Covaxin is concerned. No signal has come from anywhere in India that people are suddenly falling sick after taking these vaccines,” Dr Rajeev added.

As India reported 236 Omicron cases as till today, the government and medical experts have appealed to people to follow COVID-19 appropriate behaviour. “Specifically, I’ll focus on just one thing. Don’t hang around people inside a closed room where people are talking, cheering or singing or having festivities. If you want to meet people, meet them outside or in open premises,” Dr Rajeev said.

He further added, “We learned in the last two years to use masks. Everybody wears masks. Masks are important. You know why? Because many people who carry the virus do not know they’re infected. So if they’re wearing a mask, they’re reducing the number of viruses in the air. And so, they’re protecting other people. So, that is the main purpose of wearing a mask.”

December 24, 2021 0 comment

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Study finds efficacy of Covaxin and Covishield, Read to know indications

by Medically Speaking Team November 22, 2021

written by Medically Speaking Team

Covishield and Covaxin considerably lower the incidence of severe Covid-19 and the Delta variant among Indians aged 45 and more, according to the findings of a comprehensive research led by the Indian Council of Medical Research (ICMR). The paper was recently released as a preprint, pending peer review.

The overall effectiveness against severe Covid was 80 per cent with two doses of Covishield, and 69 per cent with two doses of Covaxin.

Vaccine effectiveness was highest with a 6-8 week interval between two doses of both vaccines. However, according to senior author Dr Manoj Murhekar, Director of ICMR–NIE (National Institute of Epidemiology), there were not enough numbers to gauge a 12-week interval. “The main point here is vaccines are effective. We do not really need a booster immediately as by June this year at least 60 per cent of the country’s population was infected with SARS-CoV2 and vaccination would have served as a boost to the immune system,” he said.

Dr Pragya Yadav of the ICMR-National Institute of Virology, another senior author, claimed Covaxin and Covishield were effective against severe Covid-19 during the Delta variant’s prevalence in the second wave.

Tarun Bhatnagar of the ICMR-NIE in Chennai, the study’s lead author, stated that increasing vaccination coverage to two doses is important for controlling the pandemic in the country.

The study was conducted between May and July 2021 in 11 hospitals. Of 1,073 cases of severe Covid and 2,264 controls (Covid-negative individuals), 6 per cent cases and 17 per cent controls reported full vaccination, and 16 per cent cases and 28 per cent controls reported partial vaccination with Covishield. The effectiveness of full vaccination was 80 per cent.

Of 887 cases and 1,384 controls, 3.4 per cent cases and 5.3 per cent controls reported full vaccination and 16 per cent cases and 28.3 per cent controls reported partial vaccination with Covaxin. The effectiveness of full vaccination was 69 per cent.

The study was conducted along with researchers from Amrita Institute of Medical Sciences, Kochi; Hamdard Institute of Medical Sciences and Research, New Delhi; AIIMS-Jodhpur, JSS Medical College, Mysuru; Government Medical College, Nagpur; SRM Medical College, Chennai; JIPMER-Puducherry; Surat Municipal Institute of Medical Education and Research, AIIMS-New Delhi, Rishikesh, and Bhubaneswar; and ICMR-National Institute of Virology, Pune.

November 22, 2021 0 comment

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Serum Institute seeks permit from DCGI for Covovax

by Medically Speaking Team October 30, 2021

written by Medically Speaking Team

Official sources said the Serum Institute of India applied to the Drugs Controller General of India (DCGI) on Friday for approval to manufacture COVID-19 vaccine Covovax for restricted usage in emergency scenarios at its Manjari production facility.

Along with its application, the business has filed an interim phase 2/3 clinical research report on Indian adults, as well as interim reports from Novavax UK and the USA-Mexico phase-3 clinical study, as well as responses to the DCGI office’s questions.

There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.

“In our government’s endeavour to fight against COVID-19 pandemic, we have also been working shoulder to shoulder with the Government of India to make available one more safe and efficacious world class COVID-19 vaccine for our country and the world at large.

“Approval of our COVOVAX and its availability will further strengthen India’s capability to fight COVID-19 pandemic and ensure vaccine security in line with our prime minister’s clarion call of Atmanirbhar Bharat,” an official so far, stated the application.

