Industrial cybersecurity startup Claroty raises $140M in pre-IPO funding round

Claroty, an industrial cybersecurity company that helps customers protect and manage their Internet of Things (IoT) and operational technology (OT) assets, has raised $140 million in its latest, and potentially last round of funding. 

With the new round of Series D funding, co-led by Bessemer Venture and 40 North, the company has now amassed a total of $235 million. Additional strategic investors include LG and I Squared Capital’s ISQ Global InfraTech Fund, with all previous investors — Team8, Rockwell Automation, Siemens, and Schneider Electric — also participating. 

Founded in 2015, the late-stage startup focuses on the industrial side of cybersecurity. Its customers include General Motors, Coca-Cola EuroPacific Partners, and Pfizer, with Claroty helping the pharmaceutical firm to secure its COVID-19 vaccine supply chain. Claroty tells TechCrunch it has seen “significant” customer growth over the past 18 months, largely fueled by the pandemic, with 110% year-over-year net new logo growth and 100% customer retention. 

It will use the newly raised funds to meet this rapidly accelerating global demand for The Claroty Platform, an end-to-end solution that provides visibility into industrial networks and combines secure remote access with continuous monitoring for threats and vulnerabilities. 

“Our mission is to drive visibility, continuity, and resiliency in the industrial economy by delivering the most comprehensive solutions that secure all connected devices within the four walls of an industrial site, including all operational technology (OT), Internet of Things (IoT), and industrial IoT (IIoT) assets,” said Claroty CEO Yaniv Vardi.

To meet this growing demand, the startup is planning to expand into new regions and verticals, including transportation government-owned industries, as well as increase its global headcount. The company, which is based in New York, currently has around 240 employees. 

Claroty hasn’t yet made any acquisitions, though CEO Yaniv Vardi tells TechCrunch that this could be part of the startup’s roadmap going forward.

“We’re waiting for the right opportunity at the right time, but it’s definitely part of the plan as part of the financial runway we just secured,” he said, adding that this latest funding round will likely be the company’s last before it explores a potential IPO.

“We are thinking that this is a pre-IPO funding round,” he said. “The end goal here is to be the market leader for industrial cybersecurity. One of the mascots can be going public with an IPO, but there are different options too, such as SPAC.”

The funding round comes amid a sharp increase in cyber targeting organizations that underpin the world’s critical infrastructure and supply chains. According to a recent survey carried out by Claroty, the majority (53%) of US industrial enterprises have seen an increase in cybersecurity threats since the start of 2020. The survey of 1,110 IT and OT security professionals also found that over half believed their organization is now more of a target for cybercriminals, with 67% having seen cybercriminals use new tactics amid the pandemic. 

“The number of attacks, and impact of these attacks, is increasing significantly, especially in verticals like food, automotive, and critical infrastructure. Vardi said. “That creates a lot of risk assessments public companies had to do, and these risks needed to be addressed with a security solution on the industrial side.”

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Russia tried to spread dangerous lies about Pfizer vaccine, France suspects

Pointy towers at sunset.

Enlarge / The Kremlin in Moscow, Russia, on Friday, Dec. 11, 2020. (credit: Getty | Bloomberg)

French authorities are investigating whether the Russian government is behind an effort to spread dangerous lies about Pfizer-BioNTech’s COVID-19 vaccine as part of a disinformation campaign peddled to French bloggers and influencers.

In recent days, several French influencers have publicly noted receiving partnership proposals from a dodgy agency, called Fazze, over email or social media. The proposals, written in broken English, offered enticing lumps of money if the influencers spread entirely false claims and doubts about COVID-19 vaccines. Among the proposed claims is the dangerous falsehood that people who received the Pfizer-BioNTech vaccine have a death rate three times higher than those who received the vaccine by AstraZeneca.

French news outlet Numerama obtained a copy of one of the emailed offers, which directed influencers to “Tell that mainstream media ignores this theme and you decided to share it with your subscriber [sic].” The offer also said to “put a question like ‘Why some governments actively purchasing Pfizer vaccine, which is dangerous to health of the people[sic]?’” The offer directed influencers to end their messages by encouraging subscribers to “draw their own conclusions.”

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Pfizer’s COVID vaccine can stay in normal fridge for up to a month, FDA says

A pharmacist holding a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19.

Enlarge / A pharmacist holding a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit: Getty | JEAN-FRANCOIS MONIER)

The US Food and Drug Administration on Wednesday announced a big change in the way doses of Pfizer-BioNTech’s COVID-19 vaccine can be handled. From now on, undiluted vials of the mRNA vaccine can stay at normal refrigerator temperatures for up to a month rather than the previous limit of just five days.

The change has the potential to significantly ease storage issues and promote the use of the highly effective vaccine, which has been hindered in some settings by its ultra-cold storage requirements.

For long-term storage, the vaccine still requires ultra-cold freezer temperatures—between -80°C to -60°C (-112°F to -76°F). But the vials can be transported and temporarily stored at normal freezer temperatures—between -25°C to -15°C (-13°F to 5°F)—for up to two weeks. According to yesterday’s update, the undiluted vials can then be thawed and kept at normal refrigerator temperatures—between 2°C to 8°C (35°F to 46°F)—for up to a month. Once the vials are diluted and ready for use, they must be used within six hours, according to the FDA’s detailed handling guide.

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FDA authorizes Pfizer’s COVID-19 vaccine for 12- to 15-year-olds

An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020.

Enlarge / An illustration picture shows vials with COVID-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS)

The US Food and Drug Administration has authorized the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents between the ages of 12 to 15, the agency announced Monday evening.

In the announcement, acting FDA Commissioner Janet Woodcock called the authorization “a significant step in the fight against the COVID-19 pandemic” that will bring the country “closer to returning to a sense of normalcy and to ending the pandemic.”

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, echoed that sentiment. He called the ability to vaccinate children and teens “a critical step” in the fight against COVID-19.

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AstraZeneca’s troubled vaccine not renewed in EU; Pfizer gets big, new deal

Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.

Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. (credit: Getty | Photonews)

The European Union has declined to renew orders for AstraZeneca’s COVID-19 vaccine, an EU official said Sunday. The decision comes after a series of production and safety troubles with AstraZeneca’s vaccine—and news on Saturday that the EU signed a deal to have Pfizer and BioNTech provide up to 1.8 billion doses of their vaccine between 2021 and 2023.

Last month, the EU took legal action against AstraZeneca, alleging that the company had failed to live up to its contract to supply the bloc with doses. The contract ends in June.

