AstraZeneca’s COVID-19 vaccine shows success: Here’s how it stacks up to others

Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020.

Enlarge / Vials in front of the AstraZeneca British biopharmaceutical company logo are seen in this creative photo taken on 18 November 2020. (credit: Getty| NurPhoto)

AstraZeneca announced in a press release on Monday that its COVID-19 vaccine showed positive results in an interim analysis of clinical trial data.

The announcement marks the third vaccine to show strong efficacy in late-stage trials against the pandemic coronavirus, SARS-CoV-2. Though AstraZeneca’s vaccine efficacy numbers are not as impressively high as those for the vaccines before it—mRNA vaccines from Pfizer/BioNTech and Moderna—AstraZeneca’s does offer some advantages over those vaccines.

In all, the news adds to ballooning optimism that effective vaccines could bring an end to the global crisis in the coming year.

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#adenovirus, #astrazeneca, #clinical-trial, #covid-19, #infectious-disease, #oxford, #public-health, #sars-cov-2, #science, #vaccine

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

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

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

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

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

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

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

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

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

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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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#biontech, #clinical-trial, #covid-19, #fda, #infectious-disease, #pandemic, #pfizer, #public-health, #sars-cov-2, #science, #vaccine

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Device that combines air circulation with UV-C light deployed in first U.S. homes to help decrease COVID-19 transmission risk

Now that we know the virus that causes COVID-19 can be transmitted via aerosol (tiny particles in the air that can hang around for a long time), researchers and engineers globally have turned their attention to helping promote air circulation where risk exposure is high, and also to kill any active viral particles that might be in the air. One such effort is the Nanowave Air, a device created by Pittsburgh-based Dynamics, Inc. (via NEXT Pittsburgh) which uses UV-C light in a safe and contained way to inactivate the virus in enclosed spaces.

The Nanowave Air operates on basically the same principal as any air purifier you might have in your home, using a fan to take in air and then passing it through a filter before putting it back out into the room. The difference is that the filter in this case is actually exposure to ultraviolet light – and specifically UV-C light, the type that has been proven to be effective in killing the SARS-CoV-2 virus that leads to COVID-19.

UV-C light differs from the more common UV-A light that we’re all generally exposed to in significant quantities from sunlight, and direct exposure to UV-C is harmful to humans. It has been used in indoor viral surface sterilization in the past, but typically the rooms where it’s used can’t be occupied at the time, and obviously it’s not effective once it’s no longer in use and people are allowed back in.

The Nanowave Air was created by the Carnegie Mellon spinout Dynamics when its CEO realized that the technology they were working on around UV-C light sources already for large-scale industrial applications could be adapted to address the COVID-19 crisis. That led to the portable design of the Air, which is roughly the size of a hobbyist telescope, and which works by containing the UV-C light within, and funneling air through it at high speeds using fans in order to be able to neutralize any active virus present while also allowing people to still continue to occupy the spaces where it’s in operation.

Nanowave Air is now shipping, with a $3,450 retail price. It’s intended for use in spaces like primary care facilities, dental offices, and other shared locations where people have to occupy the same space despite current guidance around social distancing and especially indoor exposure. The company, which has tested its technology at a number of labs across the U.S. including the University of Pittsburgh’s Center for Vaccine Research, also announced that it’s now being used in some homes with a COVID-19-positive individual, in order to reduce the exposure potential for other members of the household who haven’t yet contracted the illness.

This week saw the announcement of positive news for two of the larger efforts to develop a vaccine for COVID-19, but even if those end up providing long-term protection and ramp distribution quickly, the effort to contain COVID-19 globally will still include a lot of necessary preventative steps to avoid contraction among the unvaccinated populace. Managing airborne presence of the virus is sure to be a key ingredient, and solutions like the Nanowave Air could help to spur those efforts.

#air-purifier, #articles, #carnegie-mellon, #ceo, #health, #occupational-safety-and-health, #pittsburgh, #tc, #ultraviolet, #united-states, #vaccine, #virus

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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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#biontech, #covid-19, #fda, #immunization, #pfizer, #public-health, #sars-cov-2, #science, #vaccine

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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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#biontech, #clinical-trial, #covid-19, #moderna, #pfizer, #phase-iii, #sars-cov-2, #science, #vaccine

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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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#covid-19, #pfizer, #public-health, #sars-cov-2, #science, #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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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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Russia approves second COVID-19 vaccine without data, clinical trials

A vaguely smug man in a suit sits in front of a flag.

