Tag: Vaccine

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How Emergent BioSolutions Earned Earnings However Delivered Disappointing Vaccine Returns

How Emergent BioSolutions Earned Profits But Delivered Disappointing Vaccine Returns

After placing the no-bid contract with Emergent, the Trump administration reverted to traditional contract rules and looked for competitive proposals for additional fillings and packaging, known in the industry as fill-finish work, the documents show. Ology Bioservices, based in Alachua, Fla., Agreed to provide essentially the same services as the Camden and Rockville Emergent plants for three quarters to nearly one third the cost, according to a contract-based calculation.

According to an agreement made in August, Ology would collect state fees of $ 6.83 per vial. By comparison, Emergent’s existing lines would cost between $ 9.03 and $ 18.40 per vial.

A health department spokeswoman said Ology is cheaper in part because it can fill more than 100,000 vials in a single batch, which is five times that of Emergent. This “lowers the price per bottle by spreading the fixed costs over more bottles,” she said in an email.

Even after the launch of Ology, the government continued its higher-cost agreement with Emergent to ensure “additional capacity is available when or when it is needed to fill vaccines or therapeutics,” she said. At the time of the deal, former and current federal officials said the government wanted to secure as much manufacturing capacity as possible before commercial companies buy it out.

Over the years, Emergent has grown by funding the expansion of its manufacturing facilities and the accumulation of product reserves.

In November 2019, the company announced that it would double its sales, including by expanding its contract manufacturing business. A senior vice president, Syed Husain, outlined a “game plan” that would “cross-sell additional services” to existing customers, including the federal government. Six months later, Emergent signed the contract that expanded its existing government contract to include work in its Camden and Rockville locations.

Dr. Robert Kadlec, a former Trump administration official who oversaw the agency that awarded Covid-19 contracts, had previously worked as a consultant for Emergent. Dr. Kadlec has said that he did not negotiate the emergent deal but approved it. Emergent said it negotiated the agreement with professional government officials.

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5 years earlier than vaccine can maintain line towards Covid variants

5 years before vaccine can hold line against Covid variants

Covid vaccinator, Petra Moinar, prepares syringes with the AstraZeneca vaccine before it is administered at Battersea Arts Centre on March 8, 2021 in London, England.

Chris J Ratcliffe | Getty Images News | Getty Images

LONDON — England’s top medical officer has warned that the coming winter will continue to be difficult for the country’s health system despite the country’s successful coronavirus vaccination program.

A further easing of lockdown restrictions in England was delayed this week due to a surge in cases of the delta variant first discovered in India. 

In a speech to the NHS Confederation Thursday, Chief Medical Officer Chris Whitty said the current wave of Covid infections due to the delta variant would likely be followed by another surge in the winter.

He said that Covid-19 “has not thrown its last surprise at us and there will be several more [variants] over the next period,” according to Sky News. He added that it would likely take five years before there are vaccines that could “hold the line” to a very large degree against a range of coronavirus variants.

And until then, he said that new vaccination programs and booster shots would be needed.

In the U.K., where the delta variant is now responsible for the bulk of new infections, cases have spiked among young people and the unvaccinated, leading to a rise in hospitalizations in those cohorts.

It’s hoped that Covid-19 vaccination programs can stop the spread of the delta variant and so the race is on to protect younger people who might not be fully vaccinated. 

Analysis from Public Health England released on Monday showed that two doses of the Pfizer-BioNTech or Oxford-AstraZeneca Covid-19 vaccines are highly effective against hospitalization from the delta variant.

But some vaccines are reported to be less effective against other strains. For example, British Health Secretary Matt Hancock said earlier this month that it has started commercial negotiations with AstraZeneca to secure a variant vaccine — which has been adapted to tackle the variant first discovered in South Africa.

Meanwhile, trials of booster shots are already underway in Britain and there are reports that the population will receive a third shot before winter this year. 

Over 42 million people have had a first dose of a vaccine in Britain — that’s about 80% of the adult population — and over 30 million people have had their second dose.

