Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Magenta Investments, a leading pharmaceutical and healthcare company that is part of an investment and industrial conglomerate in the United Arab Emirates (UAE), today announced a new agreement to distribute the Moderna COVID-19 Vaccine as well as Moderna’s updated variant booster candidates, once authorized, in the UAE in 2021 and 2022.
Tuesday, June 15, 2021
Over 800 New Yorkers given expired COVID shots
Hundreds of New Yorkers learned Monday, they got expired doses of the Pfizer coronavirus vaccine.
New York City's Health Department confirmed 899 people received expired doses at a pop-up vaccination site in Times Square that used to house the NFL Experience.
Officials say they are "notifying" everyone involved that they need to receive another dose as soon as possible.
Statement from ATC Vaccination Services spox:
A spokesperson for ATC Vaccination Services released a statement late Monday:
"ATC Vaccination Services is part of a large group of vaccine distributors in partnership with the NYC Department of Health to distribute the vaccine. We apologize for the inconvenience to those receiving the vaccine batch in question and want people first and foremost to know that we have been advised that there is no danger from the vaccine they received. After consulting Pfizer, NYC Department of Health sent out an email on our behalf alerting everyone to return for another vaccine. They further instructed us to follow up via phone and mail to alert the recipients that the only way to be certain that they are fully vaccinated is to come in for another shot because the shot in question was in the freezer 'too long' to be assured of its full effectiveness. We encourage those affected to get a new dose anywhere that provides the Pfizer vaccine."
Health officials say there is no safety risk for patients to getting the expired doses and that the city has replaced the vendor giving out the shots.
The news comes as the state reached a vaccination milestone Monday evening.
According to the CDC's COVID tracker, 70% of New York's adult population have received at least one dose of the COVID vaccine.
Gov. Andrew Cuomo had said that most remaining restrictions would likely be lifted once New York hit that benchmark.
A spokesperson for ATC Vaccination Services released a statement late Monday:
"ATC Vaccination Services is part of a large group of vaccine distributors in partnership with the NYC Department of Health to distribute the vaccine. We apologize for the inconvenience to those receiving the vaccine batch in question and want people first and foremost to know that we have been advised that there is no danger from the vaccine they received. After consulting Pfizer, NYC Department of Health sent out an email on our behalf alerting everyone to return for another vaccine. They further instructed us to follow up via phone and mail to alert the recipients that the only way to be certain that they are fully vaccinated is to come in for another shot because the shot in question was in the freezer 'too long' to be assured of its full effectiveness. We encourage those affected to get a new dose anywhere that provides the Pfizer vaccine."
Health officials say there is no safety risk for patients to getting the expired doses and that the city has replaced the vendor giving out the shots.
The news comes as the state reached a vaccination milestone Monday evening.
According to the CDC's COVID tracker, 70% of New York's adult population have received at least one dose of the COVID vaccine.
Gov. Andrew Cuomo had said that most remaining restrictions would likely be lifted once New York hit that benchmark.
Coronavirus variants can evade antibodies by spreading via supercells
The antibodies we create after we're infected with a virus or vaccinated against it can be very powerful. A virus typically spreads within our bodies by entering a cell and using it as a factory to create copies of itself, which then burst out and find new cells to infect. Our antibodies work by binding to the virus and this can block it from attaching to and entering our cells in the first place.
But what happens if a virus does not need to exit the cell in order to spread to neighboring cells? Can our antibodies be effective against it?
Scientists recently asked this question for SARS-CoV-2, which causes COVID-19. This highly infectious coronavirus can change human cells, making them fuse with two or more nearby cells. These super-cells, with large merged cell bodies, are excellent viral factories.
The super-cells, known as syncytia, share multiple nuclei (the part of the cell that contains the genetic material) and abundant cytoplasm (the jelly-like substance that surrounds the nucleus). Having more of these components in one giant cell helps the virus replicate more efficiently. And by fusing cells, SARS-CoV-2 increases its resources without being exposed to the neutralizing antibodies that slosh around outside our cells.
