Europe and Canada are facing temporary hits to coronavirus vaccine supply while Pfizer renovates a Belgian plant to eventually produce more doses

pfizer vaccine
  • The pharmaceutical giant Pfizer is renovating a key manufacturing plant for its coronavirus vaccine in Puurs, Belgium.
  • This will delay shipments to Europe and Canada in late-January and early February.
  • Pfizer is still aiming to produce 2 billion doses in 2021. Mass-production a key challenge facing the world’s vaccination campaign.
  • Visit Business Insider’s homepage for more stories.

European countries and Canada will receive fewer doses of Pfizer’s coronavirus vaccine than planned in the weeks ahead, an unexpected cut as Pfizer is renovating a critical manufacturing plant to eventually boost production.

The disruption will happen in late January and early February, a Pfizer spokesperson told Insider. The global pharmaceutical giant is still aiming to produce 2 billion doses in 2021, and the work won’t impact US supply, which comes from a facility in Kalamazoo, Michigan. 

Read more: What’s coming next for COVID-19 vaccines? Here’s the latest on 11 leading programs.

Earlier this month, Pfizer boosted its 2021 supply projection from 1.3 billion to 2 billion doses. The company’s vaccine, developed alongside the German biotech BioNTech, was OK’d for emergency use in the US in December

“To do this, Pfizer is scaling up manufacturing operations to increase dose availability and output,” the company spokesperson said in a statement.

Changes to the production process at Pfizer’s facility in Puurs, Belgium, will need regulatory signoffs, which ultimately will delay shipments over the next month. But the spokesperson said the changes “will provide a significant increase in doses available for patients in late February and March.” 

The Puurs plant produces vaccine for all countries outside the US, Bloomberg reported

Mass-manufacturing is a critical challenge facing the world’s vaccination campaign

While much attention has been paid to a slow and chaotic start to the US campaign to immunize people, mass-production is another unprecedented challenge facing the world in the race to immunize billions of people.

Manufacturing issues have cropped up for pharmaceutical companies producing both COVID-19 vaccines and therapeutics.  

Problems with some raw materials led Pfizer to cut its 2020 vaccine production plans in half in November, The Wall Street Journal reported.

AstraZenecaNovavax, and Eli Lilly have all faced manufacturing stumbles in COVID-19 vaccine and therapeutic programs.

Some of AstraZeneca and University of Oxford’s clinical testing for its vaccine was thrown off by manufacturing difficulties, resulting in a half-strength dose being tried in some volunteers. Novavax’s late-stage study in the US was delayed by about a month as it worked through some manufacturing issues with its vaccine based on an engineered protein. And a key Lilly facility producing its antibody drug has been flagged by US regulators for quality-control problems.  

Moderna, the other drug company with a COVID-19 vaccine authorized in the US, is aiming to produce 600 million to 1 billion doses in 2021.

Both Pfizer’s and Moderna’s shots are messenger RNA vaccines, a new technology platform that has never before yielded an authorized medicine.

“I think the biggest risk is this is new commercial technology,” Ian Leavesley, an expert in pharmaceutical manufacturing processes, told Business Insider in an email. “Any new technology, in any field, has a finite risk of unforeseeable risks cropping up. I believe experience is the most valuable tool in rapidly addressing this risk.”

Read more:Moderna’s ambitions of pumping out up to 1 billion doses of a coronavirus vaccine rest on a former Polaroid factory that’s never produced an approved drug

Read the original article on Business Insider

Israel, already leading the world in rolling out the COVID-19 vaccines, aims to immunize entire country by the end of March

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Israeli Prime Minister Minister Benjamin Netanyahu receives a coronavirus vaccine at Sheba Medical Center in Ramat Gan, Israel on Saturday, Dec. 19, 2020.

  • Israel expects to have immunized all its citizens who are 16-years-old and up by the end of March. 
  • That timeline would likely make Israel the world’s first country to immunize the vast majority of its population from the pandemic. 
  • Israel has far outpaced the rest of the world with its vaccination campaign, already having given a first dose of a COVID-19 vaccine to about one in five citizens.
  • Visit Business Insider’s homepage for more stories.

Israel expects to administer COVID-19 vaccines to all of its citizens aged 16-years and up by the end of March, putting the Middle Eastern country on pace to become the world’s first nation to immunize its population against the coronavirus. 

“We would bring shipment after shipment and complete the vaccination of the over-16 population is Israel during March,” Prime Minister Benjamin Netanyahu said Sunday in a statement, welcoming a new shipment of doses from the pharmaceutical giant Pfizer.

Read more: What’s coming next for COVID-19 vaccines? Here’s the latest on 11 leading programs.

While many countries around the globe have yet to even launch vaccination campaigns, Israel has jumped out as the world’s leader. Last week, Netanyahu announced a supply deal with Pfizer to secure enough doses to immunize its adult population by the end of March. Already, nearly one in five Israelis have received a first dose.

“We will be the first country in the world to emerge from the coronavirus,” Netanyahu declared, dubbing the country’s vaccination campaign Operation Getting Back To Life. 

As of January 10, Israel has administered 18.7 doses per 100 people, the highest per-capita rate for any country by a large margin, according to Bloomberg’s vaccination tracker. By comparison, the US has administered 2.4 doses per 100 people, falling far short of the goal of immunizing 20 million people by the end of 2020. 

