astrazeneca – Cincy Link

WHO authorizes AstraZeneca’s COVID vaccine for emergency use

cincylink — Wed, 11 Aug 2021 05:28:06 +0000

Video above: WHO Finds Original COVID-19 Outbreak in China Was More Widespread Than ReportedThe World Health Organization has granted an emergency authorization to AstraZeneca's coronavirus vaccine, a move that should allow the U.N. agency's partners to ship millions of doses to countries as part of a U.N.-backed program to tame the pandemic.In a statement Monday, the WHO said it was clearing the AstraZeneca vaccines made by the Serum Institute of India and South Korea’s AstraZeneca-SKBio. The WHO’s green light for the AstraZeneca vaccine is only the second one the U.N. health agency has issued after authorizing the Pfizer-BioNTech vaccine in December. Monday's announcement should trigger the delivery of hundreds of millions of doses to countries that have signed up for the U.N.-backed COVAX effort, which aims to deliver vaccines to the world’s most vulnerable people.“Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk,” said Dr. Mariângela Simão, the WHO's Assistant-Director General for Access to Medicines and Health Products. The coronavirus has infected more than 109 million people and killed at least 2.4 million of them. But many countries have not yet started vaccination programs and even rich nations are facing shortages of vaccine doses as manufacturers struggle to ramp up production. The AstraZeneca vaccine has already been authorized in more than 50 countries, including Britain, India, Argentina and Mexico. It is cheaper and easier to handle than the Pfizer-BioNTech vaccine, which needs deep-cold storage that is not widespread in many developing nations. Both vaccines require two shots per person, given weeks apart.Last week, WHO vaccine experts recommended the use of the AstraZeneca vaccine for people over age 18, including in countries that have detected variants of COVID-19. But that was contrary to the recommendation from the African Centers for Disease Control and Prevention, which said countries that had identified a virus variant first seen in South Africa should be “cautious” in their use of the AstraZeneca vaccine, suggesting that other shots be prioritized instead. The AstraZeneca vaccine forms the bulk of COVAX’s stockpile and concerns were recently raised after an early study suggested it might not prevent mild and moderate disease caused by the variant first seen South Africa. Last week, South Africa scaled back its planned rollout of the AstraZeneca vaccine, opting instead to use an unlicensed shot from Johnson & Johnson for its health care workers. COVAX has already missed its own goal of beginning coronavirus vaccinations in poor countries at the same time that shots were rolled out in rich countries. Numerous developing countries have rushed in recent weeks to sign their own private deals to buy vaccines, unwilling to wait for COVAX. WHO and its partners, including the vaccines alliance GAVI, have not said which countries will receive the first doses from COVAX. But an initial plan showed a handful of rich countries that have signed multiple private vaccine deals, including Canada, South Korea and New Zealand, are also scheduled to receive early doses from COVAX. Some public health experts called that “very problematic” and attributed it to COVAX’s flawed design, which allowed donor countries to double dip by purchasing vaccines from the program while also signing their own commercial deals. “Canada has ordered enough doses to supply their population about five times over and now they’re looking to accept their share of doses from COVAX, which would otherwise be given to poor nations,” said Anna Marriott, health policy lead for Oxfam International. WHO chief scientist Dr. Soumya Swaminathan has said rich countries that have signed up to receive vaccines from COVAX won’t have their requests denied.“The COVAX facility is not going to penalize countries,” she said in early February. After pledging more than $400 million to COVAX last year, Canadian Prime Minister Justin Trudeau said it was always his country’s intention to get vaccines through COVAX. Marriott said rich countries planning to take doses from COVAX should reconsider their intentions, given their earlier calls of support for the effort’s goal of equal access to vaccines for all the world's nations, rich or poor.“It seems quite hypocritical,” she said. "Rich countries with their own supplies should make the right call and not take vaccines from countries who are really in a dire situation.”

Video above: WHO Finds Original COVID-19 Outbreak in China Was More Widespread Than Reported

The World Health Organization has granted an emergency authorization to AstraZeneca's coronavirus vaccine, a move that should allow the U.N. agency's partners to ship millions of doses to countries as part of a U.N.-backed program to tame the pandemic.

