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Johnson & Johnson vaccine supply slows inoculation efforts

“The last thing we wanted to hear is that we are getting fewer vaccines,” Gov. Larry Hogan of Maryland, a Republican, told reporters on Friday. “We were hoping to progress as they had promised.”

In a statement, Governor Andrew M. Cuomo of New York, a Democrat, said, “We won’t be able to get as many shots in the arms of New Yorkers as we would like.” He added: “As has been the case since the beginning of our vaccination effort, factor X is supply, supply, supply.”

Some state health officials had hoped to use Johnson & Johnson’s easily storable single-use vaccine to target college students and other transient groups. Others offered it at mass vaccination sites or directed it to rural areas.

Instead, Johnson & Johnson’s dose shipments next week will drop sharply in the states: California will drop from 572,700 to 67,600 doses, Texas from 392,100 to 46,300, Florida from 313,200 to 37,000, and Virginia from 253,400 to 27,900.

In Virginia, which will expand vaccine eligibility to its entire adult population in nine days, the effect will be “huge,” said Dr. Danny Avula, the national vaccine coordinator. He said officials should warn people that even though they would be eligible to register for the shots, appointments might be difficult to secure.

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Senior official warned Covid vaccine plant needs to be ‘closely watched’

Mr de Notaristefani, a former senior executive at two large pharmaceutical companies, spoke of “significant” staffing issues, writing that plans to increase staff appeared “insufficient to allow the company to manufacture at the required rate”.

He also noted that audits carried out by the FDA and the individual companies that had hired Emergent “highlighted the need for in-depth staff training and a strengthening of the quality function.”

Nonetheless, he wrote, “the organization has the necessary experience / skills” to develop its manufacturing. He wrote that “management is well informed and seems confident” and that with sufficient government oversight, “risks can be mitigated.”

At the time of the visit, Emergent was also planning to manufacture a third Covid-19 vaccine, developed by Novavax, but that company has since partnered with another manufacturer under a government-backed deal. “Offloading the Novavax program to a different facility will also help reduce the load on Emergent Bayview,” wrote Mr. de Notaristefani.

Emergent is a long-time federal entrepreneur in the field of biodefense. Sales of its anthrax vaccines have accounted for almost half of the national strategic stockpile of half a billion dollars annually for most of the past decade, The Times reported last month. This left the government with less money for items needed during a pandemic, and last year the shortage of basic medical supplies in stock became a symbol of the government’s failed response to coronaviruses.

Although the initial federal contract for the Baltimore plant required Emergent to demonstrate the full-scale manufacture of a pandemic influenza vaccine – viewed by health officials as a pressure test of its capabilities – Emergent does not. had not yet done so, The Times reported Tuesday. The company was at risk of defaulting on the original deal, which set a deadline of June 2020. The company also has separate deals with the two vaccine makers worth more than $ 875 million.

In an effort to fix the plant’s problems, federal officials have simplified Emerg’s mission, limiting it to only the production of the Johnson & Johnson vaccine and forcing AstraZeneca to move its production lines elsewhere. Johnson & Johnson also now claims direct control over manufacturing, although the workforce at the Southeast Baltimore plant remains that of Emerg.

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Video: Biden increases vaccine eligibility target for adults

I promised at the start to always give you the right scoop, straight from the shoulder, the good and the bad. Well here is the truth. The good news is that we’re on track to meet our goal of 200 million shots in the first 100 days. Over 75% of people over 65 have been vaccinated, up from 8% when we took office. This is a dramatic and critical turnaround as the elderly account for 80% of all Covid deaths. On March 11, I announced that I was opening all vaccination sites to all adults by May 1. Many governors, Democrats and Republicans, responded and decided to beat that date, which was good. Thanks to their hard work and the hard work of the American people, and the hard work of my team, I am announcing today that we are extending this date from May 1 to April 19 across the country. This means that by April 19 at the latest, in all parts of the country, any adult over the age of 18 or older can be vaccinated. No more confusing rules, no more confusing restrictions. My message today is simple. Many states have already opened up to all adults. But starting April 19, every adult in every state, every adult in this country is eligible to line up to get vaccinated against Covid.