Israel’s vaccination campaign has also been aided by the country’s small population – less than 9 million – and compact geographic footprint. Experts have also pointed to Israel’s centralized public healthcare system as an asset in its efficient vaccination campaign, Business Insider’s Susie Neilson reported

For now, the country has limited vaccinations to people 60 years of age and older, as well as healthcare workers and people at high risk of severe illness. More than 72% of that group has been immunized, the prime minister said.

Read the original article on Business Insider

Haven, the Amazon-JPMorgan-Berkshire Hathaway healthcare venture, is disbanding after 3 years of struggling to fix healthcare

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Haven is shutting down.

The company told employees on Monday that it will disband by the end of next month, CBNC reported

“In the past three years, Haven explored a wide range of healthcare solutions, as well as piloted new ways to make primary care easier to access, insurance benefits simpler to understand and easier to use, and prescription drugs more affordable,” Haven said in a statement on its website.

Haven began in 2018, when Amazon, JPMorgan, and Berkshire Hathaway got together to solve the rising cost of healthcare in the US. At the time of its announcement, Warren Buffet memorably said that the ballooning costs of healthcare act as a “hungry tapeworm” on the economy. 

Haven was supposed to use the combined companies’ resources to get costs under control and improve care for the member companies’ employee populations, but it struggled to find an identity.

It began by tackling primary care pilots that it couldn’t market widely to employees in an effort to maintain secrecy, The Information’s Paris Martineau reported in July.

The pilot connected employees to primary care teams, similar to Amazon’s app and service Amazon Care. Amazon Care, as Business Insider reported, was underway at the tech giant before Haven got started. 

Haven lost financial backing, The Information reported, as well as key leaders like Dr. Atul Gawande, the former CEO. Tensions escalated between Haven and the founding companies as the upstart struggled to come up with ideas quickly, and Amazon in particular has been the most reluctant to make commitments to Haven, according to The Information and a person close to Amazon.

“Haven will end its operations at the end of February,” Brooke Thurston, a spokesperson for Haven, told Business Insider in an email.

The three founding companies will continue to work together informally to design new healthcare programs meant for the specific needs of their own employee populations, Thurston said. 

Read the original article on Business Insider

35 healthcare startups that are set to take off, according to top VCs

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After 2020, healthcare startups will never be the same. 

Amid a pandemic, venture funding for startups hit a record, billion-dollar deals were struck, and companies braved the public markets for the first time.

With all eyes on the industry heading into 2021, Business Insider’s healthcare team interviewed 26 healthcare investors to learn which startups are poised to take off this year.

We asked the investors to name companies from their firms’ portfolios, and ones they haven’t invested in. We noted when investors have stakes in the companies they nominated. 

For some, that meant identifying startups that have seen their businesses take off amid the pandemic, like Everlywell, and others that have had to adapt as more care moved online, like Cityblock Health. Others still picked startups finding new ways to tackle conditions like ADHD, as Akili Interactive is doing with its FDA-approved video game. 

Subscribe to Business Insider to read the full story:

Meet the 35 healthcare startups VCs say will take off in 2021

Read the original article on Business Insider

Here are Business Insider’s biggest healthcare stories of 2020

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Hello,

Dear readers, somehow, we’ve made it to the final day of 2020. How are you feeling? I’m awash with emotion reflecting on this roller coaster of a year. It’s a year that’s brought so much joy and sorrow – professionally and personally – for so many. 

As we head in to 2021, the healthcare team here at Business Insider is here to guide you through all of the happenings in the industry. But before we do, I wanted to reflect on some of the stories I’m most proud of from our team, which has grown so much since the first week of January when Zach Tracer and I were a team of two blogging away about healthcare.

This year, I’m grateful for smart analysis, reporting that broke news, and – most especially – a team big enough for a few five-reporter bylines. 

Here are some of the stories we’re most proud of from the year – arranged chronologically for a reminder of just how much has transpired in the past year

With that, I hope you all have a Happy New Year! See you in 2021. 

– Lydia

Read the original article on Business Insider

Only 2.8 million Americans have received COVID-19 vaccines, far short of the Trump administration’s goal to reach 20 million by year’s end

Trump vaccine Operation Warp Speed
President Donald Trump speaks during an “Operation Warp Speed Vaccine Summit” on the White House complex, Tuesday, Dec. 8, 2020, in Washington.

  • The US is nowhere close to meeting the Trump administration’s goal of vaccinating 20 million people by the end of 2020.
  • In the absence of clear federal guidance, the vaccine rollout has devolved into a patchwork response that varies by state, experts say.
  • Many health departments are struggling to vaccinate people as coronavirus cases soar in most parts of the country.
  • Early distribution challenges also raise questions about the ability to speedily vaccinate the general population in 2021.
  • For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.

The US is nowhere close to meeting its coronavirus vaccination goal for the end of 2020, raising concerns about how long it will take to immunize a vast majority of the American public and curb the pandemic.

Operation Warp Speed, the Trump administration’s coronavirus vaccine initiative, predicted 20 million Americans would get a coronavirus shot by year’s end. Just less than 2.8 million people have received their first injections as of Wednesday morning, according to the US Centers for Disease Control and Prevention, and the US has shipped out about 12.4 million doses. 

