IMF says $50 billion is needed to end Covid pandemic in 2022

A vial with the Pfizer Biontech vaccine.

Enlarge / A vial with the Pfizer Biontech vaccine. (credit: Thomas Lohnes | Getty Images)

The world could “end the pandemic” in mid-2022 by vaccinating 60 percent of the population at a cost of $50 billion, the IMF has said, as rich countries and vaccine manufacturers pledged to address the inequality undermining the global response to coronavirus.

Countries with sufficient vaccine supplies could afford to donate 1 billion doses in 2021, even while continuing to prioritise the immunisation of their own populations against Covid-19, the IMF said in its report released at a virtual G20 Health Summit on Friday.

Combined with upfront financing, the vaccine donations would bring a faster end to the pandemic, saving millions of lives and yielding economic benefits of about $9tn to global gross domestic product by 2025, it estimated.

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#covid-19, #healthcare, #imf, #mrna, #pandemic, #policy, #science, #vaccination

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COVID-19 vaccinations are sparking 14% more matches on OkCupid

OkCupid will soon offer vaccination badges.

Enlarge / OkCupid will soon offer vaccination badges. (credit: OkCupid)

Money can’t buy happiness, as the cliché goes. But a vaccination could get you money and happiness.

While governors in various states are offering a chance at cash prizes to those who have gotten their COVID-19 shots, dating apps are heating things up with alluring vaccination-related features like badges, super swipes, and other “premium” perks.

In a blog post Thursday, OkCupid announced that it will release “I’m Vaccinated” profile badges starting on May 24, and anyone who applies the badge in the first 48 hours will get a free “Boost.” OkCupid will also hook up unvaccinated users with resources to get a shot.

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#andy-slavitt, #covid-19, #dating-apps, #okcupid, #science, #tinder, #vaccination

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White House teams up with dating apps to give vaccinated users free perks

With vaccination rates slowing in the U.S., the White House is getting creative about getting shots in arms. Beyond protecting yourself and others from from a deadly disease, the latest incentive to get vaccinated could help you find love (or get laid).

The White House COVID-19 response team announced Friday that a number of popular dating apps would offer new perks for users who get vaccinated, with Tinder, Bumble, Hinge, Match, OkCupid, BLK, Chispa, Plenty of Fish and Badoo all participating in the promotional push. The White House hopes to make inroads with the 50 million users across those dating apps where they’re already spending time.

On Tinder, anyone who adds a sticker to their profile promoting their vaccination status between June 2 and July 4 will be gifted a free Super Like. (Proof of vaccination isn’t necessary, but really, you should get vaccinated if it’s available where you live.) Tinder and other apps will also add vaccination site resources from Vaccine.gov to help people figure out where they can get the shot nearby.

“Nothing like fireworks to signal a new spark and a new start for those looking to meet new people IRL this summer,” Tinder CEO Jim Lanzone said.

According to OkCupid, getting vaccinated might help with that. The company found that people who displayed their vaccination status were 14 percent more likely to find a match. On OkCupid, vaccinated users will get a free boost, a perk that promotes their profile to potential matches. The other apps participating in the White House initiative are handing out their own premium perks to give users a competitive edge.

The effort is part of a push by the White House to get 70 percent of adults vaccinated by the Fourth of July. To reach more Americans, the Biden administration has also coordinated with popular entertainment companies like NASCAR and country music channel CMT to promote vaccination.

“Social distancing and dating were always a bit of a challenging combination,” White House Senior COVID Advisor Andy Slavitt said during a press event Friday. He characterized the vaccine push through dating apps as those companies “responding to the president’s call to action” rather than calling it an official partnership.

“We have finally found the one thing that makes use all more attractive,” Slavitt said. “A vaccination.”

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Ohio’s 53% vaccination surge tied to $1M lottery; NY and MD announce lotteries

Maryland Governor Larry Hogan stands next to a person dressed as a lottery ball during a press conference on May 20 announcing the state's VaxCash promotion.

Enlarge / Maryland Governor Larry Hogan stands next to a person dressed as a lottery ball during a press conference on May 20 announcing the state’s VaxCash promotion. (credit: Patrick Siebert)

The governors of New York and Maryland on Thursday each announced big cash lotteries to entice their residents to get vaccinated against COVID-19. The announcements came as westward-neighbor Ohio celebrated the success of its “Vax-a-Million” lottery campaign, which helped boost week-to-week vaccination numbers 53 percent.

The lotteries appear to be part of a growing trend of states and officials offering cash prizes or other incentives to combat slumping vaccination rates. The country’s seven-day average for daily vaccinations has dropped to around 1.8 million, down from a peak of nearly 3.4 million in mid-April.

In a White House COVID-19 press briefing Friday, Senior White House Advisor Andy Slavitt said that, based on the data the administration has seen, the lotteries “appear to be working.”

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CDC defends its abrupt reversal on masks after backlash from experts

A woman adjusts her face mask while sitting in front of a microphone.

Enlarge / Rochelle Walensky, director of the US Centers for Disease Control and Prevention (CDC), adjusts her protective mask during a Senate Health, Education, Labor, and Pensions Committee hearing in Washington, DC. (credit: Getty | Bloomberg)

Criticism and confusion have erupted following the Centers for Disease Control and Prevention’s abrupt recommendation last Thursday that fully vaccinated people can immediately shed masks in most settings. The agency is yet again on the defense over its mask guidance.

Mask usage has been one of the most contentious issues throughout the pandemic—and that seems unlikely to change anytime soon. Just last Tuesday, CDC Director Rochelle Walensky faced a grilling from Senate Republicans, who suggested that the agency was being too slow and too conservative in its health guidance, particularly on the issue of outdoor mask use.

At the time, the agency recommended that fully vaccinated people should continue to wear masks in many uncrowded indoor settings as well as in crowded outdoor settings. “We will continue to recommend this until widespread vaccination is achieved,” Walensky said in an April 27 briefing. On that day, around 29 percent of the US population was fully vaccinated.

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At 38.5% vaccinated, US may be running low on people eager for a shot

Residents wear protective masks while waiting to be vaccinated at a West Virginia United Health System Covid-19 vaccine clinic in Morgantown, West Virginia, U.S., on Thursday, March 11, 2021.

Enlarge / Residents wear protective masks while waiting to be vaccinated at a West Virginia United Health System Covid-19 vaccine clinic in Morgantown, West Virginia, U.S., on Thursday, March 11, 2021. (credit: Getty | Bloomberg)

The US logged another 4 million or so vaccinations Friday, bringing the total doses administered in the country over 200 million at the time of writing. Over 127 million adults—38.5 percent of the US population—have received at least one shot. Over 80 million adults—24 percent of the US population—are now fully vaccinated.

The seven-day rolling average of US vaccinations per day is now around 3.35 million and the Biden administration is on track to make its latest goal of 200 million vaccinations within the first 100 days in office.

Even with a current pause in use of Johnson & Johnson’s vaccine, Biden officials expect availability of vaccine to remain strong.

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Facebook launches profile frames that help you encourage friends to get the Covid-19 vaccine

As Covid-19 vaccines are becoming more readily available to larger groups of the U.S. population, Facebook has teamed up with the U.S. Department of Health and Human Services (HHS) and Centers for Disease Control and Prevention (CDC) to launch new Facebook profile frames that allow users to share their support for getting vaccinated with their family and friends. The effort follows a similar launch in the U.K. through a partnership with National Health Services (NHS), which has already resulted in a quarter of Facebook users in the U.K. having seen a Facebook friend with the profile frame.