The study by Alex Sigal and colleagues tested two coronavirus variants (alpha and beta) for their ability to transmit from cell to cell and investigated whether this mode of transmission was sensitive to antibody neutralization. The alpha variant (first identified in the UK) is sensitive to antibodies, and the beta variant (first identified in South Africa) is less sensitive to these antibodies.
The Sigal study, which is yet to be published in a scientific journal, revealed that cell-to-cell transmission with both variants successfully evaded antibody neutralization. This shows that when the virus takes hold, it will be more difficult to eliminate in cells that can fuse with each other.
Viruses have coexisted with humans and animals for millennia, so they have evolved tricks to avoid being recognized by our
immune system. . Such an immune evasion strategy is the
direct transmission from cell to cell, which doesn't always require cell fusion.
It is also possible for viruses to travel to their next host cells by exploiting tight associations between neighboring cells that shield them from antibodies. It is reasonable to assume that antibodies are most effective at preventing entry into the host cell and less effective in parts of the body where the infection is already established.
Does this mean that our vaccines will be ineffective against viruses that move directly from cell to cell? Luckily, our immune system has also evolved alongside viruses, and we have learned to build defenses that work in many ways.
Not the only line of defense
T cells are white blood cells that, following vaccination or infection, are trained to recognize and kill infected cells. They don't rely on recognizing free-floating virus, so cell-to-cell transmission does not reduce their ability to seek and destroy viral factories. Like cells capable of producing antibodies, T cells can remember a previous infection and act rapidly when the same virus comes along again.
It's not wise to put all your eggs in one basket, which is why vaccines induce both antibodies and virus-specific T cells. Antibodies bind to viruses either before they enter our cells or after the release of new viruses following infection. T cells act to reduce fertile cell hosts for virus replication, until the infection is eliminated. Many other cells (with no immunological memory) also work together to eradicate the virus from the body completely.
What happens in those of us that may have older or dysfunctional parts of our immune system? Coronavirus infection is usually controlled within two weeks in most young, healthy adults and children. In people with dysfunctional T cell responses, cell-to-cell transmission could hinder neutralizing antibodies and hence prolong the infection. Persistent infection increases opportunities for viruses to mutate and better adapt their lifecycle to our bodies, leading to the potential emergence of variants of concern.
We don't need to worry about cell-to-cell transmission disabling our vaccines, but it is important to understand how a virus spreads so that we can target it more effectively. A few years ago my colleagues and I showed that the hepatitis C virus transmits from cell to cell in the presence of neutralizing antibodies. This hasn't stopped scientists from developing highly successful antivirals that can cure people who had been infected with hepatitis C for decades.
With effective vaccines and antivirals, we can aim to eradicate viruses that don't integrate their genomes with our own (such as SARS-CoV-2) from human populations as we have done before. Broad resistance to infection in humans achieved by vaccination if we all work together means that if the same virus jumps again from animal hosts, its transmission journey in people would be very short. The latest technologies that enable quick vaccine updates can ensure effective control against emerging variants.
Alzheimer's Tau Vaccine Shows Immune Response, Safety
An active peptide vaccine designed to target pathological tau was safe and elicited immune responses in people with mild Alzheimer's disease, though showed no effects on cognitive decline in the overall population of the phase II placebo-controlled ADAMANT trial.
Exploratory analyses suggested the vaccine, AADvac1, also slowed accumulation of plasma neurofilament light (NfL), a marker of neurodegeneration, reported Petr Novak, MD, PhD, senior clinical research scientist at Axon Neuroscience in Bratislava, Slovakia, and co-authors, in Nature Aging.