Enlarge / Russia’s President Vladimir Putin. (credit: Getty | Mikhail Klimentyev )

Russian President Vladimir Putin on Wednesday announced the second dubious approval of a COVID-19 vaccine that has not been evaluated in clinical trials.

The vaccine, dubbed EpiVacCorona, is said to be a synthetic peptide-based vaccine, which uses fragments of the pandemic virus, SARS-CoV-2, to spur protective immune responses in those vaccinated. It was developed by Vector State Virology and Biotechnology Center, a former Soviet bioweapons research lab.

Like the first Russian-approved vaccine, whether EpiVacCorona is actually safe and effective is completely unknown. In a televised news conference, Putin said that early trials involving 100 people were successful. But researchers have not published any safety or efficacy data from those trials. Russian health officials have said they are still reviewing the vaccine for “safety and quality” but declined to provide any additional information on the vaccine, data, or approval process.

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FDA approves first treatment for Ebola, a Regeneron antibody cocktail

Staff from South Sudan's Health Ministry pose with protective suits during a drill for Ebola preparedness conducted by the World Health Organization (WHO).

Enlarge / Staff from South Sudan’s Health Ministry pose with protective suits during a drill for Ebola preparedness conducted by the World Health Organization (WHO). (credit: Getty | Patrick Meinhardt)

The Food and Drug Administration on Tuesday issued the first-ever approval for a therapy against Ebola virus disease.

Though the Ebola vaccine, Ervebo, earned approval late last year and proved 97.5 percent effective in preliminary trials, the newly approved therapy may be useful in addressing an ongoing outbreak in Democratic Republic of Congo, which began in June. The FDA’s approval may also boost the outlook for similar therapies being developed for COVID-19, which may become available before a vaccine.

The newly approved Ebola treatment, called Inmazeb (aka REGN-EB3), is a combination of three monoclonal antibodies made by Regeneron Pharmaceuticals. The antibodies target the only protein on the outside of Ebola virus particles, the glycoprotein. Ebola uses its glycoprotein to attach to and enter human cells, sparking infection. The cocktail of antibodies glom on to the protein, keeping it from invading cells.

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#antibodies, #covid-19, #ebola, #fda, #monocolonal-antibodies, #regeneron, #science, #therapy, #vaccine

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Salesforce creates for profit platform to help governments distribute COVID vaccine when it’s ready

For more than 20 years, Salesforce has been selling cloud business software, but it has also used the same platform to build ways to track other elements besides sales, marketing and service information including Work.com, the platform it created earlier this year to help companies develop and organize a safe way to begin returning to work during the pandemic.

Today, the company announced it was putting that same platform to work to help distribute and track a vaccine whenever it becomes available along with related materials like syringes that will be needed to administer it. The plan is to use Salesforce tools to solve logistical problems around distributing the vaccine, as well as data to understand where it could be needed most and the efficacy of the drug, according to Bill Patterson, EVP and general manager for CRM applications at Salesforce.

“The next wave of the virus phasing, if you will, will be [when] a vaccine is on the horizon, and we begin planning the logistics. Can we plan the orchestration? Can we measure the inventory? Can we track the outcomes of the vaccine once it reaches the public’s hands,” Patterson asked.

Salesforce has put together a new product called Work.com for Vaccines to put its platform to work to help answer these questions, which Patterson says ultimately involves logistics and data, two areas that are strengths for Salesforce.

The platform includes the core Work.com command center along with additional components for inventory management, appointment management, clinical administration, outcome monitoring and public outreach.

While this all sounds good, what Salesforce lacks of course is expertise in drug distribution or public health administration, but the company believes that by creating a flexible platform with open data that government entities can share that data with other software products outside of the Salesforce family.

“That’s why it’s important to use an open data platform that allows for aggregate data to be quickly summarized and abstracted for public use,” he said. He points to the fact that some states are using Tableau, the company that Salesforce bought last year for a tidy $15.7 billion, to track other types of COVID data.

