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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's Covid vaccine is expected to bring in $6 billion in profit in 2021. Pfizer increased its sales forecast by 70 percent. The coronavirus vaccine is expected to bring in $26 billion in revenues in 2021 with 1.6 billion vaccine doses manufactured for the year 2021. The total could be much higher with the company striving for supply contracts to manufacture 2.5 billion doses.

India has approved the Pfizer, Moderna and J&J vaccines, with this bringing American companies into the Indian vaccine market in 2021.

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EU Commission president Leyen announces Pfizer will supply EU with 1.8 billion doses of Pfizer vaccine to 2023. The increased supplies will include booster shorts to increase immunity. Another change is the new date for 70% of European Union population to be vaccinated, which is now advanced to end of July instead of end of September. With new waves of the coronavirus affecting Europe, and criticism of the EU's earlier effort in securing vaccine supplies, more urgency has gone into the new effort in 2021. Leyen told Pfizer CEO Albert Bouria- "If I may say so, engineer the mRNA in a way that it can adapt to potential escape vaccines," at a joint press conference. Leyen thanked Pfizer for its enormous effort in boosting vaccine manufacture and delivery. This will help accelerate the vaccination effort in Europe after the slow start in March and April of 2021. Bringing much needed optimism and new hope of a lasting recovery both in economic activity, health and in the mood in Europe, which can then spread from the US and Europe to the rest of the world. ...

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Pfizer coronavirus vaccine is shown to be 90% effective in results from Phase 3 trials. The findings come from a preliminary look at the first 94 infections in a group of 44,000 people in the trial. The vast majority of the cases received a control instead of vaccine. A vaccine is considered effective if it works on 50% of cases. The Pfizer vaccine is based on an experimental "mRNa" technology.

Britain has ordered 5 million till the end of 2020 and another 20 million for 2021. In total Pfizer plans to make a billion doses of the vaccine by 2021.

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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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A study shown in New England Journal of Medicine shows Pfizer vaccine 2 doses offers 88% protection from symptomatic disease for delta variant of coronavirus. The Astra Zeneca vaccine has 67% protection against delta variant after 2 doses.

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A major British and Indian collaboration and scientific achievement of both countries is not given the recognition it should get because of mismanaged communication of the results of clinical trials. Tom Whipple science editor of The Times says do not make the mistake of thinking oh Pfizer vaccine scores a 9 out of 10 and Oxford's a 7 or 8 out of 10. Pfizer vaccine says it 94% effective. But this is only part of the story. It is the first exam paper in a long number of exam papers and the final score will require scoring them all. "Oxford vaccine is complex, and we are happy with the complexity," says Adrian Hill, Oxford researcher and head of the Jenner Institute. It is not highly unusual in this complex field for a half first dose to work better than a full first dose in a two dose vaccine treatment. This happened with the Oxford vaccine. As a result the study results were harder to communicate. This happened by accident. Much of medical research and much of medicine's biggest breakthroughs in the last 200 years happened by accident, as one researcher looked for something and accidentally discovered something else profoundly useful. Whipple's points are turning out to be true now that Britain's medicine regulator has asked that Pfizer vaccine not be given to people with history of allergic reactions after 2 NHS workers had strong allergic reactions. A lot of questions remain for all vaccines. How long will the protection last? WIll it prevent transmission of coronavirus? Are there any other complications? Which vaccines can work without ultralow refrigeration storage? Ahead lie the prospect of billions of doses. Two are in final stages in India including Bharat Biotech request for emergency authorization. Johnson & Johnson has a competing one to Pfizer's in the U.S. As many as 30 are being developed in India and 100 around the world. Countries like South Korea say they will wait to find out which one works best and where cost overall combined with benefit is attractive. Some of the vaccines are coming out only weeks apart. The early ones could stumble, if something was missed. ...

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The true story of the two German scientists, children of immigrants from Germany, who did the research behind the Pfizer vaccine for coronavirus. One the son of a guest worker from Turkey who worked at a car factory in Cologne, another the daughter of a doctor who finished medical school and immigrated to Germany. They started primarily on cancer vaccines using new mRNA technologies. Much of their work focused on meeting the gap that had developed says Ozlem Tureci, between what was done in the labs and what was available to patients and doctors. 

