Steve Thomas - IT Consultant

The U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for the COVID-19 vaccine developed by Pfizer and its partner BioNTech, the New York Times first reported on Friday night, and later supported by The Wall Street Journal. This EUA follows a recommendation by an independent panel of experts commissioned by the FDA to review Pfizer’s application and provide a recommendation, which the panel unanimously supported earlier this week.

Following this authorization, shipment of the vaccine are expected to begin immediately, with 2.9 million doses in the initial shipment order. Patients in the category of highly vulnerable individuals, which include healthcare workers and senior citizens in long-term care facilities, are expected to begin receiving doses within just a few days not was the EUA is granted.

This approval isn’t a full certification by the U.S. therapeutics regulator, but it is an emergency measure that still requires a comprehensive review of the available information supplied by Pfizer based on its Phase 3 clinical trial, which covered a group of 44,000 volunteer participants. Pfizer found that its vaccine, which is an mRNA-based treatment, was 95% effective in its final analysis of the data resulting form the trial to date – and also found that safety data indicated no significant safety issues in patients who received the vaccine.

On top of the initial 2.9 million dose order, the U.S. intends to distribute around 25 million doses by the end of 2020, which could result in far fewer people actually vaccinated since the Pfizer course requires two innoculations for maximum efficacy. Most American shouldn’t expect the vaccine to be available until at least late Q1 or Q2 2021, given the pace of Pfizer’s production and the U.S. order volume.

Still, this is a promising first step, and a monumental achievement in terms of vaccine development turnaround time, since it’s been roughly eight months since work began on the Pfizer vaccine candidate. Moderna has also submitted an EUA for its vaccine candidate, which is also an mRNA treatment (which provides instructions to a person’s cells to produce effective countermeasures to the virus). That could follow shortly, meaning two vaccines might be available under EUA within the U.S. before the end of the year.

An independent panel of experts has recommended Food and Drug Administration (FDA) has now voted to approve an official Emergency Use Authorization (EUA) for the Pfizer/ class="crunchbase-link" href="https://crunchbase.com/organization/biontech-ag" target="_blank" data-type="organization" data-entity="biontech-ag">BioNTech COVID-19 vaccine. This means that it’s one step closer to beginning to be administered to people in special circumstances – including for front-line healthcare workers dealing with healthcare facilities stressed to the breaking point due to the ongoing and rising pandemic crisis in the U.S., which continues to break grim records for single death counts among afflicted patients.

The Pfizer/BionNTech vaccine is an mRNA vaccine, which means that it provides a set of instructions to a person’s cells to prompt them to begin creating antibodies that are effective against the SARS-CoV-2 virus that leads to COVID-19. So far, the vaccine has been shown to be 95% effective according to Pfizer’s own final trial data. Based on the strength of those Phase 3 results, Pfizer applied for an EUA from the FDA towards the end of November.

Already, Pfizer’s vaccine has been approved for use in other countries, including Canada, where the national health regulator granted cleared it earlier this week. The FDA’s EUA process involves reviewing key information about efficacy and safety, and the agency says that it has “reviewed thousands of pages of technical information” about the Pfizer/BioNTech vaccine, including materials related to its development and manufacturing, as well as the results of its clinical trials to date.

Now that the panel has voted in favor of approval, the FDA will make a final determination on granting the EUA, and that should come within the next few days.

 

Google announced today it’s introducing a new search feature that will surface a list of authorized vaccines in users’ location, as well as informational panels about each individual vaccine. The feature is first being launched in the U.K., which earlier this month gave emergency authorization to the BioNTech/Pfizer coronavirus vaccine.  The company says the feature will roll out to other countries as their local health authorities authorize vaccines.

The feature itself will appear at the top of Google.com searches for Covid-19 vaccines and will present the authoritative information in a box above the search results, linking to the health authority as the source. The panel will also have two tabs. One will be the overview of the vaccine, which appears above Top Stories and links to Local and National resources, like government websites. The other will organize news related to the vaccine under a separate section.

Image Credits: Google

Google positioned the new search panels as one way it’s helping to address vaccine misinformation and hesitance at scale.

However, another arm of the company, YouTube, allowed Covid-19 misinformation and conspiracies to spread during the pandemic. While YouTube in April banned “medically unsubstantiated” content after earlier banning conspiracies that linked Covid-19 to 5G networks, it didn’t ban misinformation about Covid-19 vaccines until October. In other words, it didn’t proactively create a policy to ban all aspects of Covid-19 misinformation, but waited to address the spread of Covid-19 antivax content until vaccine approvals appeared imminent. This meant that any clips making false claims — like saying vaccines would kill their recipients, cause infertility, or implant microchips –were not officially covered by YouTube’s policies until October.

