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How we have geared up the Vaccine Capital of the World for planets largest vaccination program ever.

Indian government wants to vaccinate within 6 months more than 1.3 Bn ( 130 crore ) people in the country by mid-2021 while also exporting to all the needy worldwide. Read the COVID 19 Vaccine Operational Guidelines here https://bit.ly/3rRmSUA.
Whether its RIL vaccine ( recombinant protein-based ) or Oxford-AstraZeneca CovidShield ( viral protein ) or Bharat Biotech Covaxin ( inactivated virus ) or Pfizer-BioNTech Tozinameran (INN) codenamed as BNT162b2 ( mRNA ) or Moderna ( mRNA ) or Sputnik ( adenovirus vector ) or Zydus Cadila ( plasmid DNA ) any future vaccine candidates listed in this note as they come, we are ready to distribute and provide the vaccine for the government. The cold chain infrastructure is placed to ensure last-mile delivery of COVID-19 vaccine in a temperature-controlled environment across the country. Read more about the Detailed Engineering of the Cold Chain to deliver Therapeutics, Tests and Vaccines here — https://bit.ly/2Ln2wSw.
We have sent our proposal and are waiting for the contract to be signed with the government. The vaccine will be made available to the government within 10 days of the contract. It shall also be sent to COVAX member nations. Read more here https://bit.ly/2LjuGxq
Its important to understand that the manufacturing of vaccines by the old generation technologies ( https://bit.ly/2Lg6ooj ) consumed a lot of cycle time in the research funding / manufacturing / approval process.
In the new generation technologies ( https://bit.ly/2Lg6ooj ) these 10 months are the normal time that should take to create a vaccine.
This speed to make a vaccine facilitated by a reduced cycle time does not compromise in any way the safety or efficacy of these vaccines.
Furthermore these vaccines are able to address all epitopes generated by the 27 odd proteins of the SARS-COV2 virus. To have more clarity read Vaccine Immume Memory/ Vaccines / Mutations read here ( https://bit.ly/3b6WvUv ) & for Innate and Adaptive Immune Systems read here ( https://bit.ly/2Ml1NS3 ).
To buy PPE’s, Therapeutics, Tests, Cold Chain Equipments, VTM, Glass and SIlica for vials and Vaccines read here and procure here. https://bit.ly/3hRT1XH
  • The Drug Controller General of India on Sunday gave the final approval to two vaccines against Covid-19 for restricted emergency use. With this, it can be expected that the vaccination drive in India will begin soon. All states and union territories have already conducted dry run of vaccines. With more than one vaccine now approved for emergency use, the scope of India’s first phase vaccination in which the frontline workers will be vaccinated at free of cost gets widened.

Here is all you need to know about these two vaccines: Developers and manufacturers

  • Covishield has been developed by Oxford University in collaboration with pharma major Astrazeneca. India’s Serum Institute is their manufacturing and trial partner.
  • Covaxin is India’s first indigenous vaccine against Covid-19. It has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology.
  • Covishield uses a replication-deficient chimpanzee viral vector based on a weakened version of a common cold virus (adenovirus) that causes infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.
  • Covaxin is an inactivated vaccine. An inactivated vaccine is one which is developed by inactivating (killing) the live microorganisms that cause the disease. This destroys the pathogen’s ability to replicate, but keeps it intact so that the immune system can still recognise it and produce an immune response. There are many inactivated vaccines against Hepatitis A, Influenza, Polio, Rabies, which offer “excellent protection”, Bharat Biotech has said.

Trial and efficacy

  • The Serum Institute of India submitted data of phase 1 clinical trial conducted over 23,745 overseas participants showing an overall result of 70.42 per cent efficacy, the drug controller said. In phase two and three, which were conducted in India, 1,600 participants took part and the results were comparable to that of the first phase of trial, the drug controller said.
  • Bharat Biotech conducted phase one and two trials on 800 participants, apart from its several animal trials. Its third trial is going on and a total of 22,500 already participants took part in it. The vaccine has been found effective and safe, the drug controller said.

Cost

  • India’s frontline workers will get the vaccine at free of cost, Union health minister Harsh Vardhan has already clarified. So the cost angle will come at a later stage of vaccination and also for other countries as several countries have shown interest in both the vaccine candidates. Covishield will cost around Rs 1000.

