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Health

U.S. Authorities Search Paperwork From Troubled Covid Vaccine Producer

That decision does not mean the F.D.A. has broadly authorized Johnson & Johnson to distribute doses made by Emergent on an emergency basis. The F.D.A. signed off on previous batches of vaccine made at the Baltimore factory but with a warning that it could not guarantee the company had followed good manufacturing practices. The agency has cleared the equivalent of up to 75 million doses, but tens of millions remain in limbo.

In a conference call with investors on Thursday, Emergent executives announced a $41.5 million hit from being forced to discard doses the F.D.A. had deemed unusable, and said the company had spent another $12.4 million to address manufacturing issues in Baltimore.

The newly disclosed inquiries from federal and state agencies underscore a dramatic reversal of fortune for a company that has spent much of the last two decades effectively cornering the market for biodefense, becoming the government’s go-to contractor for products to protect against bioterrorism and infectious disease outbreaks.

For most of the last decade, the government has spent nearly half of the annual budget of the nation’s emergency medical reserve, the Strategic National Stockpile, on Emergent’s anthrax vaccine alone, crowding out investments in products such as masks that were in short supply during the pandemic, a New York Times investigation found.

Understand the State of Vaccine Mandates in the U.S.

When the coronavirus pandemic hit, the government turned to Emergent to produce vaccines and treatments. Thanks to a lucrative deal struck in May 2020, Emergent earned record profits and awarded executives record bonuses.

Out of public view, however, concern about the company’s ability to deliver was mounting, as The Times has reported. A series of audits by customers, federal officials and the company’s own evaluators found repeated shortcomings in efforts to disinfect and prevent contamination, and a top federal official warned that the company would have to be “monitored closely.”

After it was discovered in late March that a batch of the Johnson & Johnson vaccine had been cross-contaminated with material from the AstraZeneca vaccine, federal inspectors descended on the factory, and members of Congress launched an investigation into both the company’s Covid-19 manufacturing work and its contracts with the stockpile.

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Politics

U.S. Faucets Johnson & Johnson to Run Troubled Vaccine Plant

WASHINGTON – The Biden government on Saturday hired Johnson & Johnson to manage a troubled Baltimore manufacturing facility that ruined 15 million doses of the Johnson & Johnson coronavirus vaccine and prevented the facility from producing another vaccine from AstraZeneca manufacture.

The Department of Health and Human Services’ extraordinary move came just days after officials learned that Emergent BioSolutions, a contract manufacturer that makes both Johnson & Johnson and AstraZeneca’s vaccines, was mixing the ingredients in the two, which regulators did delayed the approval of the plant’s production lines.

By outsourcing the AstraZeneca vaccine, according to two senior federal health officials, the facility can be dedicated solely to Johnson & Johnson’s single-dose vaccine to avoid future breakdowns.

The Department of Health and Human Services directed Johnson & Johnson to establish a new leadership team to oversee all aspects of manufacturing and manufacturing at the Emergent Baltimore facility. The company said in a statement that it took “full responsibility” for the vaccine manufactured at the Emergent facility.

Given President Biden’s aggressive efforts to have enough doses for every adult by the end of May, federal officials fear the mix-up will undermine public confidence in Covid-19 vaccines. The AstraZeneca vaccine in particular has raised safety concerns. Germany, France and other European nations have temporarily discontinued use in some vaccine recipients after reports of rare cerebral blood clots.

The ingredient mix-up and the government move on Saturday is a major setback and PR debacle for Emergent, a Maryland-based biotech company that has built a profitable business by working with the federal government, largely selling its own Anthrax vaccines against the Strategic National Stockpile.

An Emergent spokesman declined to comment, except that the company will continue to manufacture AstraZeneca cans until it receives a contract amendment from the federal government.

Unlike Johnson & Johnson, AstraZeneca does not yet have an emergency approval from the Food and Drug Administration for its vaccine. With three federally approved vaccines (the other two are from Pfizer-BioNTech and Moderna), it’s not clear whether the AstraZeneca vaccine, which has had regulatory issues in the past, could even get approved in time to meet U.S. needs .

However, one of the federal officials said the Department of Health and Human Services is discussing working with AstraZeneca to adapt its vaccine to fight new coronavirus variants. AstraZeneca said in a statement that it would work with the Biden administration to find a new location to manufacture its vaccine.