And even after the ban, YouTube’s moderation policies were found to miss many anti-vaccination videos, studies found.

This is not a new challenge for the video platform. YouTube has struggled to address antivax content for years, even allowing videos with prohibited antivax content to be monetized, at times.

Image Credits: Google

Today, Google downplayed YouTube’s issues in its fight against misinformation, saying that its Covid-19 information panels on YouTube which offer authoritative information have been viewed over 400 billion times.

However, this figure provides provides at look into the scale at which YouTube creators are publishing videos about the pandemic, often with just their opinions.

Google said, to date, it has removed over 700,000 videos related to dangerous or misleading Covid-19 health information. If the platform was regulated, however, it would not be entirely up to Google to decide when a video with dangerous information should be removed, what constitutes misinformation, or what the penalty against the creator should be.

The company also noted that it’s now helping YouTube creators by connecting them with health experts to make engaging and accurate content for their viewers, and donated $250 million in Ad Grants to help over 100 government agencies run PSAs about Covid-19 on the video platform. In April, Google donated $6.5 million to support COVID-19 related fact-checking initiatives, as well, and is now donating $1.5 million more to fund the creation of a COVID-19 Vaccine Media Hub.

As the healthtech landscape rapidly evolves another startup is making its presence known. HealNow has closed a $1.3 million round of funding from SoftBank Opportunity Fund and Redhawk VC.

The company was founded by Halston Prox and Joshua Smith. Prox has worked in healthcare for more than a decade with major organizations such as Providence Health, Mount Sinai and Baylor Scott & White, mostly focused on digitizing health records and designing and implementing software for doctors, nurses, etc. Smith, CTO at the company, has been a developer since 2012.

The duo founded HealNow to become the central nervous system for order and delivery of prescriptions, according to Prox. Your average payments processing system isn’t necessarily applicable to pharmacies large and small because of the complexities of health insurance and the regulatory landscape.

Not only is it costly to facilitate online payments for pharmacies, but they also have their own pharmacy management systems and workflows that can be easily disrupted by moving to a new payments system.

HealNow has built a system that’s specifically tailored to pharmacies of any shape or size, from grocery stores to mom and pop pharmacies and everything in between. It’s a white label solution, meaning that any pharmacy can put their brand language on the product.

“We’re embedded in their current workflows and pharmacies don’t have to do anything manual, even if they’re using a pharmacy management system,” said Prox.

When a user looks to get a prescription from their pharmacy, they are sent a link that allows them to securely answer any questions that may be necessary for the pick-up, enter insurance info, make a payment, and schedule a curbside pick-up or a delivery. The tech also integrates with third-party delivery services for pharmacies that offer deliveries.

This technology has been particularly important during the COVID-19 pandemic, giving smaller pharmacies the chance to compete with bigger chains who have digital solutions already set up that allow for curbside pick up. This is especially true now that Amazon has gotten into the space with the launch of Amazon Pharmacy.

HealNow is a SaaS company, charging a monthly subscription fee for use of the platform as well as a service fee for prescriptions purchased on the platform. However, that service fee is a flat rate that never changes based on the cost of the prescription.

The space is crowded and growing more crowded, with competitors like NimbleRX and Capsule offering their own spin on simplifying and digitizing the pharmacy. One big difference for HealNow, says Prox, is that the startup has no intention of ever being a pharmacy, but rather serving pharmacies in a way that doesn’t disrupt their current workflow or system.

“We’re not a pharmacy, and we want to enable all these pharmacies to be online,” said Prox. “To do that we have to do that in an unbiased way by focusing on being a complete tech company.”

The funding is going primarily toward building out the sales and marketing arms of the company to continue fueling growth. HealNow has a foothold in the West, Southwest and Middle America, and is opening an office in Birmingham to sprint across the East Coast. Prox says the company is processing thousands of orders a day and tens of thousands of orders each month.

HealNow launched in 2018 after graduating from the Entrepreneurs Roundtable Accelerator .

Apple is launching its subscription fitness service, which is built mainly to complement Apple Watch, on December 14. Apple Fitness+ was first announced at Apple’s iPhone event in September, and will offer guided workouts on iPhone iPad and Apple TV, with live personal metrics delivered by the Apple Watch’s health metrics monitoring.

