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10 million Johnson & Johnson vaccine doses to be released, but material to make many more to be tossed

U.S. regulators are allowing for the release of 10 million doses of Johnson & Johnson’s COVID-19 vaccine from a troubled Baltimore factory, but material to make many more must be thrown out because of possible contamination, a person familiar with the decision told The Associated Press on Friday.



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U.S. regulators are allowing for the release of 10 million doses of Johnson & Johnson’s COVID-19 vaccine from a troubled Baltimore factory, but material to make many more must be thrown out because of possible contamination, a person familiar with the decision told The Associated Press on Friday.

The Food and Drug Administration announced that it had determined that two batches from the plant could be released. But it said several other batches are not suitable for use and additional batches are still under review.

A second person familiar with the decision confirmed that it would allow for 10 million doses to be released. Both people spoke to the AP on condition of anonymity because they weren’t authorized to release details about it.

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The doses originated at an Emergent BioSolutions factory, known as Bayview, that is making the vaccine for J&J. Those doses would be the first from the factory approved for use. J&J doses that had been administered came from other plants.

Emergent is one of several contractors for J&J that produces its one-shot vaccine in bulk. The concentrated vaccine then is shipped to other factories for final steps, including diluting them to the correct strength, putting them in vials and packaging them up.

Roughly 100 million doses made from bulk vaccine produced at Emergent’s factory had been set aside for additional testing by FDA staff after factory employees accidentally contaminated a batch.

That contamination led the FDA to shut down the factory in mid-April and send in a team of inspectors. They spent a week going through the factory and reviewing security camera footage that showed employees carelessly handling vaccine materials. The inspectors reported unsanitary conditions, poorly trained employees and other problems.

The lapses have hampered J&J’s efforts to be a major player in vaccinating people, particularly in remote areas and poor countries, given that it’s the only drugmaker with an authorized vaccine that only requires one dose and standard refrigeration.

The problems forced J&J to import millions of doses from its factory in the Netherlands and to miss supply commitments.

Emergent’s factory had a history of FDA citations for problems including mold, dirty walls and floors, poorly trained employees and an inadequate strategy to prevent contamination, yet it was given a huge role in COVID-19 vaccine production by the Trump administration. Emergent was handed a lucrative contract to make many millions of COVID-19 vaccines for both J&J and AstraZeneca at the Bayview factory.

Emergent’s chief executive has blamed the contamination and other problems on the complexity of scaling up the factory in just months to make two different vaccines.

The Biden administration is working to find a different American manufacturing partner for the British drugmaker, which has yet to request authorization to distribute it in the U.S.


Border Crisis Shows Few Signs of Slowing As Migrant Encounters, Fentanyl Seizures Stay High

Border officials encountered more than 180,000 migrants in May



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The Biden administration has been facing a continuing crisis at the southern border after taking office in January, and so far there are few signs of it slowing down significantly – with the number of migrants and seizures of the deadly drug fentanyl continuing to rise.

There were more than 180,000 migrant encounters in May, yet another increase from the more than 178,000 in April and that has been increasing sharply from the 78,000 in January – although the numbers have been increasing since April of last year.

The 180,034 May encounters is up massively from the 23,237 seen last year, and even higher than the 144,166 in May 2019 at the peak of that year’s border crisis.

The Biden administration has noted that 112,302 mostly single adults were expelled via Title 42 public health restrictions due to the COVID-19 pandemic, and so the numbers of migrants making multiple efforts into the U.S. may have increased. However, Homeland Security Secretary Alejandro Mayorkas has left open the possibility of ending Title 42 restrictions once the risk of the pandemic subsides – and is under pressure from the Democratic Party’s left flank to do so.

Meanwhile, images have continued to surface of unaccompanied children – who the Biden administration is not removing via Title 42 – being dumped at the border by smugglers and left to fend for themselves.

Drug seizures over all are up by 18 percent in May from April 2021. While that number is actually lower overall compared to May 2020 and a number of other months in both FY 2020 and 2021, seizures of the deadly drug fentanyl are significantly higher – up by more than 300% over May last year. CPB said that seizures of the fatal drug through May in FY 2021 are 56% higher than all of FY 2020.

Fentanyl, an opioid for pain treatment, is between 50 and 100 times more potent than morphine. More than 36,000 people died from overdoses involving synthetic opioids like fentanyl in 2019, according to the CDC.

As more migrants come to the border, it is leaving more becoming stranded in the wilderness and the increasing heat. Agents have encountered U-Hauls packed with migrants with temperatures of more than 100 degrees.

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This $600 Billion Wealth Fund Got Caught in a Power Struggle



A $600 billion sovereign wealth fund is caught in the crosshairs of a political power struggle that’s roiling one of the world’s richest countries.