“We did not renew the order after June,” European Internal Market Commissioner Thierry Breton said in a Sunday French radio interview, which was reported by Reuters. “We’ll see what happens,” he added, leaving open the possibility of future orders.

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FDA reportedly plans to authorize Pfizer’s COVID vaccine for teens 12-15 in days

Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech.

Enlarge / Vials with COVID-19 Vaccine labels showing logos of pharmaceutical company Pfizer and German biotechnology company BioNTech. (credit: Getty | Photonews)

The Food and Drug Administration is planning to authorize the use of Pfizer-BioNTech’s COVID-19 vaccine in adolescents 12 to 15 years old later this week or early next week, according to a report by The New York Times.

The Times cited unnamed federal officials who did not have authorization to speak publicly about the FDA’s plans. If the FDA does authorize use of the vaccine in the teen group in the week, the Centers for Disease Control and Prevention’s vaccine advisory panel will likely meet a day later to review the clinical trial data and make a recommendation on use, the Times reported.

On March 31, Pfizer announced that the vaccine completely protected adolescents ages 12 to 15 against COVID-19 in a small Phase III clinical trial. The vaccine was also well-tolerated in the age group, producing mainly standard side effects.

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Real-world data shows vaccines kicking butt—including against scary variant

A healthcare worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine inside the Viejas Arena on the campus of San Diego State University in San Diego, California, US on Thursday, April 1, 2021.

Enlarge / A healthcare worker administers a dose of the Pfizer-BioNTech Covid-19 vaccine inside the Viejas Arena on the campus of San Diego State University in San Diego, California, US on Thursday, April 1, 2021. (credit: Getty | Bloomberg)

In a small trial, the Pfizer/BioNtech vaccine fully protected people from symptomatic COVID-19 caused by the worrisome B.1.351 coronavirus variant widely circulating in South Africa, the companies announced in a press release.

Though researchers will need more data to confirm the result, it is just the latest bit of positive news to come out this week about how the vaccines are performing with real-world conditions and in real-world settings.

On Monday, the Centers for Disease Control and Prevention released real-world data showing that the Pfizer/BioNTech mRNA vaccine and Moderna mRNA vaccine were, collectively, 90 percent effective at preventing infections in fully vaccinated health care, frontline, and essential workers.

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Pfizer: COVID vaccine shows “100% efficacy” in adolescents 12-15

Jonathan, a 16-year-old teenager, receives a dose of the Pfizer-BioNtech COVID-19 coronavirus vaccine at Clalit Health Services, in Israel's Mediterranean coastal city of Tel Aviv on January 23, 2021.

Enlarge / Jonathan, a 16-year-old teenager, receives a dose of the Pfizer-BioNtech COVID-19 coronavirus vaccine at Clalit Health Services, in Israel’s Mediterranean coastal city of Tel Aviv on January 23, 2021. (credit: Getty | Jack Guez)

Adolescents aged 12 to 15 were completely protected from symptomatic COVID-19 after being vaccinated with the Pfizer/BioNtech mRNA vaccine in a small Phase III clinical trial, Pfizer reported in a press release Wednesday.

The company also said that the vaccine was well tolerated in the age group, spurring only the standard side effects seen in people aged 16 to 25. The vaccine is already authorized for use in people aged 16 and over.

The vaccine appeared more effective at spurring defensive immune responses in adolescents aged 12 to 15 than in the 16- to 25-year-old group, producing even higher levels of antibodies that were able to neutralize SARS-CoV-2. In a measure of neutralizing antibodies, vaccinated youths in the new trial had geometric mean titers (GMTs) of 1,239.5, compared with the GMTs of 705.1 previously seen in those aged 16 to 25, Pfizer noted.

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#adolescents, #antibodies, #covid-19, #infectious-disease, #pfizer, #public-health, #school, #science, #teens, #vaccine

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A 3rd shot? A new booster? Vaccine makers race to trials to beat variants

COVID-19 vaccine at a vaccination center in Madrid on Feb. 26, 2021.

Enlarge / COVID-19 vaccine at a vaccination center in Madrid on Feb. 26, 2021. (credit: Getty | NurPhoto)

With worrisome coronavirus variants seemingly emerging and spreading everywhere, lead vaccine makers are wasting no time in trying to get ahead of the growing threat.

This week, Moderna and partners Pfizer and BioNTech announced they have kicked off new vaccine clinical trials aimed at boosting the effectiveness of their authorized vaccines against new, concerning SARS-CoV-2 variants—primarily B.1.351, a variant first identified in South Africa.

In a set of studies published last week in the New England Journal of Medicine, both the Moderna mRNA vaccine and Pfizer/BioNTech mRNA vaccine spurred antibodies in vaccinated people that could neutralize the B.1.351 variant. But the levels of those neutralizing antibodies were significantly lower than what was seen against past versions of the virus. (Both vaccines performed well against the B.1.1.7 variant, first identified in the UK, which is expected to become the dominant strain in the US next month.)

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CDC unveils site to help you find COVID-19 vaccine—but only in 4 states

A registered nurse practitioner holds up a sign and a flag asking for another patient to dose with the Pfizer Covid-19 vaccine as well as a more vaccine doses at a vaccination site in Seattle, Washington on January 24, 2021.

Enlarge / A registered nurse practitioner holds up a sign and a flag asking for another patient to dose with the Pfizer Covid-19 vaccine as well as a more vaccine doses at a vaccination site in Seattle, Washington on January 24, 2021. (credit: Getty | Grant Hendsley)

In its efforts to help Americans get vaccinated against COVID-19, the US Centers for Disease Control and Prevention is quietly working on a new website that will let people see every location in their community offering COVID-19 vaccinations, how many shots each of those locations has for the current day, and provide links to set up vaccination appointments.

That’s the ideal, at least; there’s a lot of work to do to get there.

Right now, the site—vaccinefinder.org—only has the full lists of vaccine providers for four states—Alaska, Indiana, Iowa, and Tennessee. Those lists include providers at hospitals, clinics, public health centers, doctor’s offices, drug stores, and grocery store pharmacies.

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#covid-19, #infectious-disease, #moderna-cdc, #pandemic, #pfizer, #science, #vaccine, #vaccinefinder

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Pfizer vaccine doesn’t need ultra-cold storage after all, company says

A picture taken on January 15, 2021 shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19.

Enlarge / A picture taken on January 15, 2021 shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit: Getty | JEAN-FRANCOIS MONIER)

In a bit of good news, Pfizer and BioNTech announced today that their highly effective COVID-19 vaccine does not require ultra-cold storage conditions after all and can be kept stable at standard freezer temperatures for two weeks.