At launch, users in the U.S. can pick between frames which include banners that say either “Let’s Get Vaccinated” or “I Got My Covid-19 Vaccine” in English or Spanish. The banner will appear overlaid on the edge of their profile picture next to a blue bubble that reads “We Can Do This.”

Although there were already a variety of vaccine-promoting profile frames to choose from on Facebook, these were all third-party efforts until now. The new frames were created, in part, by Facebook, which will allow the company to better track their usage over time.

Image Credits: Facebook

In the weeks ahead, Facebook says it will show people a summary in their News Feed of all your friends, family members and people you follow who are using the new Covid-19 vaccine profile frames. For that reason, adopting the first-party frames will be important, if you want to be a part of that list that’s shown to others.

Facebook notes that it’s launching the frames because research shows how social norms can have a major impact on people’s attitude and behavior when it comes to their health — a notable assertition, given that the company wants otherwise downplay the power its network has when it comes to the spread of disinformation or anti-vax sentiments.

For this effort, Facebook believes, and the research supports, that when people see others who they know and trust getting the vaccine, and they’ll be encouraged to do the same. This can be particularly effective when it comes to encouraging those who were otherwise unsure about getting the vaccine.

Leveraging social media to encourage vaccinations has been part of the CDC’s toolkit as well, which is why you likely saw several photos from healthcare workers and essentials workers sharing their vaccination photos and talking about their experience. The CDC had also provided a sets of sample social media graphics and messages that could be used by organizations that wanted to promote vaccinations across Facebook, Twitter and LinkedIn.

The new profile frames are rolling out starting today to Facebook users in the U.S.

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Vaccine FOMO is real. Here’s how to deal with it

Vaccine FOMO is real. Here’s how to deal with it

Enlarge (credit: Michael Ciaglo | Getty Images)

It’s late on a Tuesday night, and you’re running through your usual routine. You go through your social media, blocking everyone who has posted an ecstatic shot selfie. You check, and double-check, your state’s eligibility requirements. Maybe you monitor your state’s daily vaccine counts; maybe you have the page bookmarked.

If this describes you, you may have the symptoms of vaccine envy. This condition is characterized by jealousy, anger, or frustration at the fact that so many people—but not you!—have already received lifesaving protection from Covid-19. Yes, President Biden has announced that all Americans will be eligible for the vaccine by May 1. But after a year, waiting these last few weeks or months seems like the hardest of all.

Being stressed out is a normal response. Psychologists call this “painful uncertainty.” It’s a uniquely aggravating condition associated with life-changing situations where you have no control over the outcome. It’s also pretty common, as anyone who has waited for a positive pregnancy test or a call back from a job interview can tell you.

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Experts sound alarm of possible new COVID surge as US cases once again rise

A health advisory sign on a beach in Florida.

Enlarge / A health advisory sign on a beach in Florida. (credit: Getty | Jeff Greenberg)

In mid-January, US cases of COVID-19 were in a nosedive from a towering record of over 315,000 new cases in a single day earlier in the month. And now, the pace of vaccinations has reached a heartening clip of 2.5 million per day. There’s almost a whiff of freedom from our pandemic confines in the sweet spring breeze.

But as anxious as we all are to return to normal life, the pandemic is not yet done with us.

The dramatic decline in cases ended weeks ago and plateaued at a disturbingly high level, matching daily case numbers seen in mid-October, at the base of the winter surge. Meanwhile, more transmissible variants of the pandemic coronavirus are swirling around the country. The B.1.1.7 variant—estimated to be around 50 percent more transmissible than earlier versions of the virus—is expected to become the predominant virus circulating in the US next month.

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Apple Maps updated with Covid-19 vaccination locations in the U.S.

Google earlier this year announced an update to Google Maps to help people find Covid-19 vaccination sites nearby, and now Apple is doing the same. Apple device owners can either ask Siri or search within Apple Maps to find nearby Covid-19 vaccine providers within the U.S., the company says. These results will include key information, like operating hours, addresses, phone numbers and links to the provider’s website.

To access this information through a voice command, users can ask Siri something like “where can I get a Covid vaccination?,” which will direct them to Maps.

In addition to Siri or searching directly within Apple Maps for vaccine info, the option “Covid-19 vaccinations” will also be available in Apple Maps’ “Find Nearby” menu.

Apple says its vaccination location data is being sourced from VaccineFinder, an initiative led by Boston Children’s Hospital. This data has also been helping to power Google Maps’ vaccine finding capabilities, Google earlier said. Apple notes that healthcare providers, labs and other businesses can also choose submit their information about either Covid-19 testing or vaccination locations via the Apple Business Register page. After doing so, Apple will validate the information and then display it to users who are searching for Covid-19 resources in their local area.

At launch, there’s information about over 20,000 vaccine locations being provided through Apple Maps. Apple says more sites will be added in the weeks to come.

Throughout the pandemic, Apple has integrated other Covid-related health resources into Apple Maps both in the U.S. and internationally. Last year, for example, it updated Apple Maps to display Covid-19 testing sites in Australia, Canada, France, Germany, Japan, the Netherlands, New Zealand, Portugal, Singapore, Taiwan, Thailand, and the U.S. It also added Covid-19 modules to business pages, and updated Siri with more knowledge about Covid-19, testing sites, and, now, vaccination locations.


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“Shameful and inhumane”: DeSantis threatens to withhold vaccine amid criticism

Florida Gov. Ron DeSantis speaks during a press conference about the opening of a COVID-19 vaccination site at the Hard Rock Stadium on January 06, 2021, in Miami Gardens, Florida.

Enlarge / Florida Gov. Ron DeSantis speaks during a press conference about the opening of a COVID-19 vaccination site at the Hard Rock Stadium on January 06, 2021, in Miami Gardens, Florida. (credit: Getty | Joe Raedle)

As large swaths of the country face snags in COVID-19 vaccine distribution due to crippling snow and ice, some communities in Florida may face snags due to political windstorms from their governor, Ron DeSantis.

DeSantis was criticized this week after the state unveiled plans to open a “pop-up” clinic near Tampa that would offer vaccine doses only to residents in affluent, mostly white, mostly Republican areas of Manatee County. The clinic will vaccinate 3,000 residents of just two ZIP codes in the county, which were reportedly hand-selected by DeSantis and County Commissioner Vanessa Baugh—instead of being selected using the Sunshine State’s vaccine lottery system.

Plans for the clinic were born from a deal struck between DeSantis, Baugh, and real estate developer Rex Jensen, according to the Bradenton Herald. DeSantis reportedly reached out to Jenson, who agreed to host the clinic on his development, Lakewood Ranch. The master-planned community covers much of the two selected ZIP codes served by the clinic. The ZIP codes also overlap with Baugh’s district.

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TikTok parent ByteDance joins patent troll protection group LOT Network

LOT Network, the non-profit that helps businesses of all sizes and across industries defend themselves against patent trolls by creating a shared pool of patents to immunize themselves against them, today announced that TikTik parent ByteDance is joining its group.

ByteDance has acquired its fair share of patents in recent years and is itself embroiled in a patent fight with its rival Triller. That’s not what joining the LOT Network is about, though. ByteDance is joining a group of companies here that includes the likes of IBM, the Coca-Cola Company, Cisco, Lyft, Microsoft, Oracle, Target, Tencent, Tesla, VW, Ford, Waymo, Xiaomi and Zelle. In total, the group now has over 1,300 members.