October 30, 2021 0 comment

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There should no vaccine discrimination, Covishield is fully certified, says Dr. NK Arora

by Medically Speaking Team September 23, 2021

written by Medically Speaking Team

The United Kingdom has recognized Serum Institute of India-manufactured Covid-19 vaccine Covishield in its new travel rules but has not removed quarantine restrictions concerning Indians. In an exclusive interview with ANI, Dr. NK Arora, Chairperson NTAGI Working Group for Covid Vaccination, took exception to delay by the UK in adding Covishield to the list of approved vaccines for travel to the country and said there should not be “vaccine discrimination”.

“Covishield vaccine is manufactured in India under license from AstraZeneca. In fact, the bridging trial was done to see the parity between the vaccine manufactured in the UK and that manufactured in India. The immunogenicity results showed exactly the similar results, antibody responses and other things,” he said.

“It is only after that India gave emergency use authorization to Covishield for use in India. The country has exported about 5 million doses back to UK, which has been administered to Britishers,” he added.

Dr. Arora said India exported about 30 million doses of Covishield to a large number of countries.

He said the AstraZeneca vaccine manufactured by the Serum Institute of India has received emergency use authorization from WHO.

“In this context, if a country does not recognize a vaccine which has been used by its people, which was innovated by it and which has been approved by international regulators, I think it does not speak well. We would request British regulators and policymakersthat such kind of vaccine discrimination should not be done in a world globalised world where pandemic has affected every community, every country. Covishield given in India is fully certified,” he said.

On certification, he said India’s process is robust.

“I don’t think they are talking about anything, pointing fingers at the certificate. I think they are talking beyond that, the whole process they are talking about. Because we in India, know that it is one of the best way of giving certification,” he said.

CoWIN is the technological backbone driving vaccination in India and encompasses all constituents of the vaccination process. From validation of the supply of authentic vaccines, registration and certification of citizens, the entire value chain is administered through the CoWIN platform.

September 23, 2021 0 comment

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Centre raises gap between two doses of Covishield for better efficacy

by Medically Speaking Team August 27, 2021

written by Medically Speaking Team

The central government informed the Kerala High Court today, through affidavit, that its decision to delay the second dosage of AstraZeneca’s Covishield Covid-19 vaccine by 84 days was based on the possibility of improved effectiveness and expert scientific advice. Meanwhile, the government intends to shorten the time between Covishield doses.

Yesterday, the Kerala High Court, while hearing a plea from Kochi-based Kitex Garments, questioned the central government about the grounds for an 84-day delay, as well as whether the availability of vaccination was the cause for such a long period.

The firm petitioned the court, seeking that the government order the government to enable early second dose vaccination since it had purchased 12,000 doses to vaccinate all of its staff. Kitex told the court that the purchase was completed before the gap was increased from 45 days to 84 days.
The central government notified the court that present laws in India do not allow the third dosage of the Covid-19 vaccination, in response to the court’s instruction to answer on a different petition that requested for a third dose for travelling overseas. It stated that studies are being conducted and that it has yet to get a direction from experts to authorise the third vaccination.

A resident of Kannur in Kerala had approached the court saying he had two doses of Covaxin but was denied permission to enter Saudi Arabia as the vaccine was not approved in that country. Hence, the court should direct the government, allowing him to take a fresh vaccine with acceptance in Saudi Arabia, demanded the petitioner.

August 27, 2021 0 comment

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Chairman of the Serum Institute, Cyrus Poonawalla, on Taking the Third Covishield Dose

by Medically Speaking August 14, 2021

written by Medically Speaking

The recommended distance between two doses of Covishield is two months, and another dose should be taken after six months, according to the chairman of the Serum Institute of India (SII), Cyrus Poonawalla.

When asked about a research in the medical journal Lancet suggesting antibodies against coronavirus developed by Covishield, the SII’s vaccine, decline with time, Mr Poonawalla said that while antibodies do drop over time, “memory cells” do not.

“After six months, the antibodies go down and that is why I have taken the third dose. We have given the third dose to our seven to eight thousand SII employees. For those who have completed the second dose, it is my request to take a booster dose (third dose) after six months,” he said.

He was speaking at a press conference after receiving the prestigious Lokmanya Tilak award.

The ideal gap between two doses of Covishield is two months, he said.

“Since there was a shortage of vaccine, the Modi government changed it to three months, but a two-month gap is ideal,” Mr Poonawalla said.

He also said that lockdown was not an effective way to deal with the virus.

“Because if there is no lockdown, the disease will be there in the beginning but later the herd immunity will prevail. Why I prefer herd immunity is because the death rate (due to coronavirus) is very low. Lockdown is a good option when the death rate is high,” he said.

In most cases deaths were caused by negligence and delay in reporting the infection to doctors, he claimed.

August 14, 2021 0 comment

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