The companies have submitted data to the US Food and Drug Administration demonstrating the warmer stability in a bid for regulatory approval to relax storage requirements and labeling for the vaccine.

If the FDA greenlights the change, the warmer storage conditions could dramatically ease vaccine distribution, allowing doses to be sent to non-specialized vaccine administration sites. The change would also make it much easier to distribute the vaccine to low-income countries.

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#biontech, #covid-19, #fda, #infectious-disease, #pandemic, #pfizer, #science, #ultra-cold, #vaccine

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Pfizer-BioNTech’s COVID-19 vaccine just got a lot easier to transport and distribute

The COVID-19 vaccine developed by Pfizer and BioNTech now has less stringent and extreme transportation requirements than it debuted with. Originally, the mRNA-based vaccine had to be maintained at ultra-low temperatures throughout the transportation chain in order to remain viable – between -76°F and -112°F. New stability data collected by Pfizer and BioNTech, which has been submitted to the U.S. Food and Drug Administration (FDA) for review, allow it to be stored at temps between 5°F and -13°F – ranges available in standard medical freezers found in most clinics and care facilities.

The vaccine should remain stable for up to two weeks at that temperature, which vastly improves the flexibility of its options for transportation, and last-mile storage in preparation for administration to patients. To date, the vaccine has relied largely on existing “cold-chain” infrastructure to be in place in order for it to be able to reach the areas where it’s being used to inoculate patients. That limitation hasn’t been in place for Moderna’s vaccine, which is stable at even higher, standard refrigerator temperatures for up to a month.

This development is just one example of how work continues on the vaccines that are already being deployed under emergency approvals by health regulators across the U.S. and elsewhere in the world. Pfizer and BioNTech say they’re working on bringing those storage temp requirements down even further, so they could potentially approach the standard set by the Moderna jab.

Taken together with another fresh development, study results from Israeli researchers that found just one shot of the ordinarily two-shot Pfizer-BioNTech vaccine could be as high as 85 percent effective on its own, this is a major development for global inoculation programs. The new requirements open up participation to a whole host of potential new players in supporting delivery and distribution – including ride-hailing and on-demand delivery players with large networks like Amazon, which has offered the President Biden’s administration its support, and Uber, which is already teamed up with Moderna on vaccine education programs.

This also opens the door for participation from a range of startups and smaller companies in both the logistics and the care delivery space that don’t have the scale or the specialized equipment to be able to offer extreme ‘cold-chain’ storage. Technical barriers have been a blocker for some who have been looking for ways to assist, but lacked the necessary hardware and expertise to do so effectively.

#amazon, #articles, #biden, #biontech, #biotech, #clinical-trials, #covid-19, #covid-19-vaccine, #health, #medical-research, #medicine, #moderna, #pfizer, #president, #tc, #uber, #united-states, #vaccine

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GSK eyes next-gen COVID vaccine as it inks deal to help boost current supply

A needle is inserted into a vial held by a gloved hand.

Enlarge / A vaccine syringe and vial in front of the GSK (GlaxoSmithKline) logo. (credit: Getty | Anadolu Agency)

After its own COVID-19 vaccine setback, GlaxoSmithKline has inked a $180 million deal to help German biotech company CureVac manufacture 100 million doses of its mRNA vaccine, which is currently under development. The deal also lays the groundwork for the two to cook up a next-generation vaccine that would protect against several concerning coronavirus variants at the same time.

The partnership is the latest example of a pharmaceutical giant teaming up with a peer—in some cases a rival—to help address the global shortage of desperately needed COVID-19 vaccines.

On January 27, Sanofi—one of the world’s leading vaccine makers—announced that it would use its manufacturing prowess to produce the vaccine developed by rivals Pfizer and BioNTech, which has already been authorized for use in the US and the EU. Sanofi will begin producing over 125 million doses of the Pfizer/BioNTech vaccine from its plant in Frankfurt, Germany, later this year.

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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.

#articles, #biontech, #biotech, #clinical-trials, #disease, #fda, #health, #illness, #johnson-johnson, #medical-research, #medicine, #moderna, #pfizer, #tc, #united-kingdom, #united-states, #vaccination, #vaccine

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Moderna says it’s making variant-specific COVID-19 vaccines, but its existing vaccine should still work

Moderna has detailed some of the steps it’s taking to ensure that its vaccine remains effective in the face of emerging strains of the SARS-CoV-2 virus that leads to COVID-19. These include testing how adding a second booster, for a total of three shots, works with its existing COVID-19 vaccine, and also developing a strain-specific variant designed to target spike proteins on the new variants of the virus that were first identified in the UK and in South Africa.

The company is pursuing these measures “out of an abundance of caution,” the biotech firm said in a press release, since early studies show that the existing vaccine continues to prove effective against these new strains, albeit with some loss of efficacy specifically with the B.1.351 variant which was first identified in patients in South Africa. Even so, it’s heartening to see the company moving quickly to address the virus’ mutation, since it’s likely that similar adaptations will be required longer term to keep COVID-19 in control even once the current pandemic is ended.

Further, Moderna says that in fact, it expects both its forthcoming candidate and its existing booster vaccine should be able to provide additional immunity posting capabilities when used in combination with “all of the leading vaccine candidates” on the market. That means the company believes it could be used in combination with the Oxford or Pfizer/BioNTech vaccines to boost immunity, which could be helpful in cases where supplies of one or the other are low and there’s an urgent need to provide a booster in a timely manner.

The best news of all of this is, of course, that Moderna now has evidence that suggests the mRNA-based vaccine it’s already providing to people globally will still provide protection against SARS-CoV-2, and by extension, COVID-19. Specifically for the UK variant in particular, the study data shows no reduction in immune performance in patients who received the vaccine. As for the South African variant, that reduction in efficacy mostly translates to a potential of quicker waning of immunity provided by the jab – which hopefully just means people will need another jab sooner than expected, but shouldn’t lead to any dramatic changes in our combined global approach to providing inoculations, especially initially.

#biontech, #biotech, #clinical-trials, #health, #medical-research, #medicine, #oxford, #pfizer, #south-africa, #tc, #united-kingdom, #vaccine

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Experts debate fiddling with vaccine doses as virus rages out of control

Vials of undiluted Pfizer COVID-19 vaccine are prepared to administer to staff and residents at the Goodwin House Bailey's Crossroads, a senior living community in Falls Church, Virginia, on December 30, 2020.

