Trial started for vaccine against one of the scariest coronavirus variants

Extreme close-up photo of a gloved hand holding a tiny jar.

Enlarge / A vial of the current Moderna COVID-19 vaccine. (credit: Getty | Ivan Romano)

Researchers have given out the first jabs of a tweaked version of Moderna’s COVID-19 vaccine, one aimed at fighting one of the most concerning coronavirus variants—the B.1.351 variant, first identified in South Africa.

The jabs are part of an early trial of the tweaked vaccine, which is being run by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID). The agency aims to enroll around 210 healthy adults in the trial by the end of April.

“The B.1.351 SARS-CoV-2 variant, first identified in the Republic of South Africa, has been detected in at least nine states in the United States,” NIAID Director Anthony Fauci said in an announcement. “Preliminary data show that the COVID-19 vaccines currently available in the United States should provide an adequate degree of protection against SARS-CoV-2 variants. However, out of an abundance of caution, NIAID has continued its partnership with Moderna to evaluate this variant vaccine candidate should there be a need for an updated vaccine.”

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#clinical-trial, #covid-19, #infectious-disease, #moderna, #nih, #public-health, #sars-cov-2, #science, #vaccine, #variant

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Could Valo Health become one of Flagship Pioneering’s biggest companies yet?

The investment firm Flagship Pioneering has incubated a lot of life sciences companies since it was founded in 2000. In fact, while a general partner with Flagship Pioneering over the last 15 years, David Berry has started more than 30 companies, five of which trade publicly right now: Seres Therapeutics, Sensen Bio, Evelo Biosciences, T2 Biosystems, and Axcella Health.

Berry is often a company’s first CEO, then transitions out of the company within 18 months. But he has no plans to leave his post as CEO of Valo Health, a three-year-old, Boston-based, 110-person drug discovery company that Berry and Flagship seem to think could become one of the firm’s most important companies yet. That’s notable, considering that Flagship incubated 11-year-old Moderna, which currently boasts a $50 billion market cap thanks in large part its coronavirus vaccine.

Perhaps it’s no surprise, given Berry’s and Flagship’s track record that Valo has attracted believers. Notably, today it is announcing a fresh $110 million in extended Series B financing from Koch Disruptive Industries that brings the round total to $300 million and the overall amount the young company has raised to more than $450 million.

Still, given that there are hundreds of drug discovery companies in the world seizing on the latest advancements in AI, machine learning and computation, it’s easy to wonder what’s so special about this one. We got Berry’s take during a chat with him yesterday, parts of which we are featuring below edited for length and clarity.

TC: Valo is trying to accelerate the creation of drugs, and it has a computational platform called Opal to do it faster and more effectively than many rivals. Is there a way to make it clearer to outsiders why this platform is so unique? 

DB: First, from day one, we were operating on a different scale [than past Flagship Pioneering companies]. Typically, when you look at Flagship companies, there’s an [exclusive] initial commitment by Flagship of plus or minus $50 million. But because of the scale of the opportunity that we saw ahead of us with Valo, we actually started out by bringing in external financing partners as part of a Series A that was right around $100 million.

[Also unique is the] breadth of what we’re trying to achieve through our systematic approach to R&D, as opposed to a targeted approach to thinking about it. There’s been an historical challenge in life sciences in that companies are primarily viewed based on what their lead therapeutic asset looks like. But if you have the potential to change the scope, the scale, the potential, the speed, the probability of success, [and] the cost of developing drugs, you’re not going to look like a typical therapeutics company.

TC: So your focus on multiple therapeutic areas at once — oncology, neurodegenerative, and cardiovascular diseases — is a distinguishing element of the company. How are you tackling so much simultaneously?

DB: The legacy biopharma model is basically this point-to-point system [where up to 15 groups] do some work, and then they basically take the result of it and they throw it over a wall to another group that has its own framework. The model is intrinsically disintegrated. They use mice. They use cell lines. They use extracted organs. And those just don’t represent what a full, intact living human actually looks like, and they don’t reflect what the disease looks like in the context of that human.

What we’re doing is what I would call that next transformation . . enabled by high-quality human-centric data [that we analyze] in an end-to-end, but componentized manner. What I mean by that is we’ve created a single underlying architecture so that we’re using the same species, we’re using the same decision-making criteria. we’re using the same KPIs throughout the entirety of the R&D cascade, [and] we’re using the same bases of the core computation. We’re using the same self-reinforcing model to learn as we go. We have a local expression, because we have to perform a certain set of tasks in order to comply with the regulatory environment. But by doing it in this way as we do those tasks, we’re learning a lot more and we’re keeping that human centricity, so when we uncover for example, a new target in cardiovascular disease or neurodegenerative disease, it’s based on our human data. It’s not based on a dog model or mouse model or something along those lines. It’s not based on cells adapted to plastic in a lab.

