Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used because of possible contamination, according to people familiar with the situation.
The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices. The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months because of regulatory concerns, the people said.
The Johnson & Johnson doses administered in the United States so far were manufactured at the firm’s plant in the Netherlands, not by Emergent. For weeks the FDA has been trying to figure out what to do about at least 170 million doses of vaccine that were left in limbo after the discovery of a major production mishap involving two vaccines manufactured at the Baltimore factory.
More than 100 million doses of the Johnson & Johnson vaccine and at least 70 million doses of the AstraZeneca vaccine were put on hold after Emergent discovered in March that its workers had contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used to produce AstraZeneca’s. Federal officials then ordered the plant to pause production, stripped Emergent of its responsibility to produce AstraZeneca’s vaccine and instructed Johnson & Johnson to assert direct control over the manufacturing of its vaccine there.
Johnson & Johnson’s vaccine was once considered a potential game-changer in the nation’s vaccine stock because it required only one shot and was particularly useful in vulnerable communities. But the federal government now has an ample supply of the vaccines from Pfizer-BioNTech and Moderna, the two other federally authorised vaccine developers, and no longer needs Johnson & Johnson’s supply.
Still, the loss of 60 million Johnson & Johnson doses puts a dent in the Biden administration’s plan to distribute vaccines to other countries that are still in the grip of the pandemic. The administration had been counting on sharing doses of both Johnson & Johnson and AstraZeneca but had to delay its plan while the FDA completed a review of the facility.
After he arrived in Britain for the Group of 7 summit this week, President Joe Biden announced he had found another source for donations. Pfizer-BioNTech has now agreed to sell his administration 500 million doses at cost for donation to low- and lower-middle-income countries over the next year. The World Health Organization estimates that 11 billion doses are needed globally to stamp out the epidemic.
The FDA’s action is disappointing news for Emergent and Johnson & Johnson, which hired the firm as a subcontractor. Inspectors are still reviewing the plant and are not expected to decide whether the company can reopen it until later this month, according to people familiar with the situation. Regulators are also continuing to cast doubt on whether the company, which has been paid hundreds of millions of dollars by the federal government to manufacture coronavirus vaccines, adhered to manufacturing standards.
The agency’s plan to allow 10 million doses to be used in the United States or abroad with a warning is somewhat unusual for a product under emergency authorisation, experts said. Regulators have the discretion to take that action if the drugs are badly needed and in short supply, they said.
In a statement, the FDA said that before making its decision, it “conducted a thorough review of facility records and the results of quality testing performed by the manufacturer.” It also considered the ongoing public health emergency. The agency said it was continuing to “work through issues” at the Baltimore plant with Johnson & Johnson and Emergent.
Dr. Peter Marks, the FDA’s top vaccine regulator, said in the statement that the agency has been conducting an extensive review of batches of vaccine produced at the plant “while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements.”
Representatives from Johnson & Johnson and Emergent declined to comment on the agency’s decision.
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The suspects have admitted to trafficking more than a thousand girls, an acknowledgement that has sent shock waves across Bangladesh with people questioning what the law-enforcing agencies did to prevent the massive, organised crime.
Groups working on human rights and trafficking wonder whether influential people or the law enforcers themselves were involved with the sex trafficking rings.
Young women, who recently managed to flee the traffickers in India and return home, have now gathered the courage to speak out and take legal action after the arrests in India and Bangladesh.
The police say they act immediately whenever they get information, but other agencies also need to be more active to stop crimes like human trafficking.
VIDEO LEADS TO ARRESTS, CASES
Rifatul Islam, also known as TikTok Ridoy Babu, 21, who took the woman in the video to India promising her a job, is the coordinator of the gang, the police say.
He is among six people arrested in India after the video of the assault went viral on social media. The other suspects are also Bangladeshis. They are accused of raping the young woman as well.
