By Day 23, which is 2 days after the second shot, there is a 60% drop in hospitalizations among vaccinated people aged 60-plus, Maccabi revealed after monitoring 50,777 patients. It compared their hospitalization rate at that point with their hospitalization rate soon after receiving the vaccine, using 7-day moving averages.
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Maccabi’s graph gives a real picture of infection in Israel, showing that until Day 13, vaccinated over-60s had similar infection rates as the overall 60-plus population. Then, a gap opens, and by Day 23, there were 18 daily infections among the 50,777 overall, but just six among the vaccinated.
Merck, one of the world’s leading vaccine makers, is ending its Covid-19 vaccine development after its two candidates failed to elicit immune responses as strong as those created by shots that are already available. The US pharmaceutical company also said on Monday that its phase 1 trials showed participants’ response was not as robust as the immune response seen in recovered Covid-19 patients. There were no significant safety issues. Shares in Merck fell 1.8 per cent to $79.51 in pre-market trading in New York as the company said it would record an unspecified charge in the fourth quarter. Dean Li, president of Merck research laboratories, said the company remained “resolute in our commitment to contribute to the global effort to relieve the burden of this pandemic on patients, healthcare systems and communities”. Merck was slow to announce its entry into the race for a Covid-19 vaccine, despite previous successes in vaccines. Instead, two of the first available shots have been developed by companies that previously had no vaccine products on the market: BioNTech and Moderna. Before Covid-19, Merck had developed a mumps vaccine in what was then a record-breaking four years, created the first Ebola vaccine approved by a US regulator and launched the first vaccine designed to prevent cervical cancer.
Merck will now focus on developing drugs to treat Covid-19. The company has a deal with the US government worth up to $356m to sell a drug to treat the inflammatory response for severe Covid-19 patients if it receives emergency use authorisation. The second drug is an antiviral in phase 2/3 clinical trials, being developed with Ridgeback Bio. It could be the first oral therapeutic, which patients would be able to take outside the hospital. Merck’s abandoning of its two experimental vaccines against Covid-19 is also a blow for France because one of them — known as V591 — was developed initially by the Institut Pasteur, the country’s top biomedical research institution. The vaccine delivered a weakened form of the Sars-Cov-2 virus that causes Covid-19, using a measles vaccine as a delivery mechanism. Scientists had hoped this would make it easier and cheaper to manufacture given that many facilities already exist to make measles vaccines. The failure of the Pasteur vaccine also means that France remains without its own domestic producer, which has prompted some politicians and public health experts to lament the weakness of the country’s pharmaceutical sector and look with envy at the UK, Germany and the US. Sanofi, the country’s leading pharma company and one of the biggest makers of vaccines globally, was hit with a significant setback in December when its experimental Covid-19 vaccine, being developed in partnership with GlaxoSmithKline, failed in phase 2 trials because of a dosing error, forcing it to repeat the study. The delay means Sanofi is unlikely to be able to bring a vaccine to market until the end of this year at the earliest. It is now studying whether it can act as a contract manufacturer for rival producers. Geoffrey Porges, an analyst at SVB Leerink said it was not “encouraging” that two of the four largest vaccine companies, GSK and Merck, were “effectively out of the Covid race”. “This news makes the results from Johnson & Johnson and Novavax even more important,” he added.
Pfizer and AstraZeneca, but what about Moderna in the US? Johnson & Johnson should get approval in the US next month for their vaccine.
clinical trials have confirmed that vitamin D supplementation reduces risk of acute respiratory tract infections, and approximately 30 observational studies have shown that incidence, severity, and death from COVID-19 are inversely correlated with serum 25(OH)D concentrations (how vitamin D is measured in the blood).”