Covid Vaccination Dry Run: 286 sessions, 110,000 vaccinators trained

  • COVID 19 Vaccine Operational Guidelines https://bit.ly/3rRmSUA
  • The vaccine dry run exercise took place amid the news of government’s expert panel recommending restricted emergency approval to two Covid-19 vaccines being manufactured in the country: Serum Institute of India’s locally produced Oxford-Astrzeneca Covid-19 vaccine Covishield and Bharat Biotech’s indigenously manufactured Covaxin.
  • In a massive nation-wide exercise, an end-to-end mock drill on the vaccine administration was conducted in all States and UTs at 286 session sites spread across 125 districts.
  • Each district conducted the dry run at three sites or more which included a public health facility (District Hospital/Medical College), Private Health Facility, and rural or urban outreach sites.
  • All the State and District officials were trained on the Operational Guidelines and for conducting the dry-run. This dry run was aimed at testing the laid out mechanisms for COVID-19 vaccination roll-out in the health system and to assess operational feasibility of using Co-WIN application in field environment for planning, implementation and reporting at the block, district and state level. The dry run was also conducted to familiarize the State, District, Block and Hospital level officers on all aspects of COVID-19 roll ou, it added.
  • The States and UTs conducted the dry run from 9:00 am across the country. The activities starting from beneficiary data upload, session site allocation and micro-planning, vaccine allocation, session site management with test beneficiaries, reporting mechanism etc. were covered in this one-day dry run to execute the nearest possible simulation of the actual day, the ministry further stated.
  • The preparation to handle any Adverse Events Following Immunization (AEFI) at all session sites and functionality of the Call Centers was also tested. It was supervised by the District collectors.
  • This dry run ended with debriefing meetings at district and the state level to discuss the issues and challenges encountered during the day. MoHFW was in constant touch with the States throughout the day to seek feedback on their experience. The States/UTs have expressed complete satisfaction on the successful conduct of the dry run which included the operational process and its linkages with the Co-WIN Software.
  • To be sure, 36 states and Union Territories have concluded meetings of State Steering Committees and State Task Force. 633 districts have concluded meetings of District Task Force.
  • Furthermore, training modules for medical officers, vaccinator officers, alternative vaccinator officers, cold chain handlers, supervisors, data managers, ASHA coordinators etc are also finalized and conducted. Physical training as well as training on virtual/online platforms have started. National and State Training of Trainers (ToTs) workshops completed.

Technology For Mass Immunization .

  • Co-WIN software has been developed by MoHFW for real time information of vaccine stocks, their storage temperature and individualized tracking of beneficiaries for COVID-19 vaccine. This software will assist the programme managers across all levels through automated session allocation for pre-registered beneficiaries, their verification and a digital certificate will be generated upon successful completion of the vaccine schedule. More than 75 lakh beneficiaries have been registered on Co-WIN software till date.
  • RIL JIO — We are working very closely with all the authorities to make sure that we provide the technology tools and backbone for vaccination in the coming quarters using technology.

Cold Chain Infrastructure

  • We have focussed on creating cold chain facilies to store vaccines at -70°C only if no shot that can be stored between 2ºC and 8ºC is available.
  • Alongwith the Central health authorities we have mapped 28,932 cold chain points for all the states and Union Territories of the country. Of these, 240 are walk-in coolers, 70 ice-lined refrigerator, 40,792 deep freezers and 294 are solar units. Maharashtra (3,257) has the maximum cold chain points, followed by Karnataka (2,870), Tamil Nadu (2,599) and Rajasthan (2,405).
  • While a bulk of the vaccines will be distributed through the Centre’s Universal Immunization Programme (UIP) mechanism, government has roped in private cold chain operators.
  • The vast scale of India’s UIP is supported by more than 28,932 functional cold chain points of which 750 (3 per cent) are located at the district level and above. The rest are located below the district level, according to the government’s comprehensive multi-year UIP plan for 2018–22. This includes 76,000 cold chain ‘equipment’, 2.5 million health workers, and 55,000 cold chain staff.
  • Cold chain logistics involves many moving parts, including cold storage facilities that store products waiting to be transported, cooling systems to keep it at an appropriate temperature during all aspects of the supply chain such as storing and transporting. Gel packs are also often used for medical and pharmaceutical shipments.
  • The cold chain infrastructure is sufficient to ensure last-mile delivery of COVID-19 vaccine in a temperature-controlled environment across the country. Sufficient supplies of syringes and other logistics have also been ensured to begin COVID-19 vaccination drive. Around 1,14,100 vaccinators have been trained on the process to be followed at the vaccination sites which includes beneficiary verification, vaccination, cold chain & logistics management, Bio-Medical Waste management, AE7FI management and uploading the information on Co-WIN software.
  • The entire operational planning and IT platform has been field-tested in four states which include Andhra Pradesh, Assam, Punjab and Gujarat on 28 and 29th December, 2020 and on the basis of feedback received, minor enhancements have been made in the IT system.