To date, none of the Johnson & Johnson cans manufactured by Emergent have been cleared for distribution by the FDA. Officials have stated that it could take weeks to find out if other batches of vaccine were contaminated and that FDA inspectors are determining if the emergent facility can be cleared to release the doses it made.

Updated

April 3, 2021, 9:22 p.m. ET

Acting FDA commissioner, Dr. Janet Woodcock said in a statement on Saturday that the agency “takes its responsibility for ensuring the quality of manufacturing of vaccines and other medical products for use during this pandemic very seriously”.

However, she made it clear that the ultimate responsibility would rest with Johnson & Johnson, saying, “It is important to note that even if companies employ contract manufacturing companies, the ultimate responsibility lies with the company that has the emergency use authorization to do so ensure FDA quality standards are met. “

In another agreement brokered by the Biden administration last month, Johnson & Johnson is now working with Merck, one of the world’s largest vaccine manufacturers. Officials said Merck would help manage the Baltimore facility.

Emergent’s Baltimore facility is one of two federally designated “Centers for Innovation in Advanced Development and Manufacturing” and was built with taxpayer support. Last June, the Emergent government paid $ 628 million to reserve space as part of Operation Warp Speed, the Trump administration’s rapid initiative to develop coronavirus vaccines.

Johnson & Johnson and AstraZeneca both signed a contract with Emergent to use the space. Both vaccines are called live virus vector vaccines, which means they use a modified, harmless version of another virus as a vector or carrier to deliver instructions to the body’s immune system. The Johnson & Johnson vaccine is given in one dose, AstraZeneca in two doses.

Experts in vaccine manufacturing said the FDA has historically had a policy of preventing such mishaps by not allowing a plant to make two live viral vector vaccines as it can lead to mix-ups and contamination.

Last month, Mr Biden canceled a visit to the Emergent Baltimore plant, and his spokeswoman announced that the administration would conduct an audit of the Strategic National Stockpile, the country’s emergency medical reserve. Both measures came after an investigation by the New York Times that looked at how the company had gained oversized influence on the repository.

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World News

What to Know as Troubled Afghan Peace Talks Enter a New Part

KABUL, Afghanistan – After four decades of fierce fighting in Afghanistan, peace negotiations between the Afghan government and the Taliban have at least opened the possibility that the long cycle of violence may one day end.

But that milestone is still a long way off. The most recent round of discussions, which started in September, was fraught with bureaucratic problems and months of debates on minor issues.

And although these talks resulted in an agreement on the principles and procedures that will guide the next round of peace negotiations, they came with a price. As the two sides met in Doha, Qatar, bloodshed on battlefields and in Afghan cities rose sharply.

Now that the peace talks are due to resume on January 5th, details of the next negotiations remain unclear.

While both the Afghan government and the Taliban have announced that they will not publicly publish their priority lists for the next round of negotiations, security analysts, researchers, and government and Taliban officials expect the following – and what hinders these talks must be overcome.

The ultimate goal of the negotiations is to establish a political roadmap for a future government. The head of the government’s negotiating team, Masoom Stanikzai, said Wednesday that a ceasefire would be the delegation’s top priority. The Taliban, who have leveraged attacks against security forces and civilians, are instead trying to negotiate a form of government based on strict Islamic laws before discussing a ceasefire.

However, it will not be easy to get to these larger fundamental questions as both sides continue to cling to the meanings of fundamental terms such as “ceasefire” and “Islamic”. There are many forms of ceasefire, from permanent and federal to partial and conditional, yet the public portion of the February US-Taliban agreement calling for the full withdrawal of American troops mentions but does not specifically mandate or fully define them how it should look.

The Taliban also refuse to specify what they mean by “Islamic” and the government’s insistence on an “Islamic” republic has been the subject of intense debate.

“The Taliban say they want an Islamic system, but they don’t specify which ones,” said Abdul Haific Mansoor, a member of the Afghan negotiating team, pointing out that there are almost as many systems as there are Islamic countries.

The next round of talks will also be made more difficult by the Taliban’s demand that the government release more Taliban prisoners. The government’s release of more than 5,000 prisoners removed the final barrier to negotiations in September, but President Ashraf Ghani has so far refused to release any more.

