Biden admin will share millions of AstraZeneca vaccine doses worldwide

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POLITICO 26 April, 2021 - 12:47pm 46 views

The company has produced about 10 million doses of the vaccine for the U.S. but the FDA has not yet authorized their use.

By ERIN BANCO and ADAM CANCRYN

The company has produced about 10 million doses of the vaccine for the U.S. but the FDA has not yet authorized their use. The agency is still examining the doses to ensure they meet the necessary quality control standards. An additional 50 million doses are in production, one of the senior officials said.

It is unclear where the U.S. will send the AstraZeneca doses and whether it will send them through COVAX or directly to individual countries. The administration’s decision to commit the doses was first reported by the Associated Press.

It comes on the heels of the Biden administration’s announcement that it will send India raw materials and components to manufacture Covishield, a version of the AstraZeneca vaccine produced by the country’s Serum Institute.

Those materials were already wrapped up in contracts held by the U.S. But the administration decided over the weekend to divert pending orders of vaccine supplies such as filters to India, and to ship additional drugs, test kits and personal protective equipment. The administration has not yet decided whether to send India AstraZeneca doses directly.

The world is waiting on a coronavirus vaccine. We're tracking the global competition, the research and development, the rollout plan and how effective the vaccine will be.

U.S. production of the AstraZeneca vaccine is on hold after the FDA ordered contract manufacturer Emergent Biosolutions to stop making the drug substance for the AstraZeneca and Johnson & Johnson vaccines. In March, Emergent’s Bayview plant in Baltimore accidentally contaminated 15 million doses of the J&J vaccine by mixing them with drug substance for the AstraZeneca vaccine.

AstraZeneca is looking for an alternative to Emergent to help with production of future U.S. doses.

The Biden team’s decision to send up to 60 million doses of the vaccine across the world comes as the administration tries to ramp up vaccination in the U.S. Officials say they have begun to see the number of people signing up for Covid-19 shots go down in recent days, indicating that the U.S. might finally be hitting a point where it has more supply than demand.

One senior health official said the administration had initially pushed back on the idea of sending any doses overseas — even if they were not approved for use in the U.S. — because officials feared there could be additional production hiccups over the next several months that would limit the country’s supply.

Read full article at POLITICO

US to share AstraZeneca shots with world after safety check

The Associated Press 31 December, 1969 - 06:00pm

WASHINGTON (AP) — 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 US 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.”

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.

AstraZeneca’s vaccine was initially expected to be the first to receive federal emergency authorization, and 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.

US to share up to 60m AstraZeneca vaccine doses around the world – US politics live

The Guardian 26 April, 2021 - 02:01pm

The US Department of Justice is opening a sweeping investigation into policing in Louisville, Kentucky, over the March 2020 death of Breonna Taylor, who was shot by police during a raid at her home.

The president of the National Association for the Advancement of Colored People (NAACP), Derrick Johnson, welcomed the announcement of the Louisville investigation:

“For far too long, killings at the hands of police have only led to one hashtag after another. But true justice comes with accountability and action … No police officer or police department is above the law.

Taylor, 26 and an emergency medical technician studying to become a nurse, was roused from sleep by police who came through the door using a battering ram. Her boyfriend, Kenneth Walker, fired once. A no-knock warrant was approved as part of a narcotics investigation. No drugs were found at her home.

Former Minneapolis police officer Derek Chauvin was convicted of murder in Floyd’s death but no one has been charged in the killing of Taylor, whose case also fueled protests against police brutality and systemic racism.

Her death prompted a national debate about the use of “no knock” search warrants, which allow officers to enter a home without waiting and announcing their presence. The warrants are generally used in drug cases and other investigations where police believe a suspect might be likely to destroy evidence.

In a new book, the Republican senator Josh Hawley of Missouri attacks what he calls “woke capitalism” and claims to be a victim of cancel culture over his actions around the Capitol attack of 6 January.

In his introduction, Hawley seeks to defend his actions surrounding what he calls the “grisly riot” at the US Capitol which was stormed by a pro-Trump mob in scenes of violence that shocked the world and cost five lives.

But he does not mention his most controversial act: raising a fist in solidarity with Trump supporters told by the then president to march on the building and “fight like hell” in service of his lie that his defeat by Joe Biden was the result of electoral fraud.

Hawley’s gesture became a worldwide symbol of a riot in which the mob roamed the halls Congress, in some cases looking for lawmakers to kidnap or kill. More than 400 people have been charged.