TC: Where is that human data coming from? Is the data you’re feeing into Opal somehow better or different than what others are using?

DB: We haven’t we haven’t yet disclosed where our datasets are coming from, but we have reason to believe that the scale and quality of the data sets are substantially high. We have not seen data sets that compare in scope and size. We have announced one subset of our data lake, but I would call it a small subset through a data partnership we announced earlier. [Editor’s note: this is with a company called Global Genomics Group, which gives Valo access to a cardio-metabolic dataset.]

TC: You’ve been at this for a few years. Have you had any major breakthroughs?

DB: I believe what we’ve done over the last two years is build an incredibly strong technology basis and foundation [for] transformation. We’ve announced four therapeutic programs that we’ve launched thus far, and each represents not only something where we’ve been able to develop a therapeutic candidate in very short periods of time, but we’ve also been able to overcome issues that were historical barriers things that made developing those sorts of candidates much more difficult, and we were able to overcome those barriers in weeks.

TC: Can you elaborate on one of those therapies to underscore your point?

DB: One of the programs we announced is called NAMPT. What was really interesting about it is it’s a very powerful cancer target. The downside of it is it’s known to cause a very particular toxicological effect — it causes retinal toxicity — and what we wanted to figure out was whether we could get the benefit of the molecule by targeting the target but avoiding getting that molecule into the retina, which required a very specific design. Long story short, in a couple of weeks, we were able to achieve a molecule that had enough differentiation between the blood in the eye that it shouldn’t have any substantial effects.

TC: Are any of these four candidates heading into the market any time soon?

DB: I would love them to be in the market soon but they’re not yet there. We are expecting that with the financing in hand, we should ultimately have molecules in clinical trials, and ultimately we’re very excited to be able to transition some of the drugs that we’re developing into [viable offerings in the market].

TC: Would you sell then sell these to a big pharma company, or would Valo be marketing these itself?

DB: Both are viable potential paths. Because we’re developing a number of different therapeutics, it gives us flexibility in the way we think about our ultimate business model.

#biotech, #drug-discovery, #flagship-pioneering, #machine-learning, #medicine, #moderna, #recent-funding, #startups, #tc, #venture-capital

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

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

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

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

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

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

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#biontech, #covid-19, #infectious-disease, #moderna, #mutation, #pandemic, #pfizer, #sars-cov-2, #science, #vaccine, #variant

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

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

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

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

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

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

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

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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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Uber and Moderna partner on COVID-19 vaccine access and information

Uber and pharmaceutical company Moderna have announced a partnership around COVID-19 vaccination, which will include a number of different initiatives. To start, it’s only confirmed component is to provide users with credible, factual information about COVID-19 vaccine safety through Uber’s consumer app, but the companies have also discussed additional “options” including building ride scheduling via Uber directly into the immunization appointment booking process.

Still in its early days, the U.S. COVID-19 vaccination program is already beset with challenges, including providing timely access to vaccines to swaths of the population who need it most. The inoculation program also has to contend with significant misinformation proliferating on social media about vaccine safety, and any app with the surface area of something like Uber has a chance to get positive messages and accurate information in front of a lot of people, so that’s good news on its own.

But one of the very real challenges to an effective vaccination campaign remains logistical, and getting people to make their initial and follow-up appointments for the first round of the Moderna vaccine, and its second shot booster, is a bigger challenge than many might suspect. I spoke to Healthvana CEO Ramin Bastani about their work with  LA County on creating an immunization record that integrates with Apple Wallet to provide patients with timely info and reminders about vaccination appointments, but integrating a ride-booking service or appointment reminder directly in the Uber app that most users already have on their phone anyway could be another very effective way to increase success rates for first and follow-up inoculation visits.

Uber has already offered up free and discounted rides to help lower the friction of actually going out and getting a vaccine, but a product-level integration could do a lot more than that by providing easy, user-friendly access. As noted, this is still just one of the options being discussed, but if Uber and Moderna are willing to commit it to print, that at least means they’re serious about trying to find a way. We’re holding them to account, too, so rest assured we’ll follow up on their progress as this collaboration develops.