Enlarge / Vials of undiluted Pfizer COVID-19 vaccine are prepared to administer to staff and residents at the Goodwin House Bailey’s Crossroads, a senior living community in Falls Church, Virginia, on December 30, 2020. (credit: Getty | BRENDAN SMIALOWSKI )

With the pandemic continuing to surge to new heights, debate has erupted among experts about how to get the most protection as quickly as possible from the limited supply of COVID-19 vaccines currently available.

Suggestions floated so far include delaying the second of a two-dose regimen for maybe three to four months rather than doling them out in the planned three-to-four-week intervals evaluated in large clinical trials. With this change, more people can get a first dose now, offering ­some protection. Another possibility is simply cutting doses by half, which would immediately double the number of people who can be vaccinated now. And regulators in the United Kingdom have introduced the idea of mixing regimens—with some people getting their first dose of a vaccine by one manufacturer and then getting a second dose of vaccine from a different manufacturer based on availability at the time.

Evidence supporting these suggested tweaks in the vaccine rollout are shaky at best. But some experts argue that the dire state of the pandemic warrants a new, perhaps riskier approach.

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#astrazeneca, #covid-19, #fauci, #fda, #immunity, #moderna, #pfizer, #science, #vaccine

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Trump admin. agrees to pay Pfizer $1.95B for 100M more vaccine doses

Extreme close-up photograph of fingers holding a tiny glass jar.

Enlarge / A nurse in the UK holds a vial of the Pfizer-BioNTech COVID-19 vaccine on December 22, 2020. (credit: Lindsey Parnaby | AFP | Getty Images)

The Federal government has reached a deal with drugmaker Pfizer to secure an additional 100 million doses of the Pfizer-BioNTech COVID-19 vaccine before the end of July, the company said today.

Under the terms of the new agreement, the government will pay $1.95 billion for the additional doses. Of the new vaccine doses, 70 million are due by June 30, with the remaining 30 million to be delivered no later than July 31. The agreement also provides US authorities with the option to order up to 400 million additional doses of the vaccine later.

Health and Human Services Secretary Alex Azar said in a statement that the additional Pfizer vaccine “can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021,” when added to the 100 million doses the US government has already agreed to purchase from Pfizer, as well as the recently approved Moderna vaccine.

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#biontech, #coronavirus, #covid-19, #deals, #pfizer, #policy, #science, #vaccines

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FDA authorizes Moderna’s COVID-19 vaccine for emergency use

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, as expected after an independent panel commissioned by the administration recommended its approval earlier this week. This is the second vaccine now authorized for use in the U.S. under EUA, after the Pfizer -BioNTech vaccine was approved last week.

Moderna’s vaccine could begin being administered to Americans by “Monday or Tuesday” next week, according to Dr. Anthony Fauci speaking to NBC’s Today show in a new interview. That’s in keeping with the timelines between the Pfizer EUA and the first patients actually receiving the vaccine last week.

Like Pfizer’s vaccine, Moderna’s is an mRNA therapy. That means that it contains no actual virus — just genetic instructions that tell a person’s body to create a specific protein. That protein is more or less identical to the one that SARS-CoV-2, the virus which causes COVID-19, uses to attach to a host’s cells and replicate. Moderna’s vaccine causes a person to create just the protein, which on its own is harmless, and then their natural defenses via their immune system react to that and develop a method for fighting it off. That defense system is “remembered” by the body, while the vaccine itself naturally dissolves after a brief time, leaving a person with immunity but nothing else.

The Oxford-AstraZeneca vaccine, which has yet to be approved for use in the U.S., uses a weakened and modified common cold virus that doesn’t spread in humans to create the spike protein in recipients, resulting in the body generating its own immune response. That’s a much more tried-and-tested method for creating a vaccine, but both Moderna and Pfizer’s mRNA therapies have shown to be very effective in preliminary data from their large Phase 3 clinical trials.

#astrazeneca, #biontech, #biotech, #health, #medical-research, #medicine, #moderna, #oxford, #pfizer, #science, #tc, #united-states, #vaccine

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Finger-pointing abounds as states get fewer vaccines than planned

Fake highway sign showing the USS Enterprise hitting a speed bump

Enlarge / Operation Warp Speed hits a speed bump. (credit: Aurich Lawson / Getty Images)

As we’re waiting for word on the authorization of a second vaccine for use in the US, glitches have been striking the distribution of the first through the federal government’s “Operation Warp Speed.” This week, the US saw the first use of the vaccine developed by a Pfizer/BioNTech collaboration. But immediately afterward, many states started saying that orders for shipments in the ensuing weeks were being cut. After some in the federal government had indicated that the problem might be in production, Pfizer issued a statement indicating that it had doses in its warehouse ready to ship out but no indication of where to ship them to.

All in all, it’s about what you’d expect in the first weeks of a massive undertaking like this.

State of denial

One of the first states to report problems was Illinois, where its governor, J.B. Pritzker, said that it had indications it would only be receiving half the expected doses of the Pfizer/BioNTech vaccine next week. Since then, over a dozen states have indicated that they’ll be receiving fewer doses than planned in the second week (this article seems to have a fairly comprehensive list).

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FDA grants emergency use authorization for Pfizer’s COVID-19 vaccine, distribution to begin within days

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.

#biontech, #biotech, #covid-19, #health, #medical-research, #medicine, #moderna, #pfizer, #science, #tc, #the-new-york-times, #the-wall-street-journal, #united-states, #vaccine

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FDA advisors give thumbs up to Pfizer vaccine, paving way for authorization

An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020.

Enlarge / An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS)

The COVID-19 vaccine developed by Pfizer and BioNTech should be granted an Emergency Use Authorization from the US Food and Drug Administration, according to a committee of independent experts advising the agency.

The committee—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—made the recommendation today in a vote of 17 in favor, 4 against, and 1 abstain. Specifically, committee members voted in the affirmative to the question:

Based on the totality of scientific evidence available, do the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older?

If the FDA follows the recommendation and grants authorization, the vaccine will be widely accessible to people 16 years and older and distribution of the vaccine will likely to begin in the coming days.

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FDA panel recommends approving Pfizer’s COVID-19 vaccine emergency use authorization

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/<a 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.

 

#biontech, #biotech, #canada, #health, #manufacturing, #medical-research, #medicine, #pfizer, #tc, #united-states, #vaccine

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Two allergic reactions to Pfizer vaccine lead to warning in UK

Margaret Keenan, 90, who was the first patient in the United Kingdom to receive the first of two doses of the Pfizer-BioNTech COVID-19 vaccine, reacts as she talks with healthcare assistant Lorraine Hill, while preparing to leave University Hospital Coventry, in Coventry on December 9, 2020, a day after receiving the vaccine.