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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 third or booster dose of vaccine is needed to take out the Omicron variant. The UK Health Security Agency analyzed data from 581 Omicron cases and thousands of Delta cases to calculate how effective vaccines such as Pfizer and Astra Zeneca were against the Omicron variant. This early analysis shows a third booster dose prevents around 75% of people from getting any coronavirus symptoms. The double dose of the vaccine however provides good protection against severe coronavirus that needed hospital treatment says the UK Health Security Agency. Of equal concern is the rate of spread of the Omicron variant. Here this BBC report shows graphs of UK National Health Security Agency which show the rate of spread is rapid with cases doubling every 2-3 days. For the UK which on December 10 had about 1265 cases this means says this BBC report that the number of Omicron cases could be well above 100,000 in the UK by the end of December. The BBC graph shows the curve for Omicron cases moving in a close to vertical direction upwards. Reports say the experience in South Africa where the Omicron variant was first detected is similar in pattern causing rapid spread. ...

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Moderna has made the initial batches of doses of the vaccine for the variant of coronavirus including South African variant, and shipped these to the National Institutes of Health in the US. If the test results are positive the vaccine for variant could be given authorization by the third quarter of 2021. It is becoming crucial to stay ahead of variants developing from the coronavirus and pharmaceutical companies Pfizer, J&J, Astra Zeneca are working on the technology to tackle this.

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The story of the Pfizer BioNTech vaccine is the story of 2 chikdren of Turkish immigrants to Germany. Sahin the son of a engineer working at a Ford factory in Cologne, and Tureci the daughter of a surgeon working at a hospital in Mainz Germany. Sahin was born in 1965 on the Mediterranean coast in Iskerundun, Turkey and he went to Germany when he was 4 years old, his father being recruited in a new effort to rebuild Germany with foreign labour. Both are motivated by scientific research and the drive to come up with some method to tackle cancer for patients with new research and cures.  Both did their doctoral dissertation on experimental therapies at the Johannes-Gutenberg University of Mainz in Germany, and both joined the faculty there. Sahin spent years studying the mRNA , genetic instructions that can be delivered to the body to help it defend itself against viruses and other threats. Much of this mRNA research was already at an advanced stage in January 2020 when Sahin heard about the coronavirus in China. At that point he saw the potential of retargeting the mRNA research to tackling the coronavirus. By this time he already had his own company with over 200 million euros invested in it  by investors including Helmut Jeggle, now supervisory board chairman of BioNTech. This report says he sat down one Saturday, January 25, 2020 and working on his computer designed the template for 10 possible coronavirus vaccines, one of which would become BNT162b2, the vaccine now approved in Britain. On the same day he told a surprised Jettle that he would refocus the company on the new virus that had not yet hit Europe. Shain he says cited the Hong Kong flu that claimed 4 million lives. Why Pfizer. Pfizer had already been working with BioNTech on a new flu vaccine based on mRNA technology. A cooperation deal was signed with Pfizer in March for organizing clinical trials, manufacture globally, and distribute the vaccine. BioNTech then acquired a U.S. company and a German pharmaceutical factory in Germany. ...

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Some people experienced fever and headaches after receiving the Pfizer and Moderna vaccine which disappeared after 2-3 days after which they felt fine. This report in WSJ says people getting the vaccine still think its a lot better than getting coronavirus. About 85% of the people taking the vaccine did not experience severe symptoms of fever for 2-3 days.

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A 1 month study of 2 modified Pfizer vaccines, one targeted specifically for new Omicron variants, and the other targeted at earlier coronavirus and current Omicron variants show increases in anitbodies much higher than what current vaccines do. For Omicron specifically at 13 to 19 times more than what current vaccines increase antibodies, and for earlier variants and Omicron at 9 to 11 times more.