The EU and AstraZeneca failed to end a crisis over coronavirus vaccine supplies, as Brussels attacked the company’s “continued lack of clarity” on its delivery schedule and demanded it come up with a clear plan. While both sides said high-level emergency talks held on Wednesday night had been “constructive”, they did little to resolve the dispute over whether the company should deliver tens of millions more doses to the EU than it plans to over the first three months of the year. The negotiations came after a dramatic escalation of the spat on Wednesday, when the European Commission said AstraZeneca must use production from its UK plants to make more deliveries to the EU. The company insists that its contract with the European bloc does not bind it to stick to its original delivery schedule, but only to make its “best effort” to do so. Stella Kyriakides, the EU’s health commissioner, said late on Wednesday that the European bloc remained “united and firm” in its belief that “contractual obligations must be met”. “We regret the continued lack of clarity on the delivery schedule and request a clear plan from AstraZeneca for the fast delivery of the quantity of vaccines that we reserved for Q1,” she tweeted after the talks with company representatives including Pascal Soriot, chief executive. “We will work with the company to find solutions and deliver vaccines rapidly for EU citizens.” AstraZeneca said Mr Soriot had been pleased to participate in the meeting with the EU’s vaccine steering board, which includes representatives from the commission and member states. “We had a constructive and open conversation about the complexities of scaling up production of our vaccine, and the challenges we have encountered,” the company said. “We have committed to even closer co-ordination to jointly chart a path for the delivery of our vaccine over the coming months as we continue our efforts to bring this vaccine to millions of Europeans at no profit during the pandemic.” EU officials say AstraZeneca now plans to deliver only about a quarter of the 100m or more doses expected during the first three months of the year, dealing a heavy blow to the European bloc’s already lagging vaccine rollout. The company has blamed the shortfall on supply chain problems and has insisted that — contrary to EU officials’ suspicions — it has not diverted deliveries from the European bloc to the UK or other countries. The European Medicines Agency regulator could decide to give its long-awaited approval to the AstraZeneca vaccine at a meeting on Friday. Also on Friday, the commission is due to unveil proposals to tighten rules on exports of jabs outside the bloc, although it remains unclear whether it will give member states the powers to block shipments.
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The EU will empower member states to block exports of vaccines, forcing pharmaceutical companies to seek authorisation before shipping the life-saving jabs out of the bloc. The move comes as dose shortages and a confrontation with AstraZeneca over supplies have left the EU’s vaccination strategy in disarray, with French authorities instructing hospitals in Paris to suspend first injections due to the shortfall. EU officials said the new system would force companies to disclose export plans, as Brussels sought to reassert control of doses manufactured inside the bloc. “Any exporting company would send into national authorities their plan of what to export, when, to whom and so on,” one EU official said. “National authorities would then be allowed to check that, give an authorisation or a refusal.” A day after Madrid said it had been forced to pause vaccinations for 10 days, authorities in Paris, the northern Hauts de France and Bourgogne-Franche-Comté regions — representing a third of the French population — delayed first vaccine injections for two to four weeks to conserve doses for those in need of their second and final injection.
Portugal, meanwhile, said it now expected to take up to two months longer than initially planned to complete the first phase of its vaccinations. Francisco Ramos, head of the country’s vaccination task force, said only about 1.5m vaccine doses were likely to be delivered in the first quarter, compared with almost 3m that Portugal had initially hoped to receive. Member states anger at the shortages has focused particularly on AstraZeneca, which is awaiting expected authorisation of its vaccine in the EU on Friday. An EU official on Wednesday said the drug company was planning to deliver only a quarter of the previously planned 100m or more doses in the first quarter due to production problems at EU manufacturing sites. As the confrontation between the company and the bloc escalated on Thursday, Belgian authorities said the European Commission had asked them to inspect production flow at the facility responsible for the AstraZeneca shortfall. The review would cover multiple production sites and involve several authorities, the Belgian government said. The commission did not respond to a request for comment. The commission and EU capitals have also asked whether vaccines produced inside the EU have previously been shipped to the UK, and demanded that UK-produced vaccines be used to make up the AstraZeneca shortfall.
The new export powers, to be unveiled by the commission on Friday, will allow member states to check whether a shipment was “legitimate” and prevent exports that would violate advance purchase agreements the EU has struck with pharma companies, according to an EU official.The new rules would potentially affect supplies of all three western-made vaccines currently available for use, as all have manufacturing operations in the EU. BioNTech/Pfizer supplies the whole world apart from the US from its European plants, while Moderna produces its non-US vaccine supply in Switzerland but fills and finishes the vials in Spain. The EU’s export scheme would be put in place for the first quarter of 2021, but with the possibility for it to be prolonged. An EU official said that, in practice, they expected any rejections of exports to be “rare". Boris Johnson, the UK prime minister, has refused to be drawn into the dispute between the EU and AstraZeneca.“ Our objective is to let the EU work through this and avoid negative consequences,” said one British official. “The idea of export controls on vaccines would not just be bad for Europe it would be bad for the world.”