—CNBC’s Holly Ellyatt contributed to this article.

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Politics

Excessive Hopes for Johnson & Johnson’s Covid Vaccine Have Fizzled within the U.S.

High Hopes for Johnson & Johnson’s Covid Vaccine Have Fizzled in the U.S.

But manufacturing problems at a factory in Baltimore run by Emergent BioSolutions, Johnson & Johnson’s subcontractor, have had serious consequences for the vaccine. Because of a major production mishap that resulted in a two-month shutdown in operations, Johnson & Johnson has essentially been forced to sit out the brunt of the pandemic in the United States while Pfizer and Moderna, the other federally authorized vaccine makers, provided almost all the nation’s vaccine stock.

Johnson & Johnson has had to throw out the equivalent of 75 million doses, and the regulatory authorities in Canada, South Africa and the European Union also decided to pull back millions more doses made at the Baltimore plant. The company has been able to deliver only one-fourth of the 100 million doses it promised the federal government by the end of this month.

Dr. Anne Zink, Alaska’s chief medical officer, said that in her state, Johnson & Johnson’s shot had become a victim of its own timing. By late February, when it was authorized by the Food and Drug Administration, Alaska had figured out how to get two-dose vaccines to remote areas, leaving the one-shot regimen less crucial than she had initially imagined.

Dr. Clay Marsh, West Virginia’s Covid-19 czar, said that the pause and Johnson & Johnson’s later authorization — more than two months after Pfizer’s and Moderna’s — deprived it of a “halo effect.” By the time West Virginia had an ample supply of all three vaccines, he said, “people started to get this concept that maybe there’s something better about being immunized with Pfizer and Moderna.”

The Johnson & Johnson shot had also suffered from a “social network effect,” said Andrew C. Anderson, a professor of public health at Tulane University who researches vaccine hesitancy. Most Americans who were inoculated in the early months of the vaccine campaign received Moderna and Pfizer shots, and so their friends and family were less likely to deviate and accept a different brand.

In Louisiana, hospitals in the New Orleans area have started offering the Johnson & Johnson shot to people on their way out of the emergency room; the thinking is that people will be more likely to accept the vaccine when a doctor who has treated them asks them to take it. And in Arkansas, where only a third of the population is fully vaccinated, state officials are offering Johnson & Johnson doses to agriculture, manufacturing, wastewater and poultry workers, with gift certificates for hunting and fishing licenses as a reward.

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CureVac’s Covid Vaccine Carried out Badly in Trial, In Half As a result of Variants

CureVac’s Covid Vaccine Performed Badly in Trial, In Part Due to Variants

German company CureVac on Wednesday delivered disappointing preliminary results from a clinical trial of its Covid-19 vaccine, tarnishing hopes of meeting the world’s great needs.

The study, which included 40,000 volunteers in Latin America and Europe, estimated that CureVac’s mRNA vaccine was only 47 percent effective, one of the lowest ever reported by any Covid vaccine manufacturer. The study will continue as researchers monitor volunteers for new cases of Covid, with a final analysis expected in two to three weeks.

“We’re going into full swing for the last reading,” said Franz-Werner Haas, CEO of CureVac, in an interview. “We are still planning to submit the permit.”

CureVac plans to first apply to the European Medicines Agency for approval. The European Union reached an agreement last year to purchase 405 million doses of the vaccine if the agency approves it.

However, independent experts said it would be difficult for CureVac to recover. Natalie Dean, a biostatistician at the University of Florida, said the vaccine’s effectiveness could improve somewhat by the end of the study. However, since most of the data are already available, the vaccine is unlikely to offer high protection. “It’s not going to change dramatically,” she said.

And with such a low rate of efficacy – far less than the roughly 95 percent of competing mRNA vaccines from Pfizer-BioNTech and Moderna – the results aren’t a good sign that CureVac’s vaccines will be adopted.

“It’s pretty devastating for them,” said Jacob Kirkegaard, a vaccine supply expert at the Peterson Institute for International Economics, a Washington think tank.