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In January 2020 employees met at a local Maryland bar to find out how they might salvage their careers in a 33 year old company that had failed to develop an approved vaccine, says this story in WSJ. Only months later following the coronavirus pandemic everything changed as in a miracle for Novavax. The company had to sell manufacturing assets at one point, and had enough cash for another 6 months just months before. By Feb. 2021 shares which had dropped to $4 were up to $229 and valuation which had declined to $127 million went up to 15 billion. Coronavirus has turned things upside down where newcomers are using previously unproven technologies and making them work in this pandemic. The persistence, perseverance and confidence of Novavax even in the most difficult situations shows how the right attitude can lead to remarkable results. Novavax vaccine can be kept in refrigerators for 3 months, and do not require very low freezing temperatures like Moderna and Pfizer vaccines. This is considered a potent weapon in the fight against coronavirus. Novavax says it can produce a couple of billion doses over the next 12 months beginning in April. Novavax has released data showing its vaccine is effective for protection against coronavirus. Results of late stage US trials are expected in March. ...

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This podcast in WSJ tells the amazing story of the development of a vaccine for malaria by a British scientist that took forty years. In a world of short run startups this tells the story of medical and indirectly other research include research on renewable energy to tackle climate change that takes years to develop and makes a lasting change in our lives. This is also true of the mRNA vaccine developed by two German scientists of Turkish descent who developed the Pfizer vaccine. The Novavax vaccine in the US also has a story of resilience in the face of many challenges. Mr Scholz of the SDP, currently vice chancellor of Germany and winner of the German election said recently he wanted to expose the myth that was created of the self-made man that has penetrated our culture over the last 2 decades. One cannot even conceive of self made people at a time when the whole world depends on vaccines developed such as mRNA vaccine by these 2 German scientists at university labs that are the first line of defense against the coronavirus. Both scientists took only half a day off when they got married. Both are children of immigrants to Germany from Turkey. They both cycle to work. Mr. Shin says "I don't have a car. I am not going to get a plane. What's life changing is to be able to impact something in the medical field." The electric batteries used in today's electric cars use technology developed by a Japanese scientist and professor who also worked at Toshiba in the face of many challenges. ...

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India reports over 300,000 cases for the fourth day in a row. German chancellor Merkel passes legislation that gives the federal government the power to set curfews to control the spread of coronavirus. Cases reach 166 per 100,000 in Germany and the government sees lockdowns to be in place till the end of May. Streets in Dusseldorf and other German cities are shown deserted at night.  The European Union deal signed with Pfizer for 1.8 billion doses including booster doses of the Pfizer vaccine, provides new hope for the vigorous vaccination drive needed in Germany and the rest of Europe. 

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The new tiered system of tighter restrictions passed in the British parliament 291 to 78 with 51 Tory rebels voting against and 10 Tories abstaining. Labour abstained from the vote getting it to pass. Tory rebels are voting with their constituents in Tory seats in parliament that have lower rate from coronavirus and see the restrictions hurting the lives of people in their areas. The prime minister had to make a special plea to them to get it passed including promising to review in granular detail these areas which needed lifting restrictions because of low infection rates.

Other steps the government is taking are to seek emergency approval of vaccines with the first approval done for Pfizer vaccine. This means Britain will be the first country to start vaccinations in 24-48 hours- December 3 or December 4.

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China faces risk of a surge inthe coronavirus in June 2021. The area in and around Guangzhou appears to be seriously affected. The city tested almost its entire population of 18.7 million between June 6 Sunday and June 8 Tuesday. This report shows pictures of a deserted Beijing airport, strict restrictions on foreign travel. The SinoPharm vaccine effectiveness against the Delta variant in India and UK is unknown. The government is locking down entire neighborhoods rather than entire cities or provinces.  As the risks of the Delta variant and other new variants increases most of the population even in the US and Europe have either no dose or one dose. Researchers at the University of New South Wales in Australia show the Astra Zeneca vaccine effectiveness with one dose at only 30%, only after two weeks following the second dose does the vaccine effectiveness reach about 70%. The population of China and India are so large that much larger parts of the population remain unvaccinated. In China with 1.3 billion people and even if the figure of 800 million doses stated by the government is accepted- it could be an overestimate as the US has only managed 300 million doses with many vaccines- most of the population is unprotected. Vaccine skepticism is high in China making vaccination an uphill task. SinoPharmvaccine is not as effective as Pfizer, Moderna, Astra Zeneca, or Covaxin vaccines, making the task even more of an uphill kind. ...

