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The experience of J&J and Novavax in vaccine manufacturing shows the importance of vaccine manufacturing and of Quality Assurance in the production of vaccines for coronavirus. The success of Pfizer and Indian companies in vaccine manufacturing shows how important it is to think early and plan early for vaccine manufacturing technologies, personnel and quality assurance. This is also why the US effort, India's billion vaccine target in 6-12 months of planning, is a great effort in thinking ahead of every aspect of vaccines and vaccinating, planning of all details, hard work, by Pfizer, by Indian pharmaceutical companies, and by the Modi and Biden administrations. 

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Pfizer and Moderna's plans to make mRNA vaccines in Africa, Asia or Latin America may take much longer than 2022. The solution to producing an mRNA vaccine in Asia that could be mass manufactured and distributed throughout Africa, Asia and Latin America is now at hand. Gennova based in India, is partnering with Seattle startup HDT Bio to attack the problem of temperature and scalability in manufacturing for a mRNA vaccine that acts as a global solution using India's manufacturing capabilities. Dr Singh who founded Gennova, says- "We wanted to solve the problem of the scalability issue, and the temperature issue. If we can solve these problems, we are building a solution not just for India, but also a global solution." Gennova received seed funding from the Indian government. Other companies in Brazil and South Africa lack the manufacturing capabilities or financing needed that exist in India. The Indian government has achieved an initial goal of one billion vaccinated in just 6 months. The next step for India in its health infrastructure buildup is a mRNA vaccine that is an improvement over Pfizer and Moderna vaccines that can be stored easily, adapted for variants, and manufactured in large quantity as a global solution. ...

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In a major move president Biden backs suspending IP protection for Covid vaccines, therapeutics and tests. In fall 2020 India and South Africa submitted a resolution to WTO to suspend IP protection for Covid vaccines, therapeutics and tests, From the Indian perspective this decision comes a bit late when India has already vaccinated over 1 billion people using the Astra Zeneca Oxford vaccine. The Oxford vaccine was made available to Indian manufacturing companies to make locally in a way the could be done at low cost to meet needs of over 1 billion people in India. From the perspective of pharmaceutical companies this is giving away technology even if this was a public health emergency, as shown in this editorial from WSJ.

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The first results of India's new vaccine policy with vaccine supplies and vaccination drive entirely run by the federal government are now showing up. Early reports are for vaccine supplies of 135 million doses in July for advance planning, and 250 million vaccine doses in August. Ramped up manufacturing of vaccines in India with the entire pharmaceutical industry in India taking part is part of the new policy. Collaboration with US manufacturing and research partners is also part of the new policy being implemented.

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Serum Institute in India's vaccine developed with Oxford University is a leading one of the 6 candidates in India for coronavirus vaccine. It is expected to be ready by September. ICMR also has a vaccine that could be ready by India's Independence Day of August 15. One of the vaccines is for the elderly. Serum Institute has the advantage of being one of the leading manufacturers of vaccines in the world. India makes 60% of the world's vaccines giving it much experience in manufacturing that is needed today.

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Bharat Biotech and Biological E. are two companies developing vaccines in India. Bharat Biotech has asked for emergency authorization for use of its vaccine. Other Indian companies that have asked for emergency authorization are Pfizer India and Serum Institute of India. The foreign envoys will be flown to Hyderabad to be briefed on the vaccine readiness at Bharat Biotech and Biological E. In all 30 of 100 vaccines under development are being developed in India. India is a pioneer in vaccine development and manufacturing. Because of its huge population of 1.5 billion for India and Bangladesh, India has from the early years after independence in 1947 pursued a course of developing its own R&D and manufacturing of pharmaceuticals and vaccines, so that the large population can have access to medicine at a low price.

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Murali Krishnan of DW.com has this interview with Adar Poonavalla of Serum Institute of India the largest vaccine maker in the world that makes about 60% of all vaccines used in the world. It is beginning manufacturing of the Oxford vaccine so that the manufacturing process is ready to turn out a billion vaccine doses over a short period of 1 to 2 years. Serum's Oxford vaccine would be priced at $13 per dose for coronavirus. Serum is conducting its own trials for the vaccine. About 40 million doses would be ready by October. 