The news was disappointing to experts who had hoped the company could provide vaccines to low- and middle-income countries that don’t have nearly enough. CureVac had several advantages over the other mRNA vaccines, such as the month-long shelf life in the refrigerator. In addition, CureVac’s vaccine uses fewer mRNA molecules per injection compared to its competitors, reducing its cost.

The study results published on Wednesday were based on data from 135 volunteers suffering from Covid. An independent panel compared the number of people who had received a placebo with those who had received the vaccine. Although the vaccine appeared to offer some protection, the statistical difference between the two groups was not great, giving an effectiveness rate of 47 percent.

In comparison, annual flu vaccinations can be 40 to 60 percent effective. Both the World Health Organization and the Food and Drug Administration set a threshold of 50 percent effectiveness for considering Covid vaccines for emergency approval. If CureVac ended up staying at 47 percent, it wouldn’t meet that standard.

The results surprised the scientists. CureVac’s recordings have shown promising results in animal studies and early clinical studies.

“This is a bit of a head scratch,” said Dr. Dean.

Dr. Haas blamed the disappointing results on the high number of virus variants in the countries where the vaccine was tested. Of 124 of the Covid-19 cases that the company’s scientists have genetically sequenced, only one was caused by the original version of the coronavirus.

More than half of the cases were caused by variants that have been shown to be more transmissible or can make vaccines less effective. CureVac volunteers have also been infected by variants that have yet to be carefully investigated. Lambda, which has dominated Peru for the past few weeks, made up 21 percent of the samples.

Dr. Haas said the results should serve as a wake-up call to the threat that new variants can pose to vaccine effectiveness. “It’s a new Covid reality, that’s for sure,” he said.

Moderna and Pfizer-BioNTech were tested last year before variants emerged, which could partly explain their much higher rates of effectiveness. However, studies have shown that their effectiveness in practice falls only moderately in view of variants.

Dr. Kirkegaard predicted that it would be challenging for CureVac to compete with others Covid vaccine under development, manufactured by Novavax. Novavax reported Monday that its non-frozen vaccine was 90 percent effective in a study in the United States and Mexico.

“I suspect that it will be difficult for them to really get a significant market for developing countries,” said Dr. Kirkegaard.

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Covid Vaccine Card: What You Have to Know

Covid Vaccine Card: What You Need to Know

“Customers began seeking out ways to protect their Covid-19 vaccine record cards, knowing they will likely be important to have on hand in the future,” Craig Grayson, vice president of print and marketing services for Staples, said in an email. “Leveraging our existing capabilities in store felt like a natural way to provide a free solution.”

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

Dr. Ikediobi also recommends keeping the card in a safe place, as you would your passport, rather than carrying it around. “It does not necessarily need to be on your person at all times,” she said.

In some cases, yes. Border entry requirements are set by governments, not by airlines or by the International Air Transport Association, the trade association for the world’s airlines. Some destinations and cruise lines have started requiring that travelers be fully vaccinated before they travel. As of March 26, fully vaccinated Americans who can present proof of vaccination can visit Iceland, for example, and avoid border measures such as testing and quarantining, the country’s government said.

The cruise line Royal Caribbean is requiring passengers and crew members 16 or older to be vaccinated in order to board its ships. Virgin Voyages, Crystal Cruises and others are requiring guests to be vaccinated as well. These companies will restart cruise operations this spring and summer.

For the moment, airlines are not requiring vaccinations for travel, but some international destinations are requiring vaccination for entry. The idea has been much talked about in the industry. In an interview with NBC Nightly News, Ed Bastian, the chief executive officer of Delta Air Lines, said that proof of vaccination will likely eventually be required on international flights, but whether that is paper proof or a digital vaccine passport, is unclear.

Perry Flint, a spokesman for the I.A.T.A., said that the agency does not support a mandatory vaccine requirement for air travel because it “risks discriminating against those markets where vaccines may take longer to become widely available” or against those “who are not able to get vaccinated for medical reasons, or who are unwilling to do so owing to ethical or other concerns.”