As LOT CEO Ken Seddon told me, the six-year-old group had a record year in 2020, with 574 companies joining it and bringing its set of immunized patents to over 3 million, including 14% of all patents issued in the U.S.

Among the core features of LOT, which only charges members who make more than $25 million in annual revenue, is that its members aren’t losing control over the patents they add to the pool. They can still buy and trade them as before, but if they decide to sell to what the industry calls a ‘patent assertion entity,’ (PAE) that is, a patent troll, they automatically provide a free licence to that patent to every other member of the group. This essentially turns LOT into what Seddon calls a ‘flu shot ‘ against patent trolls (and one that’s free for startups).

“The conclusion that people are waking up to is, is that we’re basically like a herd, we’re herd immunization, effectively,” Seddon said. “And every time a company joins, people realize that the community of non-members shrinks by one. It’s like those that don’t have the vaccination shrinks — and they are, ‘wait a minute, that makes me a higher risk of getting sued. I’m a bigger target.’ And they’re like, ‘wait a minute, I don’t want to be the target.’”

ByteDance, he argues, is a good example for a company that can profit from membership in LOT. While you may think of patents as purely a sign of a company’s innovativeness, for corporate lawyers, they are also highly effective defense tools (that can be used aggressively as well, if needed). But it can take a small company years to build up a patent portfolio. But a fast-growing, successful company also becomes an obvious target for patent trolls.

“When you are a successful company, you naturally become a target,” Seddon said. “People become jealous and they become threatened by you. And they covet your money and your revenue and your success. One of the ways that companies can defend themselves and protect their innovation is through patents. Some companies grow so fast, they become so successful, that their revenue grows faster than they can grow their patent portfolio organically.” He cited Instacart, which acquired 250 patents from IBM earlier this month, and Airbnb, which was sued by IBM over patent infringement in early 2020 (the companies settled in December), as examples.

ByteDance, thanks to the success of TikTok, now finds itself in a situation where it, too, is likely to become a target of patent trolls. The company has started acquiring patents itself to grow its portfolio faster and now it is joining LOT to strengthen its protection there.

“[ByteDance] is being a visionary and trying to get ahead of the wave,” Seddon noted. “They are a successful global company that needs to develop a global IP strategy. Historically, PAEs were just a US problem, but now ByteDance has to worry about PAEs being an issue in China and Europe as well.  By joining LOT, they protect themselves and their investments from over 3 million patents should they ever fall into the hands of a PAE.”

Lynn Wu, Director and Chief IP Counsel, Global IP and Digital Licensing Strategy at ByteDance, agrees. “Innovation is core to the culture at ByteDance, and we believe it’s important to protect our diverse technical and creative community,” she said in today’s announcement. “As champions for the fair use of IP, we encourage other companies to help us make the industry safer by joining LOT Network. If we work together, we can protect the industry from exploitation and continue advancing innovation, which is key to the growth and success of the entire community.”

There’s another reason companies are so eager to join the group now, though, and that’s because these patent assertion entities, which had faded into the background a bit in the mid- to late-2010s, may be making a comeback. The core assumption here is a bit gloomy: many companies seem to assume we’re in for an economic downturn. If we hit a recession, a lot of patent holders will start looking at their patent portfolios and start selling off some their more valuable patents in order to stay afloat. Since beggars can’t be choosers, that often means they’ll sell to a patent troll if that troll is the highest bidder. Last year, a patent troll sued Uber using a patent sold by IBM, for example (and IBM gets a bit of a bad rap for this, but, hey, it’s business).

That’s what happened after the last recession — though it typically takes a few years for the effect to be felt. Nothing in the patent world moves quickly.

Now, when LOT members sell to a troll, that troll can’t sue other LOT members over it. Take IBM, for example, which joined LOT last year.

“People give IBM a lot of grief and criticism for selling to PAEs, but at least IBM is giving everybody a chance to get a free license,” Seddon told me. “IBM joined LOT last year and what IBM is effectively doing is saying to everybody, ‘look, I joined LOT.’ And they put all of their entire patent portfolio into LOT. And they’re saying to everybody, ‘look, I have the right to sell my patents to anybody I want, and I’m going to sell it to the highest bidder. And if I sell it to a patent troll and you don’t join LOT — and if you get sued by a troll, is that my fault or your fault? Because if you join LOT, you could have gotten a free license.’”

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Johnson & Johnson’s COVID-19 vaccine is 85% effective against severe cases, and 66% effective overall per trial data

Another COVID-19 vaccine is almost ready to begin being distributed – a single-shot inoculation made by Johnson & Johnson’s Janssen pharmaceutical subsidiary. The company just released an efficacy report based on data from its Phase 3 trial, which found that the new vaccine is 66% effective overall in preventing moderate to severe incarnations of COVID-19 in those who received the jab, and 85% effective in preventing sever disease.

Those numbers aren’t as impressive as the reported figures for the Moderna and Pfizer/BioNTech vaccines that are already being distributed via emergency FDA approval, both of which reported 90+% efficacy. But Johnson & Johnson’s vaccine is a single shot rather than a two-course treatment, which should make it much easier to distribute much more quickly. The vaccine also showed 100% efficacy in preventing hospitalization or death among participants in the trial, 28 days after vaccination, which is a key measure when considering the broader impact of COVID-19 on healthcare resources, and efficacy varied by region, with the jab proving 72% effective in the U.S. across moderate and severe cases vs. 66% globally.

It’s also important to note that Johnson & Johnson’s Phase 3 trial is happening amid the emergence of new strains of the virus, including much more contagious versions like the UK and South African variants. At the time that both Moderna and BioNTech released their trial data, these variants hadn’t yet emerged or been confirmed by pandemic researchers.

Johnson & Johnson’s vaccine uses a modified version of a common cold virus to deliver DNA that provides a person’s body with instructions on building a replica of the spike protein that SARS-CoV-2 uses to attach to cells. The modified adenovirus can’t replicate in human cells, however, meaning it won’t lead to illness – only an immune response that can later be employed to combat contracting the virus that leads to COVID-19. This adenovirus method is much more proven in terms of use in human patients vs. the mRNA method that the other vaccines currently in use employ.

All of which is to say, despite headline numbers that appear to fall short relative to the data we’ve seen from Moderna and Pfizer, this Johnson & Johnson report is actually very encouraging. The company says it expects to file a request for an Emergency Use Approval (EUA) from the FDA in February, which could see it begin to be distributed next month, adding yet another weapon in the arsenal to combat the global pandemic.

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Amazon offers Biden help to speed up vaccine distribution

The Amazon logo on the side of a multistory window.

Enlarge / An Amazon warehouse on a sunny day in Germany on April 2, 2020. (credit: Patrick Pleul | picture alliance | Getty Images)

Amazon is one of the country’s largest businesses—and despite its faults and flaws, the company overall excels at logistics and distribution at scale. Therefore, Amazon suggests, the brand-new Biden administration should give the company a call to help ramp up COVID-19 distribution nationwide.

“Amazon stands ready to assist you in reaching your goal of vaccinating 100 million Americans in the first 100 days of your administration,” Dave Clark, the head of Amazon’s consumer business, wrote in a letter (PDF) to President Joe Biden Wednesday.