“Many states today are running all their COVID testing and positive case reporting through the Tableau platform. We want to do the same kind of exchange of data with things like inventory management [for a vaccine],” he said.

While this sounds like a public service kind of activity, Salesforce intends to sell this product to governments to manage vaccines. Patterson says that to run a system like this at what they envision will be enormous scale, it will be a service that governments have to pay for to access.

This isn’t the first time that Salesforce has created a product that falls somewhat outside of the standard kind of business realm, but which takes advantage of the Salesforce platform. Last year it developed a tool to help companies measure how sustainable they are being. While the end goal is positive, just like Work.com for Vaccines and the broader Work.com platform, it is a tool that they charge for to help companies implement and measure these kinds of initiatives.

The tool set is available starting today. Pricing will vary depending on the requirements and components of each government entity.

The real question here is should this kind of distribution platform be created by a private company like Salesforce for profit, or perhaps would be better suited to an open source project, where a community of developers could create the software and distribute it for free.

#cloud, #covid-19, #crm, #enterprise, #government, #logistics, #saas, #salesforce, #tc, #vaccine

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Flouting all standards, Russia plans to release early COVID-19 vaccine data

An older man in a suit speaks into an array of microphones.

Enlarge / MOSCOW, RUSSIA – AUGUST 14, 2020: Alexander Gintsburg, director of the Gamaleya Scientific Research Institute of Epidemiology and Microbiology of the Russian Healthcare Ministry that produces a COVID-19 vaccine. (credit: Getty | Vyacheslav Prokofyev)

A top Russian researcher behind the Sputnik V coronavirus vaccine defended using the vaccine before testing was complete and said he plans to release clinical trial data early—so early, in fact, the data is unlikely to be interpretable.

Alexander Gintsburg, head of the Gamaleya Institute that developed Sputnik V, laid out his thoughts on the vaccine and the pandemic in an interview with Reuters published Tuesday.

“People are dying just like during a war,” Gintsburg said as he sat in his wood-paneled office in Moscow, holding a crystal model of a coronavirus. “But this fast-tracked pace is not synonymous—as some media have suggested—with corners being cut. No way.”

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#clinical-trials, #covid-19, #infectious-disease, #russia, #sars-cov-2, #science, #vaccine

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Trump may reject FDA’s stricter regulations for COVID-19 vaccine

The Food and Drug Administration headquarters in White Oak, Maryland.

Enlarge / The Food and Drug Administration headquarters in White Oak, Maryland. (credit: Getty | Congressional Quarterly)

President Donald Trump on Wednesday said he may reject the Food and Drug Administration’s plan to issue stricter safety and efficacy standards for COVID-19 vaccines, calling the plan a “political move.”

The new standards are aimed at bolstering public confidence in the FDA and its vaccine review process, which has been severely damaged by many reports of political meddling and interference by the Trump administration. Those reports include claims that the FDA was pressured by the White House into allowing COVID-19 patients to be treated with unproven blood plasma and the anti-malaria drug hydroxychloroquine, which was personally touted by Trump. (The authorization of hydroxychloroquine was later revoked by the FDA.) Just last week, Trump’s secretary of health and human services, Alex Azar, revoked the FDA’s authority to sign new regulations.

Trump himself has continually undercut federal public health guidance and government scientists, particularly Robert Redfield, his director of the Centers for Disease Control and Prevention. Trump has also repeatedly pushed for a pre-election release of a vaccine, though experts have, in turn, repeatedly pointed out that such a speedy release is nearly impossible based on the timeline of the clinical trials underway and the amount of data needed to make even preliminary evaluations of safety and efficacy.

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#cdc, #clinical-trials, #covid-19, #fda, #infectious-disease, #pandemic, #public-health, #science, #trump, #vaccine

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Russia offers its untested COVID-19 vaccine for free to UN officials

A smirking man in a suit sits in front of a UN flag.

Enlarge / Russian President Vladimir Putin address the 75th session of the United Nations General Assembly, via teleconference call, in Moscow on September 22, 2020. (credit: Getty | MIKHAIL KLIMENTYEV)

Some United Nations staff are likely brushing up on their Russian—specifically how to say “Thanks, but no thanks” in the nicest way possible.