On a call with reporters on Wednesday, Warp Speed officials acknowledged that the rollout was running behind schedule. Just an hour before the CDC provided updated vaccine data, Warp Speed officials said they didn’t know how many shots had been given to date, but acknowledged that the number was short of their goal.

“We agree that number is lower than we hoped for,” Moncef Slaoui, Warp Speed’s chief scientific advisor, said on the press call.

The slow vaccine rollout risks delaying an end to the pandemic, and calls into question the timelines top government officials have offered up. They’ve said shots could be available to most adults who want them in the Spring.

At the current pace of vaccinations, it would take years for the US to immunize enough people to end the pandemic, Dr. Leana Wen, former Baltimore health commissioner, said Monday on CNN.

“For us to reach 80% herd immunity through vaccination, it will take us 10 years at a rate of 1 million vaccines a week,” she said. “Or, put in a different way, if we want to get there within six months, we have to be doing 3.5 million vaccinations a day, not 1 million a week.” 

Dr. Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, told reporters on Wednesday that she expects the pace of vaccinations to increase after the holidays. She said some places planned for a “more measured” start to their vaccine campaigns before ramping up.

“I really expect that those numbers are going to increase fast next week,” she said on a call with reporters.

The US Defense Department and Gen. Gustave Perna are leading Warp Speed’s distribution plan, and states are ultimately responsible for administering the shots and deciding who gets them.

Read more: How the pharma giant Pfizer teamed up with a little-known biotech to develop the first authorized coronavirus vaccine in record time

‘We’re playing a lot of catch-up’

In the absence of clear federal guidance, the vaccine rollout has devolved into a patchwork response that varies by state, said Dr. Marissa Levine, a public-health professor at the University of South Florida, told Business Insider.

Local health officials have been tasked with coordinating vaccination timelines while caring for sick patients. Many health departments lack the funding to hire enough staff to administer doses in large waves. Others lack the expertise to seamlessly transfer thousands of doses from local warehouses to the arms of individuals – what experts call the “last-mile” challenge.

Read more: Primary-care clinics hope to play a big role in vaccinating Americans, but some don’t know when they’ll receive coronavirus shots. 3 major chains lay out how they’re preparing despite little information.

“A plan that took the nation as a whole into consideration probably would have been a more effective way to approach it,” Josh Michaud, associate director of global health policy at the nonprofit Kaiser Family Foundation, told Business Insider.

Deferring to local authorities has defined other aspects of the US pandemic response, including ramping up testing and scrambling to secure personal protective equipment. With vaccines, however, the US has had almost a year to prepare. 

“It seems like we’re playing a lot of catch-up, and a lot more prep work could have been done earlier on to address the many things that are leading to our patchwork rollout right now,” Michaud said.

Vaccine rollout was never going to be easy

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A worker finishes packing doses of the Moderna COVID-19 vaccine into a cooler box at McKesson’s Olive Branch, Mississippi, distribution center.

The process of delivering shots to healthcare workers and long-term care facility residents – among the first in line to be vaccinated in the US – wasn’t likely to happen overnight.

Before any shipments went out, the US Food and Drug Administration took two days to assess each one for quality control, CNN reported. Then came the delicate labyrinth of unpacking each box, taking inventory of the vaccine, and preparing each dose for injection. In Pfizer’s case, the vials must be stored at ultra-cold temperatures, then thawed and diluted.

That has posed a particular challenge for reaching healthcare workers at small, rural providers. Some states like Minnesota, Wisconsin, and Michigan only started to immunize nursing home residents this week.

But public-health experts say the lagging vaccine timeline wasn’t inevitable.

Levine said each state must demonstrate preparedness for public-health emergencies as part of a yearly CDC grant distributed to health departments. 

“Every state has already planned for this,” she said. “The question is how have they adjusted it for the specifics of COVID and these first couple of weeks and months where you have limited a vaccine are the biggest test.”

If states had been given more funding or guidance early on, Levine added, they may have had an easier time preparing for a vaccine rollout. As it stands, several health authorities made questionable choices during the first few weeks of vaccine distribution.

Health officials in Williamson County, Texas, for instance, closed their offices for Christmas without administering any of the 900 doses they had recently received, the Texas Tribune’s Shawn Mulcahy reported.

Some senior citizens in Lee County, Florida waited in line overnight to get access to the shot in a first-come, first-served system, wrote USA Today reporters Elizabeth Weise and Michael Braun, describing the rollout in Florida as “chaotic.”

Several healthcare workers have also reported that some administrative officials are getting vaccinated ahead of those who work directly with COVID-19 patients. The vaccine rollout in Maricopa County, Arizona, was “a bit disorganized and ripe for exploitation” one local doctor told NPR, after rumors circulated that anyone with access to a certain link or phone number could get a vaccine appointment. 

“We’re seeing people kind of making up their own decisions without any ethical framework,” Levine said. “That’s a worst-case scenario, because then the people with the most power or connections are more likely to get vaccine, which is the most inequitable way to do what we need to do.”

Warp Speed’s shifting milestone

Trump Gustave Perna Warp Speed
President Donald Trump and US Army Gen. Gustave Perna during a news conference at the White House on September 18, 2020.