In a statement Monday, the WHO said it was clearing the AstraZeneca vaccines made by the Serum Institute of India and South Korea’s AstraZeneca-SKBio.

The WHO’s green light for the AstraZeneca vaccine is only the second one the U.N. health agency has issued after authorizing the Pfizer-BioNTech vaccine in December. Monday's announcement should trigger the delivery of hundreds of millions of doses to countries that have signed up for the U.N.-backed COVAX effort, which aims to deliver vaccines to the world’s most vulnerable people.

“Countries with no access to vaccines to date will finally be able to start vaccinating their health workers and populations at risk,” said Dr. Mariângela Simão, the WHO's Assistant-Director General for Access to Medicines and Health Products.

The coronavirus has infected more than 109 million people and killed at least 2.4 million of them. But many countries have not yet started vaccination programs and even rich nations are facing shortages of vaccine doses as manufacturers struggle to ramp up production.

The AstraZeneca vaccine has already been authorized in more than 50 countries, including Britain, India, Argentina and Mexico. It is cheaper and easier to handle than the Pfizer-BioNTech vaccine, which needs deep-cold storage that is not widespread in many developing nations. Both vaccines require two shots per person, given weeks apart.

Last week, WHO vaccine experts recommended the use of the AstraZeneca vaccine for people over age 18, including in countries that have detected variants of COVID-19.

But that was contrary to the recommendation from the African Centers for Disease Control and Prevention, which said countries that had identified a virus variant first seen in South Africa should be “cautious” in their use of the AstraZeneca vaccine, suggesting that other shots be prioritized instead.

The AstraZeneca vaccine forms the bulk of COVAX’s stockpile and concerns were recently raised after an early study suggested it might not prevent mild and moderate disease caused by the variant first seen South Africa. Last week, South Africa scaled back its planned rollout of the AstraZeneca vaccine, opting instead to use an unlicensed shot from Johnson & Johnson for its health care workers.

COVAX has already missed its own goal of beginning coronavirus vaccinations in poor countries at the same time that shots were rolled out in rich countries. Numerous developing countries have rushed in recent weeks to sign their own private deals to buy vaccines, unwilling to wait for COVAX.

WHO and its partners, including the vaccines alliance GAVI, have not said which countries will receive the first doses from COVAX. But an initial plan showed a handful of rich countries that have signed multiple private vaccine deals, including Canada, South Korea and New Zealand, are also scheduled to receive early doses from COVAX.

Some public health experts called that “very problematic” and attributed it to COVAX’s flawed design, which allowed donor countries to double dip by purchasing vaccines from the program while also signing their own commercial deals.

“Canada has ordered enough doses to supply their population about five times over and now they’re looking to accept their share of doses from COVAX, which would otherwise be given to poor nations,” said Anna Marriott, health policy lead for Oxfam International.

WHO chief scientist Dr. Soumya Swaminathan has said rich countries that have signed up to receive vaccines from COVAX won’t have their requests denied.

“The COVAX facility is not going to penalize countries,” she said in early February.

After pledging more than $400 million to COVAX last year, Canadian Prime Minister Justin Trudeau said it was always his country’s intention to get vaccines through COVAX.

Marriott said rich countries planning to take doses from COVAX should reconsider their intentions, given their earlier calls of support for the effort’s goal of equal access to vaccines for all the world's nations, rich or poor.

“It seems quite hypocritical,” she said. "Rich countries with their own supplies should make the right call and not take vaccines from countries who are really in a dire situation.”

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Canada health experts recommend Pfizer, Moderna as second dose after AstraZenaca

cincylink — Mon, 21 Jun 2021 04:19:09 +0000

A Canadian advisory committee says Canadians who got the AstraZeneca shot for their first vaccine dose should not get the second one.

It says they should get the Pfizer or Moderna vaccine for their second shot instead.

The vice-chair of the board says new evidence suggests responses are better when the AstraZeneca vaccine is followed by an mRNA vaccine and said the new guidance also takes into account the marginal risk of blood clots associated with AstraZeneca.

However, she said anyone who got two shots of AstraZeneca can feel confident they are protected.

