JoeForkeyBolo
3 months ago
New Phase 3 Trial Data Confirm the Uniquely High Efficacy and Good Safety Profile of the R21/Matrix-M™ Malaria Vaccine in African Children
SERUM INSTITUTE OF INDIA PVT. LTD. — February 1, 2024
https://www.seruminstitute.com/press_release_sii_010224.php
• Investigators immunised over 4800 young children in a trial in Burkina Faso, Kenya, Mali and Tanzania and found on average 78% efficacy in the 5–17-month age group over the first year
• To date 25 million doses manufactured and ready for roll-out by The Serum Institute of India (SII) in the next three to four months
Phase 3 Trial data results of The R21/Matrix-M™ vaccine developed by Oxford University and Serum Institute of India Pvt Ltd, leveraging Novavax’s Matrix-M™ adjuvant has confirmed high efficacy and supported regulatory approvals and licensure in several African countries. The R21/Matrix-M™ vaccine was designed in 2011 as a potential improvement on the RTS, S/AS01 malaria vaccine designed in the 1980s. A phase II trial in Burkina Faso, reporting in 2021, was the first to show that R21/Matrix-M™ could reach the WHO-specified target of 75% efficacy in African children. Recent WHO endorsement will lead to the initial rollout of R21/Matrix-M™ in the coming months. The new results are published in The Lancet today.
The trial investigators immunised over 4800 young children in a trial in Burkina Faso, Kenya, Mali and Tanzania and found on average 78% vaccine efficacy over the first year of follow-up across all sites in the 5-17-month-old age group, the age range group which is studied for most malaria vaccines. Efficacy over this period was broadly similar across sites and in different transmission settings. Safety data from the trial have been reassuring with no serious adverse events linked to immunisation. No other vaccine has reported over 55% efficacy in the same age group. A booster dose at a year maintained good efficacy over the following 6-12 months. The vaccine also reduced infection rates in children measured at 12 and 18 months after vaccination suggesting a potentially beneficial effect in reducing malaria transmission.
R21/Matrix-M™ vaccine was well tolerated, with injection site pain and fever as the most frequent adverse events. Number of adverse events of special interest and serious adverse events did not significantly differ between the vaccine groups. There were no treatment-related deaths.
Malaria is the largest cause of death in young African children with over 600,000 deaths globally each year. Two vaccines have recently achieved and completed World Health Organization (WHO) prequalification and initial deployments are starting early this year.
Professor Adrian Hill, chief investigator of the R21/Matrix-M™ phase 3 trial said "The continued high efficacy of this new vaccine in field trials is very encouraging, and consistent with the high efficacy and excellent durability observed in a smaller four-year phase IIb trial. These data support an important role for the unique high-density nanoparticle display, of the conserved repeat region of the malaria parasite circumsporozoite protein, a feature in the design of the R21 vaccine, in providing such high vaccine efficacy and, thereby, an important new tool for malaria control".
Significantly increased immune responses to the R21/Matrix-M™ vaccine and slightly higher vaccine efficacy were observed in 5-17-month-olds compared to 18-36-month-olds malaria vaccines, supporting planned vaccine deployment initially from 5 months of age in young African children.
The vaccine is licensed to the Serum Institute of India (SII), the world’s largest vaccine manufacturer and a long-term partner of the University of Oxford. This is critical because vaccinating those at high risk of malaria will be important in stemming the spread of the disease, as well as protecting the vaccinated. Matrix-M™ adjuvant is manufactured by Novavax AB and provided to Serum Institute of India for formulation into the final vaccine drug product.
Adar Poonawalla, CEO, Serum Institute of India, said: "The Lancet study on R21/Matrix-M™ Phase 3 trials mark a significant advancement in our battle against this global threat. Our collaboration with the University of Oxford has been instrumental in developing the R21/Matrix-M™ malaria vaccine. We are dedicated to making this vaccine available, especially in Africa, where malaria poses a substantial threat to millions of lives, bringing us closer to a malaria-free world".
Professor Alassane Dicko, Principal Investigator in Mali of the R21/Matrix-M™ vaccine, said: "It has been very exciting to generate high efficacy data with the new R21/Matrix-M™ vaccine so quickly. I predict that this vaccine should be very impactful in preventing malaria deaths in African children".
John C Jacobs, CEO of Novavax commented "Approximately 1,300 children die from malaria every day, a staggering statistic for a preventable disease. The R21/Matrix-M™ Phase 3 efficacy data published in The Lancet reinforce the potential of R21/Matrix-M™ vaccine to protect children against this disease. We are proud of the role of Novavax's patented saponin-based Matrix-M™ adjuvant, which has been demonstrated to enhance the immune response, in the outcome of this clinical trial and are eager to see the realized impact of the vaccine when it is rolled out globally".
JoeForkeyBolo
3 months ago
Novavax: Creating tomorrow’s vaccines today
pharmaphorum
January 10, 2024
https://pharmaphorum.com/rd/novavax-creating-tomorrows-vaccines-today
Back in November 2023, pharmaphorum travelled to Uppsala, Sweden, for a Novavax press conference, the company celebrating a decade of doing what it does best: vaccines. From COVID-19 to malaria, Novavax focuses solely on developing vaccines against some of the world’s most serious infectious threats. What sets it apart, though, is that its vaccines are protein-based.