India's pioneering work in vaccine production on a large scale is one of the reasons the world can tackle the future with some confidence for the economy and the health of billions of people all over the world.

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Jenny Strasbourg of the WSJ provides this much needed report from London about the courageous decision by AstraZeneca and Oxford University to give vaccines away at no profit to the whole world, to billions of people in Africa, Asia, and Latin America. Without this brave decision by a British company and a British University the world would be a lot poorer, more variants could have happened, making us realize the great contribution Britain has made and how indispensable it is to the planet. Add to this the effort of Indian companies including Serum Institute that provided the manufacturing facilities and capabilities for making most of the British vaccine. AstraZeneca delivered 2.3 billion doses of the vaccine globally as of mid-December, according to the company. The International Monetary Fund estimates that low and middle income countries received 3.25 billion vaccines as of Dec. 11, About half of this or 1.6 billion doses were Astra Zeneca shots. This is a bigger share than any other vaccine by far and a life saver to the world. AstraZeneca stepped up early in a true to the best ideals in Britain to meet the needs of the world-  aiming to deliver 3 billion doses in 2022 and sell them at no profit as long as the pandemic continues. As the shot does not need cold storage it is ideal for India and other Asia, Africa and Latin America. "We are all very proud throughout the company of the impact we have had," says AstrZeneca CEO Pascal Soriot. By far the biggest manufacturing was done at Serum Institute of India which supplied 1.3 billion doses of the AstraZeneca vaccine to 70 countries. Mr. Modi pushed forward the export of vaccine made in India to the world from the beginning in the same spirit of cooperation and the best ideals that Britain was living upto. Serum Institute can produce as much as 250 million doses of vaccine a month making it possible for India to tackle the vaccination population of 1.3 billion people.   None of this could have happened without Oxford University and AstraZeneca and Indian companies with Mr. Modi's active support living up to the best ideals of Britain and India for the world. "When you add up the benefits to humanity, I think you'll find the vaccine holds up pretty well in terms of the ill health it has prevented, and the deaths it has prevented," says John Bell, a senior Oxford academic who in 2020 guided the University through its vaccine-partnership talks with Astra Zeneca. Because in the real world AstraZeneca shot has held up so well it is also a choice for booster shots. ...

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By August India will have tackled a shortage of vaccine supplies following the government decision to approve the use of Pfizer, Moderna, Novavax vaccines from US, Sputnik from Russia, and the US allowing export of vaccine manufacturing raw materials to India.

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The Oxford vaccine is shown to be effective for older adults over 70 years in age. One of the key features of the Oxford vaccine is that it is designed to be accessible in cost for not just high income countries but across all parts of the world including the countries in Asia, Africa and Latin America where some of the poorest people live. The cost will be a fraction of the cost of the Moderna and Pfizer vaccine. Results for regulatory approval are expected by Christmas. This vaccine is expected to cost about $4 a dose compared to $25 for the Pfizer or Moderna vaccines. Oxford also uses a technology for the vaccine that has already been proved effective with least side effects fr other virus such as Ebola virus. Oxford researchers took the existing vaccine technology and modified it to tackle coronavirus in a way that proves effective for this virus also. Countries such as South Korea say they will not rush into the first vaccine that is available and have not responded to requests for sale from Moderna or Pfizer. India's Serum Institute is the leading manufacturer of vaccines in the world. It is preparing for production of the Oxford vaccine. India's vaccine effort includes other vaccines developed by its research institutes. The focus of India is for a vaccine that is effective as well as meet cost so that it can be used to vaccinate over 1.3 billion people. Because India has strong already established manufacturing capabilities for vaccines and is collaborating with Oxford and Astra Zeneca for a low cost vaccine it is in a position to drive the campaign for an effective plus low cost 100% accessible vaccine for people around the world. Another aspect of the Astra Zeneca partnership with Oxford is that it has committed not to make a profit from the vaccine. This is important for Oxford researchers and its organizational goals. ...

