Johnson & Johnson takes over COVID-19 vaccine production at Baltimore plant after 15 million doses were ruined

johnson and johnson covid vaccine
Johnson & Johnson’s coronavirus vaccine is delivered as a single shot, while both Pfizer and Moderna’s require two jabs.

  • Johnson & Johnson has been put in charge of COVID-19 vaccine production at a Baltimore plant.
  • The move comes after 15 million COVID-19 vaccine doses were ruined in a mixup.
  • The error did not impact any vaccines that are currently being delivered or used.
  • See more stories on Insider’s business page.

Johnson & Johnson, with the aid of President Joe Biden’s administration, has been put in charge of a Baltimore vaccine production plant that ruined 15 million doses of its COVID-19 vaccine and has moved to stop British drugmaker AstraZeneca Plc from utilizing the facility to avoid any future mistakes, senior federal health officials said on Saturday.

The extraordinary decision, which was first reported by The New York Times, was put into action by the US Department of Health and Human Services and will allow the Emergent BioSolutions plant to focus on making the single-dose Johnson & Johnson COVID-19 vaccine.

Johnson & Johnson confirmed the move on Saturday, stating that it was “assuming full responsibility regarding the manufacturing of drug substance” at Emergent.

“Specifically, the company is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the company specialists already at Emergent,” Johnson & Johnson said in a statement.

The change comes after the disclosure that Emergent, which is a manufacturing partner to both AstraZeneca and Johnson & Johnson, mixed up ingredients from the two coronavirus vaccines in a case of human error, causing regulators to delay authorization of the facility’s vaccine production.

The mixup ruined nearly 15 million Johnson & Johnson doses.

The error did not impact any vaccines that are currently being delivered or used, according to the Times report.

Read more: Here are 9 hurdles Biden’s infrastructure plan would have to overcome in Congress before it can become law

The Biden administration has made note of the delay and has not shifted its stated goal of having enough vaccines for all adult Americans by the end of May.

According to the Times report, federal officials are concerned that the mixup could dampen confidence in the vaccines just as Biden is aggressively pushing for mask mandates to remain in place as new COVID-19 variants spread throughout the US.

Meanwhile, there are concerns about the two-dose AstraZeneca vaccine, which has had a troubled rollout in Europe due to a risk of rare blood clots possibly linked to the vaccine. However, the United Kingdom’s drug regulator deemed the vaccine as safe.

AstraZeneca said that it would work with the Biden administration to find an alternative site for its vaccine production, which has not yet been authorized in the US.

“AstraZeneca and the US government continue to work closely together to support agreed upon plans for the development, production and full delivery of the vaccine,” the company wrote in a statement.

With three vaccines authorized in the US – from Johnson & Johnson, Pfizer-BioNTech, and Moderna – it is unclear if there will even be a need for an additional vaccine.

Dr. Anthony Fauci, the nation’s top infectious-disease expert, said as much in a recent interview with Reuters.

“That’s still up in the air,” Fauci said. “My general feeling is that given the contractual relationships that we have with a number of companies, that we have enough vaccine to fulfill all of our needs without invoking AstraZeneca.”

However, a federal official said that the HHS is in talks with AstraZeneca “to adapt its vaccine to combat new coronavirus variants,” according to the Times report.

As of Sunday, nearly 30.7 million Americans have tested positive for the coronavirus and more than 554,000 people have died of the illness, based on data compiled by Johns Hopkins University.

Read the original article on Business Insider

Several patients at a Virginia Kroger clinic received an empty shot instead of COVID-19 vaccine

Vaccine distribution

A Virginia Kroger gave several people “empty” shots that were supposed to contain vaccines for COVID-19, according to ABC 8News.

The healthcare professional who gave the shots to less than 10 people believed that the syringes had been previously filled by a colleague before the appointments started, a spokesperson for Kroger told 8News.

At first, the company told outlets 8News and CBS 6 that the syringes contained saline but later clarified that they were completely empty. That risks pumping air into people’s veins that can cause air embolisms and block blood flow.

Read more: The 4 things the US is doing wrong in the fight against COVID-19, and what we should be doing instead

“All impacted customers were contacted and have received their COVID-19 vaccine. We thank these customers for their understanding and have apologized for their inconvenience,” a spokesperson for Kroger told Insider.