Amazon’s more than 800,000 employees should be in the vaccine queue as soon as possible, Clark noted, as individuals working in Amazon warehouses, AWS data centers, and Whole Foods stores are essential workers who cannot work from home. The company has inked a deal with a third-party health care firm to administer vaccines on-site at Amazon-owned facilities, Clark added—if they could just get vaccines to administer.

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Conversa Health expands its Series B round to $20M

Portland, Oregon-based Conversa Health, a virtual care and communication platform that helps health organizations stay in touch with their patients and customers, today announced that it has expanded its Series B funding round from $12 million to $20 million. The round is still co-led by Builders VC and Northwell Health’s venture arm Northwell Ventures. Additional investors include UH Ventures, the venture arm of University Hospitals and VC firms P5 Health Ventures, Epic Ventures, StartUp Health and Nassau Street Ventures, as well Genesis Merchant Capital and J-Ventures, which came in as new investors in this expanded round.

“There’s been a recognition, especially with COVID, that the need for automated and virtual — which are two big trends in healthcare — were on the horizon but now the horizon has been pulled in because of COVID and the healthcare system recognizes that that’s going to be required to be able to allow access for patients and improve both the experience for patients and providers, and get better outcomes and do it at lower cost,” Conversa CEO Murray Brozinsky told me.

Brozinsky actually believes that within the next decade, 80% of care will be done remotely. This will allow for more personalized and evidence-based care, but it will also require investments in automation.

“Conversa links providers’ EHRs and other patient data to best-of-breed interactive digital care pathways and clinical analytics engine to automate care management 24×7. This improves care plan adherence pre and post visit, reducing costs and generating better outcomes for patients,” said Builders VC partner and Conversa board member Mark Goldstein. “Conversa’s enterprise platform and library of digital pathways are used by providers to care for patients across their populations, as opposed to one-off point solutions. It fills an enormous gap in the market.”

Given the pandemic, it’s maybe no surprise that Conversa’s business also boomed. The number of customers the company its services has grown fourfold while its financial metrics are up 6x because a lot of its larger companies have expanded their use of the platform.

The team decided to expand the existing Series B round to help it capitalize on this momentum and to bring on more engineers in order to scale the platform. Brozinsky believes that the need for a platform like Conversa’s will remain after the pandemic ends. In addition, the company is also already rolling out support for vaccination programs in its service to help educate consumers but also help in monitoring efforts after people get their shots.

“Everything we’re hearing from health systems, they recognize that they need to be prepared for this to happen again, they still need to care for the core demographics that haven’t changed — this aging population — with an acute shortage of healthcare workers,” Brozinsky said. “So the need for the systems and these platforms is going to be more acute and the investment is not so much an additional cost but an enormous return.”

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With Trump’s vaccine rollout in chaos, Biden unveils five-point plan

US President-elect Joe Biden delivers remarks on his plan to administer COVID-19 vaccines in Wilmington, Delaware on January 15, 2021.

Enlarge / US President-elect Joe Biden delivers remarks on his plan to administer COVID-19 vaccines in Wilmington, Delaware on January 15, 2021. (credit: Getty | Angela Weiss)

President-elect Joe Biden on Friday unveiled a five-point plan to try to rescue the country’s beleaguered COVID-19 vaccination campaign and achieve his stated goal of reaching 100 million shots in his first 100 days in office.

The five steps include, in brief:

  • Working with states to open and clarify eligibility for vaccination
  • Help set up additional vaccination sites
  • “Fully activate” pharmacies to act as vaccination sites
  • Ramp up manufacturing of vaccine and supplies
  • Commit to transparency and rollout a massive public information campaign to combat disinformation

“The vaccine rollout in the United States has been a dismal failure thus far,” Biden said in speech. These five things are an attempt to turn things around, to “turn frustration into motivation.”

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Tech and health companies including Microsoft and Salesforce team up on digital COVID-19 vaccination records

A new cross-industry initiative is seeking to establish a standard for digital vaccination records that can be used universally to identify COVID-19 vaccination status for individuals, in a way that can be both secure via encryption and traceable and verifiable for trustworthiness regarding their contents. The so-called ‘Vaccination Credential Initiative’ includes a range of big-name companies from both the healthcare and the tech industry, including Microsoft, Oracle, Salesforce and Epic, as well as the Mayo Clinic, Safe Health, Change Healthcare and the CARIN Alliance to name a few.

The effort is beginning with existing, recognized standards already in use in digital healthcare programs, like the SMART Health Cards specification, which adheres to HL7 FHIR (Fast Healthcare Interoperability Resources) which is a standard created for use in digital health records to make them interoperable between providers. The final product that the initiative aims to establish is an “encrypted digital copy of their immunization credentials to store in a digital wallet of their choice,” with a backup available as a printed QR code that includes W3C-standards verifiable credentials for individuals who don’t own or prefer not to use smartphones.

Vaccination credentials aren’t a new thing – they’ve existed in some form or another since the 1700s. But their use and history is also mired in controversy and accusations of inequity, since this is human beings we’re dealing with. And already with COVID-19, there efforts underway to make access to certain geographies dependent upon negative COVID-19 test results (though such results don’t actually guarantee that an individual doesn’t actually have COVID-19 or won’t transfer it to others).

A recent initiative by LA County specifically also is already providing digital immunization records to individuals via a partnership with Healthvana, facilitated by Apple’s Wallet technology. But Healthvana’s CEO and founder was explicit in telling me that that isn’t about providing a proof of immunity for use in deterring an individual’s social or geographic access. Instead, it’s about informing and supporting patients for optimal care outcomes.

It sounds like this initiative is much more about using a COVID-19 immunization record as a literal passport of sorts. It’s right in the name of the initiative, for once (‘Credential’ is pretty explicit). The companies involved also at least seem cognizant of the potential pitfalls of such a program, as MITRE’s chief digital health physician Dr. Brian Anderson said that “we are working to ensure that underserved populations have access to this verification,” and added that “just as COVID-19 does not discriminate based on socio-economic status, we must ensure that convenient access to records crosses the digital divide.”

Other quotes from Oracle and Salesforce, and additional member leaders confirm that the effort is focused on fostering a reopening of social and ecomicn activity, including “resuming travel,” get[ting] back to public life,” and “get[ting] concerts and sporting events going again.” Safe Health also says that they’ll help facility a “privacy-preserving health status verification” solution that is at least in part “blockchain-enabled.”

Given the urgency of solutions that can lead to a safe re-opening, and a way to keep tabs on the massive, global vaccination program that’s already underway, it makes sense that a modern approach would include a digital version of historic vaccination record systems. But such an approach, while it leverages new conveniences and modes made possible by smartphones and the internet, also opens itself up to new potential pitfalls and risks that will no doubt be highly scrutinized, particularly by public interest groups focused on privacy and equitable treatment.

#articles, #ceo, #encryption, #epic, #health, #healthcare, #healthvana, #mayo-clinic, #microsoft, #oracle, #regulation, #salesforce, #smartphones, #standards, #tc, #vaccination

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Uber and Moderna partner on COVID-19 vaccine access and information

Uber and pharmaceutical company Moderna have announced a partnership around COVID-19 vaccination, which will include a number of different initiatives. To start, it’s only confirmed component is to provide users with credible, factual information about COVID-19 vaccine safety through Uber’s consumer app, but the companies have also discussed additional “options” including building ride scheduling via Uber directly into the immunization appointment booking process.