Downing Street fears that an outbreak of “vaccine nationalism” would have severe geopolitical consequences for the west, creating the impression that western democracies were unable to protect their people from the pandemic. Charles Michel, European Council president, wrote to the leaders of Austria, the Czech Republic, Denmark and Greece calling for the EU to explore the use of new legal powers and “enforcement measures” to ramp up vaccine production in the EU. In the letter, seen by the Financial Times, he floated the use of EU treaty powers intended to address “severe difficulties” arising in the supply of certain products. Mr Michel did not specify how such a legal mechanism would work, but one EU official suggested it could enable the bloc to require companies to share patents, licences and knowhow needed to broaden vaccine production. “I believe this solution would demonstrate the EU’s strength and reliability in protecting its citizens' health over and above all other considerations,” said Mr Michel.
Johnson & Johnson said its late-stage trial in the U.S. and seven other countries showed an overall 66% effectiveness in its vaccine in preventing moderate to severe illness. It was also 85% effective against severe disease across all regions studied, the company said, and its effectiveness against severe disease increased over time with none of the vaccinated volunteers reporting severe disease more than 49 days after vaccination..
The vaccine also worked better in the U.S., with 72% effectiveness against moderate to severe COVID-19, while it showed only 57% effectiveness in South Africa, where a more rapidly spreading variant of the virus is more prevalent.
Vaccine manufacturer Moderna has told Italy and France it will deliver fewer doses than expected in February, in another blow to struggling coronavirus vaccination plans in the EU.
Domenico Arcuri, the Italian special commissioner in charge of Italy’s pandemic response, said Moderna had told Rome that delivery volumes would be 20 per cent less than planned from early February. France’s ministry of health said it was now expecting 25 per cent fewer doses from the US biotech than had originally been scheduled next month. Moderna did not immediately respond to a request for a comment.The cuts are the latest disruptions to vaccine supplies that have left the EU’s vaccination strategy in disarray. AstraZeneca warned EU officials last week that it could supply less than half of the vaccines the bloc had ordered for the first three months of the year, provoking a bitter clash over contractual terms. Giuseppe Conte, the Italian prime minister, last week accused AstraZeneca of “a serious contractual violation” for what he said was an unexpected reduction in deliveries of the Covid-19 vaccine the company has developed with Oxford university, and said Italy would consider “all legal steps”. In response to the dispute, and with AstraZeneca’s agreement, the European Commission published a redacted copy of the supply contract, or advanced purchase agreement, on Friday. BioNTech/Pfizer have also had to reduce some deliveries of its vaccine as all three leading groups have struggled to meet high demand.“ Now almost every day the forecasted deliveries are changed,” Mr Arcuri said on Friday, emphasising Italy’s “astonishment, our concern and our disappointment”.
Moderna had told him 132,000 doses of its vaccine would arrive from the week starting February 9 compared with the 166,000 doses the Italian government had expected. In France, the health ministry said it was now expecting approximately 600,000 doses in the month of February, rather than the 800,000 doses it had planned for. BioNTech/Pfizer had already reduced its deliveries to the country in January by 200,000 doses from an original promise of 2.6m doses. Authorities in Paris, the northern Hauts-de-France and Bourgogne-Franche-Comté regions — representing a third of the French population — instructed hospitals on Thursday to delay first vaccine injections for two to four weeks to conserve doses for those in need of their second and final injection.The Spanish regions of Madrid, Catalonia, Andalucía and Valencia have also all complained of delays in Moderna shipments. Spain’s health minister Carolina Darias said on Thursday night that 52,000 Moderna doses would arrive next week. To date, Spain has taken receipt of 35,700 Moderna vaccines and 1.7m vaccines from BioNTech/Pfizer.
The company said its initial findings showed one dose prevented 85% of severe cases.
Extracted from above link.Markus Söder, the Bavarian premier and Germany's possible future chancellor, told ZDF television on Friday that it was his impression that the commission "ordered too late, and only bet on a few companies, they agreed on a price in a typically bureaucratic EU procedure and completely underestimated the fundamental importance of the situation."
Former Swedish prime minister Carl Bildt wrote on Twitter that he "had hoped not to see [the European Union] leading the world down the destructive path of vaccine nationalism".
"Our continent's entire history of success has been one of open global value chains," he added.