On Tuesday, Russian President Vladimir Putin offered UN staff free doses of the country’s COVID-19 vaccine, Sputnik V, which has not completed clinical trials for efficacy and has not been thoroughly vetted for safety.

Still, Putin suggested that his offer was prompted by the desire to give the people what they want: “Some colleagues from the UN have asked about this, and we will not remain indifferent to them,” he said during a speech Tuesday at this year’s (virtual) General Assembly.

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#clinical-trials, #covid-19, #efficacy, #putin, #russia, #safety, #sars-cov-2, #science, #sputnik-v, #un, #vaccine

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156 countries commit to fair COVID-19 vaccine access, but US won’t join

World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus attends a press conference organized by the Geneva Association of United Nations Correspondents (ACANU) amid the COVID-19 outbreak, caused by the novel coronavirus, on July 3, 2020 at the WHO headquarters in Geneva.

Enlarge / World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus attends a press conference organized by the Geneva Association of United Nations Correspondents (ACANU) amid the COVID-19 outbreak, caused by the novel coronavirus, on July 3, 2020 at the WHO headquarters in Geneva. (credit: Getty | Fabrice Cof)

A total of 156 countries—representing about 64 percent of the world’s population—have committed to pooling resources to help develop, buy, and equitably distribute two billion doses of a COVID-19 vaccine by the end of 2021.

“This isn’t just the right thing to do, it’s the smart thing to do,” said Dr. Tedros Adhanom Ghebreyesus, director-general of the World Health Organization, which is co-leading the effort along with the Coalition for Epidemic Preparedness Innovations (CEPI) and Gavi, the Vaccine Alliance.

So far, 64 high-income countries have signed on to the effort, as well as 92 low- and middle-income countries, which would be eligible for support in procuring vaccine doses. Gavi CEO Seth Berkley said in a WHO press conference on Monday that he expects 38 more countries to sign up in the coming days.

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#china, #covax, #covid-19, #infectious-disease, #pandemic, #policy, #public-health, #russia, #sars-cov-2, #science, #us, #vaccine, #who

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White House-CDC tensions explode as Trump contradicts its leadership

Image of President Trump speaking from behind a lectern.

Enlarge / US President Donald Trump speaks during a news conference in which he frequently contradicted his own health experts. (credit: Bloomberg/Getty Images)

There was good news and then bad news for public health expertise yesterday. In the wake of increasingly unhinged behavior from a President Trump-appointed communications director at the US Department of Health and Human Services, he and one of his key appointees have left their posts—one for two months, one permanently. But any hopes that science might resume being the main driver of US health policy were short-lived. Earlier in the day, CDC head Robert Redfield and other Health and Human Services officials testified before a Senate panel. By the evening, the president himself was calling his own CDC director mistaken about everything from mask use to the schedule of vaccine availability.

By the end of the day, Redfield was tweeting statements that balanced ambiguity against seeming to support Trump’s view.

A backdrop of turmoil

A constant background of tension has existed between the Trump administration (which wants the country to return to normal operations despite the medical consequences) and public health officials (who actually want to protect the public’s health). But several things have driven those tensions into the open recently, starting with last week’s revelation that political appointees were attempting to interfere with reports from career scientists at the CDC. That issue was seemingly resolved in the CDC’s favor, as a key administration figure in the Department of Health and Human Services (HHS), Michael Caputo, took a two-month medical leave after making a video in which he spoke of armed uprisings and conspiratorial cabals of CDC scientists.

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#cdc, #covid-19, #hhs, #masks, #policy, #redfield, #science, #testing, #trump, #vaccine

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“Not uncommon at all”: AstraZeneca pauses COVID-19 vaccine trial

A double-masked health care worker jabs a needle into the arm of a seated woman in a mask.

Enlarge / A volunteer receives an injection of AZD1222 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. (credit: Getty Images | Felix Dlangamandla)

With the coronavirus crisis gripping the globe, all eyes are on every bump and dip on the path to the pandemic’s end. So, of course, news that researchers triggered a common pause to the clinical trials of a leading COVID-19 vaccine candidate made swift and alarming headlines late Tuesday.

The global phase III trials for the vaccine AZD1222 (formerly ChAdOx1)—developed by the University of Oxford and pharmaceutical giant AstraZeneca—were put on a “temporary” and “voluntary” pause for a “standard review process,” AstraZeneca said in a statement Wednesday.

