AstraZeneca to seek U.S. authorization for COVID-19 vaccine this month or early next https://www.reuters.com/article/us-...his-month-or-early-next-sources-idUSKBN2B42JN AstraZeneca Plc is preparing to file for U.S. emergency use authorization (EUA) for its COVID-19 vaccine later this month or early April after accumulating enough data to judge the inoculation’s efficacy, sources with knowledge of the ongoing clinical trial told Reuters on Friday. The British drugmaker completed enrollment in its trial of more than 32,000 volunteers in January and now has data on at least 150 cases of COVID-19, two sources familiar with the trial told Reuters. The number of COVID-19 cases among those who got the vaccine versus infections in participants who received a placebo will show how effective the AstraZeneca shot was at preventing illness in those age 18 and over. The AstraZeneca vaccine, developed in collaboration with Oxford University, has been authorized for use in theEuropean Union and many countries but not yet by U.S. regulators. “The U.S. Phase III study results are necessary for the FDA’s evaluation of an EUA request for our vaccine,” a company spokeswoman said, without confirming trial details being reported by Reuters. “We expect data from our U.S. Phase III trial to be available soon, in the coming weeks, and we plan to file for emergency use authorization shortly thereafter.” Highly anticipated results from the U.S. trial could help settle safety concerns arising over reports of serious blood clots in some vaccine recipients that have led several nations to pause administering the vaccine. A World Health Organization expert advisory committee islooking into the matter. The data could also help determine what becomes of doses already sitting in U.S. warehouses awaiting approval. The New York Times reported on Thursday that some countries have been asking to procure doses of the vaccine not currently being offered in the United States. AstraZeneca said in February it expects its vaccine could receive U.S. emergency use authorization at the beginning of April and could immediately deliver 30 million doses to locations around the United States. In a Friday press briefing, White House Coronavirus Response Coordinator Jeff Zients said the United States has a small inventory of the AstraZeneca vaccine, which it plans to keep and deploy to Americans should an EUA be granted. The U.S. stance could thwart AstraZeneca’s efforts to come closer to delivering on its contractual obligation with the EU of 180 million doses in the second quarter. AstraZeneca told the EU earlier this year it would cut its supplies in the second quarter by at least half to less than 90 million doses, EU sources told Reuters, after a bigger reduction in the first three months of the year.
Ireland was added to this list today... Europe was counting on the AstraZeneca vaccine as its primary vaccine. These blood clot issues coupled with the recent announcement that AstraZeneca will only be able to deliver less than half of its promised doses by August is putting Europe in a tough predicament. Denmark, Norway, Iceland, Italy halt use of AstraZeneca vaccine due to safety concerns https://www.france24.com/en/video/2...of-astrazeneca-vaccine-due-to-safety-concerns
A lot of rough sledding for AstraZ in Europe of late. At least to their image. Poor or no performance on the production and reported problems with the vaccine. I don't have an opinion. Just sayin they are in the shiiter a bit. Could clear up, or on the other hand, countries could get more picky as other companies come on line. They actually have more than one vaccine going so there is probably a different story for each. I have not totally kept up. COVID: Several European countries halt use of AstraZeneca vaccine https://www.dw.com/en/covid-several-european-countries-halt-use-of-astrazeneca-vaccine/a-56835406
Coupled with the AstraZeneca supply issues.... it is a real mess AstraZeneca's lower EU vaccine supply target hinges on factory approval https://www.reuters.com/article/us-health-coronavirus-eu-astrazeneca-idUSKBN2B50EO
Canada just started using AstraZ. Not sure whether Astra's problems will help or hurt the Canadians. If some countries have halted use, it makes more supply available to them. On the other hand, they take heat if they unload vaccines onto their citizens that are being rejected or questioned by woke countries. I am pretty sure they will have their hands full as it is just trying to get people to feel peppy about the Indian vaccines that are coming.