Publisher Simon & Schuster dropped Hawley’s book, only for it to be swiftly picked up by Regnery, a conservative imprint for which Simon & Schuster handles distribution.

That notwithstanding, Hawley writes: “This is the book the corporate monopolies did not want you to read.”

After the Guardian published its story – which follows – Hawley addressed the matter on Twitter:

Oh dear, I’ve offended the delicate sensibilities of The Guardian! 😂 I didn’t get their approval before I wrote my book. Order a copy today and own the libs https://t.co/CUHpkvMIrI https://t.co/K2ySqK874B

In recent days, health authorities in India have diagnosed more than 350,000 Covid-19 cases per day, and scientists are researching an identified Indian variant.

The US is “in the planning process” now to ship a number of supplies, including personal protective equipment, devices to make oxygen and ventilators. Currently, part of that process involves ensuring the devices can connect to existing health infrastructure in India. The US may also consider re-routing supplies expected to go to other countries.

The news comes on top of the Biden administration’s announcement it will export as many as 60 million doses of the AstraZeneca vaccine internationally. It is not yet known where those doses would go, but Psaki said it would most likely be based on “direct” relationships.

“Before any [doses] are shipped from the US, the FDA will confirm any such doses meet its expectations for product quality,” said Psaki.

Psaki also addressed concerns that roughly 8% of people scheduled for a second dose of either the Pfizer or Moderna vaccines are not coming back for their second dose.

“We know people lead busy lives, but getting the second dose is critical,” she said. She said the administration will also work on, “making it easier to get vaccinated,” including working with doctor’s offices and encouraging employers to give workers paid time off.

Capital gains is a tax on income generally derived from investments, while income tax is generally on wages such as through paycheck. Very wealthy individuals tend to make much more income from investments, and hence be taxed at the lower capital gains rate.

Bloomberg News reported the proposal would result in the capital gains tax roughly doubling, to 39.6% for wealthy individuals, according to people who spoke on the condition of anonymity. The money would then be used to fund social programs.

The change, expected to be described further in Biden’s Wednesday speech before a joint session of Congress, would reward, “work and not just wealth,” Deese said.

He said increasing capital gains tax would also, “help to reduce the kinds of tax avoidance that undermines trust and fairness in the tax code itself,” said Deese.

Deese said the change would impact 0.3% of taxpayers and about 500,000 households.

On a call with Indian prime minister Narendra Modi, Joe Biden “pledged America’s steadfast support for the people of India who have been impacted by the recent surge in Covid cases”.

NEW: President Biden spoke to Prime Minister Modi and "pledged America’s steadfast support for the people of India who have been impacted by the recent surge in COVID-19 cases," per White House readout. #indiacovid pic.twitter.com/fygOb1h1zw

The US could share as many as 60m AstraZeneca vaccine doses in the coming month, once the vaccines passes an expected safety review, the Associated Press reported.

The move expands on a US commitment to share 4m doses with Mexico and Canada, and comes as it has enough vaccine for every eligible American from Pfizer, Moderna and Johnson & Johnson. The AstraZeneca vaccine is authorized around the world, but not yet in the US.

At the beginning of the pandemic the US contracted with multiple pharmaceutical companies to buy vaccines, not knowing which would eventually make it through safety reviews. As a result, the Biden administration has faced increasing pressure to share unneeded vaccine doses internationally.

WASHINGTON (AP) — The U.S. will begin sharing its pipeline of vaccines from AstraZeneca once the vaccine clear federal safety reviews, the White House said, with as many as 60 million doses expected to be available for export in the coming months.https://t.co/ZgYrrt5sa7

The news comes as India is experiencing its worst peak in the pandemic, and in recent days has diagnosed more than 350,000 cases of Covid-19 per day. Such widespread Covid-19 spread not only endangers people in India, but around the world as more transmissible or deadly variants may emerge.

Dr Anthony Fauci, the US’s top infectious diseases expert, said on Sunday several measures are being considered, including sending over oxygen supplies, tests, drug treatments and personal protective equipment.

“Bottom line, it’s a terrible situation that’s going on in India and other lower middle-income countries, and there is more we can do,” he said.

The White House press briefing is expected to start at 1pm ET. Watch along with us here.

The Supreme Court accepted what will be a closely watched gun rights case today –it could have a major impact on gun rights across the country.

Here’s more from the AP:

The case marks the court’s first foray into gun rights since Justice Amy Coney Barrett came on board in October, making a 6-3 conservative majority.