The fitness offering will cover 10 workout types at launch, including Hight Intensity Interval Training (HIIT), strength, yoga, dance, core, cycling, indoor walking and running, as well as rowing and cooldown. All cases are led by real trainers that Apple selected to record the interactive sessions, and they’re soundtracked from “today’s top artists” according to the company.

The interactive elements are fed mostly by Apple Watch stats, and will display heart rate metrics, countdown timers, and goal achievement ‘celebration’ graphics which display on the screen when a user fills up their Apple Watch Activity rings. This is a level of direct integration that’s similar to what Peloton achieves with its service, but without requiring a whole connected stationary bike or treadmill to work.

Other distinguishing features of the service include a recommendation engine that leverages data including previous Fitness+ courses taken by a user, as well as their Apple Watch Workout App data and other third-party health and fitness app integration information from Apple Health to recommend new workouts, trainers and exercise routines. Apple’s use of third-party integrations is particularly interesting here, since it’s using its platform advantage to inform its service personalization.

Image Credits: Apple

Apple is also committing to weekly updates of new content across all categories of workouts, with varying intensity and difficult levels. Anyone using Fitness+ can also share their workouts with friends and family, and compete with others directly in the app if they want.

There’s also an optional Apple Music integration, which allows users to favorite songs and playlists directly from workouts to add them to their library, but users won’t require Apple Music in order to access the music used for the training videos, which are divided into different selectable “styles” or genres.

Apple Fitness+ is available starting December 14, and will retail for $9.99 per month, or $79.99 when paid for a twelve month period up front. It’s also part of Apple’s new Apple One Premier service bundle alongside other services.

This is definitely a major competitive service launch to existing subscription fitness offerings, including Peloton. Apple’s bundle offering, along with its system’s flexibility and syncing across its devices, could make it an easier choice for beginners and those just getting started with more serious training, though the lack of live classes might be a downside for some.

Like a lot of startups, Aarmy faced some big challenges when the pandemic forced widespread shutdowns in March.

Up until then, Aarmy was offering in-person fitness classes from its locations in New York and Los Angeles. Trey Laird, who founded the startup with trainers Akin Akman (chief fitness officer) and Angela Manuel-Davis (chief motivation officer), told me that within 48 hours, the strategy shifted online, starting with fitness classes via Instagram Live — something it continues to offer, while also launching a digital subscription program over the summer.

The startup is backed by celebrity investors including Jay-Z, Chris Paul and Karlie Kloss, as well as firms like Mousse Partners, Valia Ventures, Pendulum and Wilshire Lane Partners. Laird said that the team always planned to launch an online business, with a few physical locations serving as “content engines.” The pandemic just accelerated those plans.

“What changed is, we thought we had time to perfect everything,” Akman said. “[Once the pandemic hit,] we didn’t have time to have all these in-depth conversations, we didn’t have time to wait. We wanted to get out there.”

An Aarmy subscription costs $35 a month or $350 a year, offering access to a full digital library, including live sessions with Aarmy trainers, with 20 new practice sessions uploaded every week. The company says it already has “thousands” of paying subscribers, with a conversion rate of more than 70% from its free trial, and an 88% retention rate overall.

Davis acknowledged that Aarmy’s coaches have had rethink their approach, particularly since they can’t shoot themselves “in a room with 60 people” as originally planned. Now they have to provide all of the energy themselves, and they need to be “super intentional” about planning their sessions, rather than simply responding to the activity of the athletes in the room.

Beyond the classes, Aarmy has also launched an apparel business, selling a variety of fitness gear on its own website and via Net a Porter. In fact, the company says this side of the business has already brought in $450,000 in sales.

Akin described the overall Aarmy strategy as one that’s as much about mental conditioning as it is about physical fitness — which he argued has been well-suited to the pandemic era, when so many people are struggling with feelings of depression, isolation and the sense that they’re “victims of circumstance.”

Laird added, “For a brand where the inspiration and the mental strength and finding that inspiration is as important as the actual movement or actual workout, it’s been the perfect time. It’s presented a great opportunity to connect with people around the world and show what differentiates us.”

The state of California has now expanded access of its CA Notify app to all in the state, after originally deploying the app in a pilot program at UC Berkeley in November, which later expanded to other UC campuses. The statewide launch of the app, announced by California Governor Gavin Newsom on Monday, means that the tool based on Apple and Google’s exposure notification API will be available for download and opt-in use to anyone with a compatible iPhone or Android device as of this Thursday, December 10.