The clinic is investigating the matter to prevent a similar situation from recurring in the future, and the Virginia Department of Health is aware of the incident, they said.

The retail chain aims to double its vaccine capacity to 1 million doses per week.

As of March 13, about 20% of the US population has received at least one dose of the vaccine for COVID-19, Bloomberg data show. More Americans have received vaccines than have tested positive for the virus, that report said. At the current rate, it will only take about 5 months until 75% of the US population, enough for “normalcy,” according to Dr. Anthony Fauci, is inoculated.

Read the original article on Business Insider

Gov. Ron DeSantis said ‘any type of lockdown’ in Florida is ‘insane,’ despite Biden’s warning of possibly reinstating restrictions

Ron DeSantis
Florida Gov. Ron DeSantis.

  • Gov. Ron DeSantis said there would be no lockdowns in the state of Florida.
  • His remarks run contrary to President Joe Biden’s warning one day earlier that the US might “have to reinstate restrictions” if the public isn’t vigilant.
  • “To even contemplate doing any type of lockdown, honestly it’s insane,” DeSantis said.
  • See more stories on Insider’s business page.

Florida Gov. Ron DeSantis on Friday shot down the notion of instituting a lockdown in his state, despite a warning from President Joe Biden that there might have to be additional coronavirus restrictions put in place if the public isn’t “vigilant.”

“To even contemplate doing any type of lockdown, honestly it’s insane,” DeSantis said during a press conference.

“That’s not gonna happen in the state of Florida,” he continued. “We’re gonna continue doing what works, but under no circumstances would we entertain anything of the sort.”

Biden in his prime-time Thursday address said beating the coronavirus pandemic depends on “national unity.”

“And national unity isn’t just how politics and politicians vote in Washington or what the loudest voices say on cable or online. Unity is what we do together as fellow Americans,” he said. “Because if we don’t stay vigilant and the conditions change, then we may have to reinstate restrictions to get back on track. And, please, we don’t want to do again.”

Biden did not specify any states when talking about the potential for added restrictions.

Still, DeSantis insisted on Friday, “we are not going to let him lock down Florida.”

“We like the fact that people have been able to work here,” the governor said. “So we’re going to continue doing what works, but under no circumstances would we entertain doing anything of the sort.”

It’s been just over one year since the WHO declared the coronavirus a pandemic. Since then, more than 29 million people in the United States have contracted the virus, according to the latest data compiled by Johns Hopkins University. Of that, more than 500,000 Americans have died.

Florida alone has more than 1.9 million confirmed coronavirus cases, according to Hopkins data.

DeSantis’ remarks come as crowds of mask-less spring breakers appear in the state, and as numerous COVID-19 variants emerge.

“We’ve made so much progress. This is not the time to let up,” Biden said in his address. “Just as we are emerging from a dark winter into a hopeful spring and summer is not the time to not stick with the rules.”

DeSantis’ office did not immediately respond to Insider’s request for comment.

Read the original article on Business Insider

CEO of Oak Street Health: When the pandemic finally subsides, let’s not forget to address root cause of health disparities

MIKE PYKOSZ   Oak Street Health (1)

With more than 525,000 lives lost to COVID-19, the United States is dealing with loss that was unimaginable just one year ago. This number is staggering, heartbreaking, and, unfortunately, growing so high that it can be difficult for people to remember that each life lost belonged to someone’s mother, father, daughter, son, or friend. Although nearly anyone is susceptible to catching the virus, people of color have been cruelly and disproportionately impacted this entire year.

While the pandemic is shining a light on the deeply rooted health disparities in our country, there is light at the end of the tunnel thanks to the marvel of science and medicine, and we are all excited for the day that we can put COVID behind us and return to a semblance of normalcy. When that happens, we must not lose focus on the need to deliver quality, equitable healthcare for all Americans – no matter their race or zip code and socioeconomic status.

