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US and Kennedy at HHS pulls back from Denmark's policy on vaccines.

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Most questions about the vaccines from Oxford, Pfizer and Moderna are answered in this Q&A in The Times.  The Oxford vaccine is the only vaccine that is being provided at cost to the public at a cost of 4 pounds, Pfizer using German technology at 15 pounds and Moderna from Cambridge, Massachusetts, at 28 pounds. The Oxford vaccine can be stored in a fridge, the others use mRNA technology of messenger RNA which requires ultra low temperature storage. Astra Zeneca could have handled the trials and methodology for results in a better way. As the two trials one that produced results of 62% and the other results of 90% cannot be combined to give results of 70% but are two distinct and separate trials. However too much emphasis has been placed on the vaccine, as other prevention measures remain important for 2021. Other vaccines are being developed in Britain with new technology and in India by ICMR which are in trials stage and about which not enough is known. The Russian and Chinese vaccines have not released detailed data limiting their use around the world. ...

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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 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 Quillay tree, a rare evergreen native of central Chile provides a key ingredient for new vaccines, including the Novavax vaccine for coronavirus and the new vaccine for malaria. FR24 provides a glimpse of this rare evergreen tree in this video. It was used by indigenous people for soap and medicine.

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On the first day of the new vaccine policy on June 21, 2021, India has vaccinated 6.9 million people. India has now vaccinated 287 million people out of a population of 1.2 billion. This is a race against time as new variants caused the second wave of coronavirus in April and May of 2021 with cases peaking at over 300,000 a day.  The shortcoming of the old vaccine policy are being corrected. The entire vaccine supply process and the vaccination drive is now being handled by the federal government. Earlier during the second wave vaccine supply and the vaccination drives were under an arrangement with no clear overall responsibility. States shared responsibility with the federal government and target vaccination goals were missed, vaccine supplies were inadequate.  A similar arrangement in Germany failed and Germany's vaccination supplies were inadequate and vaccination drive stalled. This caused immense frustration in Germany in April-May 2021. Germany's troubled history before World War II led to a reliance on decentralized actions, and state governments imposed different rules in a relatively small country compared to India. This was corrected with the federal government taking on the entire responsibility for the vaccine supply and vaccination drive leading to good results today in vaccines. With India's huge population and political process of different state governments, some lacking experience in administration for a complex process, and others failing to coordinate well with the federal government, the lack of overall responsibility at the federal government posed serious risks of missing targets for vaccines and letting the coronavirus wreck the economy and public confidence. Complex negotiations with other governments in Europe and the US for vaccine manufacture in India could only be handled at the federal level. The resources and planning at the federal level were already in place in India for infrastructure and other projects, experience and setting targets in that area at the federal level could now be transferred to this task in vaccines. Somewhere in the range of 8 million vaccines a day need to be reached and sustained from August to December 2021 for India to reach the goal of vaccinated all 1.2 billion people ahead of any further attack from a third or fourth wave, say experts. This is not a choice for the federal government, it is simply something India has got to accomplish to be a healthy nation that can grow with neighbors in Europe, the US, Australia and Japan and build confidence in its Asia-Pacific region. The entire Asia-Pacific region has a lot resting on how well India achieve this goal and moves on to the next phase of assisting its neighbors in the region.  ...

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Estimates that about 161 million people have been vaccinated in China with Sinovac vaccine made in China. That vaccine has effectiveness of 50.1% at preventing symptomatic infections, as estimated by researchers in Brazil. This compares with the newer technology used in Pfizer and Moderna vaccines that have effectiveness of over 90%. 

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In this interview in The Hindu with Public Health Foundation of India president Srinath Reddy, the importance of safe behaviours including masks and social distancing, public discipline to tackle a potential third wave. This was also pointed out separately by the Director AIIMS.  Mr. Reddy says study by Public Health England shows just one dose of Astra Zeneca vaccine is not very effective against the Delta variant- about 30% effective. As a result he suggests the need to reduce the spacing intervals which are at 8-12 weeks to a shorter interval now that adequate supplies of vaccine will be available starting in July and August till the end of the year. The initial spacing was 4 weeks when Astra Zeneca vaccine was first introduced and at which time the variants had not emerged. The Indian federal government affidavit to the Supreme Court shows that 1880 million doses of vaccine will be available by the end of the year 2021 to vaccinate fully with 2 doses the population of India over 18 years using 5 locally manufactured Made in India vaccines. This does not include the mRNA vaccines that will be made available from Moderna and Pfizer for which cold storage facilities are being prepared by the federal government.   ...