According the company, the pause was triggered by a “potentially unexplained illness” in one of thousands of participants involved in its trials. Per standard protocol, researchers must pause the trial to investigate whether the illness is related to exposure to the experimental vaccine or not.

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#adverse-event, #astrazeneca, #clinical-trial, #covid-19, #oxford-university, #pandemic, #sars-cov-2, #science, #vaccine

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

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

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

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

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

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

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

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“Shortsighted” and “Self-defeating”: US rejects global COVID-19 vaccine effort

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

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

The Trump administration will not take part in a global effort to help develop and equitably distribute a COVID-19 vaccine—a decision experts called “shortsighted” and “self-defeating”—according to a report by The Washington Post.

The White House cited the involvement of the World Health Organization in its decision to shun the effort. President Donald Trump has repeatedly criticized the WHO for being soft on China during the global health crisis, despite the fact that Trump himself repeatedly praised China for its “transparency” and response to the pandemic in January and February. At the end of May, Trump abruptly announced that he was “terminating our relationship” with the WHO, a move that alarmed public health experts.

White House spokesperson Judd Deere told the Post that “The United States will continue to engage our international partners to ensure we defeat this virus, but we will not be constrained by multilateral organizations influenced by the corrupt World Health Organization and China.”

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#cepi, #covid-19, #gavi, #pandemic, #sars-cov-2, #science, #trump, #trump-administration, #vaccine, #who

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Untested COVID-19 vaccine, Sputnik V, begins 40,000-person trial next week

Untested COVID-19 vaccine, Sputnik V, begins 40,000-person trial next week

Enlarge (credit: Aurich Lawson / Getty Images)

After hastily granting approval last week for a COVID-19 vaccine that has yet to enter rigorous clinical trials, Russia has now announced plans to give the vaccine to more than 40,000 volunteers in a trial that starts next week.

The “previously planned post-registration” injections are part of a “randomized, double-blind, placebo-controlled multicenter clinical study” of the vaccine, dubbed Sputnik V, according to an August 20 press release from the Russian Direct Investment Fund, which has financially backed the development of the vaccine. The more than 40,000 people for the trial will be recruited from more than 45 medical centers, the press release added.

On August 11, Russian President Vladimir Putin announced that Sputnik V had won regulatory approval, making it the first COVID-19 vaccine in the world to achieve domestic approval. Putin hailed Sputnik V as a breakthrough and even announced that one of his daughters had already received one dose of the two-dose vaccine.

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#covid-19, #putin, #russia, #science, #sputnik-v, #vaccine, #vaccine-development

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First US Phase III trial for COVID-19 vaccine begins

Image of a woman in a lab coat holding scientific instruments.

Enlarge / A research associate works at the Moderna Therapeutics Inc. lab in Cambridge, Massachusetts. (credit: Bloomberg/Getty Images)

Moderna has given the first doses of its experimental COVID-19 vaccine to participants in what will be a 30,000-person trial, as the United States moved into a new phase of the race to develop a vaccine by the start of next year.

The Boston-based biotech said on Monday that it had begun the first Phase III study of a vaccine in the US, a large-scale trial that is usually the last before a new product is submitted for regulatory approval.

The company’s shares were up as much as 10.6 percent before paring some of their gains.

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#covid-19, #moderna, #science, #vaccine

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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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US spends $2 billion to secure COVID-19 vaccine

Image of vials and syringes on a tray.

Enlarge / Test doses of another potential SARS-CoV-2 vaccine. (credit: MLADEN ANTONOV / Getty Images)

The Trump administration has committed to spend $1.95 billion on 100 million doses of a potential COVID-19 vaccine being developed by Germany’s BioNTech and US pharma giant Pfizer, which will be distributed free of charge to American citizens.

BioNTech announced on Wednesday that the supply agreement signed by the White House also includes the option for the US government to purchase a further 500 million doses, subject to the vaccine being granted regulatory approval.

Several governments have signed agreements with some of the 24 groups currently testing a coronavirus vaccine on humans, including a promising candidate developed by Oxford university and AstraZeneca, but most other purchasers have refused to reveal the price paid per dose.