As recently as early December, Warp Speed leaders expressed confidence that they’d immunize 20 million Americans by the end of 2020, 30 million more in January and 50 million more in February. But the program’s early struggles and slow start raise questions about these projections.

By December 19, more than two dozen states said they would be getting 30% or 40% fewer doses of Pfizer’s COVID-19 shot than they initially planned for the following week. Perna, Warp Speed’s chief operating officer, said the miscommunication was his fault: Supply estimates he previously gave to states turned out to be incorrect.

“I failed,” Perna said at a December 19 press conference. “I am adjusting, I am fixing, and we will move forward from there.”

This isn’t the first time the US government has failed to meet its lofty, publicly-stated goals. When Warp Speed launched in May, the initiative aspired to deliver 300 million doses by the end of 2020.

Top federal officials have repeatedly scaled that number back. In August, Alex Azar, Secretary of Health and Human Services, lowered the year-end projection to “the high tens of millions of doses.”

“They appear to be overpromising and underdelivering,” Michaud said.

On Wednesday, Warp Speed’s Slaoui spoke narrowly to his confidence that future estimates will hold true on manufacturing and shipping doses, but not necessarily in administering the shots. 

“From an availability standpoint, there is no issue,” he said. “From an administration standpoint, I concur with Gen. Perna that there is a learning curve into the system, and we’re going through it.”

Things could get better in the long run

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The Moderna COVID-19 vaccine is administered on December 21, 2020 in Seattle, Washington.

Even with the slow start, the US is far ahead of all other countries in the number of administered doses, according to Bloomberg’s tracker.

Like testing data, reported vaccinations lag behind the number of immunizations that have already taken place.

Both Pfizer and Moderna are confident they can deliver hundreds of millions of doses in 2021 as manufacturing is now being ramped up. Warp Speed has already struck supply deals with each drugmaker to secure hundreds of millions of doses in 2021.

Read more: Moderna’s ambitions of pumping out up to 1 billion doses of a coronavirus vaccine rest on a former Polaroid factory that’s never produced an approved drug

“The distribution process at the national level seems to be robust,” Levine said. “Unless we have huge weather issues, with the holidays behind us, hopefully we’ll be able to work relatively seamlessly.”

Challenges at the local level could also be eased by the recently passed coronavirus relief package, which gives states about $8 billion to help with distribution. That money “would have been helpful to have six months ago, but it’s better late than never,” Michaud said. 

He added that states could use the funds to hire and train more workers, set up mass-administration sites, and design and launch communication campaigns to educate the public and listen to common concerns. 

Joe Biden, who will become president on January 20, has set a goal of giving coronavirus vaccines to 100 million people in his first 100 days in office. That’s in line with Warp Speed’s timeline, but Biden has said he’ll need more funding from Congress to hit the target.

Michaud said that vaccine distribution will get more challenging as it expands beyond the initial priority groups.

“I’m not seeing a uniformly concise and clear communication about how to get vaccine as it’s being rolled out in a more public forum outside of, say, hospital personnel,” Levine added. “People need to know how to get the vaccine, when to get the vaccine, who should get the vaccine, and then how those decisions are being made.”

Update: This story has been updated with new vaccination statistics from the CDC. It was originally published on December 30.

Read the original article on Business Insider

An emergency room doctor tested positive for COVID-19 nine days after getting vaccinated. That’s not a sign the vaccine didn’t work.

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A nurse receives the Moderna COVID-19 vaccine at Northwell Health’s Long Island Jewish Valley Stream hospital on December 21, 2020 in Valley Stream, New York.

  • Josh Mugele, an emergency room doctor in Georgia, tested positive for COVID-19 on Tuesday.
  • Mugele received his first dose of the Pfizer coronavirus vaccine nine days prior.
  • Mugele’s infection isn’t a sign that the shot didn’t work.
  • The vaccine requires two shots to be fully effective. It can also take up to a few weeks for vaccinated individuals to develop immunity, so it’s important to continue to wear masks and social distance after getting the shots.
  • “This was just dumb luck,” Mugele said. “I happened to be exposed within a few days of getting the vaccine, but this still is the best tool we have for fighting the virus.”
  • Visit Business Insider’s homepage for more stories.

Josh Mugele worked the night shift on Christmas. Though he had been tending to coronavirus patients since the start of the pandemic, his Georgia hospital was stretched to capacity like never before. There was one small comfort, though: Mugele had received the first dose of Pfizer’s coronavirus vaccine on December 20.

“I had three shifts in a row right up to the vaccine date,” Mugele, an emergency room doctor at Northeast Georgia Medical Center in Gainesville, Georgia, told Business Insider. “I was just really nervous I was going to get exposed before that. I honestly felt really a sense of relief when, on the 20th, I actually was able to get the vaccine and I thought I’d kind of crossed the finish line.”

Then on Monday, he came down with a headache and cough. The following day, he tested positive for COVID-19.

“I was scared at first, but more than anything, I think I was angry,” Mugele said. “I’ve had maximum exposure, as much as any ER doc in the country, and I’ve been spared for 10 months and then to get it right after I got the vaccine is just stupid and frustrating.”

Pfizer’s vaccine is given as two injections 21 days apart

Mugele always knew there was a chance of getting sick after his first dose.