Plasma NfL rose by 28% (4.93 pg/mL) in the placebo group over the 2-year study, but by only 13% (2.09 pg/mL) in the AADvac1 group (adjusted mean difference -2.79 pg/mL; 95% CI -4.65 to -0.93, P=0.0035; Cohen's d = -0.48).
While AADvac1 showed no cognitive benefit overall compared with placebo, post hoc analyses suggested it may slow decline in some Alzheimer's patients. The most pronounced effects on clinical and functional outcomes were seen in a subgroup of people who were most likely positive for amyloid and tau pathology.
"To the extent of my knowledge, this is the first time that a tau-targeted immunotherapy showed clear evidence of impact on the neurodegenerative process and a strong indication of clinical effect in patients with a confirmed Alzheimer's disease biomarker profile," Novak told MedPage Today.
Immunotherapy is being tested in several trials to decrease levels of toxic tau proteins and help slow cognitive decline. "Tau and tau-related pathways are very important targets for the development of Alzheimer's disease therapeutics," observed Jeffrey Cummings, MD, ScD, of the University of Nevada, Las Vegas, who wasn't involved with the study.
"Tau is closely correlated with cognitive decline, and tau therapeutics may have a broad window of application from preclinical Alzheimer's disease to Alzheimer's dementia," Cummings told MedPage Today. "Tau vaccines are very early in the developmental cycle, but have the promise of application early and may avoid some of the side effects seen with other agents such as the ARIA [amyloid-related imaging abnormalities] observed with amyloid therapeutics."
The 24-month, double-blind ADAMANT study randomized 196 patients, 117 to AADvac1 and 79 to placebo, in eight European countries from June 2016 to May 2017. Nearly 17% of participants dropped out, leaving 100 in the vaccine group and 63 in the placebo group at the end of the study. The last safety visit was in June 2019.
The trial's primary objective was to evaluate safety and tolerability. Secondary objectives were to assess immunogenicity and efficacy of AADvac1 in slowing cognitive and functional decline.
The study enrolled people who had a diagnosis of probable Alzheimer's based on National Institute on Aging/Alzheimer's Association criteria, a Mini Mental State Examination (MMSE) score of 20 to 26, and medial temporal lobe atrophy on magnetic resonance imaging (MRI) or cerebrospinal fluid biomarker levels of amyloid and tau that were consistent with Alzheimer's disease. Participants had a mean age of 71, and 55% were female. All participants were white.
Eleven doses of AADvac1 were administered at 40 μg per dose: six subcutaneous injections monthly, followed by five booster shots quarterly. The vaccine led to high levels of antibodies; responder rates were 96.5% at the end of the first six doses and 98.3% overall.
Serious adverse events occurred in 17.1% of AADvac1-treated and 24.1% of placebo-treated participants. Adverse events were seen in 84.6% of vaccine-treated and 81.0% of placebo-treated participants. Vaccine-treated participants had more injection-site reactions.
Six AADvac1-treated patients had confusion, mostly transient. "As confusion naturally occurs in patients with Alzheimer's disease, a larger study is required to evaluate whether this is an adverse reaction or a chance observation; currently it constitutes a potential risk of moderate importance," Novak and co-authors wrote.
For the whole study sample, the adjusted mean point difference on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale was -0.36 (95% CI -1.31 to 0.59), with a custom cognitive battery adjusted mean z-score difference of 0.0008 (95% CI -0.17 to 0.17).
n a subgroup of 109 participants who most likely had Alzheimer's pathology, those treated with AADvac1 had 27% slower cognitive decline measured by the CDR-SB (P=0.048) than placebo and 30% slower functional decline measured by the ADCS-MCI-ADL, an activities of daily living scale for people with mild cognitive impairment (P=0.039). This subgroup was identified using a multimodal classifier that combined structural MRI, demographics, and clinical data to find participants most likely positive for amyloid and tau pathology.
The researchers noted that the post hoc analyses come with important limitations: they were not pre-specified in the study protocol and not corrected for multiplicity testing. "These results must therefore be interpreted with caution and will require confirmation in future clinical development," the team wrote.