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#covid-19, #policy, #science, #vaccine

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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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COVID-19 vaccine must protect 50% of people for approval, FDA says

A serious man in a business suit speaks into a microphone.

Enlarge / Stephen Hahn, Commissioner of Food and Drugs at the US Food and Drug Administration (FDA), speaks during a Senate Health, Education, Labor and Pensions Committee hearing on June 30, 2020, in Washington, DC. (credit: Getty | Al Drago)

Any experimental COVID-19 vaccines aspiring to earn regulatory approval from the Food and Drug Administration will need to prevent or decrease the severity of disease in at least 50 percent of people, the agency announced Tuesday.

The criterium is part of a larger set of guidelines released by the agency for developing a vaccine to halt the spread of pandemic coronavirus, SARS-CoV-2—which causes COVID-19 and is now accelerating in much of the country after months of sustained devastation.

With the guidelines, the FDA tried to dispel fears that the rush to develop a COVID-19 vaccine may come at the expense of adequate safety testing. “We recognize the urgent need to develop a safe and effective vaccine to prevent COVID-19,” FDA Commissioner Stephen Hahn said in a statement. “While the FDA is committed to expediting this work, we will not cut corners in our decisions and are making clear through this guidance what data should be submitted to meet our regulatory standards.”

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#covid-19, #drug-safety, #fda, #sars-cov-2, #science, #stephen-hahn, #vaccine, #vaccine-development

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China moves forward with COVID-19 vaccine, approving it for use in military

Men in white lab coats and face masks talk amongst themselves.

Enlarge / Chinese President Xi Jinping learns about the progress on a COVID-19 vaccine during his visit to the Academy of Military Medical Sciences in Beijing on March 2, 2020. (credit: Getty | Xinhua News Agency)

China has approved an experimental COVID-19 vaccine for use in its military after early clinical trial data suggested it was safe and spurred immune responses—but before larger trials that will test whether the vaccine can protect against SARS-CoV-2 infections.

This marks the first time any country has approved a candidate vaccine for military use. China’s Central Military Commission made the approval June 25, which will last for a year, according to a filing reported by Reuters.

The vaccine, developed by biotech company CanSino Biologics and the Chinese military, is a type of viral vector-based vaccine. That means researchers started with a viral vector, in this case a common strain of adenovirus (type-5), which typically causes mild upper respiratory infections. The researchers crippled the virus so that it doesn’t replicate in human cells and cause disease. Then, they engineered the virus to carry a signature feature of SARS-CoV-2—the coronavirus’s infamous spike protein, which juts out from the viral particle and allows the virus to get a hold on human cells.

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#adenovirus, #antibody, #cansino, #china, #coronavirus, #covid-19, #immune-response, #immunity, #sars-cov-2, #science, #vaccine, #vector

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COVID vaccine execs hyped vague data to cash in $90M in stock, watchdog says

Moderna Inc. headquarters in Cambridge, Massachusetts.

Enlarge / Moderna Inc. headquarters in Cambridge, Massachusetts. (credit: Getty | Bloomberg)

An anti-corruption watchdog is pressing the US Securities and Exchange Commission to investigate executives of the biotech company Moderna after they cashed in about $90 million in company shares days after promoting “positive” but vague data from its early COVID-19 vaccine clinical trial.

The watchdog group, Accountable.US, called the timing of the trades suspicious and questioned whether executives coordinated their stock sales prior to the data release.

In a letter to the SEC that was released to CBS Moneywatch, Accountable.US President Kyle Herrig wrote, “This misconduct was particularly egregious because it involved not only financial fraud and manipulation of the financial markets, but also because it exploited widespread fears surrounding the ongoing COVID-19 pandemic.” In all, the executives’ exploitation served to “boost the company’s value, as well as their own bank accounts.

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#antibodies, #covid-19, #insider-trading, #moderna, #nih, #pharmaceutical-industry, #public-health, #sars-cov-2, #science, #sec, #vaccine

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

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

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

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

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

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

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

#biotech, #boston, #coronavirus, #covid-19, #drugs, #flu-lab, #health, #infection, #manufacturing, #recent-funding, #science, #startups, #tc, #vaccination, #vaccine, #vaccines, #virus

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The Ars COVID-19 vaccine primer: 100-plus in the works, 8 in clinical trials

HUBEI, CHINA - APRIL 15: (CHINA MAINLAND OUT)220 volunteers from Wuhan are vaccinated with the novel coronavirus vaccine, which is in a human clinical trial.

