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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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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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-positioned to address this need, and had an advantage over other traditional medical device suppliers for enterprise and industry. The company’s DNA was in building accurate, user-friendly devices to help them keep an eye on their wellbeing at home, and so they put their focus on evolving those products so that the results they provide pass the standards of governing medical device regulatory bodies around the world.

Withings’ special advantage in this pursuit was that it knew very well how to build products that customers want to use, and have opted to pay out of pocket for in the past. Most medical equipment for at-home monitoring that comes from a payer or a healthcare institution hasn’t had to face the challenges and focusing rigor of the consumer technology market, and it’s foisted upon users, not selected by them from a field of choices. Letombe says that this consumer edge is what has helped Withings with its B2B business, and notes that both sides of the market will continue to be of equal importance to the company going forward.

The company had been turning its attention to building out a suite of products, from smart blood pressure monitors, to scales that measure body fat percentage, to contactless thermometers and much more, long before there was any hint of the current COVID-19 pandemic, obviously. But that demand from the healthcare industry has stepped up considerably in the wake of the coronavirus, which has accelerated plans from insurers, care providers and healthcare pros to develop and deploy remote care capabilities and services.

“We also got a ton of requests from a company that wanted to create back-to-work packages, were there was a thermometer or a scale or blood pressure monitor for them to help the employee understand if they are at risk for COVID,” Letombe said, noting that the B2B opportunities the company has seen extend beyond the healthcare industry itself.

Image Credits: Withings

To assist with its new medical B2B focus, Withings has also formed a Medical Advisory Board, which Letombe says they’ve actually been working with for a year but that they’re only announcing publicly alongside this funding. The board includes Mayo Clinic Platform President Dr. John Halamka, former head of Clinical Pharmacology in Hôpital Européen Georges Pompidou Dr. Stéphane Laurent, and former head of Clinical Innovation at Pfizer Craig Lipset – top medical professionals across respected institutions and one of the largest therapeutics companies in the world.

Letombe notes that Withings also has a number of medical physicians and professionals on staff, as well as a psychologist and a physicist, and so they’re involved in building the products themselves throughout their design and creation, rather than just validating their results after the fact.

Withings would seem to be in a great position to address not only the growing need for connected medical monitoring tools, but also to understand exactly what makes those products work for consumers, and become something they actively want to use as part of their lifestyle. This new $60 million round is a vote of confidence in that strategy, and in its ability to become something bigger and still more ambitious.

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Digital elective care and telemedicine provider Ro raises $200 million at a reported $1.5 billion valuation

In three years Zachariah Reitano’s startup, Ro, has managed to hit a reported $1.5 billion valuation for its transformation from a company focused on treating erectile disfunction to a telemedicine service for a range of elective and urgent care-focused treatments.

Through Rory for women’s health, Roman for men’s health, and Zero for smoking cessation, Reitano’s company now treats 20 conditions including sexual health, weight loss, dermatology, allergies and more, according to a statement from the company.

Image Credit: Zero

Ro also has a new pharmacy business, Ro Pharmacy, which is an online cash pay pharmacy offering over 500 generic medications for just $5 per month per drug. And the company is getting into the weight loss business through a partnership with the private equity-backed health care company, Gelesis.

Ro’s also becoming a gateway into patient acquisition for primary care providers through Ribbon Health, and a test-case for the use of Pfizer’s Greenstone service, which provides certification that a generic drug is validated by one of the major pharmaceuticals.

The company’s $1.5 billion valuation is courtesy of a new $200 million investment from existing investors led by General Catalyst and including FirstMark Capital, Torch, SignalFire, TQ Ventures, Initialized Capital, 3L, and BoxGroup. New first time investor The Chernin Group also participated. In all, Ro has raised $376 million since it launched in 2017.

“This new investment will further our mission to become every patient’s first call. We’ll continue to invest in our vertically-integrated healthcare ecosystem, from our Collaborative Care Center to our national pharmacy operating system. This is just the beginning of Ro’s patient-centered healthcare platform.” 

It’s all part of the company’s mission to provide a point of entry into the healthcare system independent of insurance qualifications.

“Telehealth companies like Ro are using technology to address long-standing healthcare disparities that have been exacerbated by Covid-19,” said Dr. Joycelyn Elders, MD, Ro Medical Advisor and Former US Surgeon General. “By empowering providers to leverage their skills as efficiently and effectively as possible, Ro delivers affordable, high-quality care regardless of a patient’s location, insurance status, or physical access to physicians and pharmacies.”

Ro’s new financing is one of several forays by tech investors into reshaping the healthcare system at a time when patient care has been severely disrupted by attempts to mitigate the spread of COVID-19.

Digital medicine is assuming a central position in the healthcare world with most consultations now occurring online. Reimbursement schemes for telemedicine have changed dramatically and investors see an opportunity to capitalize on these changes by aggressively backing the expansion plans of companies looking to bring digital healthcare directly to consumers.

That’s one of the reasons why Ro’s major competitor, Hims, is reported to be seeking access to public markets through its sale to a Special Purpose Acquisition Company for roughly $1 billion, according to Reuters.

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Meet the 4 frontrunners in the COVID-19 vaccine race

A volunteer receives an injection from a medical worker during the country's first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020 in Soweto, South Africa. It is reported that Africa's first COVID-19 vaccine trial began on June 24 in South Africa. The vaccine, developed by Oxford University's (UK) Jenner Institute, will inoculate 2,000 South Africans.

Enlarge / A volunteer receives an injection from a medical worker during the country’s first human clinical trial for a potential vaccine against COVID-19 at the Baragwanath Hospital on June 28, 2020 in Soweto, South Africa. It is reported that Africa’s first COVID-19 vaccine trial began on June 24 in South Africa. The vaccine, developed by Oxford University’s (UK) Jenner Institute, will inoculate 2,000 South Africans. (credit: Getty | Felix Dlangamandla)

Researchers have now reported data from early (and small) clinical trials of four candidate COVID-19 vaccines.

So far, the data is positive. The vaccines appear to be generally safe, and they spur immune responses against the novel coronavirus, SARS-CoV-2. But whether these immune responses are enough to protect people from infection and disease remains an important unknown.

The four candidates are now headed to larger trials—phase III trials—that will put them to the ultimate test: can they protect people from COVID-19 and end this pandemic?

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