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Germany's national broadcaster DW.com looks into the details of the vaccination drive in countries around the world, including Germany, and finds that there is more to the story than meets the eye in headlines about safety in vaccinations. Many headlines do not tell the whole story carefully. DW revewed reports from Italy, Austria, South Korea, Germany, Spain, the USA, Norway, Belgium and Peru, and found that in most cases health authorites have not found causal links between the vaccination and deaths.  As of March 15 it says 360 million people have been vaccinated in 120 countries, or about 9.25 million a day.  DW.com cites the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) which states: 'there is no indication that vaccination has caused these conditions, which are not listed as side effects with this vaccine. Information available so far indicates that the number of thromboembolic events in vaccinated people is no higher than that seen in the general population." As of March 10, 2021 30 cases of blood clots are recorded for 5 million people vaccinated with Astra Zeneca vaccine in the European Economic Area.  The Paul Ehrlich Institute which is in charge of vaccination in Germany has looked into 113 reported deaths in 46 years to 100 years old patients in Germany. Of these 113 deaths PEI finds that 20 died of the Covid 19 infection as it takes 14 days after the second dose for full protection, and 43 died of pre-existing conditions or other infections. For the patient population it says "they were seriously ill patients with many underlying diseases." PEI says "based on the data we have we assume they died of their underlying disease- in a coincidental time with the vaccination." A virologist at the Technical University of Munich, says that the deaths after vaccination are below the expected number of deaths without the vaccination.  ...

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Logistical problems and need to authorize it for over 65's has delayed the effective use of Astra Zeneca vaccine doses in Germany and France.

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AstraZeneca PLC showed a net profit decline of 8.3% in fourth quarter 2011, on sales that remained stable at $8.66 billion compared to $8.62 billion in the prior year quarter. AstraZeneca is facing competition from low cost generics and cuts in government health care spending similiar to the rest of the industry. The company has announced new job cuts of 7,300 job for 2012, which brings total job cuts to 30,000 for the last 5 years. Most of the job cuts are in the U.S. and Europe. Hiring has continued in emerging markets leaving the net job cuts over the last 5 years at 9,600. Of the 7,300 job cuts planned for 2012, 2,200 will be in R&D departments, 1,350 in manufacturing and 3,750 in sales. AstraZeneca is changing the way it will do research and development with these changes. It will close the neuroscience research laboratories in Sodertalje, Sweden and in Montreal. It will have in its place "virtual" neuroscience units, small groups of 40-50 researchers working with academic groups and scientists outside to utilize the best science in the field. This is one of the most radical changes in R&D practices among pharmaceutical companies. In marketing the approach has shifted from having full time sales people call doctors offices to using online marketing tools and telemarketers. This approach is also being adopted for emerging markets....

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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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Pascal Soriot is made the new CEO of AstraZeneca PLC. He was chief operating officer of Roche's pharmaceutical division and CEO of Genentech before the merger with Roche.

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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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Astra-Zeneca insists prescription drugs is an attractive business and remains focussed on that business, even as other pharmaceutical companies are reducing their exposure to prescription drugs.

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The loss of 75 million J&J vaccine doses with failure at a manufacturing plant in Baltimore. The FDA is looking at what to do with 170 million doses produced by Emergent Biosolutions, a contractor, that made vaccines for J&J and Astra Zeneca. Contamination at the Baltimore plant makes the vaccines made there unusable.

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The Chinese market for medical care is growing. China will spend $125 billion on a three year plan to boost medical care. This means funding 31,000 new hospitals by 2012. Medical equipment market is estimated to grow at 13.5% a year to $15.5 billion in 2012, according to Philips Electronics. And Credit Suisse sees the pharma market up from $44 billion in 2008 to $110 billion in 2015. GE is designing inexpensive imaging equipment for fast growing rural markets, with cost at 10% of urban markets.

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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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The chief political reporter for the German daily The Bild, says Ursula Von der Leyen EU Commission president's performance on ensuring vaccine supplies is a disgrace for the EU and Germany. For once Brexiteers are proved right he says with having negotiated a better deal with vaccine suppliers, not being stingy like the EU officials, paying good money and securing supplies as early as April.  He says the EU's bureaucracy, its sluggish response, miserly attitude is now being confirmed in this health crisis and Germany is not looking good at all. Tiede says Leyen failed at the German Defense ministry and like other ministers in this situation was shifted into the EU Commission bureaucracy,only to fail again. He suggests Merkel and the heads of France, and Italy, Spain take over negotiating directly from now on with pharmaceutical companies. The EU officials are under severe criticism in Europe, shown here for different EU countries. Leyen is shown to have blundered further by creating a spat with Astra Zeneca- either she did not read the contract or was ignorant of what it meant, say critics. The EU's deal with Astra Zeneca was not with binding provisions, making EU officials at fault. Der Tiegesspiegel called EU's failure to admit its mistakes "jaw dropping" and bordered on "shamelessness." Der Spiegel calls it the worst catastrophe of Leyen's career. This now means Germany will have only 70% of its population vaccinated by September 2021, say experts. ...