Pfizer’s vaccine is given as two injections 21 days apart. The two-dose regimen was found to be 95% effective at preventing COVID-19, but a single dose provided a lot less protection. That’s why it’s imperative for vaccine recipients to return for a second shot.

It’s also unknown whether the vaccine prevents infection altogether, and it can take up to a few weeks post-vaccination for the body to develop immunity in the form of antibodies against the virus.

“That first eight days is really critical,” Mugele said. “People still have to be absolutely isolated. They have to wear their mask, they have to wash their hands, they have to avoid going out before they get the benefit of the vaccine.”

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Hoag Hospital in Newport Beach, California administers its first doses of the Pfizer-BioNTech COVID-19 vaccine on December 17, 2020.

‘This was just dumb luck’

Mugele said he still plans on getting his second dose on January 12, assuming he has been asymptomatic for about a week beforehand. He also stressed that his infection wasn’t a sign of anything wrong with the vaccine.

“This was just dumb luck,” he said. “I happened to be exposed within a few days of getting the vaccine, but this still is the best tool we have for fighting the virus.”

As an emergency room doctor, Mugele also had a higher risk of infection than many Americans, especially because his hospital is filling with coronavirus patients.

“Our hospital’s pretty much like every other hospital in the country,” he said. “We have higher volumes than we’ve ever had.”

The US vaccine rollout is going slowly

Average daily hospitalizations have tripled across the US over the last two months, reaching a peak of nearly 125,000 on Tuesday. Mugele said he feels sorry that another doctor will have to cover his shift during this critical time.

“The shifts these days are really, really hard,” he said. “We’re seeing people in non-ideal conditions, like in the hallway or the waiting room, so it’s a stressful, stressful work environment. Everybody is already stretched thin.”

While vaccines are still the quickest way to halt the pandemic, the US’s immunization rollout has been painfully slow compared to what federal officials had anticipated. Earlier this month, the Trump administration predicted 20 million Americans would get a coronavirus shot by year’s end. The US has shipped out around 14 million doses so far, but only about 2.6 million people have received their first injections, the Centers for Disease Control and Prevention said Wednesday. 

“It’s really important that, until we have widespread vaccination rates in the entire country, even if you have both doses of vaccine, you still have to be careful,” Mugele. “You still have to wear your mask out in public and you still have to avoid large gatherings and you still have to wash your hands. We’re still in the thick of this thing.”

Read the original article on Business Insider

Moderna is on the cusp of getting its COVID-19 vaccine authorized

Welcome to Business Insiders daily healthcare newsletter, your daily dose of pharma, biotech, and healthcare news. Subscribe here to get this newsletter in your inbox every weekday.

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Hi,

Happy Friday! In a sign that it’s been quite a long week (two weeks, really), I’m so sorry for sending an energy-focused newsletter to you earlier this morning. 

(Though if you are interested in more energy reporting, do subscribe to Benji Jones’ newsletter Insider Energy here! More great stories and dog photos await.) 

Let’s get right into the healthcare news, then. It’s been a week of vetting Moderna’s vaccine, getting the scoop on Amazon’s latest healthcare ambitions, and seeing how vaccine distribution is playing out.


moderna covid vaccine record time 4x3

Moderna’s vaccine is teed up for an FDA green light

On the heels of the Food and Drug Administration giving Pfizer’s COVID-19 vaccine the green light late Friday night, the regulatory body spent this past week vetting Moderna’s coronavirus vaccine.

On Tuesday, the FDA released more details about how safe and effective Moderna’s shots are. 

As Andrew Dunn reports, more than nine in 10 people immunized with Moderna’s vaccine experienced some level of side effects. Most side effects were mild or moderate, though about 17% of those who received the vaccine reported severe side effects including pain, fever, and headache.

Here are the common side effects you should expect.

While Andrew was digging into the side effects, Hilary Brueck took a closer look at how well Moderna’s vaccine works.

One chart in particular in the FDA’s documents shows how effective Moderna’s vaccine is at preventing people from getting COVID-19.

Hilary and Andrew then spent part of the week taking a look at the evidence around both Pfizer and Moderna’s coronavirus vaccines. 

Here’s a comprehensive look at how the two stack up, from side effects, to what the data can/can’t tell us about the vaccines at this point. 

That culminated yesterday with a full-day meeting with the FDA advisory committee, which ultimately voted in favor of recommending Moderna’s shot (20 voted yes, while one abstained). Now all eyes are on the FDA to issue an emergency use authorization.

Andrew and Hilary were around all day giving play-by-play updates on the meeting. 

Read the full recap here>>

FDA expert panel endorses Moderna’s COVID-19 vaccine, clearing the way for regulators to green-light the shot


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Inside Amazon’s latest health ambitions

Somewhere far away from vaccine-land, Blake Dodge has been chasing the story of how Amazon is pushing deeper into healthcare, specifically with its health service Amazon Care.

Publicly unveiled in 2019, Amazon Care has been a pilot for Amazon employees in Seattle and later Washington state. Through an app, employees can get online or in-person care for basic medical concerns like fevers and coughs. 

But as Blake reported, Amazon’s ambitions go beyond its own employees. It wants to sell Amazon Care to other large companies. It’s already pitched at least one: Zillow. 