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The Hindu data team looks at the Indian vaccination drive with graphs by state and progress by dates. During the first 10 days of June the vaccination drive has been stepped up. It is now over 3 million a day and at this rate should reach 400 million vaccinated by the end of July, 100 million below target. For the remainder of the year vaccine supplies have to be pushed up so that 8 million doses can be given each day. This would get India to where everyone in the country of 1.2 billion has been vaccinated by Dec 31, 2021. This would make it possible for India to then use its technology and large manufacturing capacity to help other nations in Asia, Africa and Latin America in 2022. This is the first time in history that India has taken on a challenge of this size and complexity. The vaccine strategy has changed to where the federal government is taking over the overall responsibility of coordinating the production of vaccines in the country and providing access to vaccines from other countries. Federal government is also taking on overall responsibility for distribution of vaccines and setting up the logistical effort. Vaccine supply is being opened up by opening India to multiple vaccines including Pfizer, Moderna, and other vaccines. Production of Covaxin is being stepped up. This strategy is designed to get India to somewhere closer to the 8 million doses a day needed and to ensure distribution and logistical efforts are in place. More resources are put into the effort. The speed of economic recovery also depends on the vaccination drive. Lessons were learned during the second wave in May 2021 and the government is better prepared for the hard work ahead. ...

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The Oxford vaccine is showing promising results and is expected to be authorized for use by December 2020. The vaccine being developed in partnership with Astra Zeneca PLC for marketing and Serum Institute of India for mass manufacturing is shown to be proven 90% effective in preventing infections in clinical trials. The partners say there were no serous safety events and the vaccine has proven 62% to 90% effective with an average of 70%.  This vaccine is significant because it is being developed with this partnership not seeking profits from this venture, providing it at cost and keeping the price to about $4 a dose compared to competitors Moderna and Pfizer whose vaccine is expected to be at $24 a dose. The Oxford vaccine also uses existing technology for vaccines and manufacturing is being done in India with the world's top manufacturer of vaccines. By using existing technology unlike the Pfizer and Moderna technology Oxford has taken an approach that could prove to be unique by minimizing side effects for vaccines that are being developed with such speed. By not requiring refrigeration at very low temperatures the vaccine makes itself ready for immediate and widespread uses all over the world. By use in its home country India with its large population Oxford vaccine can gain even wider acceptance because of India's long experience in pharmaceutical technology and manufacturing. Of particular interest is the study of 23,000 participants showing that the 90% effective dosage is one that only requires half a dose for the first shot. This say scientists is because the vaccine first dose prepares the body for a more powerful second dose and creates the maximum effect. This means the vaccine can be used for more doses than 2 full doses. It can be stored in a fridge making it easy to use in many countries. The full study will have 60,000 participants spread across U.S. Britain, Brazil South Africa and India. ...

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The Oxford vaccine developed in partnership with Astra Zeneca aims to be the vaccine for the world. The partnership has said it will make 2 billion doses and will provide this without making a profit at about $3 for one dose. Serum Institute of India was the leading supplier of vaccines to the world before the pandemic. Now it is preparing to make 1 billion doses of the Oxford vaccine. Already Astra Zenca has setup agreements for manufacturing  in other countries, with about 24 manufacturing facilities in countries such as Brazil, Japan, and Australia. Arrangements are also made with Russia and Mexico. The Russian partner has capacity to make 1 billion doses of the vaccine. In May the U.S. agreed to buy 300 million doses for $1.6 billion and manufacturing facilities are already being setup in the U.S.  The U.S. and other governments are sharing the risks as Astra Zeneca is hiring other companies to build the manufacturing capacity and working with them to install the new machines and supply the vaccine ingredients. For this the U.S. has Operation Warp Speed a $10 billion vaccine initiative and its organization, including the military. ...

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This video in The Indian Express shows how president Biden invoking US defense act provisions to ensure supplies of vaccine ingredients to US companies prevents exports to countries that badly need it. India has surpassed 300,000 daily cases of coronavirus on April 22, and India's largest vaccine manufacturer Serum Institute of India says vaccine manufacturing in India is restricted because of president Biden invoking that law. 