Enlarge / HUBEI, CHINA – APRIL 15: (CHINA MAINLAND OUT)220 volunteers from Wuhan are vaccinated with the novel coronavirus vaccine, which is in a human clinical trial. (credit: Getty | TPG)

The clearest way out of the COVID-19 crisis is to develop a safe, effective vaccine—and scientists have wasted no time in getting started.

They have at least 102 vaccine candidates in development worldwide. Eight of those have already entered early clinical trials in people. At least two have protected a small number of monkeys from infection with the novel coronavirus, SARS-CoV-2, that causes COVID-19.

Some optimistic vaccine developers say that, if all goes perfectly, we could see large-scale production and limited deployment of vaccines as early as this fall. If true, it would be an extraordinary achievement. Less than four months ago, SARS-CoV-2 was an unnamed, never-before-seen virus that abruptly emerged in the central Chinese city of Wuhan. Researchers there quickly identified it and, by late January, had deciphered and shared its genetic code, allowing researchers around the world to get to work on defeating it. By late February, researchers on multiple continents were working up clinical trials for vaccine candidates. By mid-March, two of them began, and volunteers began receiving the first jabs of candidate vaccines against COVID-19.

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#covid-19, #features, #pharmaceutical-industry, #sars-cov-2, #science, #vaccine, #vaccine-development, #virology, #virus

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Head of US’ pandemic vaccine group says he was demoted in retaliation

Image of three men walking across a lawn.

Enlarge / Secretary of Health and Human Services Alex Azar (right), shown here with Dr. Anthony Fauci and President Trump, has reportedly clashed with a key director in his agency. (credit: Drew Angerer / Getty Images)

Today, the former head of the agency responsible for rapid development of pandemic responses such as therapies and vaccines announced he would file a whistleblower complaint with the Department of Health and Human Services (HHS). Rick Bright, who had led the Biomedical Advanced Research and Development Authority until this week, says he was transferred to a different position because he insisted on funding scientifically valid vaccine and therapy research over the objections of political appointees at HHS.

The Biomedical Advanced Research and Development Authority (BARDA) has been a relatively obscure agency. It has a broad remit: to enable a rapid response to emerging biomedical threats. Many of its listed threats are focused on terrorism issues, like biological, chemical, and radioactive attacks. But it also handles the related issue of pandemics and emerging diseases, which makes it very relevant at the moment.

The responses BARDA is meant to foster include diagnostics, therapies, and vaccines, and it provides both funding to advance their development as well as technical consulting to help companies overcome bottlenecks in the development process. As such, it has played a key role in determining the government’s response to the SARS-CoV-2 pandemic, and it has seen its budget tripled in a recent coronavirus response bill.

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#barda, #covid-19, #hhs, #pandemic, #policy, #politics, #sars-cov-2, #science, #vaccine, #whistleblower

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University of Oxford coronavirus vaccine trial aims to have 500 people in testing by mid-May

One of the largest COVID-19 vaccine trials currently underway will have over 500 volunteers actively testing its solution by the middle of next month. Researchers at the University of Oxford have already secured that number of participants, including a representative sample of people between the ages of 18 to 55, for a large-scale randomized clinical early and mid-stage trial of its potential vaccine, which uses a harmless, modified virus to trigger an immune response that is also effective against the novel coronavirus.

The trial will divide a total of 510 participant sent five groups, with one group receiving a follow-up, booster shot of the vaccine after the original does. The technology behind the vaccine has already been used in developing about 10 different other treatments, but will require an approach that includes setting up different test groups in different countries to ensure representative results, since infection rates are varying greatly place to place with prevention measures in place, study lead Sarah Gilbert told Bloomberg.

The team behind the vaccine is also still seeking additional funding to help scale manufacturing, since it aims to begin producing it in volume following the six month period this human trial phase will span. The goal is to have mass production up and running by this fall, under the assumption that the trial proves the potential vaccine effective, with a final stage trial of 5,000 people and the potential to begin providing some doses for use by frontline healthcare workers by as early as September.