Manufacturing / Warehousing Capacity

  • RIL Life Sciences RLS — The Reliance group plans to leverage its existing businesses — pharmaceuticals. retail and technology, for Covid-19, right from developing test kits, operating testing laboratory, to vaccine development, manufacturing and even distribution. The vaccine under development is a recombinant protein-based Covid-19 vaccine, and is expected to enter human trials in the first quarter, Q12021. Distribution of vaccines of Reliance Life Sciences, as well as of other partners, is planned to be leveraged through its group businesses, Reliance Retail and Reliance Jio. Both organizations have a pan-India footprint reaching every village in the country. Reliance Retail product distribution system caters to 11,784 stores and about 200 cities, and Reliance Jio digital services encompasses 6,000 physical customer touchpoints. Besides, RLS has developed and started manufacture of Molecular Transport Medium (MTM) for collection and transportation of Covid-19 swab samples, after receiving regulatory approvals. MTM inactivates the virus within the sample and stabilizes the RNA, to make collection, transportation and processing safer. It also obviates the need for a cold chain in transportation of samples. In contrast, the conventional Viral Transport Medium may not be safe, as the virus is active in the collection tube, and also requires cold chain (2 to 8 deg C) transportation. Further, Reliance Industries’ RT-PCR (reverse transcription polymerase chain reaction) kits for Covid-19 were validated by Indian Council of Medical Research. The diagnostic kits are competitively priced with the scale-up in manufacturing now, prices of RT-PCR kits have reduced to around Rs 500–700 each.
  • Serum Institute of India (SII) — Pune based Serum Institute of India (SII), the world’s largest manufacturer of vaccines, is going to scale up manufacturing of Covishield, the Covid-19 vaccine it licensed from the Oxford University-Astra Zeneca combine, to 100 million doses a month from the current 50–60 million doses for stockpiling now. Serum Institute will have a capacity to make over 2.5 billion doses of vaccines a year as it is currently upscaling the capacity from over 1.6 billion doses. COVAX Alliance, envisaged by the World Health Organisation (WHO), GAVI, the vaccine alliance of a public-private global health partnership and mainly funded by billionaire Bill Gates, is planning to vaccinate over 3 billion worldwide with affordable COVID-19 vaccines in over 90–120 countries. Under this, Serum has received at-risk pre-funding of $300 million from the Melinda and Bill Gates Foundation and the GAVI. SII can provide Rs 5,000 crore of vaccine free for India under this alliance. While some of the western vaccines require -20 degree Celsius to -70 degree Celsius cold chain, Covishield requires only -2 to -8 degree Celsius cold chain, as in normal vaccines and mass immunisation.
  • Bharat Biotech — In terms of manufacturing capacity, Bharat Biotech is at about 150 million doses per year right now at their existing facility and are building a brand new facility in Hyderabad itself right next to current one that went online in December. They are also exploring another facility in another city, which is very early stage exploratory work, to see whether they can make Covaxin over there. In short they are trying best to increase this capacity north of 500 million doses as soon as possible. In terms of our own cold chain capacity, they have two locations in Hyderabad … which have large cold chain capacities. They are also building a very large integrated warehouse right on their campus which will have enough capacity in Hyderabad. They have a very similar kind of capacity in Bangalore — and have another site where they do other kinds of products over there. They also have a site in Ankleshwar in Gujarat, which is the Chiron Behring (site) that they acquired recently from GSK.
  • Moderna — Moderna is planning to increase production between 500 million and one billion. The government has been considering the Moderna vaccine as it can be stored at 2–8 Degree Celsius for a period of up to one month, making it suitable for Indian conditions where maintaining extremely cold conditions for long periods may be tough. The ideal temperature for storing the vaccine, which has a six-month shelf life, is -20 Degree Celsius. Government representatives have approached Indian vaccine makers to check whether they will be able to spare their capacities for making the Moderna vaccine in the country. Indian government is talking to biotech biggie Moderna for procuring the technology for its candidate — mRNA 1273 — so that it can be made locally.