#apps, #ceo, #health, #healthvana, #medicine, #moderna, #pharmaceutical, #social-media, #tc, #transportation, #uber, #united-states, #vaccination, #vaccine, #vaccines

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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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“Shkreli Award” goes to Moderna for “blatantly greedy” COVID vaccine prices

COVID-vaccine-maker Moderna (right), has been placed in the ranks of Martin Shkreli (left).

Enlarge / COVID-vaccine-maker Moderna (right), has been placed in the ranks of Martin Shkreli (left). (credit: Drew Angerer / Florian Gaertner / Getty Images)

One of the leading developers of COVID-19 vaccines has now been placed in the ranks of people like Martin Shkreli—the disgraced pharmaceutical executive infamous for jacking up the price of an old, life-saving drug by more than 5,000 percent. He is now serving an 84-month prison sentence from a 2017 conviction on fraud counts unrelated to the drug pricing.

Moderna, maker of one of only two vaccines granted emergency authorizations to prevent COVID-19 in the US, has been shamed with a 2020 “Shkreli Award” by the Lown Institute, a healthcare think tank. The awards, announced annually for four years now, go to “perpetrators of the ten most egregious examples of profiteering and dysfunction in health care.”

Award judges cited Moderna’s pricing of its COVID-19 vaccine, which was developed with $1 billion in federal funding. Still, despite the tax-payer backing, Moderna set the estimated prices for its vaccine significantly higher than other vaccine developers.

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

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

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

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

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

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

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

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

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Second COVID vaccine approved for use in the US

Image of a syringe in front of a Moderna company logo.

Enlarge (credit: DeFodi Images )

Late Friday, the Food and Drug Administration issued an emergency authorization to a COVID-19 vaccine from a company called Moderna. The move follows an enthusiastic endorsement of the vaccine following an evaluation of clinical trial data by the FDA’s Vaccines and Related Biological Products Advisory Committee. Moderna already has millions of doses prepared, and the federal government has pre-issued a large order for more, which will enable more extensive vaccinations than would be possible previously, where the agency had only issued an authorization to the Pfizer/BioNTech vaccine.

The authorization was considered to be a matter of time following the release of safety and efficacy data from a large clinical trial that had enrolled over 30,000 people. Emergency Use Authorizations require that a product or treatment meet a number of criteria, including the declaration of a medical emergency, which was done earlier this year, and the lack of an FDA approved alternative. (FDA approval is distinct from an Emergency Use Authorization, so the authorization of the Pfizer/BioNTech vaccine isn’t a barrier to further authorizations.)

Beyond that, the product must be considered likely to be effective, and its potential benefits need to outweigh its potential risks. The votes from the members of the Vaccine Advisory Committee were unanimous that the benefits outweighed the risks, a conclusion that was well supported by the clinical trial data. That cleared the way for Friday’s Authorization, which took place on a similar schedule to the authorization of the Pfizer/BioNTech vaccine the week prior.

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#covid-19, #fda, #medicine, #moderna, #policy, #sars-cov-2, #science, #vaccine

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

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

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

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

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

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

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Finger-pointing abounds as states get fewer vaccines than planned

Fake highway sign showing the USS Enterprise hitting a speed bump

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

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

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

State of denial

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

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#moderna, #operation-warp-speed, #pfizer, #policy, #science, #us-government, #vaccine

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Moderna vaccine gets the thumbs-up for emergency use

Image of a building with the Moderna logo behind a security fence.

Enlarge / This unassuming building in Massachusetts has taken on remarkable significance in recent weeks. (credit: JOSEPH PREZIOSO / Getty Images)

Earlier this week, the FDA released documents that summarized the data on a second SARS-CoV-2 vaccine candidate, this one from a company called Moderna. That document was the background for a meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee, which would consider whether the benefits of the vaccine outweigh its potential risks. That question is one of the key considerations for the agency as it decides whether to grant an emergency use authorization similar to the one it gave the Pfizer/BioNTech vaccine.

After an all-day meeting that frequently focused on other topics, the committee was near unanimous: 20 votes for approval, none against, and one abstention.

Emergency use authorizations have a number of requirements once a health emergency has been declared. There must be no alternatives that have achieved full FDA approval, there must be reasons to think that the treatment will be effective, and its benefits are considered likely to outweigh its risks. It’s that final question—the risk versus benefit balance—that the advisory committee was called to address.