"We plan on running a phase IIb study in patients with biomarker evidence of both tau and amyloid pathology to confirm the findings in a larger, well-defined sample," Novak said. "Ideally, we'd initiate the study around the end of this year, or start of the next year."
"Given that aducanumab was approved by the FDA based on a surrogate biomarker outcome using the accelerated approval pathway, should this study be positive, we could explore possibilities for an accelerated approval," he added.
Disclosures
The study was funded by Axon Neuroscience.
Researchers reported relationships with Axon, Niogen, People Bio, Roche Diagnostics, Novartis, Vivoryon, Ionis, CogRx, AC Immune, Toyama, Genentech, AlzeCure, Aptinyx, AstraZeneca, Athira Therapeutics, Axovant, Biogen Idec, BlackThornRx, Boehringer Ingelheim, Cerecin, Cognition Therapeutics, Compass Pathways, CRF Health, CuraSen, EIP Pharma, Eisai, Eli Lilly, FSV7, G4X Discovery, GfHEU, Heptares, Ki Elements, Lundbeck, Lysosome Therapeutics, MyCognition, Neurocentria, Neurocog, Neurodyn Inc., Neurotrack, Nutricia, Probiodrug, Regeneron, Rodin Therapeutics, Samumed, Sanofi, Servier, Signant, Syndesi Therapeutics, Takeda, vTv Therapeutics, and Winterlight Labs.
As trials progress, FDA weighs COVID-19 vaccine authorizations for children
When the Food and Drug Administration gave emergency authorization to coronavirus vaccines from Pfizer and Moderna last December, it wasn't a hard decision. COVID-19 cases, hospitalizations and deaths were skyrocketing to record levels and public health officials were desperate to bring the pandemic under control. Clinical trial results showed both vaccines to be safe and highly effective in adults.
Now, as the FDA considers expanding authorization to young children, the U.S. finds itself in a very different stage of the pandemic, complicating how much data the agency will ask of vaccine makers and whether it will require standard approvals rather than emergency clearances. Dramatically reduced caseloads have shifted the risk-benefit balance, especially given emerging concerns over heart muscle inflammation in very small numbers of younger vaccine recipients.
These questions were debated at an FDA vaccines advisory committee meeting Thursday, during which some experts urged a go-slow approach to authorizing vaccines in children. Others warned cases could rebound as social distancing measures lift and coronavirus variants begin to spread.
"Before we start vaccinating millions of adolescents and children, it is so important to find out what the consequences are, because COVID-19 disease is disappearing in adolescents and children," said Cody Meissner, the director of pediatric infectious diseases at Tufts Medical Center.
The FDA convened the meeting to review the data that would support either an emergency use authorization, which the vaccines from Pfizer and partner BioNTech and Moderna have received, or a full approval.
Pfizer's vaccine received an EUA for 12- to 15-year-olds in May, while Moderna filed its application for 12- to 17-year-olds on Thursday. Trials are underway in younger age groups for both vaccines.
For those age groups, the companies didn't conduct the massively large efficacy trials as they did with adults, but instead took an "immunobridging" approach that evaluated whether the immune response seen in the adolescents matched that of adults, as well as measuring the safety of the vaccine.
A similar approach would likely be taken for the younger age groups. The main questions on which the FDA sought input was on what basis approval should be granted, as well as the size of the studies and the length of safety follow-up.
Countering Meissner, Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, argued that vaccinating children as young as six months was necessary to bring the pandemic completely under control.
"We are going to have a highly vaccinated, highly immune population for years if not decades. It just seems silly to think that we're not going to have to include children as part of that," he said. "We still vaccinate children in this country for polio every year even though we haven't had a case of polio since the 1970s."