  • Pfizer — By the next year, Pfizer will expand their production and increase to producing 1.3 billion units. .American pharma giant Pfizer has sought approval from the country’s drug regulator — the DCGI (Drugs Controller General of India) — for emergency use authorisation of its coronavirus vaccine, say sources. The vaccine is ready to be rolled out in the United Kingdom and Bahrain. The drug regulator may give emergency approval if it is satisfied by the results of the trials conducted outside India, sources have added. Pfizer India has sought permission to “import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019. Pfizer will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorization or approval. Pfizer has “developed detailed logistical plans and tools to support effective vaccine transport, storage and temperature monitoring” and will be using different options for storage, ranging from temperature-controlled thermal shippers to refrigeration units that are commonly available in hospitals.
  • Sputnik — India to produce 300 million doses of Sputnik V vaccine as Russia signs more deals. Russia is already testing the first samples of the Sputnik V vaccine that were produced in India. It has reportedly signed deals with more Indian pharmaceutical companies to produce up to 300 million doses of the Sputnik V vaccine. India’s Hetero Biopharma has already announced a deal with the Russian Direct Investment Fund (RDIF) to make more than 100 million doses of the Sputnik V vaccine against the novel coronavirus. The vaccine’s efficacy has been found to be more than 91 per cent in trials conducted outside India. Dr Reddy’s Laboratories Limited is conducting clinical trials of the Sputnik V vaccine in India and it will also distribute the finished vaccine.
  • Zydus Cadilal — Zydus is currently developing an indigenous plasmid DNA vaccine, ZyCov-D, which could be made available in the country as early as March 2021, if it meets all the regulatory approvals. The company is in the midst of Phase 3 trials. The firm is looking to hire contract manufacturers for an additional 50 million to 70 million doses of its plasmid DNA vaccine, on top of the 100 million that will come from its own capacity.
  • Panacea Biotec — Panacea Biotec aims to make 1-bn doses of COVID-19 inactivated COVID-19 vaccine candidate by 2022. The company is to partner with US-based Refana Inc to make a potential COVID-19 vaccine, in a collaboration that expects to have over 40 million doses available early 2021. It has set production targets of 500 million doses for 2021 and one billion doses in 2022 for its COVID-19 vaccine candidate.
  • Indian Immunologicals — Indian Immunologicals is in trials for its ‘Live Attenuated SARS — CoV-2 vaccine’ or COVID-19 vaccine using the latest codon de-optimization technology. IIL is to set up new vaccine plant, raise capacity by 35%. IIL has four manufacturing facilities at various locations: Karkapatla, Telangana for human vaccines & animal health formulations; Ooty, Tamil Nadu for anti rabies; Hyderabad, Telangana for human biologicals (Gachibowli) and animal vaccines; Dargaville, New Zealand (New Bovine Serum(. IIL exports various Human and animal vaccines to over 50 countries. The company is one of the largest producers of foot-and-mouth disease vaccine in the world and was the first in India to launch the purified Vero cell rabies vaccine for humans (PVRV) and second globally.
  • Mynvax — Mynvax’s “warm COVID-19 vaccine” is ready for safety tests and human clinical trials. Mynvax, a startup that is developing a homegrown recombinant subunit vaccine to prevent Covid-19 infections, expects a safe and efficacious one to be ready in about 18 months. The vaccine candidate can be stored at 37°C for over a month without losing its ability to fight the virus thereby eliminating the need for a cold chain.
  • Biological E — Indian firm Biological E initiates clinical trial of Covid-19 vaccine candidate. Indian pharma firm Biological E (BE) has initiated a Phase I/II clinical trial to evaluate the safety and immunogenicity of its Covid-19 subunit vaccine candidate. The vaccine candidate has an antigen in-licensed from US-based Baylor College of Medicine’s integrated commercialisation team, BCM Ventures. It also contains an advanced adjuvant CpG 1018 from Dynavax Technologies. Adjuvant is a pharmacological or immunological agent and boosts the immune response of a vaccine. The trial will also analyse the ability to induce an immune response, of the vaccine candidate, which has the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum. International Finance Corporation, a member of the World Bank Group, is providing a loan of up to $30 million (around Rs 220 crore) to pharma company Biological E. Biological E. Ltd on Monday has acquired Akorn India Ltd, a subsidiary of US-based Akorn Inc, providing a boost to the Hyderabad-based company’s manufacturing capacity as it prepares to mass produce two vaccine candidates, including that of Johnson & Johnson. Akorn India’s 14-acre campus facility at Paonta Sahib in Himachal Pradesh has a sterile injectable plant which can manufacture about 135 million units annual capacity and has the potential to immediately expand by a further 30 million units.

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