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What Are The Roadblocks to a Covid Vaccine Passport?

What Are The Roadblocks to a Covid Vaccine Passport?

With all American adults now eligible for Covid-19 vaccines and with businesses and international borders reopening, a heated debate has begun in the United States over whether a digital health certificate (often and somewhat misleadingly called a “vaccine passport”) will be required should to prove vaccination status.

Currently, Americans are being issued a white paper card as evidence of their Covid-19 shots, which can be easily forged, and online scammers are already selling fake and stolen vaccination cards.

While the federal government has announced that it will not introduce federal mandate digital vaccination records, a growing number of companies – from cruise ships to sports venues – are saying that they need proof of vaccination for entry or services. Hundreds of digital health passport initiatives are struggling to bring apps to market that provide a verified electronic record of vaccinations and negative Covid-19 test results to streamline the process.

The initiative has raised privacy and equity concerns, and some states like Florida and Texas have banned companies from requiring vaccination certificates. However, the developers argue that the digital infrastructure is secure and will help expedite the process of reopening society and revitalizing travel.

Governments, tech companies, airlines and other companies are testing different versions of the digital health passports and trying to develop common standards so that each system is compatible and health records can be created in a secure and controlled format.

The process is associated with major technical challenges, especially due to the large number of ongoing app initiatives. For the certificates to be useful, countries, airlines and companies must agree on common standards and the infrastructure they use must be compatible. In the United States, getting individual states to share vaccination data with different certificate platforms while preserving the privacy of residents is also complicated.

Here’s what we know about the current state of digital health passports and some of the obstacles they face in the United States.

In March, New York became the first state in the United States to introduce a digital health certificate called the Excelsior Pass, which checks a person’s negative coronavirus test result and whether they are fully vaccinated.

The app and website, which have now been downloaded more than a million times, are free and voluntary for all New Yorkers, and offer a QR code that can be scanned or printed out to check a person’s health records. The pass has been used by thousands of New Yorkers to enter Yankee Stadium, Madison Square Garden, and other smaller public venues.

Most companies require individuals to present their government ID along with their Excelsior passport to prevent possible fraud.

In Israel, where more than half of the population is fully vaccinated, residents are required to show an electronic “Green Pass” to visit places such as gyms, concerts, wedding halls and dine indoors.

The European Union has approved an electronic vaccination certificate, due to be recognized from July 1, that a number of European countries have already used, but each individual member country can set its own rules for travel requirements. The UK has also started testing a Covid-19 certificate system designed to help companies reopen safely.

Some airlines, including Lufthansa, Virgin Atlantic and Jet Blue, have started using the Common Pass digital health app to check passengers’ Covid-19 test results before boarding. The International Air Transport Association’s Health Pass is used by more than 20 airlines and allows passengers to upload health certificates required for international travel.

That depends on the state regulations. The Biden government has announced that there will be no federal immunization system or mandate. Individual states have primary public health powers in the United States and have the power to request vaccines.

Let us help you protect your digital life

“We assume that a vaccine pass, or whatever you want to call it, is being driven by the private sector,” White House press secretary Jen Psaki said at a briefing in March. “There will be no centralized, universal federal vaccination database and no federal mandate that prescribes a single vaccination card for everyone.”

In April, Texas Governor Greg Abbott issued an executive order banning government agencies, private companies, and institutions receiving state funding from requiring individuals to prove they had been vaccinated against the coronavirus.

Florida Governor Ron DeSantis issued a similar order, saying that demonstrating vaccination would “limit individual freedom” and “harm patient privacy” as well as “create two classes of citizens based on vaccinations.”

But these orders cannot be held liable. “The governors are on uncertain legal ground,” said Lawrence Gostin, director of the O’Neill Institute for National and Global Health Law at Georgetown University. “Of course, lawmakers have the power to regulate businesses in the state, and they can stop counties and local governments from issuing vaccine passports. But a governor who acts alone has no inherent power to regulate businesses except through emergency or other health powers given to them by law. “

There is no centralized federal vaccine database in the United States. Instead, states collect this information. All states except New Hampshire have their own vaccination registers, and some cities, like New York, have their own.