No consensus was reached on whether companies should pursue an EUA or standard approval for children younger than 12, leaving it to discussions between vaccine makers and the FDA on which path to take. The difference would likely be in the duration of the safety follow-up, which would be six months in the case of a full approval. For the vaccine EUA in adults, two months worth of safety follow-up was required.
FDA advisers gave some numbers on the enrollment necessary to assess immune response and safety, ranging from 1,500 to 10,000 study participants per age group.
https://www.biopharmadive.com/news/fda-advisory-committee-coronavirus-vaccine-kids/601691/
Moderna founder raises another $2B to fuel new startups
- Flagship Pioneering, the investment firm behind Moderna and dozens of other biotechs, said Monday it has raised billions of dollars more to support new health and sustainability companies.
- Flagship closed its seventh so-called "Origination Fund" in spring 2020, after bringing in $1.1 billion. But the firm just announced that it had re-opened the fund in April to current limited partners, as well as a "select group" of fresh investors. The fund has since raised an additional $2.2 billion, for a total pool of $3.4 billion.
- Noubar Afeyan, Flagship's founder and CEO, told BioPharma Dive the fund's cash should be enough to finance between 20 and 25 companies, around a dozen of which are already being formed.
The money comes from firms like Flagship, Third Rock Ventures, Polaris Partners and Versant Ventures, which collectively raised billions of dollars over the last few years. The fresh funds suggest investors are confident they'll see returns. Indeed, the two main ways these firms cash out on their companies — biopharma acquisitions and initial public offerings — both recently hit historic highs, although dealmaking has since slowed and many newly public biotechs have seen their share prices tumble.
The COVID-19 pandemic is likely still influencing investors, too, as it underscored the vital need for healthcare infrastructure and new drug development. Moderna, for example, proved with its highly effective vaccine the immense value of messenger RNA medicines, and in doing so has seen its stock price grow almost 10-fold since March 2020.
"A lot of the new investors, certainly, I'm sure looked at Moderna. But also there's another dozen or so highly visible platforms that we've created," said Flagship's Afeyan in an interview.
Alongside Moderna, Flagship has founded and incubated high-profile biotechs like Sana Biotechnology and Denali Therapeutics. Now, with the re-closing of its seventh fund, the firm has much more money at its disposal for company creation. Flagship said the new funding will support startups focused on human therapeutics, agriculture and nutrition.
Recently, Flagship has unveiled several startups, including a company called Laronde that's developing a new type of RNA technology and has ambitions as lofty as Moderna.
"People are beginning to see that this is a moment in biotech, where more and more there's a proof point of what's possible," said Afeyan.
Flagship also plans to direct funds at two of its divisions: the Pioneering Medicine Division, which launched this year, and the Preemptive Medicine and Health Security Initiative, which Flagship said will debut soon, with the aim of safeguarding and improving health before a person gets sick.
Flagship said it has an aggregate pool of $6.7 billion on hand, and $14.1 billion assets under management. According to the firm, its portfolio companies have received a total $4.8 billion over the past year, with $370 million coming from Flagship and more than $4.4 billion coming from other capital providers.
https://www.biopharmadive.com/news/flagship-raises-2-billion-biotech-creation-fund/601763/
Roche data at EAN 2021 showcase significant impact of neuroscience therapies
-- Data for EVRYSDI reinforce safety profile and efficacy in a broad spinal
muscular atrophy (SMA) population, following recent EU approval
-- Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) build
on safety profile and efficacy following recent CHMP opinion, including
in adults with concomitant autoimmune diseases (CAIDs)
-- OCREVUS data continue to show consistent benefit on slowing disease
progression in relapsing MS (RMS) and primary progressive MS (PPMS)
-- Additional presentations in Alzheimer's disease (AD), Huntington's
disease (HD) and Parkinson's disease (PD) continue to contribute to
understanding of these complex neurological disorders https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Press-Release-nbsp-Roche-data-at-EAN-2021-showcase-significant-impact-of-therapies-across-diverse-35605052/
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