India's vaccination drive is stalling because of not enough vaccine supplies.

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Mr. Pascal Soriot of Astra Zeneca says his company has signed agreements for production of 2 billion doses of the coronavirus vaccine being developed by Oxford University. He says manufacturing is starting now because "we want it to be as fast as possible." One of the deals is with Serum Institute of India, the other is with Bill Gates of the Bill and Melinda Gates Foundation for $750 million for CEPI and GAVI organizations which he supports. Mr. Soriot says the licensing agreement with Serum Institute is to supply one billion doses for low and middle income countries, with 400 million doses ready by end of 2020. He says Astra Zeneca is building supply chains across the world and so far has secured manufacturing capacity for 2 billion doses of the vaccine. Mr Soriot tells BBC that manufacturing vaccines on this scale is not an easy thing to do. He says that Astra Zeneca will not make a profit in production of these Oxford University developed vaccines. The U.S. has secured 300 million doses of the Oxford vaccine, and the UK 100 million doses.   ...

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How do you setup a vaccine business. Consider Mr. Adar Poonavalla in the city of Pune in India. His company Serum Institute of India, remains family owned. Founded in 1966 by Cyrus Poonavalla, it produces billions of doses of vaccines for measles, polio and other diseases. It is expected to be one of the key sources of vaccines because of its expertise and the stocks of vials and other supplies that it has in stock for the next 2 years of vaccine production. It is working on a separate facility for coronavirus production that could turn out 800 million doses of vaccine at a price of about $13 a dose over 2 years. Serum Institute is working with 3 companies that are doing the research on the vaccine for coronavirus in the U.S. and Europe, and will play a key role in the manufacturing of vaccines. To respond to the question how do you setup a company to produce vaccines for the people of the world. This is what Mr. Poonavalla says- he will only work with ethical long term funds and sovereign funds because he does not want to be in the situation where he has to charge high prices to give them returns. Unlike most countries in the world, India is unique in making certain that most of the basic pharmaceutical drugs are available to over a billion people at a low cost. Serum's goal is low cost quality vaccine production so that over a billion people in Asia can be "protected from the birth onwards." As the U.S. and Europe and large parts of Asia, Africa and Latin America, face the second vaccine phase of the coronavirus response following difficulties in PPE, Ventilators, and Masks in the first phase, they can have confidence because of companies such as Serum and the research centers in U.S. and Europe like the one at Oxford University. ...

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In a bold decision that shows courage and foresight president Biden lifts IP protection for Covid 19 vaccine patents of American companies such as Pfizer, Moderna, J&J and Novavax. This has huge implications for vaccination supplies for countries such as India, Indonesia, Brazil, Mexico, that are hard hit by the pandemic as well as the rest of the world. It will open up manufacturing additional vaccine supplies in countries as diverse as France and India, that can ramp up quickly because of already established pharmaceutical bases.

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The Oxford vaccine manufactured and distributed by Astra Zeneca faced manufacturing problems in 2020. The company is fixing these manufacturing problems and plans to meet demand from Britain, the European Union, and the rest of the world. It plans to double vaccine monthly production to 200 million doses monthly by April. CEO Pascal Soriot says "Is it perfect? No, it's not perfect, but it's great, and tell me who else is making 100 million doses in February?" The Oxford vaccine has shown strong protection against severe coronavirus symptoms and is important in the fight against the pandemic. To tackle variants of the coronavirus the company plans to have another jab developed by autumn this year.

Britain and India are depending on Oxford vaccine to vaccinate large parts of the population. India has a second vaccine developed by Indian scientists at Bharat Biotech that is also in use.

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Astra Zeneca vaccine effectiveness gets a new boost from the late stage trial results for US, Chile and Peru that has 32,000 volunteers. The study shows Astra Zeneca vaccine 100% effective to prevent hospitalization and deaths, and 79% effective to prevent symptomatic illness. The vaccine is also known as the Oxford vaccine because it was developed at labs in Oxford University, England.