Currently, states are required to share their registers with the Centers for Disease Control and Prevention, but the data is not public and could be withheld.

That means anyone developing a digital vaccination certificate in the United States will need to obtain vaccination records from individual states, which could be problematic in states that oppose health passport initiatives.

One of the problems is the terminology. A passport is issued by a government and certifies personal information, including an individual’s legal name and date of birth. Many people fear that they are giving out personal and sensitive health information to private companies that could be stolen or used for other purposes.

“There are many legitimate concerns about how privacy and technology would work with these systems, especially since Silicon Valley doesn’t have a great history in providing privacy enhancing technology,” said Brian Behlendorf, executive director of the Linux Foundation Public Health. an open source, technology oriented organization.

“And the concept of privacy here is complicated because, ultimately, you are trying to prove to someone that you received something,” he said. “You don’t keep a secret, so the challenge is to come up with something and prove it without forever creating a traceability chain that could be used.”

The Linux Foundation works with a network of technology companies called the Covid-19 Credentials Initiative to develop a set of privacy standards when using vaccine certificates. The main goal of the initiative is to create a verifiable ID (similar to a card in a wallet) that contains a range of information about a person, but is digitally native and cryptographically secure.

Some argue that such an ID would encroach on personal freedoms and private health decisions.

“‘Vaccine passports’ must stop,” former Texas representative Ron Paul wrote in a tweet last week. “To accept them is to accept the misconception that the government owns your life, your body and your freedom.”

Others fear that an all-digital system would leave some communities behind, especially those with no access to smartphones or the internet.

“All solutions in this area should be simple, free, open source, accessible to people both digitally and on paper, and designed from the start to protect people’s privacy,” said Jeff Zients, the coronavirus coordinator of the White House, in a statement.

The World Health Organization said in April that it does not yet support the need for vaccination certificates for travel due to uncertainty about whether vaccination will prevent transmission of the virus and equity concerns. But the organization is working with a number of agencies such as UNICEF, ITU and the European Commission to set the standards and specifications for a possible globally recognized digital vaccination card.

Follow the New York Times Travel on Instagram, Twitter and Facebook. And sign up for our weekly Travel Dispatch newsletter for expert tips on smarter travel and inspiration for your next vacation. Are you dreaming of a future short vacation or just traveling in an armchair? Check out our 52 places list for 2021.

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Novavax says its Covid vaccine is 90% efficient, plans FDA submission in Q3

Novavax says its Covid vaccine is 90% effective, plans FDA submission in Q3

A woman holds a small bottle with a sticker “Coronavirus COVID-19 Vaccine” and a medical syringe in front of the Novavax logo displayed in this image dated October 30, 2020.

Given Ruvic | Reuters

Biotech company Novavax said Monday its Covid-19 vaccine had been shown to be safe and 90.4% overall effective in a Phase III clinical trial involving nearly 30,000 participants in the United States and Mexico.

In addition, the two-dose vaccine was found to be 100% effective in preventing moderate and severe illness, and 93% effective in some variants. The company plans to file a regulatory filing with the Food and Drug Administration in the third quarter.

The late-stage study “confirms that NVX-CoV2373 has an encouraging tolerability and safety profile,” said Dr. Gregory Glenn, President of Research and Development at Novavax, in a press release. “These data show consistent, high efficacy and reaffirm the vaccine’s ability to prevent COVID-19 amid the virus’ s ongoing genetic evolution.”

With an abundance of vaccines already available in the US, it is possible that the government could donate the Novavax doses to other countries.

The company’s analysis evaluated 77 confirmed Covid infections among the 29,960 participants in the study. Novavax said 63 cases of Covid were seen in the placebo group, up from 14 cases seen in the group that received their two-dose vaccine. That resulted in an estimated vaccine effectiveness of 90.4%, it said.

The vaccine also appeared to be well tolerated, the company said. The most common side effects were fatigue, headache, muscle aches and pain at the injection site, which usually didn’t last more than two or three days, the company said.