The Kuwait Investment Authority, the world’s oldest state investment vehicle, has been in limbo since its board’s tenure expired two months ago. A new term has yet to be approved as political differences spill over into a disagreement over the make-up of the nine-member board, according to a person familiar with the matter.

The uncertainty now hanging over the KIA, which manages Kuwait’s vast oil wealth through two key funds, is emblematic of a broader malaise that’s paralyzed policy making, prompted ratings agencies to warn of downgrades and perversely left the government of a major OPEC crude exporter scrambling for cash. KIA officials were not immediately available for comment.

It’s all part of a deep standoff between members of the only elected parliament in the Gulf and a government whose leader is appointed by the ruling Emir, a deadlock that’s blocked the state from borrowing and left it with barely enough to pay public sector salaries. The dispute’s also delaying investment and economic reforms, including an overhaul of the welfare state the government says is needed to end eight consecutive years of budget deficits.

“The signals this sends are very negative,” said Kuwaiti businessman and economist Abdullah Al-Shami, who owns two companies specialized in medical and financial services. “It is a new low and I can justify that by saying we have two political agendas and so two economic agendas. The first is going toward new liberal policies adopted by the West and the other wants to maintain the welfare system as it is.”

arliament speaker Marzouq Alghanim called Sunday for a special session this week to approve the budget, a pressing item currently on the assembly’s agenda. In a message that appeared to be aimed at feuding politicians, he said the interests of citizens should rise above all political differences.

Once a booming economy at the forefront of Gulf Arab affairs, Kuwait has long since been eclipsed by neighbors unshackled by elected institutions and bent on securing their seat on the international stage. Dubai established itself as the region’s business capital, while in Saudi Arabia, Crown Prince Mohammed bin Salman has embarked on an ambitious plan to remake the economy.

In contrast, Kuwait’s new Emir is already in his 80s and contends with an outspoken 50-member National Assembly dominated since elections in December by independent and opposition lawmakers representing constituents increasingly angry with the status quo and pushing a populist agenda.

The death of Kuwait’s former Emir in September left a vacuum in a decision-making machine that looks to the ruler to set the national trajectory, dashing early hopes that change at the top would imbue the country with a new sense of purpose.

“People are trying to survive in the private sector but the government has no strategy,” said Khaled Al-Ansari who is partner in a law firm and is involved in three family businesses. “The future is unimaginable. We see Dubai and Saudi trying to attract business and develop. They may survive better than us, based on what they’re doing now.”

Corruption Crackdown

Allegations of bribe-taking, money-laundering and influence-peddling by senior judges and officials have dominated social media in recent months, as the government embarks on an unprecedented and very public cleanup it hopes will appease critics and pave the way to fiscal reforms that can get the economy back on track.

An ex-premier and other high-ranking officials have been arrested in the anti-corruption drive, but it’s been dismissed as window-dressing by many Kuwaitis while parliamentarians are absorbed by a tug-of-war playing out in the house.

Opposition lawmakers have focused their attention on trying to unseat the speaker and overturn a government-backed vote that prevents them from questioning the premier until late 2022. They’ve vowed to block regular sessions until their demands are met, paralyzing decision-making.

“We’re calling for the Emir to intervene because we refuse to deal with a prime minister who violates the constitution and a speaker who won by government votes,” said opposition lawmaker Mubarak Al-Hajraf. “Now we have the former prime minister and his interior minister in prison on embezzlement charges. People are more convinced by our rhetoric.”

In the midst of that wrangling, parliament has paid scant attention to a bill that would allow the government to issue international bonds to finance the deficit, and have opposed any reallocation of state handouts, though nearly three-quarters of expenditure is soaked up by salaries and subsidies.

The government needs parliamentary approval for most major initiatives in its economic program, including the introduction of a Value Added Tax and an excise duty to boost non-oil revenues as well as a plan to rethink state subsidies and privatize some of Kuwait’s state-owned assets. All have been blocked for the past decade.

Running a deficit of $3.3 billion a month, the government resorted to quick-fix measures to meet financial commitments last year when oil prices plunged and the pandemic hit. If the situation continues as is, Kuwait will build a cumulative budget deficit of $184 billion over the next five years.

“There’s a real failure of leadership. The ruling transition as well as the test of the pandemic offered the opportunity to build national unity and shared purpose but that moment has been lost,” said Kristin Diwan, a senior resident scholar at the Arab Gulf States Institute in Washington. “There’s no escape from politics in Kuwait. Leaders have to build coalitions for change by working the public and the parliament. It is a strenuous test, but one with potential payoffs unavailable to more autocratic rulers.”

A Backward Trajectory

The economy’s saving grace, the $600 billion Future Generations Fund that’s run by the KIA and designed as a savings pot for life after oil, is also largely unbreakable without parliament’s approval. The General Reserve, used for government spending and also managed by the KIA, is now only sustained by higher oil prices.