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#covid-19, #fda, #medicine, #moderna, #policy, #sars-cov-2, #science, #vaccines

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FDA releases data on Moderna’s COVID vaccine: It looks good

Image of a syringe in front of a Moderna company logo.

Enlarge (credit: DeFodi Images )

As the first doses of the Pfizer/BioNTech vaccine were administered yesterday, most of the US public began a potentially long waiting game, as the vaccine will be in short supply for many months and is being administered to healthcare workers and the elderly first. For most of the US, that means waiting until manufacturing can catch up with our needs.

One thing that could significantly speed vaccinations is the approval of additional vaccines, and here the news is also good: today, the Food and Drug Administration released detailed data on Moderna’s RNA-based vaccine, finding it well over 90 percent effective. These numbers make it highly likely that the FDA will issue an Emergency Use Authorization when it considers the issue on Thursday.

Looking good

The previous data on the vaccine’s efficacy had been delivered by press release in mid-November. The FDA’s documentation is, as you’d expect, far more detailed. We’ll provide a summary of it here and will update the story as we get a chance to look through all 54 pages the FDA has released.

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#covid-19, #moderna, #rna, #sars-cov-2, #science, #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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Trump to hold “Vaccine Summit” today—no vaccine-makers agreed to come

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

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

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

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

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

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

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The NIH’s top vaccine maker wants Warp Speed to be the new normal

The NIH’s top vaccine maker wants Warp Speed to be the new normal

Enlarge (credit: Krisana Antharith | Getty Images)

If the first vaccines against COVID-19 really do start coming online in a couple of weeks, that’ll be a blazingly fast scientific achievement—from new virus to new vaccine in just about 12 months, faster than ever before, and using a new vaccine technology, too. Amazing! And also only sort of true, because the path of the two vaccines likeliest to become available first, one from the pharmaceutical companies Pfizer and BioNTech and one from Moderna, began long before people started getting sick in Wuhan in December 2019.

Like all scientific discoveries, that path has many trailheads. One of them is the lab of John Mascola, director of the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases. He didn’t come up with the idea of using genetic material to make vaccines, but he and collaborators around the US spent years trying to direct those efforts against coronaviruses, the family that includes SARS-CoV-2, the cause of COVID-19. Most vaccines against the disease clue the immune system into seeing a specific protein on the surface of the virus; it was Mascola’s VRC that brought the mRNA for that “spike protein” to Moderna.

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#covid-19, #moderna, #science, #vaccines, #warp-speed

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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 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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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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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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Meet the 4 frontrunners in the COVID-19 vaccine race

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

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

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

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

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

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#antibodieis, #astrazeneca, #cansino, #china, #covid-19, #features, #immune-system, #immune-system-response, #immunity, #immunology, #moderna, #mrna, #pfizer, #public-health, #sars-cov-2, #science, #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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Moderna set to start final-stage trial of its coronavirus vaccine by July

Pharmaceutical company Moderna told Bloomberg on Thursday that it’s on pace to begin the final-stage clinical trial of its vaccine for the novel coronavirus that causes COVID-19 by July. Moderna was the first company to begin human clinical trials of its vaccine candidate in the U.S., and the last stage of its study will include 30,000 people and be conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

The aim of the study will be to show definitive clinical proof that Moderna’s vaccine actually does prevent people from developing COVID-19, and, secondarily, that it prevents at least severe symptoms and cases that require hospitalization from materializing. Moderna’s second-stage clinical trial kicked off last month, and the company has previously said that it could potentially begin offering experimental doses available to healthcare workers in limited capacities as early as this fall.

The pace of development of a number of leading vaccine candidates is actually moving just as quickly, if not more quickly. Johnson & Johnson said early this week that it would start trials of its vaccine later in July, while AstraZeneca and its research and development partner the University of Oxford will be entering its own final-stage clinical trials as of this month.

Moderna’s vaccine candidate is an mRNA vaccine, which is a technology that essentially provides instructions to healthy cells to produce antibodies to the coronavirus, without having to actually introduce any of the active or inactive virus itself. mRNA vaccines, while used in veterinary medicines, are relatively new technology and have not yet been approved for use in human patients, but they represent a number of the early vaccine attempts, because of their advantages in terms of speed of development and the lessened theoretical health risk they pose to people, including early trial participants.

#astrazeneca, #coronavirus, #covid-19, #drugs, #health, #johnson-johnson, #medicine, #moderna, #tc, #united-states, #vaccines

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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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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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