Still in its early days, the U.S. COVID-19 vaccination program is already beset with challenges, including providing timely access to vaccines to swaths of the population who need it most. The inoculation program also has to contend with significant misinformation proliferating on social media about vaccine safety, and any app with the surface area of something like Uber has a chance to get positive messages and accurate information in front of a lot of people, so that’s good news on its own.

But one of the very real challenges to an effective vaccination campaign remains logistical, and getting people to make their initial and follow-up appointments for the first round of the Moderna vaccine, and its second shot booster, is a bigger challenge than many might suspect. I spoke to Healthvana CEO Ramin Bastani about their work with  LA County on creating an immunization record that integrates with Apple Wallet to provide patients with timely info and reminders about vaccination appointments, but integrating a ride-booking service or appointment reminder directly in the Uber app that most users already have on their phone anyway could be another very effective way to increase success rates for first and follow-up inoculation visits.

Uber has already offered up free and discounted rides to help lower the friction of actually going out and getting a vaccine, but a product-level integration could do a lot more than that by providing easy, user-friendly access. As noted, this is still just one of the options being discussed, but if Uber and Moderna are willing to commit it to print, that at least means they’re serious about trying to find a way. We’re holding them to account, too, so rest assured we’ll follow up on their progress as this collaboration develops.

#apps, #ceo, #health, #healthvana, #medicine, #moderna, #pharmaceutical, #social-media, #tc, #transportation, #uber, #united-states, #vaccination, #vaccine, #vaccines

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Healthvana’s digital COVID-19 vaccination records are about communication, not passports for the immune

As the vaccination campaign to counter COVID-19 gets underway (albeit with a rocky start), a number of companies are attempting to support its rollout in a variety of ways. Healthvana, a health tech startup that began with a specific focus on providing patient information digitally for individuals living with HIV, is helping Los Angeles County roll out mobile vaccination records for COVID-19 using Apple’s Wallet technology. A cursory appraisal of the implementation of this tech might lead one to believe it’s about providing individuals with easy proof of vaccination — but the tech, and Healthvana, are focused on informing individuals to ensure they participate in their own healthcare programs, not providing an immunity pass.

“I generally consider most of healthcare to look and feel like Windows 95,” Healthvana CEO and founder Ramin Bastani said. “We look and feel like Instagram . Why is that important? Because patients can engage in things they understand, it’s easier for them to communicate in the way they’re used to communicating, and that ends up leading them to better health outcomes.”

Bastani points out that they began the company by focusing this approach to patient education and communication on HIV, and demonstrated that using their software led to patients being 7.4 times more likely to show up for their next follow-up appointment versus patients who received follow-up information and appointment notices via traditional methods. The company has built their tooling and their approach around not only producing better health for individuals, but also on reducing costs for healthcare providers by eliminating the need for a lot of the work that goes into clearing up misunderstandings, and essentially hounding patients to follow-up, which can significantly dig into clinician and care staff hours.

“We’re actually also reducing the cost to healthcare providers, because you don’t have 1,000 people calling you asking what are their results, and saying ‘I don’t understand, I can’t log in, I don’t know what it means to be SARS nonreactive,’ or all those things we address through simplicity,” Bastani said. “That’s made a huge difference. Overall, I think the key to all healthcare is going to be to be able to get patients to pay attention, and take action to things around their health.”

That’s the goal of Healthvana’s partnership with LA County on COVID-19 immunization records, too — taking vitally important action to ensure the successful rollout of its vaccination program. All approved COVID-19 vaccines to date require a two-course treatment, including one initial inoculation followed by a booster to be administered sometime later. Keeping LA county residents informed about their COVID-19 inoculation, and when they’re due for a second dose, is the primary purpose of the partnership, and benefits from Healthvana’s experience in improving patient follow-up activities. But the app is also providing users with information about COVID-19 care, and, most usefully, prevention and ways to slow the spread.

While Bastani stresses that Healthvana is, in the end, just “the last mile” for message delivery, and that there are many other layers involved in determining the right steps for proper care and prevention, the way in which they provide actionable info has already proven a big boon to one key measure: contact tracing. In select municipalities, Healthvana will also prompt users who’ve tested positive to anonymously notify close contacts directly from their device, which will provide those individuals with both free testing options and information resources.

“Just us doing this in the greater Los Angeles area for less than two months, 12,000+ people have been notified that they’ve been exposed,” Bastani said. “Each of them likely lives with other people and families — this is how you can help slow the spread.”

Contrast that with the relatively slow uptake of the exposure notification tools built into iOS and Android devices via recent software updates provided by Google and Apple working in a rare collaboration. While the technology that underlies it is sound, and focused on user privacy, its usage numbers thus far are far from earthshaking; only 388 people have sent alerts through Virginia’s app-based on the exposure notification framework in three months since its launch, for instance.

Healthvana’s focus on timely and relevant delivery of information, offered to users in ways they’re mostly likely to understand and engage with, is already showing its ability to have an impact on COVID-19 and its community transmission. The startup is already in talks to launch similar programs elsewhere in the country, and that could help improve national vaccination outcomes, and how people handle COVID-19 once they have it, too.

#android, #apple, #biotech, #biotechnology, #covid-19, #google, #health, #healthvana, #hiv, #instagram, #life-sciences, #los-angeles, #startups, #tc, #vaccination, #virginia, #windows-95

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Moderna is developing three new mRNA-based vaccines for seasonal flu, HIV and Nipah virus

Moderna, the biotech company behind one of the two mRNA-based vaccines currently being rolled out globally to stem the tide of COVID-19, has announced that it will purse development programs around three new vaccine candidates in 2021. These include potential vaccines for HIV, seasonal flu and the Nipah virus. Moderna’s development and clinical trial of its COVID-19 vaccine is among the fastest in history, and thus far its results have been very promising, buoying hopes for the efficacy of other preventative treatments being generated using this technology which is new to human clinical use.

An mRNA vaccine differs from typical, historical vaccines because it involves providing a person with just a set of instructions on how to build specific proteins that will trigger a body’s natural defenses. The mRNA instructions, which are temporary and do not affect a person’s actual DNA, simply prompt the body’s cells to produce proteins that mirror those used by a virus to attach to and infect cells. The independent proteins are then fought off by a person’s natural immune response, which provides a lasting lesson in how to fight off any future proteins that match that profile, including those which help viruses attach to and infect people.

Moderna’s new programs will target not only seasonal flu, but also a combinatory vaccine that could target both the regular flu and SARS-CoV-2, the virus that leads to COVID-19. The HIV candidate, which is developed in collaboration with both the AIDS Vaccine Initiative and the Bill and Melinda Gates Foundation, is expected to enter into Phase 1 trials this year, as will the flue face. Nipah virus is a highly lethal illness that can cause respiratory and neurological symptoms, and which is particularly a threat in India, Bangladesh, Malaysia and Singapore.

mRNA-based vaccines have long held potential for future vaccine development, in part because of their flexibility and programmability, and in part because they don’t use any active or dormant virus, which reduces their risks in terms of causing any direct infections up front. The COVID-19 pandemic spurred significant investment and regulatory/health and safety investment into the technology, paving the way for its use in other areas, including these new vaccine candidate trials by Moderna.