Markets took note (as they often do when more is revealed about Amazon’s healthcare plans). On Wednesday after her report, telemedicine stocks like Teladoc and Amwell took a hit

Amazon’s plans to sell Amazon Care come as Haven – the joint health venture Amazon is a part of with JPMorgan and Berkshire Hathaway – is moving away from a focus on primary care as its approach to tackle the rising costs of healthcare facing large employers. Read more about the dynamics between Haven and Amazon Care here. 

Already read Blake’s reporting on Amazon Care and want more? Tune in to hear us chat more about it. It’ll be like this newsletter, but in Zoom form (what could be better?) You can register here.

And in case you missed it on Wednesday…

Read Blake’s full scoop here>>

Amazon wants to provide medical care to workers at major companies. Here’s an inside look at Amazon Care.


Pfizer Vaccine Transport

Hospitals across the US spent the week administering Pfizer’s vaccine

With an emergency use authorization for its coronavirus vaccine under its belt, Pfizer started distributing shots to sites around the US. 

On Sunday, the world got a look at the first vaccine doses rolling out of Pfizer’s Michigan factory.

Then on Monday, New York administered its first vaccine outside of a trial to Sandra Lindsay, a nurse in Queens.

Allana Akhtar spoke to Lindsay about the experience. You can read the full Q&A here.

Meanwhile, CVS Health, one of the pharmacies that’ll play a big role in distributing vaccines beyond hospitals, is giving its workers a $250 pandemic bonus. Shelby Livingston has the scoop here. 

Shelby also spent the week seeing vaccinations take place in-person, as well as detailing the logitsical challenges of getting vaccines distributed to healthcare workers across rural areas. One (Sanford Health) has enlisted a fleet of minivans to shuttle vaccines across the Dakotas and Minnesota. 

Read the full story here>>

How one hospital system is relying on a fleet of Dodge minivans to make sure healthcare workers in remote areas can get their COVID shots


More stories you might’ve missed this week:


With that, I believe this might be the final Friday recap newsletter of 2020. I’ll be in your inbox to start the week with some more great stories from the team before signing off for a bit of cookie-baking and skiing. 

Need me in the meantime? Reach me at lramsey@businessinsider.com, or you can reach our entire team at healthcare@businessinsider.com.

– Lydia

Read the original article on Business Insider

LIVE: An FDA expert panel is meeting today to discuss Moderna’s coronavirus vaccine, likely paving the way for the 2nd authorized COVID-19 shot in the US

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  • An influential expert panel is meeting Thursday to vote on authorizing Moderna’s coronavirus vaccine. 
  • By the end of the day, the committee will vote on whether or not to recommend emergency use authorization.
  • The US Food and Drug Administration isn’t required to follow the group’s advice, but often does so. The agency could OK Moderna’s shot as soon as Thursday night or Friday, according to media reports.
  • Healthcare and science reporters Andrew Dunn and Hilary Brueck are providing live updates from the day-long meeting.
  • For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.
3:00 PM: Could Moderna’s shot provide some protection after a single dose? It’s possible, FDA says

Moderna vaccine
A nurse prepares a coronavirus vaccine shot developed by the National Institutes of Health and Moderna Inc.

Moderna’s COVID-19 vaccine trial was designed to measure how well two shots, given 28 days apart, protect people from infections. And it showed the vaccination works very well at that: it is 94% effective at preventing symptomatic COVID-19, 14 days after a second shot. 

But, it’s possible that good protection from infection starts much sooner than that. 

Preliminary trial data suggests the first dose of Moderna’s vaccine likely provides a decent measure of protection from infection all on its own.

Researchers found fewer COVID-19 cases among people who got Moderna’s shot compared to the placebo group after volunteers got their first injection, but before they got the second booster dose. That protection appeared to ramp up over time, generally kicking in a couple weeks after the initial shot. 

“This could suggest some protection after the first dose, but data is limited by the very short follow-up, around 28 days, as the majority of the study subjects received a second dose,” Dr. Rachel Zhang, an FDA medical officer said.

Overall, the single shot appeared to be about 70% effective at preventing symptomatic infections. That looks better than Pfizer’s potential one shot protection, which appeared to be about 54% effective in the 21-day period before participants in that trial got a second injection. 

Evercore ISI biotech analyst Umer Raffat also pointed out how well Moderna’s first dose might work on its own in a recent research note to investors. Data suggests the first dose was about 92% effective compared to a placebo, when looking at first COVID-19 occurrences starting two weeks after the first dose, Raffat said. 

It’s still unclear how protective one dose would be in the long run, without a second shot. But Raffat, along with a handful of thought leaders in the drug industry like Pfizer board member and former FDA head Scott Gottlieb and University of Pittsburgh researcher Walid Gellad, have advocated the potential benefits after one dose should be considered, especially given the state of the pandemic right now. 

Dr. James Hildreth, an immunologist on the committee, and an esteemed HIV researcher, also suggested that since so many people in the US have already had COVID-19, they might receive ample benefit from just one dose of Moderna’s vaccine. 

“There are probably tens of millions of Americans who’ve already been infected,” Hildreth said Thursday during the meeting. “What I’m asking is, if you took the ones who have been infected, and gave them an injection of your vaccine, could that possibly serve as a boost?”