Enlarge / Margaret Keenan, 90, who was the first patient in the United Kingdom to receive the first of two doses of the Pfizer-BioNTech COVID-19 vaccine, reacts as she talks with healthcare assistant Lorraine Hill, while preparing to leave University Hospital Coventry, in Coventry on December 9, 2020, a day after receiving the vaccine. (credit: Johnny Weeks | Getty Images)

People with a significant history of allergies should not receive the Pfizer/BioNTech coronavirus vaccine, the UK medical regulator has said after two NHS staff experienced an adverse reaction.

June Raine, chief executive for the Medicines and Healthcare products Regulatory Agency (MHRA), told a UK parliamentary committee that the two individuals had the allergic reaction shortly after receiving the vaccine and that the regulator was investigating. Both people had a history of serious allergies and carried adrenalin pens.

“We know from the very extensive clinical trials that this wasn’t a feature but if we need to strengthen our advice… we get that advice to the field immediately,” Dr. Raine said.

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Trump to hold “Vaccine Summit” today—no vaccine-makers agreed to come

US President Donald Trump in the Oval Office of the White House in Washington, DC on December 7, 2020.

Enlarge / US President Donald Trump in the Oval Office of the White House in Washington, DC on December 7, 2020. (credit: Getty | Saul Loeb)

The Trump administration will host a “Vaccine Summit” today at the White House. But notably absent from the vaccine-centered event will be any companies that actually make vaccines—including the companies leading the race for a COVID-19 vaccine, Moderna, Pfizer, and Pfizer’s partner BioNTech.

The companies reportedly declined to attend or withdrew, which is seen as a snub to lame-duck President Trump. Senior officials for the Trump administration, meanwhile, said the administration decided to go “in a different direction.”

The Trump administration has pitched the unusual event as a way to educate the public about vaccine development, regulatory approval, and distribution processes and to congratulate the many players helping to develop COVID-19 vaccine candidates. The event includes a “fire-side chat” with top vaccine regulator Peter Marks from the Food and Drug Administration. There will also be talks with representatives from FedEx, UPS, McKesson, CVS, and Walgreens, who will all help get any FDA-approved vaccines to people’s arms.

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Moderna claims 94% efficacy for COVID-19 vaccine, will ask FDA for emergency use authorization today

Drugmaker Moderna has completed its initial efficacy analysis of its COVID-19 vaccine from the drug’s Phase 3 clinical study, and determined that it was 94.1% effective in preventing people from contracting COVID-19 across 196 confirmed cases from among 30,000 participants in the study. Moderna also found that it was 100% effective in preventing severe cases (such as those that would require hospitalization) and says it hasn’t found any significant safety concerns during the trial. On the basis of these results, the company will file an application for emergency use authorization (EUA) with the U.S. Food and Drug Administration (FDA) on Monday.

Seeking an EUA is the next step towards actually beginning to distribute and administer Moderna’s COVID-19 vaccine, and if granted the authorization, it will be able to provide it to high-risk individuals in settings where it could help prevent more deaths, such as with front-line healthcare workers, ahead of receiving a full and final regulatory approval from the U.S. healthcare monitoring agency. Moderna will also seek conditional approval from the European Medicines Agency, which will enable similar use ing the EU.

Moderna’s vaccine is an mRNA vaccine, which provides genetic instructions to a person’s body that prompts them to create their own powerful antibodies to block the receptor sites that allows COVID-19 to infect a patient. It’s a relatively new therapeutic approach for human use, but has the potential to provide potentially even more resistance to COVID-19 than do natural antibodies, and without the risk associated with introducing any actual virus, active or otherwise, to an inoculated individual in order to prompt their immune response.

In mid-November, Moderna announced that its COVID-19 vaccine showed 94.5% efficacy in its preliminary results. This final analysis of that same data hews very close to the original, which is promising news for anyone hoping for an effective solution to be available soon. This data has yet to be peer reviewed, though Moderna says that it will now be submitting data from the Phase 3 study to a scientific publication specifically for that purpose.

Moderna’s vaccine candidate is part of the U.S’s Operation Warp Speed program to expedite the development, production and distribution of a COVID-19 vaccine, initiated earlier this year as a response to the unprecedented global pandemic. Other vaccines, including one created by Pfizer working with partner BioNTech, as well as an Oxford University/AstraZeneca-developed candidate, are also far along in their Phase 3 testing and readying for emergency approval and use. Pfizer has already applied with the FDA for its own EUA, while the Oxford vaccine likely won’t be taking that step in the U.S. until it completes another round of final testing after discovering an error in the dosage of its first trial – which led to surprising efficacy results.

#astrazeneca, #biontech, #biotech, #coronavirus, #covid-19, #european-union, #health, #healthcare, #medical-research, #medicine, #moderna, #oxford-university, #pfizer, #tc, #united-states, #vaccine

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AstraZeneca says it will likely do another study of COVID-19 vaccine after accidental lower dose shows higher efficacy

AstraZeneca’s CEO told Bloomberg that the pharmaceutical company will likely conduct another global trial of the effectiveness of its COVID-19 vaccine trial, following the disclosure that the more effective dosage in the existing Phase 3 clinical trial was actually administered by accident. AstraZeneca and its partner the University of Oxford reported interim results that showed 62% efficacy for a full two-dose regimen, and a 90% efficacy rate for a half-dose followed by a full dose – which the scientists developing the drug later acknowledged was actually just an accidental administration of what was supposed to be two full doses.

To be clear, this shouldn’t dampen anyone’s optimism about the Oxford/AstraZeneca vaccine. The results are still very promising, and an additional trial is being done only to ensure that what was seen as a result of the accidental half-dosage is actually borne out when the vaccine is administered that way intentionally. That said, this could extend the amount of time that it takes for the Oxford vaccine to be approved in the U.S., since this will proceed ahead of a planned U.S. trial that would be required for the FDA to approve it for use domestically.

The Oxford vaccine’s rollout to the rest of the world likely won’t be affected, according to AstraZeneca’s CEO, since the studies that have been conducted, including safety data, are already in place from participants around the world outside of the U.S.

While vaccine candidates from Moderna and Pfizer have also shown very strong efficacy in early Phase 3 data, hopes are riding high on the AstraZeneca version because it relies on a different technology, can be stored and transported at standard refrigerator temperatures rather than frozen, and costs just a fraction per dose compared to the other two leading vaccines in development.