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Johnson & Johnson begins a 60,000 person clinical trial on 3 continents in the final stage of testing. It could learn vital results in early next year which if positive would lead to government authorization for emergency use soon after. J&J will test whether a single dose of vaccine will work. It is also doing work separately with the UK government for a separate phase three study to test whether a 2 dose vaccine will work.

Other companies in final stage of testing are Moderna and Pfizer with studies results expected in October and Astra Zeneca working with Oxford expecting results by the end of 2020.

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Medtronic's former CEO, Bill George, says Medtronic's plan to reincorporate in Ireland as part of the merger with Covidien is intended to make it possible to use cash piled up overseas. The cash overseas if repatriated to the U.S. would incur corporate taxes of 35%. Medtronic can use its overseas cash resources to finance the acquisition of Covidien. The combination of the two companies will enhance cash flow, says Medtronic's CEO, Omar Ishak. Covidien's overseas cash and future earning from its businesses is not subject to U.S. repatriation taxes. As a result the combined company following merger will have only 40% of total cash "trapped" overseas, compared to 60% before a merger.

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Medtronic pursues tax avoidance strategies as it merges with Covidien, which is based in Ireland. Ireland's corporate tax rate is 12.5% compared to 35% in the U.S. Medronic had $14 billion in cash in 2014, much of it overseas. The merger helps Medtronic use some of the overseas cash to finance the deal, and will help Medtronic distribute half of free cash flow to shareholders.

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Jens Thurau talks about the chaos in Germany during this wave of the coronavirus in DW.com, and asks who is to blame- Merkel? The deniers? German behaviour sticking to rules? Lack of digitization technology culture? 

A German man 3 days short of his 60th birthday is turned away from a vaccination center because Astra Zeneca vaccine can only be given to persons above 60 years. The man is sent away starting a heated discussion at the vaccination center whether this was the right thing to do. He is ironically sent way because he is too young. Common sense has not prevailed.

Elsewhere local rules that are set down to the streets and house numbers where masks must be worn have been written down and followed. And deniers seem to think they have gone through enough hardships, when Italy and other countries have gone through much worse. German angst, he asks?

 

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Questions raised about Dr Pazdur's decisions at FDA for anemia drugs made by Amgen and Johnson and Johnson. Dr Pazdur is head of the FDA office that regulates oncology drugs, all cancer drugs. Dr Pazdur's review process and decision shows how reviewers are human and their own experience helps determine what they see prominently. His experience with his father who suffered severely from the side effects of steroid drugs would make him aware of the the other effects of drugs. He is an oncologist, his wife is an oncology nurse, and some relatives have died of cancer, so he has lived with cancer patients. It appears from close associates that he like open communication and hears all sides but makes the final decision himself. He had an experience with a drug for lung cancer Iressa made by Astra -Zeneca, which the FDA approved based on testimonials, but not enough statistical evidence, which later failed and approval had to be withdrawn. This may have made him more inclined to look for strong results and statistical evidence before concluding on the safety and effectivenes of a drug. An approach evident with Amgen's anemia drug. It also appears that the FDA is not clear on whether the drug's effectiveness is to be judged by what result, is it whether it prolongs life only that counts, or whether the effectiveness in relieving significantly the symptoms of a patient even if life is not prolonged. There is the controversy surrounding the FDA's rejection of a drug by Genta Inc Genasense that relieved patient symptoms for leukemia but did not prolong their life. These and other questions continue to give sleepless nights to people at the FDA and outside as the drug review process faces difficult balancing act between what to give importance and what direction to take with a drug in patient's interests. In Dr Pazdur's case this is made more difficult as he thinks every day of his father who died in 1979 and suffered from the side effects of steroid drugs, went blind when Dr Pazdur was only a teen, and had pulmonary fibrosis and diabetes. He is described by doctors who trained under him as gentle but did meet a patient's eyes and tell him that he had to come to terms with his disease. ...