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Biden extends vaccine eligibility deadline for all adults to April 19

But in California, cases have been on the decline since peaking earlier this year, with the state now averaging about 2,700 new cases per day, the lowest figure since June. The CDC said that as of Tuesday, 35% of the state’s total population had received at least one vaccine and 18% were fully vaccinated.

“With over 20 million vaccines administered across the state, it’s time to turn the page on our tier system and start looking to fully reopen the California economy,” said Gov. Gavin Newsom, a Democrat. , in a press release. “We can now start planning our lives after the pandemic.”

Many public health experts say the nation is in a race between vaccines and variants and that, for the time being at least, vaccines seem to have the upper hand. But public health officials fear that future iterations of the virus may no longer be resistant.

At the same time, they are seeing an increase in cases among young people, especially those aged 18-24. Dr Walensky told reporters on Monday that the CDC was working with states to investigate outbreaks among young people that she said could be linked to extracurricular activities or sports.

Mr Biden spoke on Tuesday after visiting a vaccination clinic at Virginia Theological Seminary in Alexandria, Va., Which works with community health centers to provide vaccines. Walking around the makeshift clinic, he showed flashes of his former self – the sunny retail politician who likes to hang out with people, with a pat on the arm or a squeeze on the shoulder.

“He’s going to be tough – he’s got so much muscle in there,” the president joked to a nurse, squeezing the shoulder of a muscular man who was about to be vaccinated. “I’m telling you what, I could have been an All-American if I had had that.

But his lightness belied the gravity of the message he would later deliver to the White House. There, he marked an important milestone: since Mr. Biden has been in office, more than 150 million shots of Covid-19 have been administered to Americans, putting the country on track to meet its goal of 200 million shots by his 100th day in office. , at the end of this month.

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Likely legal, ‘vaccine passports’ emerge as upcoming coronavirus divides

Likely legal, ‘vaccine passports’ emerge as upcoming coronavirus divides Businesses and universities want quick and easy ways to see if students and clients are vaccinated, but conservative politicians have transformed’ passports Vaccines ” into a Cultural Flashpoint.By Sheryl Gay Stolberg and Adam Liptak

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How white evangelicals’ vaccine refusal could prolong pandemic

These are questions secular public health entities are unable to answer, he said. “The even deeper problem is that white evangelicals are not even on their screens.”

Mr Chang said he recently spoke to a colleague in Uganda whose hospital had received 5,000 doses of the vaccine, but was only able to administer about 400, due to the reluctance of the government. strongly evangelical population.

“The way American evangelicals think, write, feel about problems is reproducing quickly around the world,” he said.

At this critical moment, even pastoralists are struggling to know how to reach their flocks. Joel Rainey, who heads Covenant Church in Shepherdstown, W.Va., said several colleagues were forced to leave their churches after promoting the health and vaccination guidelines.

Politics have increasingly shaped the faith among white evangelicals, rather than the other way around, he said. The influence of pastors over their churches is diminishing. “They get their employees for an hour, and Sean Hannity gets them for the next 20,” he said.

Mr Rainey helped his own Southern Baptist congregation stay ahead of false information by publicly interviewing medical experts – a retired infectious disease colonel, a church member who is an analyst in Walter’s logistics management Reed and a church elder who is a nurse for the Department of Veterans Affairs.

On the worship stage, in front of the praise group drums, he asked them “all the questions that a follower of Jesus might have,” he later said.

“There is a need for pastors to educate their people that we don’t always have to be adversaries with the culture around us,” he said. “We believe that Jesus died for these people, so why would we view them as adversaries?”

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US asks Johnson & Johnson to run struggling vaccine factory

WASHINGTON – The Biden administration on Saturday handed Johnson & Johnson responsibility for a struggling manufacturing plant in Baltimore that ruined 15 million doses of the Johnson & Johnson coronavirus vaccine and decided to block the plant from make another vaccine by AstraZeneca, senior federal health officials said.

The extraordinary move from the Department of Health and Human Services came just days after officials learned that Emerging BioSolutions, a contract manufacturer that makes both the Johnson & Johnson and AstraZeneca vaccines, had mixed the ingredients of both, which has led regulators to delay the authorization of the plant’s production lines.

By moving the AstraZeneca vaccine, two senior federal health officials said, the plant can be devoted solely to the Johnson & Johnson single-dose vaccine and avoid future accidents.