#aids, #bangladesh, #biotech, #health, #hiv, #india, #malaysia, #medical-research, #medicine, #moderna, #singapore, #tc, #vaccination, #vaccine, #vaccines, #virus

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Stanford hospital erupts in protest after vaccine plan leaves out residents

Images of people protesting while wearing medical garb.

Enlarge / Protests by medical staff took place both inside and out of the hospital. (credit: Ars Technica)

One of the more challenging aspects of the initial round of vaccinations is deciding who gets the first doses of a limited supply. The need to have a functional medical system in the face of an out-of-control pandemic has meant that most places have prioritized doctors and nurses who provide most face-to-face patient care. But an apparent failure to prioritize those caregivers at Stanford Medical Center has caused many of its doctors to stage protests today.

Ars received a copy of an open letter sent by the Chief Medical Residents to the Stanford administration that outlines the problems that sparked these protests.

In the US, a residency occurs after the completion of medical school, and is a requirement for the practice of medicine. Residents typically operate under the supervision of a physician in a training program at teaching hospitals, and they learn to practice a specialized branch of medicine, such as internal medicine or pediatrics. In many cases, residencies are followed by fellowships, which are used to develop further specializations. Because these positions are both temporary and required for practicing medicine, however, those occupying them have little political weight within hospitals.

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#covid-19, #hospitals, #medicine, #sars-cov-2, #science, #vaccination

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Alibaba and Ethiopian Airlines to launch cold chain exporting China’s COVID vaccines

China has pledged that it would be sharing its COVID-19 vaccines with other countries, especially those with which it has close ties. While the country is not ready to deploy its vaccines internationally, it is gearing up the infrastructure for mass distribution.

This week, Alibaba announced that it has struck a partnership with Ethiopian Airlines to introduce a cold chain capable of transporting temperature-sensitive medicines from China to the rest of the world. The air freight will depart from Shenzhen Airport, which Alibaba says houses China’s first cross-border medical cold chain facility, twice a week to countries via Dubai and Addis Ababa.

“As soon as the vaccines are ready, we will have the capabilities to transport them,” a Cainiao spokesperson told TechCrunch.

Shenzhen is the home base of SF Express, another major logistics operator in China that has also been working on storing and shipping vaccines.

The Alibaba route is carried out by the firm’s logistics arm Cainiao, which operates in over 200 countries and regions. It’s certified by the International Air Transport Association to fly Covid-19 vaccines, which normally need to be stored at low temperatures. Cabins will contain temperature-controlled monitors, for instance, and Ethiopia’s cargo terminal comes with facilities that can be adjusted between -23°C and 25°C, or -9.4°F and 77°F.

“The launch of the cold chain air freight has further bolstered our global logistics capabilities and allow us to offer a one-stop solution for the global distribution of medical products such as the COVID-19 vaccines,” said James Zhao, general manager of Cainiao’s international supply chain unit.

China is a major exporter of personal protective equipment (PPE) during the COVID-19 pandemic and the country’s logistics giants, from Cainiao to SF Express, all promptly introduced programs specifically for shipping medical relief items.

#alibaba-group, #cainiao, #china, #cold-chain, #ethiopia, #health, #jack-ma, #logistics, #shenzhen, #supply-chain, #supply-chain-management, #transportation, #vaccination, #vaccine

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Oxford University’s COVID-19 vaccine shows high efficacy, and is cheaper to make and easier to store

Oxford University’s COVID-19 vaccine, being developed in partnership with drugmaker AstraZeneca, has shown to be 70.4% effective in preliminary results from its Phase 3 clinical trial. That rate actually includes data from two different approaches to dosing, including one where two full strength does were applied, which was 62% effective, and a much more promising dosage trial which used one half-dose and one full strength dose to follow – that one was 90% effective.

Oxford’s results may not have the eye-catching high efficacy headline totals of the recent announcements from Pfizer and Moderna, but they could actually represent some of the most promising yet for a few different reasons. First, if that second dosage strategy holds true across later results and further analysis, it means that the Oxford vaccine can be administered in lower amounts and provide stronger efficacy (there’s no reason to use the full two-dose method if it’s that much less effective).

Second, the Oxford vaccine can be stored and transported at standard refrigerator temperatures – between 35° and 45°F – whereas the other two vaccine candidates require storage at lower temperatures. That helps obviate the need for more specialized equipment during transportation and on-site at clinics and hospitals where it will be administered.

Oxford’s COVID-19 vaccine also uses a different approach to either Moderna’s or Pfizer’s, which are both mRNA vaccines. That’s a relatively unproven technology when it comes to human therapeutics, which involves using messenger RNA to provide blueprints to a person’s body to build proteins effective at blocking a virus, without any virus present. The Oxford University candidate is an adenovirus vaccine, which is a much more established technology that’s already been in use for decades, and which involves genetically altering a weekend common cold virus and using that to trigger a person’s own natural immune response.

Finally, it’s also cheaper – in part because it uses tried and tested technology for which there’s already a robust and mature supply chain, and in part because it’s easier to transport and store.

The Phase 3 trial for the Oxford vaccine included 24,000 participants, and it’s expected to grow to 60,000 by the end of the year. Safety data so far shows no significant risks, and among the 131 confirmed cases in the interim analysis that produced these results, none of those who received either vaccine dosage developed a severe case, or one requiring hospitalization.

This is great news for potential vaccination programs, since it introduces variety of supply chain into an apparently effective vaccine treatment for COVID-19. We’re much better off if we have not only multiple effective vaccines, but multiple different types of effective vaccines, in terms of being able to inoculate widely as quickly as possible.

#astrazeneca, #biotech, #health, #medical-research, #medicine, #messenger, #moderna, #oxford-university, #pfizer, #tc, #unproven-technology, #vaccination, #vaccine, #vaccines

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Pfizer and BioNTech to submit request for emergency use approval of their COVID-19 vaccine today

Two of the companies behind one of the leading COVID-19 vaccine candidates will seek approval from the U.S. Food and Drug Administration for emergency use authorization (EUA) of their preventative treatment with an application to be delivered today. Pfizer and BioNTech, who revealed earlier this week that their vaccine was 95% effective based on Phase 3 clinical trial data, are submitting for the emergency authorization in the U.S., as well as in Australia, Canada, Europe, Japan and the U.K., and says that could pave the way for use of the vaccine to begin in “high-risk populations” by the end of next month.

The FDA’s EUA program allows therapeutics companies to seek early approval when mitigating circumstances are met, as is the case with the current global pandemic. EUA’s still require that supporting information and safety data are provided, but they are fast-tracked relative to the full, formal and more permanent approval process typically used for new drugs and treatments that come before they’re able to actually be administered broadly.

Pfizer and BioNTech’s vaccine candidate, which is an mRNA-based vaccine that essentially provides a recipient’s body with instructions on how to produce specific proteins to block the ability of SARS-CoV-19 (the virus that causes COVID-19) to attach to cells. The vaccine has recently been undergoing a Phase 3 clinical trial, that included 43,661 participants so far. The companies are submitting supporting information they hope will convince the FDA to grant the EUA, including data from 170 confirmed cases from among the participants, and safety information actively solicited from 8,000 participants, and supplementary data form another 38,000 who that was passively collected.

While production is ramping globally for this and other vaccines in late stage development, and EUA will potentially open up access to high-risk individuals including frontline healthcare workers, it’s worth pointing out that any wide vaccination programs likely aren’t set to begin until next year, and likely later in 2021.