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This report in The Times shows the need to counter misinformation in parts of the media about vaccines. Inadvertently or through a poor comprehension of the data, German media reports in Handelsblatt and the Bild have stated that vaccine effectiveness for older people is 8%. Here in The Times of London, Oxford University and Astra Zeneca point out that the 8% figure is for the number of people in the trials who were given the vaccine in the age group 56-70 years. This does not refer to how effective the vaccines were in older people.  The first dose increases monoclonal antibodies for people of all ages, say Astra Zeneca and Oxford. We are now beyond trials in a sense today as Israel has vaccinated large parts of the population and the UK, India are vaccinating millions of British and Indian citizens. Israeli reports from one of the major medical centres show that the second dose increases monoclonal antibodies by multiple times and provides effective protection. As British data is available from medical research institutions from the vaccination drive in Britain, and from India, the effectiveness of the vaccines used in Britain and India will be shown more clearly. India today has used a package with near 100% compliance to tackle the virus relatively effectively by combining safety protocols (masks+ social distancing+ hygiene) with nutritional, medicinal protocols, restricted overseas flights. Cases are down to 13,000 for 1.2 billion people, with positivity rate in testing down to 1.66%. One readers comment in The Times says a lot- She says her 79 year old Irish mother was given the vaccine today in Coventry, England. She was given the Astra Zeneca Oxford vaccine jab by a British Asian doctor who took the time to talk to her, and listened to her and thanked her for her service as a midwife for 40 years. That these few minutes were the happiest time in 10 months for her mother. It also showed she says the very best of this country.   ...

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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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Thre drug companies are placing bets on the vaccine business. Johnson and Johnson paid 302 million euros for 18% of Dutch biotech company Crucell NV, to jointly develop vaccines. Abbott Labs says it will acquire a unit of Belgian conglomerate Solvay SA for 4.5 billion euros in adeal that includes a vaccine business. And Merck obtained the marketing rights for a seasonal flu vaccine from Australia's CSL Ltd. This follows Pfizer's Wyeth acquisition. Low prices, high costs and fear of lawsuits made most drug makers to exit the business in the 1980's and 1990's. Now vaccine sales are growing faster than other prescription drugs and are largely protected from generic competition. And government agencies here in the USA and around the world are reliable buyers of vaccines as they seek to stockpile medicines that could be needed in aflu outbreak. Merck never exit the vaccine business and now makes 8 of 10 vaccines recommended for adults. Flu and other vaccines are especially attractive for entering drug markets in Brazil and China and developing countries. Governments lke the idea of lowcost prevention at $10 adose, and with this new relationships are developed in these countries. And even at price of $10 or $20 a dose they provide asteady stream of revenue.Vaccines are estimated to generate $21.5 billion in revenues by 2012 according to Sanofi-Aventis SA, which is a leading vaccine maker....

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At a time in Jan. 2022 when 73% of Americans have received two dose vaccines and 39% have a booster shot according to the CDC, the US Supreme Court is deliberating on the Biden vaccine mandate that seeks to get the rest of the people vaccinated.

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Encouraging early results for a vaccine from Moderna Inc. which tested on a small group of 8 healthy humans. A key requirement that the neutralizing antibodies created by the vaccine stop the coronavirus from replicating was met in the vaccine developed by Moderna. A larger human trial will now proceed for hundreds of healthy people. In July another trial will have thousands of healthy people. By the end of the year the company plans to make millions of vaccines.

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With better control over the coronavirus than U.S. and Europe, South Korea is not rushing to buy the vaccines developed by Pfizer or Moderna. It is waiting to see how the vaccine rollouts work in other countries before buying the vaccine. South Korea is also looking at getting better price from manufacturers after the rollouts in the U.S. and Europe. South Korea is moving cautiously and has said it wants to get 10 million doses through the Covax initiative the main global effort to provide broad access to vaccines. Another 20 million doses would be secured from private companies. This is in contrast to the approach in Japan where the government has signed deals for purchase of 290 million doses for 145 million people for its population of 126 million. The money allocated is $6.5 billion and the goal is to vaccinate everyone by first half of 2021.  If it works this would prepare Japan for the Tokyo Summer Olympics to open in July, after 1 year delay. South Korea has the freedom to do this and wait to see what vaccine works best with least long term effects because their are relatively fewer cases there. A total of 313 new daily cases on November 18, lower than daily cases in a single county in the state of Michigan in the U.S. Moderna and Pfizer vaccines use anew kind of gene based technology that has never been approved to prevent infectious diseases. Other competition is the vaccine from Oxford and Astra Zeneca which uses an existing technology that is used in existing vaccines modified for use in coronavirus. The Oxford vaccine and a vaccine from Johnson and Johnson are expected to have a lower price. Because life is functioning very close to normal South Korea is in the unusual position of saying that its people have no reason to be anxious for vaccine procurement, as indicated by its deputy director of Korea Disease Control and Prevention Agency. Only three fifths of the population is the target for vaccination by fall of 2021. ...

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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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The National Childhood Vaccine Injury Compensation Program protects vaccine makers from much of the litigation risk faced by pharmaceutical manufacturers. It limits compensation for death to $250,000. This special vaccines court is called Office of Special Masters at the U.S. Court of Federal Claims. This may be one reason for Pfizer's willingness to pay $68 billion for Wyeth which is amaker of childhood vaccines. Vaccines will generate $21.5 billion in sales by 2012, according to Sanofi-Aventis. Vaccines are biologic products that can't be copied. Wyeth's Prevnar is designed to protect children against 7 strains of pneumococcal disease. It has sales of $2.7 billion projected to grow to $5.5 billion in 2015 according to Sanford C. Bernstein & Co. Vaccines have driven huge reductions in childhood diseases, and the Act is designed to potect makers of vaccines, who suffered from excessive litigation in the 1980's.