The vaccine is now preparing for US FDA regulatory approval. Its worldwide use will give new hope to the world's population because it is being given at cost and can be stored in ordinary refrigerators for long periods. Conditions that give it wide access in poor countries. It is also manufactured in India by The Serum Institute, one of the largest vaccine manufacturing labs in the world, which would make it possible to make the billions of doses needed.

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The Indian prime minister reviewed progress of the vaccination drive. On July 26, in the last 6 days about 38 million doses of vaccine have been adminstered in India. In a separate affidavit to the Supreme Court the government laid out its plan for making enough vaccine supplies to vaccinate the entire population over 18 by December 31, 2021, over 940 million people requiring over 1880 million doses.  "Out of this requirement for 1880 million doses 516 million doses will be made available by July 31, 2021, in about 34 days. The remaining 1350 million doses for complete vaccination to the eligible population" says the government information provided to the Supreme Court. The breakdown of vaccine supplies manufacturing is also given to SC. Of the total of 1350 million vaccine doses the following is how it will be manufactured in India in the next 6 months. Covishield  vaccine     500 million Covaxin vaccine          400 million Bio E Subunit vaccine  300 million Zydus Cadila DNA vaccine  50 million Sputnik V  vaccine          100 million The government told the Supreme Court that the procurement of Bio E Subunit vaccine and Zydus Cadila DNA vaccine will be subject to approval that is expected in the near future. From this new vaccine supplies picture it is clear that Covaxin and Bio E Unit will play a major part in the second half of 2021 in vaccinating India's entire population with 2 doses. This would be a historic achievement for the federal government after the lessons learned and the action taken with a new vaccine supplies policy for India in June 2021. There is also the challenge to be overcome of maintaining the vaccination drive at 6-8 million doses a day which would be another historic achievement for the federal and state, and local governments in India working with community education and logistical setup, medical staff.  ...

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A Phase 1 trial of over a thousand volunteers shows the Oxford vaccine works well with minimum side effects that can be handled with acetaminophen. Phase 2 trial is underway with volunteers in UK, Brazil and South Africa. Participants given the vaccine had significant increase in antibodies to neutralize the disease, and T cells for long term protection. About 70% reported fatigue or headaches which can be handled with acetaminophen. After the Ebola crisis of 2014 in West Africa the British government invested 120 million pounds to form a group to develop vaccines for top 10 likely threats dubbed "Disease X." On this list was the coronavirus. Scientists at the Jenner Institute at Oxford formed a team as part of this effort. Sarah Gilbert and Adrian Hill led the scientists at Jenner and pioneered research for  a new way to do this- to first replace a part of the virus with a component of the new virus. Then to remove the part of the virus that allows it to replicate in humans. This method is called recombinant adenovirus vector. The Oxford scientists used existing technology in new ways to increase the chances of getting a good vaccine early.  The first vaccine could be developed and tested for mass production by September. A 30,000 participant trial begins in U.S. in August. About 1 billion doses could be manufactured by end of 2020. India's Serum Institute has the manufacturing facilities to do this near Pune, India.  ...

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Indian prime minister Modi says he welcomes US president Biden's strong commitment to strengthen India-US strategic partnership, and says it will be a force for global good. The first action planned on which discussions were made is how to make vaccine supplies accessible and affordable in needed quantities in Asia, Africa and Latin America. US and India bring technology and manufacturing knowhow to do this. 