All Covid hospital admissions in the study were in the placebo group, the company said.

Novavax said the vaccine appears to be effective against a few variants, including the alpha variant, which was first identified in the UK. About 65% of the cases where sequence data were available were of worrying variants, the company said.

If Novavax’s vaccine is FDA approved, it would follow three Covid-19 vaccines already approved in the U.S. by Pfizer-BioNTech, Moderna, and Johnson & Johnson for emergency use.

The new data comes as federal officials say the U.S. has more than enough doses of Covid vaccine to vaccinate the entire American population. According to the Centers for Disease Control and Prevention, more than 173 million Americans had received at least one dose of a Covid-19 vaccine as of Sunday.

The Biden government has already committed to donating at least 20 million doses of Covid vaccines from Pfizer-BioNTech, Moderna and J&J, and 60 million doses of AstraZeneca’s vaccine, which is not yet approved for use in the United States

Earlier this month, the White House announced it was lifting restrictions under the Defense Production Act, which gives the US priority to vaccines developed by AstraZeneca, Sanofi and Novavax.

Novavax said Monday it is still on track to hit production capacity of 100 million cans per month by the end of the third quarter and 150 million cans per month by the fourth quarter of 2021.

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Dr. Scott Gottlieb on uncommon coronary heart irritation in younger Covid vaccine recipients

Dr. Scott Gottlieb on rare heart inflammation in young Covid vaccine recipients

Rare instances of heart inflammation in young people after receiving their second Covid vaccine dose require further inquiry, Dr. Scott Gottlieb told CNBC on Friday.

However, the former Food and Drug Administration commissioner said the cases have mostly been mild and should not dissuade people from signing up for the two-shot regimens from Pfizer and Moderna.

“At this point, the risk/benefit still favors vaccination certainly in this age group,” Gottlieb, a Pfizer board member, said in an interview on “Squawk Box.” “That’s what CDC and FDA have also affirmed.”

A day earlier, the Centers for Disease Control and Prevention indicated it has seen a higher-than-projected number of cases of heart inflammation in 16-to-24-year-olds following their second Covid shot—  275 recorded occurrences compared with expectations of 10 to 102.

In people age 30 and below, there’s been 475 total reports of myocarditis or pericarditis, which according to the CDC involves inflammation of the heart muscle or the lining around it. Men make up the vast majority of reported instances of post-vaccine myocarditis or pericarditis.

Of the 270 people who developed the conditions and have been discharged from the hospital, 81% have fully recovered, according to CDC data. The remaining 19% either still have symptoms or their status is not known. Fifteen people are still hospitalized, the CDC said.

Symptoms, which include chest pain and shortness of breath, typically develop when a few days of receiving the vaccine, according to the CDC.

Gottlieb said many questions remain about the connection between the heart inflammation and the Covid vaccines from Pfizer and Moderna.

“I think at this point you need to assume there’s a causal relationship between the vaccine and these observations until you can prove otherwise,” said Gottlieb, who led the FDA from 2017 to 2019 in the Trump administration.

Gottlieb said what’s not known yet is whether there’s something specific about the vaccines that are causing heart inflammation. “We know the vaccine induces inflammatory response. That’s why you get a fever. That’s why you get injection-site pain because your immune system is stimulated.”

“Is this a more generalized inflammatory response from the vaccine that’s localizing in the heart in some patients?” Gottlieb asked. “Or is this something that’s more direct, where the vaccine itself is triggering some kind of very targeted immune reaction and it’s manifesting in this way? We don’t have the answers to these questions.”

It’s possible additional cases haven’t been recorded, Gottlieb said, but “we are probably capturing most of the severe cases.” He added, “When you look at the number of people who are having severe cases of pericarditis, it’s very small numbers right now.”

Roughly 141.5 million people in the U.S. have been fully vaccinated against Covid, according to CDC data. The vaccines have been critical in driving down the number of coronavirus cases in the U.S. to their lowest levels since early in the pandemic.