These health disparities have existed well before COVID-19 did. More than a decade ago, I worked as a healthcare consultant in Chicago and was struck by the decades-wide gap in life expectancy between affluent, mostly white neighborhoods like the Gold Coast and poor, mostly black South-side neighborhoods just a few miles away. And this is still true today. Residents of Chicago’s Streeterville neighborhood live an average of 30 years longer than those in Englewood, just nine miles away. This challenging year has exacerbated existing issues with access and care quality; and we’ve seen it in COVID death rates, access to testing and as I write this now, the vaccine rollout.

So how do we fix the underlying issues with the healthcare system once mask mandates are rescinded and social distancing is behind us?

First, we continue to focus on building trust with underserved communities, educating people who have not traditionally had access to the healthcare system around the importance of longitudinal preventative care. In particular, people of color have historical mistrust in healthcare and therefore often wait until an acute episode has occurred before engaging with the healthcare system. However, when they are cared for by someone who takes the time to get to know them, treats them like a person and not a number, puts in the hard work to build trust, and provides culturally sensitive and unbiased quality care, health outcomes will greatly improve and the gap can start to close.

It also means that today’s healthcare providers need to roll up their sleeves and become part of the community they serve. Building partnerships with community leaders like Pastors and Alderman, and being a true pillar of a neighborhood in order to build relationships and educate patients and community members on important health issues.

Second, we continue structural changes to improve access. When the testing and vaccine sites set up in health care deserts and underserved communities are no longer needed they should be replaced with primary care centers. In Chicago, for example, there are mass vaccination sites held in neighborhoods that have been hardest hit by the pandemic, as designated by the City’s Protect Chicago Plus initiative. The effort includes partnerships with existing health care organizations along with proactive, targeted outreach by community organizations directly to community members to ensure the vaccine reaches Black and Latinx residents. This means that people who lack the resources like time or technology needed to secure a highly sought after appointment won’t be left behind. This strategy is working, and should be a playbook for cities across the country, both for vaccine distribution and for primary care when the pandemic subsides.

Third, we must focus on innovation and nimbleness to adapt to the needs of individuals and communities. Traditional fee-for-service, one-size-fits-all healthcare organizations can’t sustainably serve people in an equitable, culturally competent, and compassionate way. When the pandemic first hit, many primary care providers across the country had to shut down, or at the very least greatly restrict patient access. Value-based care organizations that are focused on outcomes rather than volume of services rendered have the ability to provide as much proactive, preventive care, and adapt as needed to keep patients healthy. These types of organizations were able to greatly ramp the care they were providing while traditional organizations were pulling back.

We are at an inflection point in our country as it relates to healthcare, but nothing we have learned this year is new information. We have an opportunity to rethink how we offer healthcare to the patients who need it most, and build a better healthcare system that is more equitable and just for all.

Read the original article on Business Insider

I’m a healthy 40-year-old who received the COVID-19 vaccine – and I’m scared to tell anyone

Vaccine
  • Covid-19 vaccine cancellation lists are luck of the draw but can be worthwhile.
  • Healthy individuals who do not yet qualify for the Covid-19 vaccine can still receive it…if they are in the right place at the right time.
  • Receiving the Covid-19 vaccine ahead of your allotted time comes with a plethora of ethical dilemmas.
  • Erin Marsh is a writer and yoga teacher from the Midwest.
  • Visit the Business section of Insider for more stories.

I am a healthy 40-year-old woman who works remotely…and I just received my first dose of the Moderna COVID-19 vaccine. I did this despite the fact that Ohio is still in Phase 1B, which means only those who are 65 years and older, have a qualifying condition, or work in a school setting are eligible for the vaccine.

When the COVID-19 vaccines first became available, I remember feeling an odd sense of relief I wouldn’t be in Phase 1 rollout – or even Phase 2. Yet as I watched friends, family, and acquaintances share their vaccine posts and videos, often with the hashtag #FauciOuchie, my fear dissipated and optimism crept in. After nearly a year of being quarantined and working from home with two young kids who are learning virtually, I finally allowed myself to believe there might be a light at the end of the tunnel.

Skipping the line? 

When my close friend Aya Khalil, an award-winning children’s author, explained what vaccine cancellation lists were, I dismissed her. After all, what were the chances I would make the cut? It felt akin to winning the lottery! 