Apple and Google’s jointly-developed exposure notification API uses Bluetooth to determine contact between confirmed COVID-positive individuals and others, alerting users to potential exposure without storing or transmitting any data related to their identity or location. The system uses a randomized, rolling identifier to communicate possible exposure to other devices, and individual state health authorities can customize specific details like how close, and for how long individuals need to be in contact in order to quality as an exposure risk.

In the case of California, the state has set contact with a confirmed COVID-19 positive individual of within 6 feet, for a period of 15 minutes or more as meriting an exposure notification. Users who receive a positive COVID-19 test will get a text message from the Department of Public Health for the state that contains a code they input in the CA Notify app in order to trigger an alert broadcast to any phones that met the criteria above during the prior 14 days (the period during which the virus is transmissible).

As mentioned, there’s no personal information transmitted from a user’s device via the notification system, and it’s a fully opt-in arrangement. Other states have already deployed exposure notification apps based on the Apple/Google API, as have many other countries around the world. It’s not a replacement for a contact tracing system, in which healthcare professionals attempt to determine who a COVID-19 patient came in contact with to find out how they might have contracted the virus, and to whom they may spread it, but it is a valuable component of a comprehensive tracing program that can improve its efficacy and success.

Digital health startup Everlywell has raised a $175 million Series D funding round, following relatively fast on the heels of a $75 million Series C round it closed in February of this year. The Series D included a host of new investors, including BlackRock, The Chernin Group (TCG), Foresite Capital, Greenspring Associates, Morningside Ventures and Portfolio, along with existing investors including Highland Capital Partners, which led the Series C round. The startup has now raised over $250 million to date.

Everlywell, which launched to the public at TechCrunch Disrupt SF 2016 as a participant in Startup Battlefield, specializes in home health care, and specifically on home health care tests supported by their digital platform for providing customers with their results and helping them understand the diagnostics, and how to seek the right follow-on care and expert medical advice.

Earlier this year, Everlywell launched an at-home COVID-19 test collection kit – the first of this type of test to receive an emergency authorization from the U.S. Food and Drug Administration (FDA) for its use. The COVID-19 test kit joins its many other offerings, which include tests for thyroid hormone levels, food and allergen sensitivity, women’s health and fertility, vitamin D deficiency and more. I spoke to Everlywell CEO and founder Julia Cheek about the raise, and she acknowledged that the COVID-19 pandemic was definitely behind the decision to raise such a large amount so quickly again after the close of the Series C, since the company saw a sharp increase in demand coming out of the coronavirus crisis – not only for its COVID-19 test kit, but for at-home digital health care options in general.

“We obviously have a very successful COVID-19 test,” she said. “But we’ve also seen three-fourths of our test menu just explode at well over 100% year-over-year growth, and several of our tests are at 4x or 5x growth. That is really representative of this shift in consumer health behavior that will continue in a big way in many different verticals that include testing, and making things more convenient, digitally-enabled, and in the home.”

Like other companies built on solving for a shift to more remote and virtual care options, Cheek said that Everlywell had already anticipated this kind of consumer demand – but COVID-19 has dramatically accelerated the pace of change, which is why the startup put together this round, at this size, this quickly (she says they started the process of putting together the Series D just in September).

“We’ve been talking about the digital health movement, and the consumer-directed movement probably for a decade now,” she told me. “I do believe that this will be the watershed moment, unfortunately. But hopefully, we will come out on the other side of the pandemic and say, ‘There are some good things that happened broadly for healthcare.’ That is the hope of what we lean into everyday, and  fundamentally, why we went out and raised this amount of capital in this tremendous growth year.”

Image Credits: Everlywell

Everlywell has also expanded availability of its products this year, with distribution in over 10,000 retail locations across Target, Walgreens, CVS and Kroger stores across the U.S. The company also landed a number of new partnerships on the diagnostic lab and insurance payer side, as well as with major employers – a key customer group since employers shoulder the largest share of healthcare spending in the U.S. due to employee benefit plans. Cheek says that despite their commercial and enterprise customer wins, the focus remains squarely on consumer satisfaction, which is what distinguishes their offering.

“Our COVID-19 test is 75% new people buying our product, and it has an NPS [net promoter score] of 75,” she said. “And then it’s the most highly-referred product, and also one of our top tests where people buy other tests. Experience matters here – we know that if someone is a promoter of Everlywell, if they rate us a nine or a 10, on NPS, they are five times more likely to purchase again on the platform.”