The justices said Monday they will review a lower-court ruling that upheld New York’s restrictive gun permit law. The court’s decision to take on the case follows mass shootings in recent weeks in Indiana, Georgia, Colorado and California and comes amid congressional efforts to tighten gun laws.

President Joe Biden also has announced several executive actions to combat what he called an “epidemic and an international embarrassment” of gun violence in America.

The case is especially significant during the coronavirus pandemic, said Eric Tirschwell, the legal director of Everytown for Gun Safety, a gun control group backed by former New York Mayor Michael Bloomberg.

The court had turned down review of the issue in June, before Justice Ruth Bader Ginsburg’s death.

New York is among eight states that limit who has the right to carry a weapon in public. The others are: California, Delaware, Hawaii, Maryland, Massachusetts, New Jersey and Rhode Island. In the rest of the country, gun owners have little trouble legally carrying their weapons when they go out.

In June, Justice Clarence Thomas, joined by Justice Brett Kavanaugh, complained that rather than take on the constitutional issue, “the Court simply looks the other way.”

But Barrett has a more expansive view of gun rights than Ginsburg. She wrote a dissent in 2019, when she was a judge on the federal appeals court in Chicago, that argued that a conviction for a nonviolent felony in this case, mail fraud shouldn’t automatically disqualify someone from owning a gun.

She said that her colleagues in the majority were treating the Second Amendment as a “second-class right, subject to an entirely different body of rules than the other Bill of Rights guarantees.”

"The outlook does not look good for gun safety laws at the Supreme Court...the Court could issue a radical Second Amendment ruling that jeopardizes future progress as well as lifesaving gun laws already on the books." @GiffordsCourage says in a statement.

Republican Alaska lawmaker Lora Reinbold is banned from Alaska Airlines flights, after she has repeatedly refused to wear a mask. Masks can help protect other people from exposure to Covid-19 and other illnesses, if worn properly.

The ban is a major problem for the lawmaker, because Alaska Airlines operates the only flight to and from the capital, Juneau. Instead, she had to make a 14-hour trek to get to work

“This suspension is effective immediately, pending further review. Federal law requires all guests to wear a mask over their nose and mouth at all times during travel, including throughout the flight, during boarding and deplaning, and while traveling through an airport,” he said.

EU begins legal action against AstraZeneca over 'breach of contract'

euronews (in English) 26 April, 2021 - 02:00pm

EU takes legal action against AstraZeneca over supply

Al Jazeera English 26 April, 2021 - 02:00pm

US to begin sharing AstraZeneca coronavirus vaccine doses soon

CNN 26 April, 2021 - 02:00pm

Updated 2:18 PM ET, Mon April 26, 2021

U.S. to share up to 60 million AstraZeneca COVID-19 vaccine doses with other countries

USA TODAY 26 April, 2021 - 12:34pm

The U.S. on Monday announced plans to share doses of the AstraZeneca COVID-19 vaccine as soon as it receives federal approval.

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President Joe Biden announced his administration met the goal of administering 200 million shots in 100 days. USA TODAY

WASHINGTON – The U.S. on announced plans to share as many as 60 million doses of the AstraZeneca COVID-19 vaccine as soon as it receives federal approval in the coming months, White House press secretary Jen Psaki said Monday.

The announcement comes as the Biden administration has faced increased pressure to share its supply of vaccines as more than 40% of Americans are at least partially vaccinated and other countries like India grapple with a devastating spike in cases. India reported nearly 353,000 new COVID-19 infections on Monday, setting a new world record for the fifth straight day, as overwhelmed hospitals face a critical oxygen shortage. 

Psaki said the administration's confidence in its supply of the three federally approved vaccines - Pfizer, Moderna and Johnson & Johnson - was behind the decision to share more vaccines. The U.S. restarted its use of the single-dose Johnson & Johnson vaccine on Friday after it was briefly paused to review a rare blood-clot disorder linked to the shot. 

"Given the strong portfolio of vaccines that the United States has already authorized... We do not need to use AstraZeneca in our fight against COVID over the next few months before any AstraZeneca doses are shipped from the United States," Psaki told reporters during a White House press briefing.

The Biden administration last month "loaned" to Mexico and Canada about 4 million doses of the AstraZeneca vaccine, which has yet to receive emergency authorization approval from the Food and Drug Administration. But the White House has continued to face questions about plans to share more vaccines as supply begins to outweigh demand across the U.S. Some states have already turned down or scaled back vaccine shipments.