Yet Khalil insisted and pointed out it had worked for others, and to appease her, I called my local Rite Aid Pharmacy early Saturday morning and requested to be added to their cancellation list. The pharmacy tech assured me anyone could join the list (even a healthy 40-year-old), reminded me my chances were slim, and suggested I check regularly online for cancellations.

The odds of receiving a slot were so dubious I neglected to sign up my husband as well, even though his work at hospitals increases his risk and he does not qualify as an essential worker. To my amazement, I received a call from Rite Aid the very same afternoon. I had less than an hour from the time of the call to arrive at the pharmacy in order to receive the vaccine before it was too late. I hung up in a stupor. 

I felt joy and disbelief over my good fortune. With such a tight time-frame, I was prevented from diving into the feelings of guilt and doubt I experienced below the surface of my excitement. Catapulted into action, I didn’t have the luxury of overthinking. 

The overall vaccine process was efficient and relatively painless. When I arrived, the pharmacist, who appeared flustered and overworked, thanked me for arriving quickly so the vaccine “didn’t go to waste.” I filled out some forms and took my seat. I waited with three others who had also been on the cancellation list: a UPS driver who delivered regularly to Rite Aid and had the inside scoop, a newly retired woman who had called every location to be added to their waitlists, and a quiet man around my age who paced nervously. 

Eventually, the pharmacist ushered me into the room, quickly administered the vaccine, and then asked me to wait for 15 minutes to watch for adverse reactions. Overall, the process took about an hour from start to finish. 

In chatting with the UPS driver, he claimed the first weekend of vaccine distribution had been reserved for Rite Aid staff and their families. Maybe our spots were available due to cancellations or perhaps because of employees’ unwillingness to get vaccinated; either way, we were grateful for the opportunity.

According to the pharmacist, Rite Aid had not yet been listed on the Lucas County Health Department website as a COVID-19 vaccine distribution site, so their cancellation list was small. She frankly said, “You got lucky. In another week, our cancellation list will be so long that few people will be as lucky.” Hearing this, I promptly added my husband’s name to the list. Shockingly, a week later he was called and received his first dose.  

Outside of a slightly sore arm where the vaccine was administered, I experienced zero side effects. Once the deed was completed and I had time to process, I began to question whether or not I should have received the vaccine.

A question of ethics

My brother, Chad Schoen, a 36-year-old public school substitute teacher and musician, is at an increased risk as a smoker but refuses to get the vaccine. He explains, “There are people out there who need it more than I do. Yes, I’m a smoker, but I run every day, and I’m at a much lower risk statistically than other people, and I’d rather they get it than me.” 

Recently the Centers for Disease Control and Prevention (CDC) prioritized teachers and school staff as “essential workers,” and Ohio is one of the 37 jurisdictions that moved educators to Phase 1. Reopening schools safely has been a priority for the Biden administration, and one component is vaccinating as many adults in education as possible. 

Schoen replies, “Everyone is an essential worker in my eyes, and every job is essential in its own aspect. But when it comes to being a teacher and dealing with kids, the guidelines from last week to this week are contradictory.”

Others in education don’t feel the same. Phoebe Samuel Rapp, a long-term substitute art teacher at a private all-girls high school, reveals why she received the vaccine: “I’m in school every single day and I’m constantly in contact with students, and with the hands-on nature of art, it’s challenging to stay socially distant. By getting vaccinated, even as a healthy person, you help the overall population.”

Rapp, who was born in Egypt and moved to the United States at a young age, jokes, “My mom has a background in microbiology, and we look at vaccinations as a great alternative to death. We came from a third world country where access to this kind of thing is nothing short of a miracle. I think anyone who has the opportunity to get the vaccine is serving the community by taking it.”

Khalil also received a vaccination due to a cancellation. Mother to three little ones, she shares, “My husband is a healthcare worker who interacts directly with COVID patients, so it’s possible that he can pass it on to our family. Having that added protection [of me also being vaccinated] is reassuring. At first I was pretty hesitant when I heard about the cancellation lists, but then I read up on it. Epidemiologists say the more people who get it, the better, and…the vaccines don’t go to waste. That made me feel better about it.”