That’s not new for Everlywell, according to Cheek – customers have always had a high degree of satisfaction with the company’s products. But what is new is the expanded reach, and the realization among many Americans that virtual care and at-home options are available, and are effective.

“What you have is this lightbulb moment for Americans in a new way that care can be delivered where then they definitely don’t want to go back,” she said. “It’s not just for Everlywell. This is all of these verticals, that have really shifted consumer behavior around healthcare in the home, and I think that will be somewhat permanent. That is the main driver here, and is what we’re seeing, and it’s why Everlywell has resonated so well with so many Americans.”

There are now about 50 million people with dementia globally, a number the World Health Organization expects to triple by 2050. Alzheimer’s is the leading cause of dementia and caregivers are often overwhelmed, without enough support.

Neuroglee, a Singapore-based health tech startup, wants to help with a digital therapeutic platform created to treat patients in the early stages of the disease. Founded this year to focus on neurodegenerative diseases, Neuroglee announced today it has raised $2.3 million in pre-seed funding.

The round was led by Eisai Co., one of Japan’s largest pharmaceutical companies, and Kuldeep Singh Rajput, the founder and chief executive officer of predictive healthcare startup Biofourmis.

Neuroglee’s prescription digital therapy software for Alzheimer’s, called NG-001, is its main product. The company plans to start clinical trials next year. NG-001 is meant to complement medication and other treatments, and once it is prescribed by a clinician, patients can access its cognitive exercises and tasks through a tablet.

The software tracks patients’ progress, such as the speed of their fingers and the time it takes to complete an exercise, and delivers personalized treatment programs. It also has features to address the mental health of patients, including one that shows images that can bring up positive memories, which in turn can help alleviate depression and anxiety when used in tandem with other cognitive behavioral therapy techniques.

For caregivers and clinicians, NG-001 helps them track patient progress and their compliance with other treatments, like medications. This means that healthcare providers can work closely with patients even remotely, which is especially important during the COVID-19 pandemic.

Neuroglee founder and CEO Aniket Singh Rajput told TechCrunch that its first target markets for NG-001 are the United States and Singapore, followed by Japan. NG-001 needs to gain regulatory approval in each country, and it will start by seeking U.S. Food and Drug Administration clearance.

Once it launches, clinicians will have two ways to prescribe NG-001, through their healthcare provider platform or an electronic prescription tool. A platform called Neuroglee Connect will give clinicians, caregivers and patients access to support and features for reimbursement and coverage.

Wellory, a startup that bills itself as taking an “anti-diet approach” to nutrition and wellness, is announcing that it has raised $4.2 million in funding.

The round was led by Story Ventures, with participation from Harlem Capital, Tinder co-founders Sean Rad and Justin Mateen, Ground Up Ventures, NBA Player Wayne Ellington, Hannah Bronfman and others.

Wellory founder and CEO Emily Hochman (who was previously the head of customer success at WayUp) told me that she struggled with dieting in college, to the point where she was risking chronic illness and infertility. As a result, she became determined to gain a better understanding of nutrition and her own health, eventually studying and becoming a certified health coach at the Institute for Integrative Nutrition.

Hochman said that through Wellory, she wants to offer that same understanding to others, which she said has created a “managed marketplace” matching users with a licensed nutritionist, registered dietitian or certified health coach. Those coaches create a personalized plan for losing weight or achieving other health goals, then continue to provide feedback as users share photos of each meal and additional health data.

For example, she said that a customer who had just given birth and was interested in postpartum weight loss would get matched with a coach who specializes in that area.

“The thing that is so important is that we build personalized plans,” she added. “We don’t have anything that says, ‘At Wellory, we do these 10 things and that’s a standard diet.’ We’re actually going to help you learn how to make smart and healthy decisions.”

Wellory CEO Emily Hochman

Wellory CEO Emily Hochman

Wellory officially launched in September, but Hochman said some beta testers have been using the service for nine, 10 or 11 months. She said early customers include people who are interested in weight loss, those who need nutrition advice due to chronic illness and “optimizers” who simply want to make sure they’re eating as healthily as possible.

She also noted that although customers usually sign up with a specific goal in mind, “once they hit their goal, because the power of a strong relationship, they say, ‘I don’t want to go back to where I was, let’s keep building, let’s make sure I can sustain this.'”

The app is available on iOS and Android and currently costs $59.99 per month. Hochman plans to introduce additional pricing tiers. and she said the funding will allow Wellory to expand the technology and marketing teams, and to explore new partnerships.