This story originally reported by Simon Kaufman and Jay Strubberg on Newsy.com

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US to share AstraZeneca vaccine shots with other countries

cincylink — Fri, 28 May 2021 05:07:33 +0000

The U.S. will begin sharing its entire stock of AstraZeneca COVID-19 vaccines with the world once it clears federal safety reviews, the White House said Monday, with as many as 60 million doses expected to be available for export in the coming months.The move greatly expands on the Biden administration's action last month to share about 4 million doses of the vaccine with Mexico and Canada. The AstraZeneca vaccine is widely in use around the world but has not yet been authorized by the U.S. Food and Drug Administration.The White House is increasingly feeling assured about the supply of the three vaccines being administered in the U.S., particularly following the restart of the single-dose Johnson & Johnson shot over the weekend. The U.S. has also been under mounting pressure in recent weeks to share more of its vaccine supply with the world, as countries like India experience devastating surges of the virus and others struggle to access doses needed to protect their most vulnerable populations."Given the strong portfolio of vaccines that the U.S. already has and that have been authorized by the FDA, and given that the AstraZeneca vaccine is not authorized for use in the U.S., we do not need to use the AstraZeneca vaccine here during the next several months," said White House COVID-19 coordinator Jeff Zients. "Therefore the U.S. is looking at options to share the AstraZeneca doses with other countries as they become available."More than 3 million people worldwide have died of COVID-19, including more than 572,000 in the U.S. The U.S. has vaccinated more than 53% of its adult population with at least one dose of its three authorized vaccines from Pfizer, Moderna and J&J, and it expects to have enough supply for its entire population by early summer.About 10 million doses of AstraZeneca vaccine have been produced but have yet to pass review by the FDA to "meet its expectations for product quality," Zients said, noting the U.S. regulator is recognized as the "gold standard" for safety around the world. That process could be completed in the next several weeks. About 50 million more doses are in various stages of production and could be available to ship in May and June pending FDA sign-off.The U.S. has yet to finalize where the AstraZeneca doses will go, Zients said. Neighbors Mexico and Canada have asked the Biden administration to share more doses, while dozens of other countries are looking to access supplies of the vaccine."We're in the planning process at this point in time," said White House press secretary Jen Psaki, when asked where the doses would go.The AstraZeneca doses will be donated by the U.S. government, which has contracted with the company for a total of 300 million doses — though the company has faced production issues.The administration's move to share vaccines drew praise from nongovernmental aid groups, who encouraged the White House to develop plans to share even more doses."The Biden administration's decision to begin sharing AstraZeneca vaccines is welcome news and an important first step towards the U.S. sharing more of its massive vaccine stockpile," said Tom Hart, acting CEO at The ONE Campaign. "The Biden administration should build on this welcome first step and start sharing more vaccines as soon as possible."In part because the AstraZeneca vaccine is not expected to play a significant factor in the U.S. virus response, the White House was also moving to share raw materials for the production of the AstraZeneca vaccine with India, which has emerged as a global hotspot for the virus, by diverting some of its orders to the vaccine manufacturer Serum Institute of India.Zients told the AP that the Biden administration was working to satisfy other "key requests" from the Indian government, namely for personal protective equipment, tests, therapeutics and supplies of oxygen and respiratory assistance devices."The administration's identified U.S. commercial suppliers of therapeutics that are immediately available to help relieve the suffering of the COVID-19 patients in India," said Zients. "We've identified rapid diagnostic tests and supplies and PPE, and additional ventilators that are available to transferred to India."Epidemiologists from the Centers for Disease Control and Prevention were also expected to soon travel to India to assist the country with its virus response.The additional quality review before the U.S. shares the AstraZeneca doses were in order because of issues at the facility that produced them, White House officials said.AstraZeneca's doses in the U.S. were produced at an Emergent BioSolutions plant in Baltimore that has come under increased regulatory and public scrutiny after botching batches of the J&J vaccine. The U.S. pressed J&J to take over the plant and, as part of the effort to ensure the quality of newly produced vaccines, directed the facility to stop making the AstraZeneca shot. AstraZeneca is still looking to identify a new U.S. production facility for its future doses.The U.S. government ordered enough for 150 million Americans before issues with the vaccine's clinical trial held up clearance. The company's 30,000-person U.S. trial didn't complete enrollment until January, and it still has not filed for an emergency-use authorization with the FDA.