While I’m (mostly) confident in my decision to get the last-minute Moderna COVID-19 vaccine, I can’t help worrying about the judgment I will face from others and have yet to publicly share my good fortune. It’s a strange world to live in where getting a vaccine has become an ethical and exceedingly debated topic. The only thing I can do is focus on the benefits for me, my family and my community.

Erin Marsh is a writer and yoga teacher from the Midwest who enjoys looking at the world upside down and using semicolons whenever possible.

Read the original article on Business Insider

J&J’s coronavirus shot could dramatically accelerate the US vaccine rollout. Here’s your new vaccination timeline.

Johnson & Johnson coronavirus vaccine clinical trial, volunteer dosed with experimental COVID-19 vaccine
A clinical trial volunteer participates in Johnson & Johnson’s study to test a coronavirus vaccine.

A shot for every American. Political leaders and vaccine manufacturers have endeavored to meet this goal since the start of the pandemic, and it could finally become a reality this summer.

An advisory committee to the Food and Drug Administration will vote Friday on whether to recommend Johnson & Johnson’s single-dose coronavirus shot for emergency authorization. An FDA review on Wednesday showed the shot is safe and effective against COVID-19.

If J&J’s shot gets the green light as expected, it will be the third coronavirus shot to be distributed across the US. Vaccines from Pfizer and Moderna have been administered to more than 45 million Americans thus far, though fewer than 21 million Americans have gotten the full two-dose regimen. 

Pfizer and Moderna have pledged to distribute 600 million doses to the US public by the end of July – enough to fully vaccinate 300 million people. J&J, meanwhile, has said it could deliver up to 100 million doses of its vaccine by the end of June.

That means that by the summer, the US would have more than enough doses to vaccinate all 332 million-plus Americans (though shots haven’t been authorized for children under 16 yet).

Here’s a timeline of how vaccinations could ramp up in the next five months:

  • March 31: 240 million doses distributed
  • May 31: 420 million doses distributed
  • June 30: 500 million doses distributed
  • July 31: 700 million doses distributed

Pfizer’s and Moderna’s vaccines are each more than 90% effective at preventing symptomatic COVID-19, while J&J’s appears to be 66% effective at preventing moderate and severe cases. It’s difficult to compare the companies’ trials side-by-side, though, since they happened at different stages in the pandemic and in different geographic regions.

End of March: Wrapping up vaccinations for priority groups

J&J originally planned to deliver 12 million doses by the end of February. But federal officials have said that just 3 to 4 million doses would be immediately available next week, assuming the FDA authorizes the shot.

By the end of March, the company will likely have produced 20 million doses, Richard Nettles, J&J’s vice president of US medical affairs, said at a House committee hearing on Tuesday.

Jeffrey Zients, the White House coronavirus czar, called the slow pace of J&J’s manufacturing “disappointing” on Wednesday. But the government has started helping the company procure equipment and raw materials, he said, which is accelerating the pace.

Pfizer and Moderna, meanwhile, are on track to distribute a cumulative 220 million doses by March 31.

pfizer vaccine
UPS employees move a shipping container with Pfizer’s COVID-19 vaccine inside a sorting facility in Louisville, Kentucky on December 13, 2020.

At Tuesday’s hearing, Pfizer’s chief business officer, John Young, said the company intends to make 120 million doses available by the end of March (including the roughly 40 million doses shipped so far). Moderna’s president, Stephen Hoge, said the company would deliver 100 million doses (including 54 million that have gone out already) within the same time frame.

That means the US could finish vaccinating priority groups – including the elderly, essential workers, and people with high-risk medical conditions – next month. The Centers for Disease Control and Prevention estimates that these groups encompass roughly 200 million people.

End of May: The general population gets its shots 

In total, all three pharmaceutical companies are expected to deliver around 420 million doses by the end of May. Vaccinations for the general public could be in full swing by April.

Pfizer is on track to produce an additional 80 million doses by the end of May, bringing the company’s US total to 200 million. Moderna originally planned to deliver an additional 100 million doses in the US by the end of June, but now those should arrive in May.

COVID Vaccine Line
People wait in line in a Disneyland parking lot to receive COVID-19 vaccines in Anaheim, California.

Both companies are also still trying to speed up their vaccine rollouts.