“As a data technology investor, we get approached by different types of wearable or diagnostic companies nearly every week,” said Jake Yormak of Story Ventures in a statement. “We love the category but what we saw in Wellory was a way to put a human coach at the center of understanding this health data. With nutrition as the wedge, Wellory has built a trusted relationship with people who affirmatively want to better understand and improve their wellbeing.”

A new $65 million investment led by the growth capital and public investment arm of Sequoia Capital will give Virta Health, a developer of a behavioral-focused diabetes treatment, a valuation of over $1 billion.

Virta’s approach, which uses a combination of approaches to change diet and exercise to reverse the presence of type 2 diabetes and other chronic metabolic conditions, has shown clinical success and attracted 100 health care payers to endorse the company’s treatments.

“We partnered with Virta for their ability to deliver unmatched health improvement and cost savings—two clear differentiators from other offerings on the market,” said William Ashmore, CEO of the State Employees’ Insurance Board of Alabama, in a statement. “Especially amid the COVID-19 pandemic, it’s vital that we provide our members the life-changing results Virta is known for delivering, through expert, virtual care delivered right to their home.”

The company said it would use the funding to expand sales and marketing efforts for its services as well as expand its research and development into other non-pharmaceutical therapies for metabolic conditions.

The financing came from Sequoia Capital Global Equities and Caffeinated Capital and brings the company’s total funding to over $230 million and gives it a $1.1 billion valuation, according to a statement.

Alongside Sequoia Capital Global Equities, Caffeinated Capital participated in the round, which brings total funding to more than $230 million and values Virta Health at over $1.1 billion.

Diabetes has long been an attractive condition for startups and has been the first target that companies focused on behavior changes to influence metabolic conditions aim to address. The reason why there are so many diabetes-focused businesses is because of the prevalence of the disease in the U.S. Almost half of adults in the U.S. suffer from obesity, pre-diabetes, or type 2 diabetes and the disease kills thirty people every hour. Diabetes also doubles the risk of death from COVID-19 infections.

Beyond the risks, the costs of treatment are skyrocketing. According to data from the American Diabetes Association released in March 2018, the total costs of treating diagnosed diabetes have risen to $327 billion in 2017 from $245 billion in 2012, when the cost was last examined.

“Given the scope of the metabolic crisis in the U.S. and globally, it cannot be understated how game-changing Virta’s results and care delivery are,” said Patrick Fu, managing partner at Sequoia Capital Global Equities, in a statement. “Virta’s technology-driven, non-pharmaceutical approach has fundamentally changed how diabetes is cared for, and our collective belief in what is possible for population health improvement. This is the future of chronic disease care.”

The UK’s medicines regulator has approved the BioNTech/Pfizer vaccine against COVID-19 for emergency use, the companies said today.

The UK is the first country to approve the vaccine for widespread use — paving the way for some of the most “high risk” citizens, such as elderly care home residents, to get the jab before the end of the year.

The BBC reports that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has said the vaccine is safe to be rolled out from next week.

The request for emergency authorization was submitted by BioNTech and Pfizer to the MHRA last month — as well as to regulators in Australia, Canada, Europe, Japan and the U.S., none of which has yet given the go ahead.

The UK approval is based on trial data, including a worldwide Phase 3 clinical study carried out by BioNTech/Pfizer  which demonstrated an efficacy rate for the vaccine of 95% and raised no serious safety concerns.

The vaccine was also shown to be effective both in participants who had not previously contracted the SARS-CoV-2 virus and those who had — based on measuring efficacy seven days after the second dose.

Efficacy was also reported as consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%, the companies said.

UK prime minister Boris Johnson tweeted the news of the formal authorization this morning — writing that the vaccine will “begin to be made available across the UK from next week”. A second tweet anticipated how vaccination in general will “ultimately” enable a return to economic life as usual.

The UK has ordered 40M doses of the BioNTech/Pfizer vaccine, or enough vaccine for 20M people (as it requires two doses), though it will take time for the country to receive all the doses ordered.

“The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts,” the companies wrote in a press release.

“Now that the vaccine is authorized in the U.K., the companies will take immediate action to begin the delivery of vaccine doses. The first doses are expected to arrive in the U.K. in the coming days, with complete delivery fulfilment expected in 2021,” they added.

The UK’s National Health Service is gearing up for what NHS chief executive, Sir Simon Stevens, described as “the largest-scale vaccination campaign in our country’s history”. Per the BBC, some 50 hospitals are on standby and vaccination centers in venues such as conference centres are also being set up.