Ashraful Islam alias Rafi, 30, one of several people arrested in Bangladesh, leads the ring. After the arrests in border areas, the Rapid Action Battalion said Ridoy helped Rafi traffic around 50 women since the duo had met two years ago.The international human-trafficking ring has around 50 members, including foreigners, who trick women into travelling to India by promising them jobs at markets, superstores and salons, the RAB said.
The culprits drug and film their victims in an objectionable position. They then use the videos to blackmail them into doing paid sex.
Rafi had earlier worked as a driver and clothing trader in Bengaluru for eight years during which time he came into contact with the human traffickers. He later formed his own gang, the RAB said.
The woman in the video was assaulted because she had helped two others to flee the traffickers, according to the law enforcers.
Meanwhile, a victim escaped the ring and returned home on May 7. She started a case against 12 people at Hatirjheel Police Station in Dhaka on Jun 1 after the police traced her.
Another case was filed under the anti-trafficking law at the same police station by a garment factory worker on Jun 10. She alleged that her husband Jahidul Islam Rony, a 27-year-old bus conductor and a drug abuser, sold her off to traffickers for Tk 40,000.
The group offered her a job at an old-age home for a monthly salary of Tk 30,000 and took her to Chennai where they forced her in sex work. She escaped and returned home in May.
According to the victims’ accounts in the cases, they were trafficked through te borders in Satkhira along with the several other women.
Members of the gang used houses and motorcycles at the borders to traffic the women.
They took the victims’ photos and information to create fake identity cards as soon as they entered India.
The victims said they saw other Bangladeshi girls in the houses they were kept in Indian cities, including Bengaluru and Chennai.
Noor Khan, secretary general of legal rights group Ain O Salish Kendra, raised questions over how it has been possible to take so many girls across the border unbeknownst to the police, RAB, Border Guard Bangladesh and other agencies.
The trafficking of 500 Dhaka-based girls to India should be considered a terrible crime and a huge failure of the law-enforcing agencies, he said.
“So many incidents have occurred quietly although so many agencies are at work, we haven’t noticed a thing. We’ve only come to know about it when the video went viral on social media.
“It means our agencies and organisations working to prevent this at the expense of tens of millions of takas every year have nothing but failure to show for it. It means they will have to take responsibility of the failure,” Khan said,
“There may be weakness in awareness raising activities, preserving law and order. And these incidents prove the failure of the government’s cell formed to prevent human trafficking.”
“Now we need to find out whether someone from the law-enforcing agencies or anyone from an influential section of the society is connected to this. Something as huge as this cannot happen so silently.”
Salma Ali, president of Bangladesh National Woman Lawyers’ Association who is also an adviser to the Human Trafficking Monitoring Cell under the home ministry, said many of the victims might have been trafficked when the coronavirus pandemic hampered surveillance.
“The leaders of these human-trafficking groups are still at large. It was time we arrest them and others in these groups,” she said.
Many of the victims were tempted by the traffickers’ promise to make them stars on the video-sharing network TikTok. Suspect Ridoy was a known face in Dhaka’s Moghbazar for shooting videos for TikTok.
“Did the law-enforcers not notice these? Did they only come to know about it after the [torture] video went viral?” Salma asked.
Many of the victims who had returned from India earlier said they had been caught by the law enforcers, especially in India, a number of times but the traffickers had them released, she said.“Influential people have been named in drug smuggling incidents different times. It is very much important to find out who is backing these human-trafficking groups as well. Simply arresting small fries will not work.”
WHAT POLICE SAY
bdnews24.com asked the police whether they had knowledge of the human-trafficking incidents and whether they admit that they failed to prevent the crime. Sohel Rana, an assistant inspector general of the police, had the following to say in a written statement: “Monitoring the growing number of interactions on social media is a challenge. The technical capacity of the police has been enhanced to tackle this challenge. The police are monitoring things 24/7.”
He said many people are being arrested and brought under the law over different crimes because the police are taking immediate action upon receiving information. Rana mentioned a recent nationwide crackdown on human trafficking after 26 Bangladeshi victims were shot dead in Libya. He said the other agencies also need to work more actively to prevent organised crimes like human trafficking where the police are only one barrier to the criminals.