The Department of Health and Human Services has asked Johnson & Johnson to install a new management team to oversee all aspects of production and manufacturing at the Emergent plant in Baltimore, officials said. The company said in a statement that it “takes full responsibility” for the vaccine made at the Emergent plant.

As President Biden strives to have enough doses to cover every adult by the end of May, federal officials fear the confusion could erode public confidence in Covid-19 vaccines. The AstraZeneca vaccine in particular has created safety concerns; Germany, France and other European countries briefly suspended its use after reporting rare brain blood clots in some vaccinees.

The confusion of ingredients and Saturday’s administration decision are a major setback and public relations debacle for Emergent, a Maryland-based biotech company that has built a profitable business by partnering with the federal government, primarily by selling his anthrax. vaccines to the strategic national stock.

A spokesperson for Emerg declined to comment except to say the company would continue to manufacture doses of AstraZeneca until it receives a contract amendment from the federal government.

Unlike Johnson & Johnson, AstraZeneca does not yet have emergency clearance from the Food and Drug Administration for its vaccine. With three federally licensed vaccines (the other two are from Pfizer-BioNTech and Moderna), it’s not clear whether the AstraZeneca vaccine, which has had a troubled history with regulators, might even be cleared in time to respond. to the needs of the United States.

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

So far, none of the doses of Johnson & Johnson manufactured by Emergent have been released by the FDA for distribution. Officials said it could take weeks to determine if other batches of the vaccine were contaminated and for FDA inspectors to determine if the Emergent Factory can be allowed to release the doses it made.

Acting FDA Commissioner Dr Janet Woodcock said in a statement on Saturday that the agency “is taking its responsibility to help ensure the quality of manufacture of vaccines and other medical products for use during this very high pandemic. serious.”

But she clarified that the ultimate responsibility would rest with Johnson & Johnson, saying: “It’s important to note that even when companies use contract manufacturing organizations, it ultimately rests with the company that holds the authorization. emergency use to ensure that FDA quality standards are met. “

In another arrangement brokered by the Biden administration last month, Johnson & Johnson is now working with Merck, one of the world’s largest vaccine makers. Officials said Merck would help run the Baltimore plant.

The Emergent plant in Baltimore is one of two factories designated by the federal government as “Centers for Innovation in Advanced Development and Manufacturing” and which were built with taxpayer support. Last June, the government paid Emergent $ 628 million to set aside space for Operation Warp Speed, the Trump administration’s fast-track initiative to develop coronavirus vaccines.

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

Vaccine manufacturing experts have said that in the past, the FDA had a policy of preventing such accidents by not allowing a factory to make two live viral vector vaccines, due to the potential for confusion and contamination.

Last month, Biden canceled a visit to the Emergent Baltimore plant and his spokesperson announced that the administration would conduct an audit of the national strategic stock, the country’s emergency medical reserve. Both actions came after a New York Times investigation into how the company had gained inordinate influence over the repository.

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What you need to know about your vaccine card

“Customers have started looking for ways to protect their Covid-19 immunization records, knowing that they will likely be important to have on hand in the future,” said Craig Grayson, vice president of services for the future, Wednesday. Staples printing and marketing. . “Leveraging our existing in-store capabilities seemed like a natural way to provide a free solution.”

People can also have their completed vaccine cards laminated for free at Office Depot and OfficeMax stores nationwide using code 52516714 until July 25.

Dr Ikediobi also recommends keeping the card in a safe place, like you would your passport, rather than carrying it around. “It doesn’t have to be on you at all times,” she said.

In some cases, yes. Some destinations and cruise lines have started requiring travelers to be fully vaccinated before traveling. From March 26, fully vaccinated Americans who can show proof of vaccination can travel to Iceland, for example, and avoid border measures such as testing and quarantine, the country’s government said.

The Royal Caribbean cruise line requires passengers and crew 18 years or older to be vaccinated to board its ships, as do Virgin Voyages, Crystal Cruises and others. These companies will restart cruises this spring and summer. None of the companies still operate cruises from U.S. ports because the CDC has yet to give them guidelines to follow.