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The Moderna and Pfizer vaccines are effective against the virus variant identified in Britain. It is less effective against the virus variant from South Africa. The U.S. banned all travel to and from South Africa effective Jan 30. U.S. coronavirus cases were at 125,000 on Jan 24 down 20% for the week. 

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As the coronavirus surges in India with over 300,000 cases a day on April 26, a clear picture on the vaccination drive in the country is critical. The following is the picture of the vaccination progress from Union Health Ministry in India as shown in The Hindustan Times. India has vaccinated 140 million people with at least one dose says this report in The Hindustan Times.  On Saturday 24th April 2.4 million doses were given for that day at 8 pm. This was done over 99 days. This means about 12% of the population of 1.2 billion has been vaccinated.  This compares with the vaccination in Germany for about 21% of people vaccinated with over 18 million getting the first dose in Germany by around April 25. Both Germany and India have suffered from vaccine shortages, some skepticism about vaccinations. Gradually sentiment is shifting in both countries so that once skeptical Germany now has about 75% of people willing to take vaccine on April 25, 2021. In India about 6 million healthcare workers have 2 doses of vaccine, and about 9 million have 1 dose. About 6 million frontline workers have 2 doses and 12 million frontline workers have 1 dose of vaccine.  There is a shortage of vaccine supplies and a bold decision was made by the Indian government on April 25th 2021, after the surge of cases to a world wide maximum of over 300,000 cases a day. The decision was to give immediate regulatory approval for the three major vaccines in the US to be brought and used in India. And delivery will be speeded up - no customs duties and fast processing of supplies access to speedy logistical supply routes. This is a huge step forward for the vaccination drive as this means Pfizer, Moderna and J&J vaccines can now be used in India. The government is also urging the companies to make in India or export to India with prices that provide flexibility in pricing for the private market. The locally produced Covishield Astra Zeneca based vaccine produced by Serum Institute will be allowed to be sold to the private market at 600 rupees or close to about $10. Pfizer and Moderna, J&J can price in a way that would be somewhere around this price range. The access to more vaccines and the ability of the companies to make a reasonable profit in the Indian private market means that vaccine supplies should open up in May and June.  This could give a huge boost to vaccination numbers so that India's vaccination percentage of population vaccinated should keep up with that in countries like Germany and France that were slower to get started in Europe but are now catching up quickly. This is a massive achievement because the population numbers are huge compared to Europe. ...

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How is it that Britain's regulatory agency approved the Pfizer vaccine before the U.S. FDA agency? This report in the NYT says FDA looks at the raw data. Britain's Medicine and Healthcare Products Regulatory Agency looks at the information provided by the company. It still does the testing batch by batch and has access to the data and looks at thousands of pages of data. What about the European Union? The European Union Medicines Agency meets on December 29. It takes days after it meets to get input of 27 countries so that vaccination cannot start till January. The U.S. president summoned the FDA to the White House to find out how soon the FDA could act. Both Britain and the U.S. are feeling the impact of the second wave of coronavirus.

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So far 17 million people in the UK have received the Astra Zeneca vaccine.  35 cases of blood clots, 15 of pulmonary embolism and 22 of deep vein thrombosis have been reported across the UK and EU. In a normal year more than this number of cases of blood clots are seen say experts. These occur naturally in the population, including elderly population. Astra Zeneca's chief medical officer, Ann Taylor, says the number of blood clots in the 17 million people who have received the vaccine across Europe is actually lower than would be expected in the general population. The EU countries of Germany, France, Netherlands and Italy have temporarily stopped using it after 3 healthcare workers in Norway had blood clots. In Germany 7 out of 1.6 million had a rare condition of cerebral sinus thrombosis. Both EU and medical regulators say that there is no evidence that these blood clots are caused by the vaccine. The number of clots are similar to what was seen in the population before the coronavirus. Also this report in The Times says taken together there is no difference between the number of clots in the population that received the Pfizer vaccine or the Astra Zeneca vaccine.  The Daily Telegraph reports that one in 1000 people have blood clots every year, so that for 17 million people in vaccinated population with the Astra Zeneca vaccine there would be 17000 cases of blood clots over 12 months. During the clinical trials Astra Zeneca reported there were fewer people with blood clots who had been vaccinated than in the people who were not vaccinated. ...