#australia, #biontech, #biotech, #canada, #coronavirus, #covid-19, #europe, #health, #japan, #medical-research, #medicine, #pfizer, #tc, #united-kingdom, #united-states, #vaccination, #vaccines

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Moderna reports its COVID-19 vaccine is 94.5% effective in first data from Phase 3 trial

Following fast on the heels of Pfizer’s announcement of its COVID-19 vaccine efficacy, Moderna is also sharing positive results from its Phase 3 trial on Monday. The biotech company says that its COVID-19 vaccine candidate has shown efficacy of 94.5% in its first interim data analysis, which covers 95 confirmed COVID cases among its study participants, of which 90 were given the placebo, and only 5 received Moderna’s mRNA-based vaccine. Further, of 11 severe cases of COVID-19, none were found among those who received the actual vaccine candidate.

This is another very promising sign for the potential of having effective vaccines available to the public in some kind of significant volume at some point next year. As mentioned, it’s worth pointing out that this is just a first interim report, but it is data that comes from the safety board overseeing the trial appointed by the National Institutes of Health, which is an independent body not affiliated with Moderna, so it’s a reliable result that provides hope for continued and final analysis.

Moderna says that it will be submitting for an Emergency Use Authorization of its vaccine candidate based on the results within the coming weeks, looking to get approval from the FDA to use it in emergency circumstances ahead of a full and final approval. That EUA, should it be granted, will be based on data from 151 confirmed cases among the Phase 3 participant group (which included 30,000 participants in total), and data from follow-ups extending on average over two months after case confirmation.

All final data will also be submitted to the scientific community for independent peer review, which is a standard part of the ultimate vaccine trial and approval process.

Both these and Pfizer’s vaccine candidate, which it developed in partnership with BioNTech, are mRNA-based vaccines. These are relatively new in terms of human use, and differ from traditional vaccines in that they use messenger RNA to instruct a recipient’s cells to generate effective antibodies, without actually exposing them to any virus, whereas more traditional vaccines in general use typically use either small, safe doses of active or inactive virus in order to trigger a patient’s immune system to generate their own antibodies.

#biontech, #biotech, #coronavirus, #covid-19, #fda, #health, #medical-research, #medicine, #messenger, #moderna, #pfizer, #tc, #vaccination, #vaccine, #vaccines

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We’ll need more than one vaccine to beat the pandemic

Close-up photograph of a gloved hand holding a tiny bottle of clear liquid.

Enlarge / A medical worker holds a bottle of a candidate COVID-19 vaccine developed by Oxford University that is being tested in a trial in Soweto, South Africa. (credit: Getty | Gallo Images)

On Monday, a press release from the transnational pharmaceutical company Pfizer dropped a rare spark of hope into the ongoing misery of the Covid-19 pandemic. Yes, new infections have hit an all-time high in the United States, and, yes, cities and states around the world are walking back their reopenings. But Pfizer says it has results from a massive clinical trial showing that its vaccine against the disease works, and works well. The release touted “a vaccine efficacy rate above 90 percent,” and it announced the company’s intention to seek from the US Food and Drug Administration an authorization to start giving people shots. The company’s ready to make 50 million doses this year and 1.3 billion doses in 2021.

That’s an ember of hope, but it’s sitting under a bucket of cold water, ready to pour. The Pfizer vaccine is finicky—hard to make, transport, and deliver. Because of desperate need, it’s in short supply even before it becomes available—1.3 billion doses is several billion short of what the world needs. The press release wasn’t peer-reviewed science, and it lacked critical details about how the vaccine works, and on whom. Even the simple fact of this vaccine’s existence, some analysts have argued, might jeopardize the testing and success of potentially better vaccines down the line, a case of the imperfect being the enemy of the good.

Before the ember dies out completely, here’s a theory: No. The Pfizer vaccine’s imperfections make it a perfect prime mover, because if it works as well as the company says, it’ll help people now and require research into more, better, different vaccines for later. All the things nobody knows about the Pfizer vaccine mean that the door is wide open. “Whether its effects are durable, whether it’s effective in the elderly, whether it has safety issues, the cold chain issues, the ability to have access,” says Wayne Koff, president and CEO of the nonprofit Human Vaccines Project, “all that points to the need for a number of vaccines.”

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#covid-19, #mrna, #pandemic, #science, #vaccination, #vaccines

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Pfizer’s COVID-19 vaccine proves 90% effective in first results from Phase 3 clinical trial

The COVID-19 vaccine being developed by Pfizer and its partner BioNTech has shown to be effective blocking vaccine in 90 percent of participants in its Phase 3 clinical trial, the companies announced on Monday. That’s based on data analyzed by an external, independent committee assigned to check the results of the trial, and reflects only early results from the trial, and not the final verified result, but it’s still extremely promising news for progress towards a viable and more broadly available vaccine.

Pfizer and BioNTech’s vaccine candidate is an mRNA-based vaccine, which is a newer technology that many companies pursued for COVID-19 in part because it offers some advantages in pace of development and potential efficacy. These results from the test were based on an equable case total of 94 confirmed COVID-19 cases among study participants – passing the minimum threshold agreed to by the companies and the FDA of 62 confirmed cases for a proper, scientifically rigorous assessment.

The Phase 3 trial conducted by the companies included 43,358 participants, and Pfizer reports “no serious safety concerns have been observed” thus far in addition to the positive prevention rate. Based on this early data, individuals who receive the vaccine are protected at 28 days after first dose, and the vaccine uses a two-dose process.

There is still additional safety testing and continued studies to conduct, with the companies estimating that two full months of safety data (which is what the FDA requires for Emergency Use Authorization) will be available in the third week of this month. Participants will also be monitored for two full years after they receive their second and final dose in order to test for long-term effects. Pfizer still thinks that it can produce up to 50 million doses of its vaccine by the end of this year, and as many as 1.3 billion doses through 2021.

Full data from this trial still need to undergo peer-review by other researchers and scientific publications, but this is definitely the most promising and clearly positive news yet from the vaccine development front, and could mean that large-scale distribution of a vaccine begins even before the end of 2020 if all goes well.

#biontech, #biotech, #coronavirus, #covid-19, #fda, #health, #medical-research, #medicine, #pfizer, #tc, #vaccination, #vaccine, #vaccines

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Moderna’s 30,000-participant Phase 3 COVID-19 vaccine trial kicks off in the U.S.

The largest trial yet for a potential COVID-19 vaccine began on Monday, as drug company Moderna began providing the first of an anticipated 30,000 volunteers with shots of its candidates. This is a blind trial, wherein some participants will get the vaccine and some will get placebos. Each participant will get two does, and researchers will study them to see which group suffers more actual infections as they proceed about their lives as they would normally.

There are more than 70 anticipated trial sites across the U.S. for this study,; and the first to begin vaccinating the volunteer participants is located in Savannah, Georgia. The makeup of the overall group of participants is intended to study not only geographical distribution, covering regions hard-hit by the virus and those with less severe outbreaks, but also to represent a wide sample when it comes to demographics of those participating.

The Moderna trial is begin undertaken in partnership with the U.S. National Institutes of Health (NIH), and represents one of the fastest development cycles of a vaccine ever. Just around two months after work was begun on the Moderna vaccine, it was already begin tested in humans for the first time, and early data from its Phase 1 tests (which were on a much smaller scale) have shown promising indications that it does indeed provide some infection protection – though large scale tests like this 30,000-person strong one are definitely required before anyone can say anything definitive about its efficacy.