It's going to take a while for world-wide vaccination... Most of the world's poorest countries haven't administered a single COVID-19 vaccine dose https://www.businessinsider.com/man...t-administered-single-covid-19-vaccine-2021-3 At the start of March, at least 47 poor countries reportedly had not given any COVID-19 shots. The data came from the People's Vaccine Alliance. Suspending patents would speed up production, experts said. As wealthier nations speed up their COVID-19 vaccine rollout, poorer countries are being left behind. Rich nations, on average, vaccinated one person every second throughout January and February, while the majority of the poorest nations are yet to give a single dose, according to the People's Vaccine Alliance. Developing countries also face "critical shortages" of oxygen and medical supplies to cope with COVID-19 cases, the Alliance, a coalition of campaigning organizations including Oxfam, the International Trade Union Confederation, and ActionAid, said. Vaccine doses are going to wealthier countries To prevent wealthier countries from snatching up vital doses of the vaccine, groups including the World Health Organization (WHO) launched the COVAX scheme in April 2020. Countries sign up to access an equal share of successful vaccine candidates, meaning the doses are shared among richer and poorer countries. The companies behind the initiative said: "For lower-income funded nations ... COVAX is quite literally a lifeline and the only viable way in which their citizens will get access to COVID-19 vaccines." Despite being a "phenomenal effort at international collaboration," Covax is "seriously underfunded," Ted Schrecker, professor of global health policy at Newcastle University Medical School, told Insider. Covax made its first delivery to Ghana in February. Even as the doses procured through COVAX roll out to poor countries, however, the scheme will only be able to vaccinate 3% of their populations by mid-year, and "at best" 20% by the end of 2021, the Alliance said. As of 4 March, at least 47 of the world's 79 lowest-income countries hadn't vaccinated any of their population, according to the Alliance. In comparison, President Joe Biden said the US would have enough vaccines for every adult in America by the end of May. Throughout the pandemic, groups including the People's Vaccine Alliance have been raising concerns about "vaccine nationalism." This is when richer countries hoard vaccines, while poorer countries are left scrambling to get their own stocks. Dr. Tedros Adhanom Ghebreyesus, head of the WHO, said in February rich countries with only 16% of the world's population had purchased 60% of available vaccine supplies. Suspending patents would speed up production Vaccines doses need to be produced in different areas, priced affordably, allocated globally, and widely deployed for free in local communities, the Alliance said. "Thus far, the world is failing on all four fronts," it concluded. The Alliance added that vaccine producers across the world would be ready to produce COVID-19 vaccines if the pharmaceutical companies with authorized vaccines shared their technology and expertise. A modern factory should be able to start producing vaccines within four months if given the blueprint and technical advice, Suhaib Siddiqi, former director of chemistry at Moderna, said. "It's an outrage that vaccine factories are lying idle, unable to produce COVID-19 vaccines because rich countries are prioritizing the patents of pharmaceutical companies ahead of the lives of people across the world," Nick Dearden, director of Global Justice Now, said. He urged pharmaceutical companies to suspend the patents on their COVID-19 vaccines so that they can be produced more quickly. Gabriela Bucher, executive director at Oxfam International, said: "By allowing a small group of pharmaceutical companies to decide who lives and who dies, rich nations are prolonging this unprecedented global health emergency and putting countless more lives on the line." Wealthier countries could be motivated to ensure all countries have access to a vaccine because of herd immunity beliefs, however. "In order to control the virus, we need worldwide herd immunity, so between 60% and 72% of the population need immunizing," Alison Copeland, professor of human geography at Newcastle University, told Insider. "This will hopefully be enough incentive for richer countries to help out."
There may be an example of the first death caused by a COVID vaccine anywhere on the face of the earth. At this point over 360 million COVID vaccine doses have been administered world-wide and there is only one possible example of a death that may be medically attributed to a vaccine dose. The AstraZeneca vaccine is having an issue with blood clots - causing some European countries to suspend its use. Obviously blood clots which can travel in the body can cause serious medical issues. Dane who died from blood clot after AstraZeneca shot had `unusual symptoms', agency says https://www.reuters.com/article/health-coronavirus-denmark-int-idUSKBN2B70TS A 60-year old Danish woman who died of a blood clot after receiving AstraZeneca’s COVID-19 vaccine had “highly unusual” symptoms, according to the Danish Medicines Agency. The woman had a low number of blood platelets and clots in small and large vessels, as well as bleeding, it said. A few similar cases were found in Norway and in the European Medicines Agency’s (EMA) database of drug side effects, Danish Medicines Agency said. “It was an unusual course of illness around the death that made the Danish Medicines Agency react,” it said in a statement late on Sunday. Norway said on Saturday that three people, all under the age of 50, who had received the AstraZeneca vaccine were being treated in hospital for bleeding, blood clots and a low count of blood platelets, which were labeled “unusual symptoms” by health authorities. Denmark, Norway and Iceland said last week they would halt the introduction of the AstraZeneca vaccine. European vaccination programmes have been upset in the last two weeks by reports that recipients of the AstraZeneca inoculation have suffered blood clots. The European Medicines Agency has said there is no indication that the events were caused by the vaccination, a view that was echoed by the World Health Organization on Friday. AstraZeneca Plc said on Sunday a review of safety data of people vaccinated with its COVID-19 vaccine has shown no evidence of an increased risk of blood clots.