The result is a country that despite its enormous wealth is ill-prepared to withstand external shocks such as Covid-19. The economy contracted by almost 10% in 2020, worse than any of its Gulf peers bar neighboring Iraq, a country battered by decades of war and sanctions.

Because Kuwait hasn’t experienced the generational transition in leadership seen elsewhere in the Gulf, there’s a failure to connect with younger Kuwaitis and benefit from their full potential, according to Diwan. It’s a disconnect that’s left younger generations with a sense that change is coming.

“We’re worried about the future but young Kuwaitis are more empowered now, many are trying to create their own wealth and are less tolerant of corruption,” said Anan Al-Subaihi, who has a doctorate in banking and investment. She said Kuwaitis have many ways to raise their grievances now, especially via social media, where they can criticize more freely.

“The balance of power is changing, even though the strategic direction isn’t clear.”

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Kim Jong-un Says He’s Ready for ‘Dialogue and Confrontation’ With Biden

During a Workers’ Party meeting, the North Korean leader reviewed the new U.S. policy on his country and ordered “counteraction,” state news media reported.



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During a Workers’ Party meeting, the North Korean leader reviewed the new U.S. policy on his country and ordered “counteraction,” state news media reported.

North Korea’s leader, Kim Jong-un, ordered his government to prepare for “both dialogue and confrontation” with the United States, in his first reaction to the Biden administration’s new policy on how to deal with the country’s growing nuclear and missile threat, state news media reported on Friday.

After a months long policy review, the White House said in April that it had reached “a clear understanding​”​ that the efforts of the past four U.S. administrations ​had failed to denuclearize North Korea, although they had tried both dialogue and sanctions. It added that President Biden would pursue “a calibrated, practical approach that is open to and will explore diplomacy” with North Korea​.

During a meeting of the ruling Workers’ Party on Thursday, Mr. Kim “made a detailed analysis” of the Biden administration’s North Korea policy, “clarified appropriate strategic and tactical counteraction” and “stressed the need to get prepared for both dialogue and confrontation, especially to get fully prepared for confrontation,” the North’s official Korean Central News Agency reported.

Although the news agency said that the party had unanimously adopted a resolution, it did not disclose details. It indicated that the meeting would continue on Friday.

Mr. Kim’s comments came days before Sung Kim, Mr. Biden’s new special envoy on North Korea, was to meet with senior South Korean and Japanese officials in Seoul next week to discuss how to deal with North Korea. The North’s nuclear arsenal has been expanding despite international sanctions and the country’s deepening economic difficulties.

This week, Mr. Kim warned of a looming food shortage​, ​prompting some analysts in ​South Korea to suggest that North Korea might be more willing to start a dialogue to win outside aid.

During a summit in Washington last month, Mr. Biden and his South Korean counterpart, President Moon Jae-in, agreed to build on the 2018 Singapore agreement struck by Mr. Kim and President Donald J. Trump​. Both Mr. Kim and Mr. Trump have counted that deal as one of their biggest foreign-policy achievements, although it set only a vaguely worded goal of denuclearizing and settling peace on the peninsula.

Officials in the Biden administration have said they have been trying to establish contact with North Korea to explain their new policy. ​ The United States and North Korea have also not disclosed details of their broadly worded approaches, closely guarding them ahead of the possible resumption of negotiations.

But North Korea has insisted ​since January ​that it will “counter the U.S. on the principle of power for power and good will for good will” — a stance Mr. Kim appeared to reiterate this week.

Mr. Kim declared his power-for-power approach during a Workers’ Party congress in January, emphasizing that his country was willing to establish a “new relationship” with the United States ​only ​if Washington withdrew its “hostile policy,” a stock phrase the North has used to refer to sanctions and the threat it said the United States military presence posed in the region. Mr. Kim also called his country “a responsible nuclear weapons state” that would not misuse its nuclear weapons. ​

North Korea successfully launched three intercontinental ballistic missiles in 2017 that it said were powerful enough to reach parts or all of the continental United States. Mr. Kim then declared a moratorium on nuclear and long-range missile tests and met with Mr. Trump three times between 2018 and early 2019 with the hopes of lifting sanctions that have increasingly strangled his country’s economy.

But his diplomacy with Mr. Trump collapsed without an agreement on how to dismantle the North’s nuclear arsenal or when to ease sanctions.

North Korea has since resumed missile tests that involved short-range projectiles. It demonstrated its expanding weapons threat by launching a new ballistic missile in March — the first such test by the country in a year and its first significant provocation against the United States under Mr. Biden.

Commercial satellite images have ​also shown activities in a nuclear complex north of Pyongyang, where the country has been making fuel for atomic bombs.

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