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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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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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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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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Carbon Health to launch 100 pop-up COVID-19 testing clinics across the U.S.

Primary care health tech startup Carbon Health has added a new element to its “omnichannel” healthcare approach with the launch of a new pop-up clinic model that is already live in San Francisco, LA, Seattle, Brooklyn and Manhattan, with Detroit to follow soon – and that will be rolling out over the next weeks and months across a variety of major markets in the U.S., ultimately resulting in 100 new COVID-19 testing sites that will add testing capacity on the order of around an additional 100,000 patients per month across the country.

So far, Carbon Health has focused its COVID-19 efforts around its existing facilities in the Bay Area, and also around pop-up testing sites set up in and around San Francisco through collaboration with genomics startup Color, and municipal authorities. Now, Carbon Health CEO and co-founder Even Bali tells me in an interview that the company believes the time is right for it to take what it has learned and apply that on a more national scale, with a model that allows for flexible and rapid deployment. In fact, Bali says the they realized and began working towards this goal as early as March.

“We started working on COVID response as early as February, because we were seeing patients who are literally coming from Wuhan, China to our clinics,” Bali said. “We expected the pandemic to hit any time. And partially because of the failure of federal government control, we decided to do everything we can to be able to help out with certain things.”

That began with things that Carbon could do locally, more close to home in its existing footprint. But it was obvious early on to Bali and his team that there would be a need to scale efforts more broadly. To do that, Carbon was able to draw on its early experience.

“We have been doing on-site, we have been going to nursing homes, we have been working with companies to help them reopen,” he told me. “At this point, I think we’ve done more than 200,000 COVID tests by ourselves. And I think I do more than half of all the Bay Area, if you include that the San Francisco City initiative is also partly powered by Carbon Health, so we’re already trying to scale as much as possible, but at some point we were hitting some physical space limits, and had the idea back in March to scale with more pop-up, more mobile clinics that you can actually put up like faster than a physical location.”

Interior of one of Carbon Health’s COVID-19 testing pop-up clinics in Brooklyn.

To this end, Carbon Health also began using a mobile trailer that would travel from town to town in order to provide testing to communities that weren’t typically well-served. That ended up being a kind of prototype of this model, which employs construction trailers like you’d see at a new condo under development acting as a foreman’s office, but refurbished and equipped with everything needed for on-site COVID testing run by medical professionals. These, too, are a more temporary solution, as Carbon Health is working with a manufacturing company to create a more fit-for-purpose custom design that can be manufactured at scale to help them ramp deployment of these even faster.

Carbon Health is partnering with Reef Technologies, a SoftBank -backed startup that turns parking garage spots into locations for businesses, including foodservice, fulfilment, and now Carbon’s medical clinics. This has helped immensely with the complications of local permitting and real estate regulations, Bali says. That means that Carbon Health’s pop-up clinics can bypass a lot of the red tape that slows the process of opening more traditional, permanent locations.

While cost is one advantage of using this model, Bali says that actually it’s not nearly as inexpensive as you might think relative to opening a more traditional clinic – at least until their custom manufacturing and economies of scale kick in. But speed is the big advantage, and that’s what is helping Carbon Health look ahead from this particular moment, to how these might be used either post-pandemic, or during the eventual vaccine distribution phase of the COVID crisis. Bali points out that any approved vaccine will need administration to patients, which will require as much, if not more infrastructure than testing.

Exterior of one of Carbon Health’s COVID-19 testing pop-up clinics in Brooklyn.

Meanwhile, Carbon Health’s pop-up model could bridge the gap between traditional primary care and telehealth, for ongoing care needs unrelated to COVID.

“A lot of the problems that telemedicine is not a good solution for, are the things where a video check-in with a doctor is nearly enough, but you do need some diagnostic tests – maybe you might you may need some administration, or you may need like a really simple physical examination that nursing staff can do with the instructions of the doctor. So if you think about those cases, pretty much 90% of all visits can actually be done with a doctor on video, and nursing staff in person.”

COVID testing is an imminent, important need nationwide – and COVID vaccine administration will hopefully soon replace it, with just as much urgency. But even after the pandemic has passed, healthcare in general will change dramatically, and Carbon Health’s model could be a more permanent and scalable way to address the needs of distributed care everywhere.

#articles, #brooklyn, #bypass, #carbon-health, #china, #detroit, #genomics, #health, #healthcare, #louisiana, #manhattan, #manufacturing, #medical-research, #model, #occupational-safety-and-health, #san-francisco, #seattle, #softbank, #startups, #tc, #telemedicine, #united-states, #vaccines

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MedTech startup uMotif raises £5m from AlbionVC, as COVID-19 accelerates remote clinical studies

couMotif has an app that allows patients to monitor themselves for treatments or drug trials which then feeds into a platform allowing a much faster approach to clinical studies. It’s now raised £5 million in a Series A investment round led by existing UK investor AlbionVC, with participation from Oslo-based DNV-GL and existing angel investors. This latest round takes it to a total funding size of £7.5m.