That makes it an incredibly valuable resource for global inoculation programs, including distribution where cost and transportation infrastructures are major concerns.

#astrazeneca, #biotech, #ceo, #coronavirus, #covid-19, #fda, #health, #medical-research, #moderna, #oxford, #pfizer, #pharmaceutical, #tc, #united-states, #vaccine, #vaccines

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We don’t have a COVID vaccine yet, but distribution is already messy

A sign on the entrance to a pharmacy reads "Covid-19 Vaccine Not Yet Available", November 23, 2020 in Burbank, California.

Enlarge / A sign on the entrance to a pharmacy reads “Covid-19 Vaccine Not Yet Available”, November 23, 2020 in Burbank, California. (credit: Getty | Robyn Beck)

Individual states will ultimately decide who will get the first 6.4 million doses of COVID-19 vaccine, which will be distributed based on each state’s population rather than the levels of disease spread or number of high-risk people.

The approach, announced in a press briefing Tuesday, is a departure from earlier plans and reflects the frenzied effort to vaccinate a country of nearly 330 million as quickly as possible.

Top officials for Operation Warp Speed—the federal government’s program to swiftly develop and deliver COVID-19 vaccines and therapies—said at the briefing that the current approach is intended to “keep this simple.” However, the potential for state-by-state variation in early access to vaccines could easily become complicated—and time is ticking for states to get their distribution plans clarified. There’s just a matter of weeks before the Food and Drug Administration may grant an emergency authorization for a vaccine by Pfizer and BioNTech.

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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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First COVID-19 vaccine goes to FDA today for emergency authorization

Pfizer headquarters in Manhattan, New York City, United States on November 19, 2020.

Enlarge / Pfizer headquarters in Manhattan, New York City, United States on November 19, 2020. (credit: Getty | Anadolu Agency)

Today the US Food and Drug Administration will receive its first submission of a candidate vaccine to fight the pandemic coronavirus.

Pharmaceutical giant Pfizer and German biotech firm BioNTech announced early this morning that they are submitting the formal request to obtain an Emergency Use Authorization (EUA) from the FDA for the companies’ mRNA vaccine, BNT162b2.

The submission follows the celebrated news just Wednesday that the companies had wrapped up their Phase III trial and found the vaccine to be 95-percent effective at preventing symptomatic COVID-19, the disease caused by the coronavirus, SARS-CoV-2.

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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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Pfizer reports final vaccine results: 95% efficacy

An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020.

Enlarge / An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (credit: Getty | JUSTIN TALLIS)

Pharmaceutical giant Pfizer and German biotech firm BioNTech announced Wednesday that they have wrapped up the Phase III trial of their COVID-19 mRNA vaccine, finding it to be 95 percent effective at preventing disease and consistently effective across age, gender, race, and ethnicity demographics. The vaccine appeared effective at preventing cases of severe disease as well.

The companies added that they have also met a safety milestone—collecting a median of two months of safety monitoring data on trial participants—to file a request for an Emergency Use Authorization (EUA) with the US Food and Drug Administration. They plan to file the request “within days.”

“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Dr. Albert Bourla, Pfizer Chairman and CEO, said in a statement. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”

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Pfizer says its COVID-19 vaccine is 95% effective in final clinical trial results analysis

Drugmaker Pfizer has provided updated analysis around its COVID-19 vaccine Phase 3 clinical trial data, saying that in the final result of its analysis of the 44,000-participant trial, its COVID-19 vaccine candidate proved 95% percent effective. This is a better efficacy rate than Pfizer reported previously, when it announced a 90% effectiveness metric based on preliminary analysis of the Phase 3 trial data.

This result also follows a preliminary data report from Moderna about their own Phase 3 trial of their vaccine candidate, which they reported showed 94.5% effectiveness. Pfizer and partner BioNTech’s vaccine is an mRNA-based preventative treatment, similar to the Moderna one, and now it looks like they should be roughly similar in efficacy – at least in the early offing, based on a limited sample of total cases and prior to peer review by the scientific community, which is yet to come.

The Pfizer data in its final analysis shows that among a total of 170 confirmed COVID-19 cases so far among the 44,000 people who took part in the study, 162 cases came from the placebo group while only eight were from the group of those who received the actual vaccine candidate. The company also reported that 9 out of 10 of the severe cases among those who were infected occurred in the placebo group, suggesting that even in the rare occasion that the vaccine didn’t prevent contraction of COVID-19, it helped reduce its severity.

This should help Pfizer make its case that it be granted an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to be able to provide the vaccine early pending full and final approval as an emergency measure. Earlier this week, the company reported that it has already collected two months’ worth of follow-up data about participants in its trial, which is a required component for said approval, and it’s pursuing it with hopes of seeking that EUA “within days.” The company intends to ramp production of its vaccine beginning later this year, and achieving a run rate of up to 1.3 billion doses by next year.

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

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More good COVID-19 vaccine news—but it won’t save us

A serious man in a suit speaks in front of a blurry World Health Organization logo.

Enlarge / Geneva: WHO Director-General Tedros Adhanom Ghebreyesus announced on March 11, 2020, that the new coronavirus outbreak can now be characterized as a pandemic. (credit: Getty | FABRICE COFFRINI)

There’s more good news on the COVID-19 vaccine front today: biotechnology company Moderna reported in a press release this morning that its mRNA vaccine appeared 94.5 percent effective at preventing COVID-19 in an interim analysis of a large, Phase III trial. The news comes exactly one week after similar results came out via press release for another mRNA vaccine developed by pharmaceutical giant Pfizer and German biotech firm BioNTech.

But while health experts are “cautiously optimistic” for this and many other vaccines in the coming months, they warn that such a timeline will not be fast enough to spare lives and health care systems from the current spike in disease.

“Right now, we are extremely concerned by the surge in cases we’re seeing in some countries,” Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, said in a press conference Monday. “Particularly in Europe and the Americas, health workers and health systems are being pushed to the breaking point.”

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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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Carbon Health raises $100 million with plans to expand pop-up clinics ahead of COVID-19 vaccination programs

Carbon Health has raised a $100 million Series C funding round, led by Dragoneer Investment Group and including participation from prior investors Brookfield Technology Partners, DCVC and Builders VC. This funding will be used to help the SF-based healthcare provider startup to continue to expand its nationwide footprint, including with the opening of 100 pop-up clinics planned for across 20 markets across the U.S.