The Oxford trial is one of just a handful that have progressed to the human testing phase, but more are coming online all the time. Existing clinical human trials from Moderna and Inovio are underway in the U.S., and those have also expressed the potential for earlier access for emergency use prior to broad rollout following the initial clinical results.

Even if there is some availability by fall of some of these vaccine candidates (and that assumes they even prove effective), that doesn’t mean they’ll be broadly available: That will still require further testing, and scaling manufacturing, as well as working out distribution and administration – all processes that will add months of work. Already, however, the unprecedented nature of the COVID-19 pandemic has resulted in new efficiencies in the development process, and more could follow in these extraordinary times.

#biotech, #coronavirus, #covid-19, #health, #infection, #inovio, #medicine, #moderna, #oxford, #science, #tc, #united-states, #vaccine, #vaccines

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New model looks at what might happen if SARS-CoV-2 is here to stay

Image of two people walking a dog wearing face protection.

Enlarge / Face masks may be a regular feature in our near-term future. (credit: Rob Kim/Getty Images)

Most of the optimistic ideas about what to do about SARS-CoV-2 involve engineering the virus’ extinction. We could ramp up testing and isolate anyone who’s been in contact with an infected individual. We could carefully manage infections to build up herd immunity without exceeding our hospital capacity. Or, in an ideal world, we could develop herd immunity using an effective vaccine.

Unfortunately, there are reasons to be worried that none of these will work. Tracing the contacts of infected individuals may be impossible with a virus that spreads as easily as SARS-CoV-2. And some of the virus’ closest relatives don’t build up the long-lasting immune response that’s needed for persistent herd immunity. All of which raises a disturbing question: what happens then?

A group of Harvard epidemiologists attempted to answer the question by trying out models that tested the impacts of different assumptions about the virus’ behavior and the immune system’s response to it. The researchers find that there’s a risk that it could become a seasonal menace, and we might have to be socially isolating every winter.

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#biology, #coronavirus, #epidemiology, #herd-immunity, #pandemic, #science, #vaccine

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

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

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

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

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

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

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

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Pandemic “will last 18 months or longer,” leaked US gov’t report warns

A person holding a bottle of soap and washing their hands.

Enlarge (credit: Getty Images | Jena Ardell)

The US government is reportedly preparing for the coronavirus pandemic to last 18 months or longer and result in “significant shortages for government, private sector, and individual US consumers.”

A 100-page US government plan was leaked to The New York Times, which today published an article summarizing the highlights.

“A federal government plan to combat the coronavirus warned policymakers last week that a pandemic ‘will last 18 months or longer’ and could include ‘multiple waves,’ resulting in widespread shortages that would strain consumers and the nation’s health care system,” the Times wrote.

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#coronavirus, #pandemic, #policy, #science, #trump, #vaccine

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US starts safety testing of coronavirus vaccine

Image of a woman in a lab coat holding scientific instruments.

Enlarge / A research associate works at the Moderna Therapeutics Inc. lab in Cambridge, Massachusetts. (credit: Bloomberg/Getty Images)

On Monday, the Associated Press reported watching the first safety tests of a vaccine against SARS-CoV-2, the coronavirus that recently spread into a global pandemic. Considering we didn’t even know the virus existed five months ago, this represents remarkable progress. But the technology that allowed such rapid development is relatively untested at the scale we’d need for a global vaccine.

How to make a vaccine quickly

Most vaccines use viruses or bacteria that are either treated so that they are unable to reproduce or damaged in a way that ensures that they reproduce very poorly. These vaccines are generally very effective, as they expose the immune systems to many of the proteins normally made by the pathogen, thereby ensuring a robust immune response. The downside, however, is that you have to be able to isolate and manipulate the bacteria or virus, and then you have to grow and purify it at scale. This means a significant amount of time is needed to build up a production stock for widespread use.

Many viruses, however, have a limited number of proteins on their surface that the immune system typically responds to. For these viruses, it’s possible to focus on the genes for these proteins, either cloning them into a harmless virus or producing large quantities of the proteins themselves. This still involves challenges with large-scale production but avoids the steps involved with isolating the pathogen and figuring out how to grow large quantities safely.

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#biology, #coronavirus, #health, #medicine, #rna, #science, #vaccine

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