Pfizer told USA TODAY it has added more production lines at its manufacturing plants, reduced the amount of time it takes to produce vaccine batches, and will soon cut down the time it takes to make DNA for the vaccines. In January, the FDA also instructed vaccinators to squeeze six doses from every vial of Pfizer’s vaccine, rather than the five that were initially authorized in December.

Hoge said Moderna is “working to enable up to 15 doses per vial in the near term,” instead of the 10 that vaccinators extract right now.

A recent report from the American Enterprise Institute, a right-leaning think tank, found that 50% of the US population could be protected from COVID-19 by mid-May if the J&J shot gets authorized. Without that third vaccine, it could take an additional two to three weeks to reach that point, the researchers said. 

End of June: All adults could have access to a shot

Nettles said J&J could deliver up to 100 million vaccine doses by June 30 (including the 20 million doses from the spring). That would bring the total coronavirus shots distributed in the US to 500 million – enough to vaccinate 300 million people, or all of the roughly 259 million adults in the US.

Federal officials still hope J&J can speed up that timeline.

“We’re working with the company to accelerate the pace and timeframe by which they deliver the full 100 million doses, which is required by contract by the end of June,” Zients said Wednesday. 

The American Enterprise Institute estimated that 75% of the US population could be protected from COVID-19 by mid- to late June, assuming that J&J’s shot gets authorized. 

vaccine healthcare workers us
A dentist receives the Moderna COVID-19 vaccine in Anaheim, California on January 8, 2020.

End of July: The US could have a surplus of doses

By the end of July, the US could have more vaccines than it’s able to distribute.

Experts don’t expect the nation’s roughly 73 million children to start getting coronavirus shots until the fall or winter – or perhaps early 2022 – because there is not yet data about the vaccines’ safety or efficacy among younger age groups. (The exception is Moderna’s shot, which is authorized for ages 16 and up.)

Both Pfizer and Moderna intend to deliver another 100 million doses each by the end of July, bringing the companies’ total doses to 300 million each. The US hasn’t purchased more than that, though it has the option to buy 200 million more doses each from J&J, Moderna, and Pfizer.

According to the American Enterprise Institute, “the addition of a third [vaccine] candidate will mean that anywhere from 22% to 33% more of the population can be vaccinated by July.”

Read the original article on Business Insider

Pfizer commits to doubling vaccine supply in response to President Biden’s call for a quicker rollout

Joe Biden vaccine
President Joe Biden receives his first dose of the coronavirus vaccine.

  • Pfizer committed to double its vaccine supply to the US government by summer, Reuters reported
  • 12.7% of Americans have received one or more doses of a COVID-19 vaccine, BBG data shows.
  • “We’re now on track to have enough vaccine supply for all Americans by the end of July,” Biden said.
  • Visit the Business section of Insider for more stories.

On Friday, President Joe Biden secured a commitment from US pharmaceutical company Pfizer to double its COVID-19 vaccine supply to the nation, Reuters reported.

Biden has set a target to fill the country’s vaccine stockpile by summer, a situation that Pfizer may have just made a reality.

Pfizer’s chief executive, Albert Bourla, announced that he expects to more than double the approximately 5 million doses per week that the company provides to the US government. Per Reuters, he made the comments when the president visited one of its biggest manufacturing facilities.

Around 2.7% of the US population has already received one or more shots of a COVID-19 vaccine, according to Bloomberg data.

“We’re now on track to have enough vaccine supply for all Americans by the end of July,” Biden said previously, according to CNN. “That doesn’t mean it’ll be in all Americans’ arms, but enough vaccine will be available,” he added.

The increase in supply has been made possible due to improvements in the manufacturing processes and better lab testing methods, Bourla said, according to the Reuters report. Biden’s invocation of the US’s Defense Production Act has also sped up the process, he added.

By the end of the year, Pfizer said it will add manufacturing capacity in Michigan, raw material production capacity both in Michigan and Connecticut, per Reuters. It will increase the production lines that put the vaccine into vials in Kansas, the report said. The company has also engaged two US contract manufacturers to help produce the shots.

“I can’t give you a date when this crisis will end,” Biden said. “But I can tell you: we’re doing everything possible to have that day come sooner rather than later.”

Read the original article on Business Insider