This past year has seen Carbon Health expand from just seven clinics to 27, spread out across six different states. The company, which focuses on primary care, has also introduced virtual care options with an emphasis on what it calls “omnichannel” care, or offering services in whatever method is most convenient, effective and appropriate for its customers. The startup has always aimed at a hybrid care approach, but it’s emphasizing the flexibility of its model in response to COVID-19, and has in particular accelerated its plans around its pop-up clinics.

These are deployed in under-utilized spaces in regions where additional care options are needed, including parking lots and garages. Carbon Health partnered early with Reef Technology on opening these locations, using shipping-container style mobile trailers to provide on-site care. Carbon Health founder and CEO Eren Bali explained to me that while remote care can be very effective, in some instances, it requires some nurse practitioner support with virtual physician-guided services to provide a complete solution for customers.

The company is also looking to support greater testing capacity using this model, and eventually looking ahead to providing an infrastructure that can help with widespread COVID-19 vaccine distribution, once one is ready to go. While some scientific results this week have been very promising, including with Pfizer’s Phase 3 clinical trial, ultimately the effort of undertaking a national vaccine inoculation program will require cooperation among many stakeholders, including primary care providers.

#biotech, #builders-vc, #ceo, #dcvc, #dragoneer-investment-group, #eren-bali, #funding, #health, #health-care, #medical-research, #omnichannel, #pfizer, #primary-care, #recent-funding, #reef-technology, #startup-funding, #startups, #tc, #united-states, #vaccine

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Here’s everything you need to know about Pfizer’s positive vaccine news

A woman wears a facemask as she walks by the Pfizer world headquarters in New York on November 9, 2020.

Enlarge / A woman wears a facemask as she walks by the Pfizer world headquarters in New York on November 9, 2020. (credit: Getty | KENA BETANCUR )

An experimental mRNA coronavirus vaccine developed by pharmaceutical giant Pfizer and German firm BioNTech appeared to be more than 90-percent effective at preventing symptomatic COVID-19 cases in an interim analysis of their large Phase III clinical trial.

The two companies reported the top-line results of the analysis in a press release early Monday but have not yet published or released detailed data from the trial.

The companies said that they could file for an Emergency Use Authorization (EUA) from the US Food and Drug Administration in the third week of November. That’s the point at which the companies will have a median of two months of safety monitoring data on trial participants, a milestone specified by the FDA—at the objection of the Trump administration.

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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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Pfizer dashes hope for COVID-19 vaccine data before the election

Albert Bourla, chief executive officer of Pfizer pharmaceutical company, bangs a gavel after ringing the closing bell at the New York Stock Exchange (NYSE) on Thursday afternoon, January 17, 2019 in New York City.

Enlarge / Albert Bourla, chief executive officer of Pfizer pharmaceutical company, bangs a gavel after ringing the closing bell at the New York Stock Exchange (NYSE) on Thursday afternoon, January 17, 2019 in New York City. (credit: Getty | Drew Angerer)

Pfizer’s chief executive has dashed any lingering hope that we’ll glimpse COVID-19 vaccine data before next week’s election.

The pharmaceutical giant has the speediest clinical-trial design among the frontrunners in the COVID-19 vaccine race. And for weeks, Pfizer CEO Albert Bourla has dangled the possibility that his company would have results by the end of October—an enticing prospect picked up by President Donald Trump, who has pushed for October vaccine news to bolster his re-election bid.

But in a call with investors Tuesday, Bourla indicated an October release was nearly impossible now. Researchers conducting the over 40,000-person trial have not yet analyzed preliminary data and, even if the data were available tomorrow, an outside panel would need at least a week to analyze any results, Bourla said.

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#clinical-trial, #covid-19, #pfizer, #sars-cov-2, #science, #vaccine

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The US now seems to be pinning all of its hopes on COVID-19 therapies and vaccines

Almost eight months after the White House first announced it would move from containment to mitigation efforts to stop the spread of the COVID-19 epidemic, the Administration is now pinning its hopes on vaccines to inoculate the population and therapies to treat the disease.

Months after announcing it would be working with technology giants Apple and Google on a contact tracing app (and nearly two months after Google and Apple rolled out their exposure notification features) and initiating wide spread testing efforts nationwide with the largest national pharmacies (which never received the coordinated support it needed),  the Administration appears to be giving up on a national effort to stop the spread of the COVID-19 epidemic.

In an interview with CNN’s Jake Tapper White House Chief of Staff Mark Meadows said that the US is “not going to control the pandemic… We are gonna control the fact that we get vaccines, therapeutics and other mitigation.”

The admission is a final nail in the coffin for a federal response that could have involved a return to lockdowns to stop the spread of the virus, or national testing and contact tracing and other mitigation measures. Meadows statement comes as the US experiences a second peak in infection rates. There are now over 8.1 million cases and over 220,000 deaths since the first confirmed infection on US soil on January 20. 

Now, the focus is all on the vaccines, therapies and treatments being developed by large pharma companies and startups alike that are making their way through the approval processes of regulatory agencies around the world.

The vaccines in phase three clinical trials

There are currently 12 vaccines in large scale, late-stage clinical trials around the world, including ones from American companies Novavax, Johnson & Johnson, Moderna Therapeutics, and Pfizer who are recruiting tens of thousands of people in the US and UK to volunteer for testing.

In China, the state run pharmaceutical company Sinopharm has filed its application to China’s regulatory commission for the approval of a vaccine and hundreds of thousands of civilians have already been vaccinated under emergency use approvals from the Chinese government, according to a report in the New Yorker. Meanwhile the privately held Chinese pharmaceutical company, Sinovac, is moving forward with phase three trials for its own vaccine in Brazil, Bangladesh and Indonesia. Another private Chinese company, CanSino Biologics developed a vaccine that was already being distributed to members of the Chinese military in late July,

A collaboration in the U.K. between the University of Oxford and European pharmaceutical company AstraZeneca is also recruiting volunteers in Brazil, India, the United Kingdom, the US and South Africa. And, in Australia, the Murdoch Children’s Research Institute is trying to see whether a vaccine used to prevent tuberculosis could be used to vaccinate against the coronavirus.

Finally in Russia, the Gamaleya National Center of Epidemiology and Microbiology in partnership with the state-run Russian Direct Investment Fund have claimed to have developed a vaccine that the country has registered as the first one on the market cleared for widespread use. Russia has not published any data from the clinical trials it claims to have conducted to prove the efficacy of the vaccine and the World Health Organization still considers the treatment to be in the first phase of development.

Therapies in phase three clinical trials

If vaccines can prevent against infection, a slew of companies are also working on ways to limit the severity of the disease should someone become infected with Sars-Cov-2, the novel coronavirus that causes COVID-19.