Moderna’s Dr. Jaqueline Miller said that as more study data becomes available in the weeks and months ahead, that could be something to look into.

Operation Warp Speed is holding back half of the available doses to ensure each vaccine recipient gets their booster dose at the right time — after three weeks for Pfizer’s shot, and after four weeks for Moderna’s.

Gottlieb and Gellad have argued it would be better to distribute all the doses right away, getting a first dose to twice as many people. While this opens up a risk that there may not be enough supply for everyone to get their booster shot on time, they say this could be an acceptable risk to take during the most deadly period of the pandemic. 

2:45 PM: One panelist inquires about above-average Bell’s palsy rates, but the numbers are too small to draw conclusions

Dr. Paul Offit, a committee member and vaccine expert at the University of Pennsylvania, highlighted that both Moderna’s and Pfizer’s vaccine studies appeared to have higher rates than usual of Bell’s palsy. 

Bell’s palsy is a typically temporary condition marked by weakness or paralysis in facial muscles. FDA scientists have acknowledged more people getting the coronavirus vaccines developed this condition than those getting placebo.

But the number of cases — seven among more than 30,000 vaccinated volunteers — is too small to say if the vaccine caused these cases. Agency reviewers said the Bell’s palsy cases in the studies were in line with typical incidence rates.

Offit also said it’s important to not fall victim to “the tyranny of small numbers” and conclude a relationship just yet, saying he is pleased the agency will closely monitor these vaccines going forward.

But Offit questioned the notion that the studies had typical rates of Bell’s palsy cases. “I’m just not quite sure how we are so comfortable that this was a background rate,” he said. 

“If you look at the Pfizer trial, there were four cases of Bell’s palsy in a group of 22,000 [vaccinated people] per three months, which works out to about 8 cases per 10,000 per year,” Offit said. “If you look at the Moderna trial, it’s 3 cases for 15,000 for three months, which also works out to about 8 cases per 10,000 per year.”

Combining the two placebo groups together, Offit said those volunteers had about 1.2 cases per 10,000 per year. He said that’s roughly in line with the background rate.

FDA medical officer Dr. Rachel Zhang said the agency is looking into this. 

“There is still no clear basis upon which to conclude a causal relationship, but we definitely see your point with the two studies combined,” she said. 

She did not dispute Offit’s point that the vaccinated groups seemed to have higher-than-normal rates.

11:00 AM: Moderna pitches plan to immunize placebo volunteers without ‘jumping the line’

Moderna has a plan to offer trial volunteers who received placebo shots the actual vaccine, while side-stepping some of the key ethical concerns.

What to do with ongoing placebo-controlled trials during the pandemic has become a top conundrum facing vaccine developers like Pfizer and Moderna. On one hand, researchers want to keep following the placebo group to have high-quality, long-term data to see how these shots work. But ethicists also wonder if studies can, or should, withhold an effective vaccine from volunteers.

Moderna’s proposal is to ask participants whether or not they want to know if they got the real vaccine or a placebo. They can choose to remain blinded and in the study, or they can decide to know which arm they were in. Placebo participants who choose to become unblinded are then offered the real vaccine from clinical trial stocks, if they want it. All of those participants would be followed for long-term data.

Tal Zaks, Moderna’s chief medical officer, said this would not take doses away from priority groups. Instead, placebo recipients would get doses already produced for the sole purpose of clinical trial use that can’t be dispatched to the general public.

“None of our vaccine trial participants would be ‘jumping the line’ ahead of others, because we have clinical trial supplies available that would in fact expire and go to waste if we don’t use them,” Zaks told the panel.

Dr. Lindsey Baden, an infectious-disease expert at Brigham and Women’s Hospital, also spoke as part of Moderna’s presentation as one of the study’s investigators. 

Baden said there have been a “substantial” number of volunteers dropping out of the trial in the last week since Pfizer’s vaccine secured an emergency OK last Friday.

“This dropout undermines the data integrity and what can be learned,” Baden said. “We must be proactive to ensure that the best choice is for our participants to remain in the study.”

Giving placebo recipients the chance to be vaccinated is important, because Zaks said many of the volunteers are at higher risk of infection and also have risk factors for severe disease.

A 54-year-old man with diabetes who got placebo shots in Moderna’s trial ultimately died from COVID-19, Zaks said, highlighting the risk in not immunizing these volunteers. 

9:50 AM: FDA and CDC are investigating allergic reactions to Pfizer’s vaccine, but have no answers or recommendations yet

EpiPen allergic reaction treatment
An EpiPen can be used in an emergency to treat anaphylactic shock by injecting epinephrine through clothing.

Dr. Stanley Perlman, a University of Iowa immunologist, asked about possible explanations for allergic reactions to COVID-19 vaccines, after two healthcare workers in the UK, and then two more in Alaska, had anaphylactic reactions after receiving Pfizer’s vaccine. 

Pfizer’s vaccine ingredients don’t seem to be anything highly allergenic, and at least one of the healthcare workers had no history of allergies, leaving experts (like Perlman) puzzled as to what’s going on. 

“At this point we and CDC are continuing to investigate cases and consider data,” said Doran Fink, an FDA vaccine expert. “At this point, we don’t have enough information to make definitive recommendations one way or another, and as we continue to investigate and evaluate the data we will consider whether additional recommendations need to be made.”