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Contrast the slow US vaccine export response with that of India, Russia, EU and China. Only in May 2021 after India's daily Covid cases were close to 400,000 a day did the US make a serious offer of vaccines to other countries in need of assistance. U.S. president Biden says that 80 million vaccine doses would be exported by the end of June 2021. The WSJ says citing Airfinity, a London research firm, as of May 10 more than 333 million doses of vaccine were produced by the US and only 3 million vaccine doses were exported. Contrast that with the European Union which has shipped 111 million doses overseas one third of its total production, Russia which has exported 27 million doses.  India has exported 66 million doses according to the Ministry of External Affairs website as of May 17, 2021. This includes 4 million doses to Brazil, 4 million to Nigeria. Within its own region Bangladesh received 10 million and Sri Lanka 1.2 million doses, Afghanistan 1 million. Mexico received about 1 million doses. In Africa the Democratic Republic of the Congo which has suffered from many epidemics including Ebola virus received 1.7 million doses, Nigeria 4 million doses, Kenya 1 million, Uganda 1 million. Of the 66 million about half of it is a direct grant assistance and Brazil, Mexico, Morocco received all vaccine as grant assistance, 70% of Bangladesh's is grant assistance. The list on the Ministry of External Affairs site of the Government of India shows 95 countries including many of the most struggling nations of Latin America and Africa, bringing hope to countries which are struggling to hold onto hope for a better life beyond the pandemic. Sending help overseas through vaccine supplies is suspended for the moment but will resume in July after India has pulled in all of its pharmaceutical manufacturing industry under a government guided effort to go all out. Never has so much help bringing much needed hope gone to so many countries of the world in the twentieth or twenty first century from a nation that is struggling to meet its own needs. The US in pursuing a US first policy of vaccinating all its citizens has not taken into account the need to bring this evolving vaccine technology into the hands of as many qualified pharmaceutical manufacturers as possible. This in a rapid response to expand manufacturing capabilities to meet world wide demand. The risks of not doing so were not taken on early- the very same way the virus spread in January to March of 2020 can be repeated as people travel around the world particularly for tourism, business family reasons. This risk takes on anew dimension of contagious mutations of the virus which are 50% more- the Indian variant being 50% more contagious by some estimates than the UK variant, which itself was estimated to be 50% more contagious than the original one.  The result a pandemic that stretches out indefinitely unless billions of doses are made in a short timetable to beat the timetable of Nature through the coronavirus. India is doing this for the first time with plans to produce billions of doses by engaging the whole of the Indian pharmaceutical manufacturing industry in the effort in a rapid response so that July to December would see 1.2 billion people vaccinated. The US effort, the European effort is left to the individual effort of pharmaceutical makers in the US and Europe, not a government guided effort to engage the entire pharmaceutical industry of the US and Europe in a rapid response timetable of 2-6 months.  ...

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Oxford Biomedica is the company that is part of the consortium making the coronavirus vaccine being developed by Oxford University's Jenner Institute.  Her Mr. Dawson describes the challenges he faced and cash crunches 4 times in 12 years, the last 4 years ago. The turning point he says was in 2012 when the cell and gene therapy was validated with a new drug developed for a form of cancer using this method. Oxford Biomedica is setting up a facility for manufacturing the vaccine in England at a 84,000 square foot former Royal Mail sorting facility in the city's business park called Oxpark. Dawson says cell and gene therapy is going to be big in health care. He did not see it coming till 2012. In 2014 he says during a cash crunch they had realized that what they had to do at Biomedica was to get to the time when it was going to be big. Today Astra Zeneca of the UK is organizing the effort and includes the use of British and Indian facilities for manufacturing, and Oxford University for research effort. ...

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Speaking for the Biden administration Anthony Blinken says that "on the current trajectory, if we don't do more, if the entire world doesn't do more, the entire world won't be vaccinated until 2024." What is needed he said is to "speed this up, and get that done, I think, in a much shorter time." Experts say the immediate impact of the Biden decision to give waivers on transfer of patents technologies is to get drug companies to cooperate with each other and for them to voluntarily join in the manufacture of vaccines globally. This would be done through global manufacturing alliances in major pharmaceutical manufacturing nations such as France, India and other countries that can quickly ramp up manufacturing if they have access to the technologies involved and the knowhow itself. The Biden decision is then the first of many decisions that would lead to voluntary action by pharmaceutical companies cooperating say Novartis and Sanofi in France and Switzerland with a Pfizer or Moderna in increasing manufacturing capacity or a Serum Institute or Reddy Labs in India working with Pfizer and Moderna or Novavax. These companies already have the basic structures to ramp up. This would take months yet the process has to start immediately. Today many companies such as Glaxo Smith Kline in UK and US are in a position to get involved in manufacturing but need access to the technologies and knowhow. Leadership by the US plays a huge part in making that happen.  ...