In addition to making sure that the vaccine is actually effective as a vaccine, this large-scale test is intended to prove it’s safe to take. Early results indicated some side effects, but again, it’s impossible to say anything definitively about downsides wither until you test at scale.

Other trials are also making quick progress, including one for a vaccine developed by the University of Oxford. Moderna has previously said that experimental versions of the vaccine might be available on an emergency basis for healthcare workers by this fall, if all goes to plan.

#biotech, #coronavirus, #covid-19, #georgia, #health, #infection, #medical-research, #medicine, #moderna, #national-institute-of-health, #savannah, #tc, #united-states, #vaccination, #vaccine, #vaccines

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COVID-19 vaccine trials from the University of Oxford and Wuhan both show early positive results

There are more promising signs from ongoing efforts to develop a vaccine that’s effective in preventing COVID-19: Two early trials, one from the University of Oxford, and one from a group of researchers in Wuhan funded in part by the National Key R&D Programme of China. Both early trials showed efficacy in increasing the presence of antibody responses to SARS-CoV-2, the virus that leads to COVID-19, and also indicated that these prospective vaccines were safe to administer based on available information.

The University of Oxford study is one of the leading vaccine development efforts in the world, and among those that are furthest along in development. The results of their study covered 1,077 participants, all of whom were health adults aged between 18 and 55 with no prior confirmed history of having contracted SARS-CoV-2. That’s important because they received double randomized trials of the vaccine candidate, or an existing vaccine for meningitis as a control acting as a placebo. The results showed that across the group, 100 percent of the participants had demonstrated neutralizing antibody responses by the end of the course, which include a booster does.

Additionally, while some participants exhibited side effects, including “pain, feeling feverish, chills, muscle ache, headache and malaise,” none of these represented what the researchers consider serious reactions, and these were also mitigated with use of paracetamol (standard painkillers available over the counter). Patient reactions were monitored for 28 days following the administration of the vaccine.

Oxford’s team is now ready to move on to its Phase 3 trial, which is a large-scale human trial that is effectively the last major step before it moves on to potential approval, production and distribution. That’s a time consuming process, but it does put this development on pace for a remarkably fast research and development process relative to prior vaccines.

Meanwhile the study in China covered health adults 18 or older, and included 603 participants, screened down to 508 who received either the vaccine candidate or a placebo. The participants also showed no adverse reactions, according to the researchers, and they’re also now likely to move on to a phase 3 development program.

Earlier this month, Moderna also announced promising early results from its phase 1 trial, but that was limited to just 45 participants between 18 and 55, and indicated some potentially serious side effects that will need to be watched in later, larger trials. These new results, while also early and requiring further development and research, are much more encouraging given the scale of both trials.

It is very early to make too many assumptions about what these early trials indicate, however. For instance, we still don’t really know how effective antibodies are in patients that have recovered from having COVID-19 once, so a lot more investigation is required by scientists in better understanding the efficacy of antibodies, and potentially vaccines, over the long term.

#biotech, #china, #health, #medical-research, #medicine, #moderna, #oxford, #pain, #science, #tc, #vaccination, #vaccine, #vaccines

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GreenLight Biosciences raises $17m to ramp mRNA production for COVID-19 vaccine candidate trials

One of the approaches therapeutics companies are taking to developing vaccines for COVID-19 relies on what’s called an mRNA (messenger RNA, which essentially provides cells with protein production instructions) vaccine, a relatively novel method that hasn’t yet resulted in a vaccine approved for human use (though approved mRNA vaccines do exist for veterinary treatment). Making mRNA is a fairly specialized affair, and one biotech startup that focuses on its production has raised $17 million in special purpose funding to ramp up its manufacturing capacity.

Boston-based GreenLight Biosciences raided the additional funding from a combination of new and existing investors, including Flu Lab, Xeraya Capital, and Board Capital, and will use the new funds to both expand its mRNA production capacity in order to support the creation of “billions of doses” of potential COVID-19 vaccines for use in trials and eventual deployment, should any candidates prove effective.

Meanwhile, GreenLight is also developing several different versions of its own mRNA-based vaccine candidates to potentially prevent individuals from contracting SARS-CoV-2, the virus that leads to the COVID-19 infection. Some of the funding will also go towards its work in this area.

Various companies have spun up mRNA vaccine candidate development, and some have already entered into clinical trials, in response to the current global COVID-19 pandemic. These mRNA vaccines essentially work by providing a set of specific instructions to a person’s cells to produce proteins that are capable of blocking a virus, preventing it from getting a foothold in the body. It’s a different approach from traditional vaccine development, which involves using either deactivated, or small doses of activated actual virus to trigger an immune response in individuals.

mRNA vaccines have that advantage of being relatively safe because they contain no actual virus, with shorter pre-clinical development times as well, meaning the whole cycle from development to testing and deployment is shortened. That’s made them a popular area of focus and investment specifically to handle outbreaks and pandemics, but as mentioned, thus far none has been fully developed and approved for human treatemen.

This investment is a bet that mRNA vaccines not only prove effective in humans, but that they become a valuable and ongoing resource in curbing not only this pandemic, but other viral threats, including the existing standard influenza and others.

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Non-profit launches COVID-19 treatment and vaccine tracker with daily updates

There are a lot of global efforts underway to develop vaccines and treatments for COVID-19, including repurposing of existing drugs approved for use in treating other forms of coronavirus and respiratory diseases. Many of these efforts are just entering into the formal clinical study phase, which will be required before any treatment is certified for widespread use in patients diagnosed with the illness. Vaccines are still likely at least a year out from approvals, though some have already entered into clinical human trials at unprecedented speed owing to the unprecedented nature of the pandemic.

It’s definitely a challenge to keep up with all the existing efforts to pursue effective treatments and develop vaccines, but public health non-profit the Milken Institute has a new resource that aims to keep track of at least the efforts from leading research institutions and drug makers. Its COVID-19 treatment and vaccine tracker currently offers a list of nearly 60 treatments, as well as 43 vaccines in development.

This list details the type of treatment or vaccine being studied or developed, as well as their FDA-approved status (for other conditions – none have been approved specifically for treating COVID-19 to date). They also indicate who is doing the drug development or research, and what stage the research project is at (either pre-clinical or clinical). The table lists the source of funding, if available, as well as the anticipated timetable for the phases of the project if known. It provides sourcing for each, as well, including credible media sources, journals and the World Health Organization.

This kind of tracker is a good resource for anyone looking to keep tabs on the ongoing work that people are doing to take on COVID-19, though it’s a high-level view that is probably of most interest to other ongoing projects, as well as health and research professionals who might be able to assist in the development of these solutions, or to collaborate with partners. The Milken Institute says that it’s going to be updating the tracker daily at noon eastern with any additional fresh info from reliable sources.

As mentioned, even vaccines that are already in development, like the mRNA-based immune therapy that began human trials last week in the U.S., will take many months to come to market, and they still have to demonstrate their effectiveness, too. In the meantime, people should do everything they can to isolate and remain indoors in order to help buy time for the healthcare system to develop treatments that can mitigate the impact of the disease, and eventually, ways to introduce immunity in order to block its transmission.

#coronavirus, #covid-19, #drug-development, #drugs, #fda, #health, #illness, #tc, #vaccination, #vaccine, #vaccines, #world-health-organization

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