If the AstraZeneca vaccine receives federal clearance, the U.S. expects to be able to send up to 10 million doses in the coming weeks, Psaki said. An additional 50 million doses which are in various stages of production could be completed in May and June.

The U.S. announced Sunday it would send raw materials to make vaccines, rapid diagnostic testing kits and other medical equipment to India that was previously subject to an export ban. The administration is also looking at options to provide oxygen generation "on an urgent basis" and funding to boost India's domestic production of vaccines. 

"Just as India sent assistance to the United States as our hospitals were strained early in the pandemic, the United States is determined to help India in its time of need," NSC spokeswoman Emily Horne said in a statement.

The apparent U-turn came a day after National Security Adviser Jake Sullivan said he spoke to his Indian counterpart, Ajit Doval, as the number of coronavirus cases continue to climb.

More than 40% of the total population have been at least partially vaccinated, ranking the U.S. near the top in vaccination rates, Our World In Data reports. Meanwhile, more than 145.9 million cases and 3 million deaths have been reported worldwide, according to Johns Hopkins University data.

Biden opened his first formal news conference by setting a new goal of administering 200 million COVID vaccine shots in his first 100 days in office. USA TODAY

© 2021 USA TODAY, a division of Gannett Satellite Information Network, LLC.

EU launches legal action against AstraZeneca over vaccine delays

FRANCE 24 English 26 April, 2021 - 07:29am

The legal action was launched on behalf of the bloc's 27 member states, he added. 

AstraZeneca responded to the EU legal action Monday saying it was without merit and pledged to defend itself strongly in court.

"AstraZeneca has fully complied with the Advance Purchase Agreement with the European Commission and will strongly defend itself in court. We believe any litigation is without merit and we welcome this opportunity to resolve this dispute as soon as possible," AstraZeneca said in a statement.

The EU's executive body said it was suing AstraZeneca over its failure to respect a contract for the supply of vaccine doses and for not having a "reliable" plan to ensure timely deliveries.

Under the contract, the company had committed to making its "best reasonable efforts" to deliver 180 million vaccine doses to the EU in the second quarter of this year, for a total of 300 million in the period from December to June.

But the company said in a statement on March 12 it would aim to deliver only one-third of that. A week after that, the EU Commission sent a legal letter to the company in the first step of a formal procedure to resolve disputes.

"Some terms of the contract have not been respected and the company has not been in a position to come up with a reliable strategy to ensure timely delivery of doses," the EU spokesman said.

"We want to make sure there is a speedy delivery of a sufficient number of doses that European citizens are entitled to and which have been promised on the basis of the contract," he added.

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EU launches legal action against AstraZeneca due to vaccine shortages

CNBC 26 April, 2021 - 06:57am

The European Union confirmed Monday it's taking legal action against AstraZeneca over shortfalls in the deliveries of its coronavirus vaccine.

"Our priority is to ensure Covid-19 vaccine deliveries take place to protect the health of European Union," the EU's commissioner for health, Stella Kyriakides, said Monday via Twitter.

"This is why the European Commission has decided jointly with all Member States to bring legal proceedings against AstraZeneca."

"Every vaccine dose counts. Every vaccine dose saves lives," she added.

The EU and the pharmaceutical giant have been at odds several times this year. The Anglo-Swedish drug company said it could not deliver as many vaccines as the bloc was counting on, both during the first and second quarters. This has delayed the rollout of Covid-19 vaccines across the 27 EU nations.

"Following an unprecedented year of scientific discovery, very complex negotiations, and manufacturing challenges, our company is about to deliver almost 50m doses to European countries by the end of April, in line with our forecast," AstraZeneca said in a statement on Monday.

"AstraZeneca has fully complied with the Advance Purchase Agreement with the European Commission and will strongly defend itself in court. We believe any litigation is without merit and we welcome this opportunity to resolve this dispute as soon as possible," the firm also said.

In March, European Commission President Ursula von der Leyen had expressed disappointment with the company, saying that "AstraZeneca has unfortunately under-produced and under-delivered. And this painfully, of course, reduced the speed of the vaccination campaign."

At the time, von der Leyen said the bloc was expecting 70 million doses from the company in the second quarter, down from 180 million originally anticipated. The bloc was also expecting 120 million doses in the first three months of the year, but received only about 30 million.

AstraZeneca CEO Pascal Soriot had told EU lawmakers in February that low production at EU plants were causing the delays.

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