Both sides used the violence on the ground in Afghanistan as leverage during the Doha negotiations, but the Taliban have been more aggressive in their attacks than the government, whose troops tend to stay at bases and checkpoints to respond to sustained attacks.

According to a New York Times review, the number of security forces and civilians rose during the ongoing talks in the fall, before the Afghan government and Taliban negotiators announced in early December that they had reached an agreement on procedures for future talks had cold weather likely contributed to the decline as well. At least 429 pro-government forces were killed in September and at least 212 civilians were killed in October – the worst tolls in any category in more than a year.

“The killing and bloodshed have reached new heights,” said Atiqullah Amarkhel, a military analyst in Kabul. “What kind of will for peace is that?”

Ibraheem Bahiss, an independent Afghan research analyst, said the Taliban are pursuing two paths simultaneously: violence and negotiation.

“Your goal is to come to power and have a particular system of government,” said Bahiss. “Whether they achieve it through conversation or through fighting, both of them have costs that they are willing to bear.”

Although the Taliban have greatly reduced direct attacks on US forces since February, the insurgent group has relentlessly expanded the territory it controls by besieging local security forces.

In response, the Americans have launched air strikes where Afghan troops were under extreme stress during the Taliban’s attacks. One Taliban official said the level of violence in the group was direct response to air strikes from the United States or to military and poorly received diplomatic action by the Afghan government.

US air strikes this fall rescued the crumpled defenses of Afghan units in Kandahar and Helmand provinces, revealing deficiencies in Afghan ground and air forces that are under constant attack. US officials said the deteriorating morale of the armed forces has raised concerns about General Austin S. Miller, commander of the US-led mission in the country.

At the same time, the number of American troops dropped from around 12,000 in February to an estimated 2,500 by mid-January. A full withdrawal is planned by May, when the deal goes into effect. This has left Afghan officials unsure of how their forces can survive without American support.

The importance of the talks with the United States was underscored in November when Secretary of State Mike Pompeo visited Doha and met with negotiators, and again in mid-December when the Chairman of the Joint Chiefs, General Mark A. Milley, did the same.

A Pentagon statement said General Milley urged the Taliban to “reduce violence immediately,” a term that American officials have used several times this year and that is open to a wide range of interpretations. US officials are trying to balance the battlefield.

Both sides are also waiting to see whether President-elect Joseph R. Biden Jr. will stick to the troop withdrawal schedule or possibly renegotiate the entire deal.

If Mr Biden decides to leave any remaining American anti-terrorist military force in Afghanistan after May 2021, as suggested by some US lawmakers, Mr Bahiss said, “The Taliban have made it clear that the entire deal would be void.”

In light of the allegations and suspicions in Doha, some Afghan analysts fear that talks could stall for months.

“The distrust between the two sides has increased violence, but nothing has been done to eradicate that distrust,” said Syed Akbar Agha, a former leader of the Taliban’s Jaish-ul Muslim group.

This could indefinitely delay serious attempts to address core government issues such as human rights, free press, rights for women and religious minorities, and democratic elections, among others.

Taliban negotiators have stated that they support women’s rights, for example, but only under strict Islamic law. Many analysts interpret this as the same harsh oppression of women practiced by the Taliban when they ruled Afghanistan from 1996 to 2001.

The deeply divided government in Kabul also fears that the Taliban will try to shorten the time before all American forces depart, while the Taliban claim that Mr Ghani, who was re-elected in a bitterly controversial election last spring, stands still to serve out his five year tenure. If a form of national unity or an interim government were agreed, Mr Ghani would be unlikely to remain in office.

Another complication is the division within the Taliban, from stubborn commanders in Afghanistan to political negotiators in Doha’s hotels. Some Taliban factions believe they should fight and defeat the Americans and the Afghan government, not negotiate with them.

Mr. Agha, the former Taliban leader, said little progress was likely unless an impartial mediator emerged that could destroy the lack of confidence in Doha.

“If not,” he said, “I don’t think the next round of talks will end with a positive result.”

Some analysts fear an even more threatening result. Torek Farhadi, a former advisor to the Afghan government, said: “One thing is clear – without an agreement we are facing civil war.”

Najim Rahim, Fahim Abed and Fatima Faizi reported from Kabul.