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India plans 10 million daily vaccines by the middle of July 2021 as it pushes forward with an aggressive vaccination strategy for the large population of 1.2 billion people. Daily covid cases have dropped to about 150,000 as the intensity of the current wave declines.

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The world's larges vaccine supplier Serum Institute of India syas it will not be able to meet its target production of 2 billion doses for 2021. It says vaccines will not be available for export from the Institute till the end of the year. The Indian government has initiated an effort to diversify its vaccine production by distributing it among many suppliers in India's large pharmaceutical industry so that constraints at any one supplier would not affect the overall supply for use inside India and the production that can be sent overseas.

Another setback was seen in the US as 100 million doses of J&J one dose vaccine at a Baltimore plant are being checked for contamination.

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Protection from hospitalization for Omicron variants can drop to 57% from 81% after 6 months from second dose, and can be pushed back up to 90% using booster shots for Pfizer and Moderna vaccines, according to a large CDC study in the US. For Delta variant period last year the vaccine effectiveness against hospitalization was 90% from about two weeks after dose two till 6 months, dropping to 81% after 6 months, and up to 94% after a booster shot. For Omicron variant the currently vaccine effectiveness for same periods is 81%, 57%, and 90%.

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Sanofi will use its manufacturing plant in Ridgefield, New Jersey, in the US to fill vials and finish packaging of 200 million doses of Moderna vaccine, under a new agreement. This will supply the US under Moderna's US supply of vaccine agreements that run through April 2022. This is part of industry collaboration to expand supply of global vaccines, that includes Merck and Novartis.

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The Oxford vaccine developed by British scientists could be ready by September. Astra Zeneca has joined with Oxford so that it can produce 100 million vaccine doses by the end of the year. This is because in a sense the vaccine is not new. It uses an existing tech platform where there is a lot of experience. The use of ring vaccination method shortens the process of testing on humans the vaccine to a few months. The core of the virus ChAdox1 already exists in chimpanzees and has a mild effect on humans. This is an adenovirus. It is combined with another virus to produce the covid vaccine for coronavirus. Researchers at Oxford have used ChAdox1 in the past to test vaccines for Ebola and MERS as well as other virus.  Already tests have been conducted on rhesus macaques. The rhesus macaques given the vaccine at a Montana lab did not get coronavirus.The surface protein of coronavirus is simply added to the ChAdox1 so that it is able to attach to host cells and infect them in the human body, and let antibodies develop from this. The purpose is to let the human body develop defense mechanism against this attaching to a human cell.   ...

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Germany's chancellor Angela Merkel says she will not support the moves by the EU commission to impose export bans on export of Astra Zeneca vaccines made in EU countries to Britain. A Dutch factory has 4 million doses of this vaccine ready for shipment.  Merkel says, "there are a huge range of international interdependencies when it comes to vaccine production. You have to be very careful when it comes to imposing export bans. You have to take a close look at supply chains."  Merkel's action comes as Britain makes an effort to talk to German and French leaders for a fair way to allocate supplies of vaccine. France and Germany see the need for the principles of "reciprocity" and "equivalence" to be covered in settling the differences on vaccine supplies. Equivalence refers to the sense that there should not be a big gap between EU and non EU countries in vaccine access. On March 24, Britain had vaccinated 45 of 100 people in the country, and EU had vaccinated only 13 people in a hundred. ...

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From now on the vaccination program in India will be run nationally by the federal government. This will ensure fair access to vaccines to all parts of the Indian population. Earlier vaccine costs were bid up as states and private hospitals bid up prices. Under the new national program 75% of vaccines will be given out by the federal government and 25%  by private hospitals and other private health institutions. The government in New Delhi under prime minister Modi will offer adults free vaccinations. Modi said "We will increase the speed of procuring vaccines and also increase the pace of the vaccination program." Even in private hospitals the cost of vaccine will be kept at Rupees 150 or $2.06. Experts say this is the right policy and the government has learned from errors in letting states and other private institutions run vaccine policy, which made it too fragmented and subject to too many variables, resulting in inequity, and slowing vaccination drives. The Supreme Court stepped in asking for clarity, leading to the clear policy from the federal government announced today.  Advantage of the new policy is that the responsibility lies in one place, and the federal government also has the clout to make things happen, to negotiate with companies and other parties involved effectively. India has vaccinated 222 million people but because of the population being so large at 1.2 billion this comes out to be a small fraction of the population. This puts the task of getting vaccine supplies and getting the vaccination drives to work in the only place that has the determination and the resources to deliver results by vaccinating 1.2 billion people by December 2021. It has never been done before in history says Mr. Modi, and it is a challenge that India is now taking up for itself and for the global community. It also lays the ground for India to help its neighbors in Asia and in Africa, Latin America in 2022.   ...