WASHINGTON —

The U.S. will begin sharing its entire stock of AstraZeneca COVID-19 vaccines with the world once it clears federal safety reviews, the White House said Monday, with as many as 60 million doses expected to be available for export in the coming months.

The move greatly expands on the Biden administration's action last month to share about 4 million doses of the vaccine with Mexico and Canada. The AstraZeneca vaccine is widely in use around the world but has not yet been authorized by the U.S. Food and Drug Administration.

The White House is increasingly feeling assured about the supply of the three vaccines being administered in the U.S., particularly following the restart of the single-dose Johnson & Johnson shot over the weekend. The U.S. has also been under mounting pressure in recent weeks to share more of its vaccine supply with the world, as countries like India experience devastating surges of the virus and others struggle to access doses needed to protect their most vulnerable populations.

"Given the strong portfolio of vaccines that the U.S. already has and that have been authorized by the FDA, and given that the AstraZeneca vaccine is not authorized for use in the U.S., we do not need to use the AstraZeneca vaccine here during the next several months," said White House COVID-19 coordinator Jeff Zients. "Therefore the U.S. is looking at options to share the AstraZeneca doses with other countries as they become available."

More than 3 million people worldwide have died of COVID-19, including more than 572,000 in the U.S. The U.S. has vaccinated more than 53% of its adult population with at least one dose of its three authorized vaccines from Pfizer, Moderna and J&J, and it expects to have enough supply for its entire population by early summer.

About 10 million doses of AstraZeneca vaccine have been produced but have yet to pass review by the FDA to "meet its expectations for product quality," Zients said, noting the U.S. regulator is recognized as the "gold standard" for safety around the world. That process could be completed in the next several weeks. About 50 million more doses are in various stages of production and could be available to ship in May and June pending FDA sign-off.

The U.S. has yet to finalize where the AstraZeneca doses will go, Zients said. Neighbors Mexico and Canada have asked the Biden administration to share more doses, while dozens of other countries are looking to access supplies of the vaccine.

"We're in the planning process at this point in time," said White House press secretary Jen Psaki, when asked where the doses would go.

The AstraZeneca doses will be donated by the U.S. government, which has contracted with the company for a total of 300 million doses — though the company has faced production issues.

The administration's move to share vaccines drew praise from nongovernmental aid groups, who encouraged the White House to develop plans to share even more doses.

"The Biden administration's decision to begin sharing AstraZeneca vaccines is welcome news and an important first step towards the U.S. sharing more of its massive vaccine stockpile," said Tom Hart, acting CEO at The ONE Campaign. "The Biden administration should build on this welcome first step and start sharing more vaccines as soon as possible."

In part because the AstraZeneca vaccine is not expected to play a significant factor in the U.S. virus response, the White House was also moving to share raw materials for the production of the AstraZeneca vaccine with India, which has emerged as a global hotspot for the virus, by diverting some of its orders to the vaccine manufacturer Serum Institute of India.

Zients told the AP that the Biden administration was working to satisfy other "key requests" from the Indian government, namely for personal protective equipment, tests, therapeutics and supplies of oxygen and respiratory assistance devices.

"The administration's identified U.S. commercial suppliers of therapeutics that are immediately available to help relieve the suffering of the COVID-19 patients in India," said Zients. "We've identified rapid diagnostic tests and supplies and PPE, and additional ventilators that are available to transferred to India."

Epidemiologists from the Centers for Disease Control and Prevention were also expected to soon travel to India to assist the country with its virus response.

The additional quality review before the U.S. shares the AstraZeneca doses were in order because of issues at the facility that produced them, White House officials said.

AstraZeneca's doses in the U.S. were produced at an Emergent BioSolutions plant in Baltimore that has come under increased regulatory and public scrutiny after botching batches of the J&J vaccine. The U.S. pressed J&J to take over the plant and, as part of the effort to ensure the quality of newly produced vaccines, directed the facility to stop making the AstraZeneca shot. AstraZeneca is still looking to identify a new U.S. production facility for its future doses.

The U.S. government ordered enough for 150 million Americans before issues with the vaccine's clinical trial held up clearance. The company's 30,000-person U.S. trial didn't complete enrollment until January, and it still has not filed for an emergency-use authorization with the FDA.

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