The platform is sold into life sciences companies which are gradually replacing centralized studies where patients have to go to a site, such as a hospital, to submit their data. The trend has obviously been catalyzed by Covid-19. The platform is now used by studies taking place in 26 countries from clinical to real-world settings, and across more than 25 therapeutic areas – from dermatology and rare disease to oncology and cardiology. The largest study involved over 13,000 participants tracking their pain levels and the weather. This was featured on the BBC and published in Nature.

Its competitors are almost entirely US-based and include organizations such as SnapIOT, Medable, and ClinicalInk as well as other large platform companies.

“We’re excited to help our customers implement patient-centered research designs by using the uMotif platform to capture high-quality data,” siad Bruce Hellman, CEO and Co-Founder of uMotif in a statement. “This new funding will rapidly accelerate our development and will ultimately help our customers to get new therapies to patients faster”.

Dr. Andrew Elder, deputy managing partner at AlbionVC says: “Now more than ever, having access to reliable patient data during clinical trials is crucial. uMotif’s platform is built with patients in mind; designed to help academics, researchers and healthcare professionals to capture the best quality data in a way that suits the participants. It’s a win-win for all stakeholders and the platform has the potential and momentum to revolutionize the speed and efficiency with which therapies can reach and help millions of patients.”

#covid, #drug-discovery, #europe, #health, #medical-research, #oslo, #pain, #tc, #united-kingdom

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Unlearn.AI nabs $12M to build “digital twins” to speed up and improve clinical trials

Twins have long played a role in the world of medical research, specifically in the area of clinical trials, where they can help measure the effectiveness of a therapy by applying a control to one of a genetically-similar pair. Today, a startup founded by a former principal scientist at Pfizer, which has developed a way of digitising this concept through the use of AI, is announcing some funding to further its efforts. Unlearn.AI, which has built a machine learning platform that builds “digital twin” profiles of patients that become the controls in clinical trials — is announcing that it has raised $12 million in a Series A round.

The round is being led by 8VC with previous investors DCVC, DCVC Bio and Mubadala Capital Ventures also participating.

The startup’s DiGenesis platform is first being applied to neurological diseases, specifically Alzheimer’s Disease and Multiple Sclerosis, where effective treatment options remain an elusive goal and it has been hard to build clinical trials around patients with already-impacted health.

Although Unlearn.AI is not working on anything close to medicines related to the COVID-19 pandemic, it’s a timely reminder of why improving clinical trials is important. We’re now in an urgent race to find vaccines and treatments for this new virus, and that highlights the need for more efficient approaches to trials, and that is an area where AI could prove to be a boost.

Unlearn does not disclose who its commercial partners are today, nor how far they’ve come with rolling out active, live trials. The funding will be used to inch closer to that point, it seems.

“This new financing marks an important milestone in our growth and will contribute to the significant progress we are making with regulators and with our commercial partners, who are already running studies with Digital Twins and demonstrating their value in generating robust evidence and increasing the potential for trial success,” said Charles K. Fisher, Ph.D., founder and CEO of Unlearn.AI, in a statement.

“Clinical trials are facing a number of persistent challenges that have only been exacerbated in recent weeks. With support from our forward-thinking investors and industry partners, we are excited to continue growing our exceptional team and advancing the science behind our first-of-its-kind Digital Twin approach.”

Fisher’s background is one that falls squarely at the nexus of technology and medical research. In addition to time spent as a principal scientist at pharma giant Pfizer, he has also worked at Leap Motion, and those roles followed years of studying and researching biophysics in academia.

Unlearn approaches the idea of building these so-called digital twins as a classic machine learning problem, using “clinical trial datasets from thousands of patients to build the disease-specific machine learning models used to create Digital Twins and their corresponding virtual medical records.”

These are more than simple medical profiles: they match people according to demographics, lab tests and biomarkers. The idea is that by building AI-based twins, there is less of a need to find similar actual pairs of people — actual twins, even — to run tests and controls.

Unlearn has been working on its platform since 2017, but the use of twins (and the pair’s very close genetic makeups in medical research) to track pathology and treatments goes back decades, and interestingly one of the novel coronavirus tracking apps that has seen some strong traction was borne out of a long-term twins study run out of Kings College Hospital in London working with Stanford and Massachusetts General Hospital in the US.

The growth of using AI to build “people” to run the effects of drugs also follows a much bigger theme of using computers and algorithms to test and create chemical combinations and therapies that would have in the past taken much longer, and cost much more, to run out manually. (Another example of where this is being applied is in the world of product development, where consumer goods companies are using AI platforms to formulate new soaps and other goods.)

“Unlearn’s pioneering use of Digital Twins will limit the number of patients that need to go on placebo while also reducing overall trial enrollment time,” said 8VC Principal, Dr Francisco Gimenez, in a statement. “As investors at the intersection of healthcare and technology, we’re passionate about companies that pair cutting-edge computational techniques and innovative business models to meaningfully improve patient care. 8VC is excited to partner with Unlearn to bring about the biggest change in the drug approval process since the RCT.” Gimenez is joining the board of the startup with this round.

#artificial-intelligence, #biotech, #clinical-trials, #coronavirus, #covid-19, #health, #medical-research, #recent-funding, #startups, #tc, #twins, #unlearn-ai

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