9:00 AM: Panel kicks off, releasing key voting question

FDA advisory committee voting question Moderna coronavirus vaccine
The key voting question facing the FDA’s expert panel on Moderna’s coronavirus vaccine

We are off and running for a marathon meeting expected to wrap up at 5:15 p.m. 

On Tuesday, the FDA released the most detailed results yet from Moderna’s late-stage study in preparation for this meeting. The agency’s summary showed the two-dose vaccine to be overwhelmingly protective at preventing symptomatic COVID-19 with no major safety concerns.

All in all, it’s a very similar profile to Pfizer’s vaccine, which was authorized last Friday, and we compared what we know about each shot here.

It’s poised to be a long but important day. The panel’s recommendation on whether or not to OK Moderna’s vaccine is seen as the last remaining barrier to an FDA authorization decision.

Here’s the agenda for the day: 

9:00 a.m. — Introductions

9:30 a.m. — FDA deputy director Doran Fink outlines emergency use authorization

10:05 a.m. — Stanford researcher Steven Goodman discusses the possible options for ongoing placebo-controlled vaccine trials, given COVID-19 shots are now being rolled out

10:45 a.m. — Moderna chief medical officer Tal Zaks and senior vice president Jacqueline Miller present the biotech’s vaccine data

12:00 p.m. — Public comment

1:00 p.m. — Zaks and Miller answer questions from committee members

2:00 p.m. — FDA medical officer Rachel Zhang presents the agency’s perspective on the vaccine data

3:10 p.m. — Committee discusses, ultimately votes, and adjourns

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Operation Warp Speed’s co-leader says every US state will start receiving Pfizer’s coronavirus vaccine Monday morning, with immunizations starting by the end of the week

General Gustave Perna, chief operating officer for the Defense Department's Project Warp Speed, speaks during a White House Coronavirus Task Force press briefing
General Gustave Perna, chief operating officer for the Defense Department’s Project Warp Speed, speaks during a White House Coronavirus Task Force press briefing

  • The largest vaccination campaign in the history of the US has begun, with Pfizer preparing to ship the first doses out Sunday morning. 
  • Gen. Gustave Perna, chief operating officer of the federal government’s vaccine initiative Operation Warp Speed, said the first shipments should arrive in every US state on Monday morning. 
  • The US Food and Drug Administration authorized Pfizer’s two-dose vaccine for emergency use on Friday night. 
  • The first doses could start going into American arms “as early as the end of next week,” Perna told reporters at a Saturday morning press conference. 
  • For more stories like this, sign up here for Business Insider’s daily healthcare newsletter.

The first doses of a coronavirus vaccine should arrive in every US state on Monday morning, Operation Warp Speed co-leader Gen. Gustave Perna said Saturday. 

The US Food and Drug Administration authorized Pfizer’s two-dose vaccine for emergency use on Friday night, effectively launching the largest vaccination campaign in US history. 

Perna, a four-star general, stands at the forefront of the mammoth logistical challenge to immunize a nation of 328 million. He likened the challenge to D-Day, a crucial turning point in World War II that sparked the liberation fo German-occupied France.

“D-Day was the beginning of the end, and that’s where we are today,” Perna said at a Saturday morning news conference.

But the end remains in the distant future, with the worst days of the pandemic likely still ahead. Infections, hospitalizations, and deaths have all surged over the past two months, routinely setting new record highs. On Friday, the US recorded 2,951 deaths and 280,514 new cases.

“We are not taking a victory lap,” Perna said. “We know that the road ahead of us will be tough. We know that situations will occur, but we will figure it out together collectively.”

Sites will receive doses starting Monday

The first shipments are expected to leave Pfizer’s manufacturing plant in Kalamazoo, Michigan, on Sunday morning. Perna said he expects 145 sites – encompassing every US state – to receive doses on Monday. 

Perna said 425 more sites should receive shipments on Tuesday, and the final 66 sites will get the vaccine on Wednesday. That will complete an initial shipment of 2.9 million doses of Pfizer’s shot, with Warp Speed holding back another 2.9 million doses to ensure each immunized person can get a second booster dose 21 days later.

From there, local officials from states, counties, and cities will take the lead. Perna said vaccines could be going into people’s arms “as early as the end of next week.” 

States will determine how to prioritize the initial vaccine doses

States are making their own decisions on how they wish to prioritize the limited supply. An advisory panel for the Centers for Disease Control and Prevention has recommended that frontline healthcare workers and nursing home residents be placed at the front of the line.

Perna said Saturday he has talked to many states that plan to start vaccinating those two populations simultaneously to start.

Overall, Warp Speed is expecting to soon start shipping doses of another vaccine developed by Moderna. The FDA’s expert panel will debate Moderna’s emergency use authorization application next Thursday, likely setting up agency scientists to make an equally speedy review decision.

Based on supply estimates from Pfizer and Moderna, Warp Speed projects that 20 million Americans will begin to be immunized in December, 30 million more in January, and 50 million more in February. 

“We are not done until every American has access to this vaccine, until every American that wants it, receives it,” Perna said. “This is our only goal.”

Read the original article on Business Insider