Chile becomes Latin America's COVID-19 vaccination champion https://www.post-gazette.com/news/w...er-J-and-J-South-America/stories/202103140229 After being among the world’s hardest-hit nations with COVID-19, Chile is now near the top among countries at vaccinating its population against the disease caused by the coronavirus. With more than 25% of its people having received at least one shot, the country of 19 million on South America’s Pacific coast is the champion of Latin America. Globally, it is just behind Israel, the United Arab Emirates and the United Kingdom. That’s a far cry from the beginning of the pandemic, when Chile was criticized over its inability to trace and isolate infected people. So what is the secret to its success? Government officials and health experts say it was the country’s early negotiations with vaccine producers, as well as its past experience with robust vaccination programs, a record praised by the World Health Organization. During the first months of the pandemic, the headlines in Chile were bleak, with the country’s intensive care units almost full and the government unable to control the virus’s spread, despite restrictions that included mandatory lockdowns. But another story was developing in parallel that few people knew about — one that had begun months before and would later guarantee Chile fast access to vaccines. Andrés Couve, Chile’s minister of science, told The Associated Press that formal negotiations with vaccine-producing companies started in April, only a month after COVID-19 was declared a pandemic. By May, Mr. Couve said, a team of experts and officials presented a plan to President Sebastián Piñera, including a road map about how to use the country’s network of trade agreements and its previous contacts with pharmaceutical companies to get vaccines once they were developed. Recommendations included being part of clinical trials. This effort was helped by contacts made years earlier in China. In October 2019, Chilean biochemist Dr. Alexis Kalergis had traveled to Beijing with two Chilean colleagues for an international congress on immunology. There Dr. Kalergis met experts from Chinese pharmaceutical firm Sinovac Biotech Ltd. Dr. Kalergis had already approached Sinovac about working on vaccine research. So when China announced in January 2020 that it had identified a novel virus — and within weeks, the world watched as it spread around the globe — Dr. Kalergis knew he needed to reach out to his colleagues at Sinovac. “Taking advantage of our experience, the contacts and the interest that we expressed ... we started conversations with Sinovac,” said Dr. Kalergis, director of the Milenio Institute for Immunology and Immunotherapy at Chile’s Catholic University. He spoke to Sinovac employees in January and February 2020, then went to Catholic University Dean Ignacio Sánchez with the details, saying they needed to be passed on to the government. Mr. Sánchez approached Chile’s health minister and foreign secretary, urging early negotiations with Sinovac and other pharmaceuticals and for Chile to be part of their clinical trials. The ministers agreed, and the Chilean government began making diplomatic contacts. By June — long before any other country in Latin America — Chile had secured a contract with Sinovac, which agreed to deliver an early batch once its COVID-19 vaccine was authorized, Dr. Kalergis said. Rodrigo Yáñez, undersecretary for international economic relations and lead negotiator with companies to get the vaccines, said Chile understood from the beginning that it needed to work with different pharmaceutical companies at the same time. “We looked at different alternatives and didn’t put all the eggs in the same basket,” he said. Chile was part of a Sinovac clinical trial that started in December and involved 2,300 medical workers. The government has not published its results, saying only that they were good. Trials for the COVID-19 vaccines being produced by AstraZeneca, Johnson & Johnson subsidiary Janssen and Chinese pharmaceutical company CanSino were also done in Chile; those results also have not been disclosed. Chile received its first vaccine doses in December — some 21,000 from Pfizer — but they were fewer than promised. The country immediately began vaccinating medical workers. By the end of January, Chile had received the first 4 million doses from Sinovac and was able to speed up inoculation. Massive vaccination started in February. Chile was administering more than 100,000 shots almost daily since early February, and that more than tripled this week. On Wednesday, it reached a daily global record of 1.3 shots per 100 inhabitants, followed by Israel with 1.04 doses, according to Our World in Data, a collaboration between researchers at the University of Oxford and the nonprofit Global Change Data Lab. No other country in Latin America has had anything near Chile’s success. Brazil, for example, has vaccinated only 4% of its population; Argentina, around 3%. Health Minister Enrique París said Chile has now secured 35 million doses to vaccinate 15 million people, and it’s already helping other countries. Earlier this month, Chilean authorities donated 20,000 Sinovac doses to Paraguay and the same amount to Ecuador. Chile had “good planning and wisely used the resources it has to make bilateral agreements with some producers,” Jarbas Barbosa, deputy director of the Pan American Health Organization, said this week. This is not the first time Chile has conducted a successful vaccination program: Last year, between March and April when the coronavirus was emerging, Chilean authorities vaccinated 8 million people against the flu. Mario Patiño, 75, was among the first to be vaccinated against COVID-19 with a Sinovac dose in February at a school in Lo Prado, a poor residential area of Santiago. “Everything was perfect, fast, with an excellent service, well-organized,” said Mr. Patiño, who got his second shot Saturday. “For me, the vaccine means to be calmer.”
Add Germany to the list of countries suspending the use of the AstraZeneca vaccine... Germany suspends AstraZeneca COVID-19 vaccinations amid blood clotting reports Investigations are underway at the European Medicines Agency https://www.foxnews.com/health/germ...d-19-vaccinations-amid-blood-clotting-reports