The Milken Institute lists 41 different therapies that have made it through to phase three of their clinical trials (the last phase before approval for widespread delivery).

These therapies come in one of five primary categories: antibody therapies, antivirals, cell-based therapies, RNA-based treatments, and repurposing existing treatments that may be in pharmaceutical purgatory.

Antibody therapies use the body’s natural defense systems either taken from the blood of people who have recovered from an infection or manufactured in a lab to neutralize the spread of a virus or bacteria. Antivirals, by contrast, stop a virus from spreading by attacking the viruses’ ability to replicate. Cell-based therapies are designed to boost the immune system’s ability to fight pathogens like viruses or bacteria. Meanwhile RNA-based treatments are another method to stop the virus from replicating by blocking the construction of viral proteins. Finally, several companies are mining their libraries of old drug compounds to see if any might be candidates for COVID-19 treatments.

So far, only three therapeutics have been approved to treat COVID-19. In the U.K. and Japan dexamethasone has received approvals, while favilavir is being used in China, Italy and Russia; and — famously thanks to its use by the President — remdesivir has been approved in the United States, Japan and Australia.

The US is also using convalescent plasma to treat hospitalized patients under emergency use authorizations. And special cases, like the President’s, have had access to other experimental treatments like Regeneron’s cell therapy under emergency use authorizations.

And there are several US-based startups developing potential COVID-19 therapies in each of these areas.

Adaptive Biotechnologies, Cytovia Therapeutics, and SAB Biotherapeutics are all developing antibody treatments. Applied Therapeutics is using an understanding of existing compounds to develop treatments for specific conditions associated with COVID-19. Cellularity has a cell-therapy that could reduce a patient’s viral load by stimulating so-called natural killer cells to attack infected cells. Humanigen has developed a new drug that could reduce fatalities in high-risk COVID-19 patients with severe pneumonia. Meanwhile Partner Therapeutics is working on a drug that could improve lung function in COVID-19 patients — and potentially boost antibody production against the virus and restore damaged lung cells. Finally, Sarepta Therapeutics has been working with the United States Army Medical Research Institute of Infectious Diseases to find ways for its RNA-based treatment to stop the spread of coronaviruses by attacking the ability for the virus to replicate.

Beyond therapies, startups are finding other ways to play a role in helping the nation address the COVID-19 epidemic.

“At this point the U.S. doesn’t have the best public health system, but at the same time we have best-in-class private companies who can sometimes operate a lot more efficiently than governments can,” Carbon Health chief executive Eran Bali told the audience at TechCrunch’s Disrupt 2020 conference. “We also just recently launched a program to help COVID-positive patients get back to health quickly, a rehabilitation program. Because as you know even if you survive it doesn’t mean your body was not affected, there are permanent effects.”

Indeed the drive for more effective at-home tests and remote treatments for consumers are arguably more important when the federal government refuses to make the prevention of viral spread a priority, because consumers may voluntarily lock down if the government won’t.

“This is an opportunity to take a technology that naturally is all about detecting viruses — that’s what CRISPR does in [its native environment] bacteria — and repurposing it to use it as a rapid diagnostic for coronavirus,” said the Nobel Prize-winning co-inventor of some foundational CRISPR gene-editing technology, Jennifer Doudna. “We’re finding in the laboratory that that means that you can get a signal faster, and you can also get a signal that is more directly correlated to the level of the virus.”

#astrazeneca, #covid-19, #jake-tapper, #jennifer-doudna, #johnson-johnson, #moderna-therapeutics, #pfizer, #pharmaceutical, #tc, #vaccine, #world-health-organization

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COVID vaccine makers vow science—not Trump—will dictate release timing

Woman receives an experimental COVID-19 vaccine at the University of Massachusetts Medical School in Worcester, MA on September 04, 2020, as part of a clinical trial.

Enlarge / Woman receives an experimental COVID-19 vaccine at the University of Massachusetts Medical School in Worcester, MA on September 04, 2020, as part of a clinical trial. (credit: Getty | Boston Globe)

In an extraordinary move Tuesday, nine top pharmaceutical executives made a public pledge that they will not prematurely release a COVID-19 vaccine and that they will only seek federal approval to distribute a vaccine after rigorous ethical and scientific standards are met.

The pledge was signed by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi. All of the represented companies are working on a vaccine against COVID-19 and four—AstraZeneca, Moderna, and a joint venture between BioNTech and Pfizer—have vaccines in phase 3 clinical trials.

The vow appears to be a coordinated resistance to pressure from the Trump administration, which is pushing for a rollout of a vaccine by November 1, just before the presidential election. Last week, the Centers for Disease Control and Prevention told states to be ready to start distributing vaccines by November 1.

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#astrazeneca, #cdc, #covid-19, #fda, #gsk, #infectious-diseases, #moderna, #pfizer, #public-health, #sars-cov-2, #science, #trump, #vaccine

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Withings raises $60 million to bridge the gap between consumer tech and healthcare providers

Since being re-acquired from Nokia in 2018 by a group including its original founders and some of its original investors, health tech company Withings has been focused on evolving their offering of consumer health hardware to provide medical-grade data that can be shared with, and leveraged by healthcare professionals to deliver better, more personalized care. The company has now raised another $60 million to continue pursuing that goal, a Series B funding round co-led by Glide Healthcare, along with existing Withings investors IDinvest Partners, Bpfrance and BNP Paribas Développement, ODDO BHF and Adelle Capital.

Withings will use the funds to ramp up its MED PRO division, a part of the business formed last year that focuses on the company’s B2B efforts, placing its medical-grade consumer health devices in programs and deployments managed by medical professionals, health institutions, insurance payers, researchers and more.

In an interview, Withings CEO Mathieu Letombe explained that following the re-acquisition of the company, the team set out to “pivot slightly” in regards: First, the company would only focus on medical grade products and services from here on out, something that Letombe said was done at least in part because of how crowded the general ‘wellness’ tech category has become, and in part because players like Apple had really, in their view, made the most of that category with their Apple Watch and other health features.

The second was to shift on their business side to better address the B2B market – primarily due to inbound requests to do so.

“We were getting a lot of requests from the healthcare industry,” Letombe told me. “And by the healthcare industry I mean major healthcare programs, like the diabetes prevention program, the hypertension program. Also hospitals, insurers and Pharma, so we decided to dig into it and we saw the there was a huge demand for medical connected devices from this world.”

According to Letombe, Withings was well-pos