At this time, airlines do not require vaccines for travel. But the idea has been discussed a lot in the industry. In a recent interview with NBC Nightly News, Ed Bastian, managing director of Delta Air Lines, said that proof of vaccination will likely eventually be required on international flights, but whether it is paper proof or of a digital vaccine passport, is unclear.

Governor Andrew Cuomo last week announced the launch of the Excelsior Pass, a free app that will allow businesses to scan a code to confirm whether someone has been vaccinated or tested negative for the coronavirus. To register, New York residents should visit the Excelsior Pass website, where they will be asked to enter their name, date of birth, and zip code. A pass – a QR code that can be scanned by businesses – will be automatically generated using data from state immunization registries or data from the testing lab.

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Jill Biden, Calif., Supports farm workers in vaccine research

During her remarks, Dr Biden said the president supports the Farm Workforce Modernization Act, a bill that would grant temporary legal status to seasonal farm workers, many of whom are undocumented, and would offer a 10-year path to citizenship.

“As president, Joe fights for people who often go unnoticed,” Dr. Biden said. “And that is exactly the kind of immigration policy he is striving to craft – one that treats children and families with dignity and creates fair paths to citizenship, including for essential workers.”

Thousands of farm workers in the Central Valley are expected to receive the coronavirus vaccine in Forty Acres over six weekends in March and April. Governor Gavin Newsom of California, a Democrat, and his partner, Jennifer Siebel Newsom, joined the first lady on Wednesday at the site. Later, Dr Biden handed out vaccination cards and ‘I got my Covid-19 vaccination’ buttons to workers waiting to be vaccinated.

This year, California launched a historic effort to provide vaccines to farm workers, many of whom are undocumented and whose conditions of working closely together have made them particularly vulnerable to the virus. Researchers at Purdue University estimate that around 500,000 farm workers have tested positive for the virus and at least 9,000 have died from it. The coronavirus has killed more than 551,000 people in the United States, according to a New York Times tally.

In President Biden’s first two months in office, union leaders hailed his administration as one of the most worker-friendly in modern history. One of his first official acts was to move a bust of Mr Chávez into the Oval Office, a decision Dr Biden underscored to applause at Wednesday’s event. The first lady also frequently repeated the motto of the agricultural workers’ union, “Sí, se puede” or “Yes, we can”, several times during her speech.

“Caesar dared to believe that our country could change – that we could change it,” she said. “Now it’s up to us to keep that promise.”

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For Biden, a new viral dilemma: how to deal with an impending vaccine glut

But while Johnson & Johnson has lagged behind other manufacturers, its technology holds great promise for mass production as it can deliver many more doses per batch.

Later this year, when Merck & Company is expected to start producing Johnson & Johnson’s vaccine, it could produce 100 million doses per month – or as many as Pfizer and Moderna together deliver each month. The White House has welcomed the deal between Johnson & Johnson and Merck, but by the time production levels up, those doses could be destined for a growing surplus or for export.

One option is to ship the frozen vaccine that will be manufactured at the Merck plant overseas, where it can be bottled at a lower cost. Of the $ 10 the federal government has agreed to pay for a dose of Johnson & Johnson’s vaccine, the drug substance itself is only about 30 cents, federal officials said. The rest corresponds to the so-called filling and finishing cost.

If AstraZeneca gets emergency use clearance from US regulators, that will throw even more hits into the mix. Authorities expect around 50 million doses to be ready for delivery in May.

But officials in the Biden administration are worried about AstraZeneca’s vaccine. It appears to be about as efficient as that of Johnson & Johnson, but requires additional fire, which means a more complicated deployment. Some health officials fear that if there are already enough doses in the pipeline to cover every adult who wants a vaccine, the introduction of a fourth vaccine will only create confusion.

On the other hand, if the administration decides to give the doses of AstraZeneca without offering them to its own citizens, other countries could conclude that the United States lacks confidence in the safety or effectiveness of the vaccine. .

“As we gain confidence in the doses we have and the ability or the need or not to boost, then we can make a more definitive statement about the role of the AZ product in the United States.” he gets clearance, Dr Fauci said in an interview this week, “but at the moment I think he’s too premature to say anything.”

Sheryl Gay Stolberg, Benjamin mueller and Matina Stevis-Gridneff contribution to reports. Kitty bennett contributed to the research.