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What to Know About Testing and Vaccine Necessities for Journey

What to Know About Testing and Vaccine Requirements for Travel

Celebrity Cruises, due to be the first U.S. cruise ship to resume operations on June 26 from Fort Lauderdale, Florida, said it was optimistic that a solution would be found in time. Guests 16 and over must be vaccinated while children are tested at the terminal.

Carnival Cruises announced Monday that its first ship would set sail from the port of Galveston, Texas on July 3 and would only be available for vaccinated passengers. Norwegian, which will operate cruises from Miami starting in August, said it would request it by October 31st and has threatened to skip the ports of Florida if the state doesn’t allow cruise lines an exception to the law banning vaccination.

Christine Duffy, President of Carnival Cruise Line, said in a statement on June 7th that “the current CDC requirements for cruises with an unvaccinated guest base will make it very difficult to deliver the experience our guests have come to expect, especially given that it is the great number “. from families with younger children who sail with us. “

“So our alternative is to operate our ships from the US with vaccinated guests in July,” she said.

But even if you are vaccinated, you need to consider the requirements of the country where the cruise is disembarking. The Caribbean island of St. Maarten, for example, where Celebrity Cruises started sailing on June 5th, requires a negative test in addition to proof of vaccination.

This also depends on where you are going, but a good rule of thumb is to have your physical vaccination card (if you have one) and proof of a negative test if necessary.

Mr. Alexander, the travel agent, recommends bringing the original documents with you. While a number of digital health certificates – showing vaccine status and test results – are in the works, he said, they are not yet widely accepted. You should also check that your document is in the correct language. For example, the UK requires test results to be in English, Spanish or French.

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The FDA reportedly forces J&J to scrap about 60 million doses of its Covid vaccine

The FDA reportedly forces J&J to scrap about 60 million doses of its Covid vaccine

A detail of the Janssen Johnson & Johnson COVID-19 vaccine that is not currently being issued because it has been put on hold.

Allen J. Cockroaches | Los Angeles Times | Getty Images

Federal regulators are forcing Johnson & Johnson to scrap approximately 60 million doses of the Covid-19 vaccine made at a troubled Baltimore facility operated by Emergent BioSolutions due to possible contamination, the New York Times reported on Friday, citing with people familiar with the matter.

The facility closed in April after an inspection revealed several violations, including possible contamination of J & J’s vaccines with a key ingredient from AstraZeneca’s Covid vaccine. About 170 million doses of both vaccines were eligible after the inspection, the Times reported.

The FDA confirmed to CNBC that several lots were not “suitable for use” without confirming the exact number of doses discarded. According to an email statement, the agency announced that it is releasing two batches of vaccine materials made at the facility for use. The Associated Press reported that the two batches would make 10 million cans.

“The FDA has determined that several other lots are unsuitable for use, but additional lots are still being tested and the agency will inform the public of the completion of these tests,” said a statement sent via email.

The US currently has more than enough doses of two other vaccines approved by Pfizer and Moderna to complete vaccination of the American population.

Approximately 10 million doses of the Johnson & Johnson vaccine continue to be distributed in the United States and donated to other countries. The rescued cans will come with a warning stating that federal regulators cannot guarantee that the manufacturing facility operator, Emergent BioSolutions, is following good manufacturing practices, the Times reported.

“Before making this decision, the FDA conducted a thorough review of the facility records and the results of the manufacturer’s quality checks,” the agency said. “Although the FDA is not yet ready to include the Emergent BioSolutions facility in the Janssen EUA as an authorized manufacturing facility, the agency continues to address issues with Janssen and the management of Emergent BioSolutions.”

The Biden government planned to donate more cans of the shots, but those plans were stifled by the investigation of the emergent facility.

The World Health Organization said it would take 11 billion doses worldwide to stop the pandemic from getting worse. The US is buying 500 million doses of Pfizer’s two-shot vaccine to be distributed to countries in need, President Joe Biden is expected to announce at G-7 meetings this weekend.

– CNBC’s Berkeley Lovelace Jr. contributed to this article.