Founded in 1987 in the US, Gale Smith – VP of vaccine development at Novavax – invented the technique of using insect cells for producing recombinant protein vaccines. A further milestone came in 1998 in Uppsala, with the development of adjuvants for veterinary use and for humans after that. By 2013, European Novavax AB was acquired by the US Novavax Inc, combining the two techniques of recombinant proteins and S-based adjuvants, Magnus Savenhed, managing director of Novavax AB, told journalists.
Creating immunological memory without causing disease
Before a tour of the facility, Dirk Poelaert, MD and senior director of medical affairs in Europe for Novavax, who has worked in vaccines for 20 years or so, explained that protein-based vaccines work, very simply, by protecting humans by triggering the immune system to produce antibodies against a specific pathogen, making a person sick and mimicking nature by providing an antigen. “In short, vaccines create immunological memory without causing disease,” he said.
Nonetheless, recombinant protein vaccines often need an adjuvant, or a substance that increases or modulates the immune response to a vaccine. This is why the Novavax vaccine platform comprises a recombinant protein particle plus Matrix-M adjuvant, which is manufactured in Uppsala itself.
Poelaert described how a recombinant protein particle has a native 3-dimensional conformation, with truncated S. frugiperda glycans and a particulate structure that facilitates antigen presentation and processing. Meanwhile, the Matrix-M adjuvant induces robust neutralising antibodies and induces polyfunctional CD4+TH1 lymphocytes (T helper cells). Formulation is in a nanoparticle with the recombinant protein particle.
Protein-based vaccines and recombinant expression systems
What might not be realised is that protein-based vaccines have existed for many decades for the prophylaxis of bacterial and viral diseases. They are indicated across the spectrum of infants, children, and adults, and have a favourable safety profile with well-known benefits. Nevertheless, originally the proteins used in vaccines were purified exclusively from cultures of an infectious agent, while today, specific immunogenic proteins can be generated through recombinant expression systems, said Poelaert.
Novavax takes the RNA sequence that codes and then incorporates into a baculovirus that can only infect insects, not humans. It uses the Sf9 cell, an ovary cell of an army moth, and the baculovirus enters the insect cell, including its nucleus, wherein it releases its genetic material. The machinery of this cell will produce the original protein had in mind, which then rises to the surface of the cell, where it is harvested and put into contact with the core, the polysorbate 80, the emulsifiers, and go towards a full vaccine.
Global public health: The malaria case
In terms of the global context, also in attendance was Dr Ole Olesen, PhD, executive director of the European Vaccine Initiative (EVI). EVI is an independent, non-profit research organisation that supports the development of safe and effective vaccines for global health – including affordability. It supports vaccine R&D through pre-clinical and clinical development, having helped with over 40 vaccine formulations. Dr Olesen noted how infectious diseases are often forgotten in the Western world.
“However, in the poorer parts of the world, infectious diseases are still a huge problem,” he reminded journalists. “More than 10 million people each year die from such. If one looks specifically at the malaria example, there are almost 250 million cases per year […] As a global community, this needs to be addressed.” Indeed, in 2022, there were 608,000 deaths from malaria across 85 countries worldwide.
As of December 2023, though, Novavax’s R21/Matrix-M malaria vaccine received pre-qualification from the World Health Organization (WHO), to prevent malarial disease in children caused by the P. falciparum parasite in endemic areas, allowing United Nations (UN) agencies to procure the vaccine in eligible countries and enable rollout of the vaccine.
The power of partnerships (and adjuvants)
Developed by the University of Oxford and the Serum Institute of India using Novavax’ saponin-based Matrix-M adjuvant – which helps stimulate immune responses to the vaccine – the R21/Matrix-M malaria vaccine has gained authorisation for use in children in Burkina Faso, Ghana, and Nigeria. Meanwhile, R21/Matrix-M is one of several ongoing collaborations involving Novavax’s adjuvant technology, with additional research in malaria and other infectious diseases in both humans and animals.
“In an ideal world, the disease burden should match the amount of research investment going into solving them,” he continued. “Malaria has, though, an enormous discrepancy between the disease burden and the amount of global investment. It costs over $500 million to develop a new vaccine, though; it is expensive, and this is a conservative figure. Some other projections are four or five times that amount. Clearly, it’s an expensive business. Additionally, there is a complexity to the disease itself […], and malaria has taken almost 150 years to get to the point now where there is a potential vaccine.”
“The immune system is like a sleeping dog,” Dr Olesen said. “Non-vaccinated, [it] remains asleep; immunised with active ingredient only, it remains in semi-dormancy. It is only when immunised with an active ingredient adjuvant that the dog is alive and kicking (and barking and biting, as one’s immune system should in the face of the infection). Companies like Novavax, with unique technologies like the Matrix-M adjuvant (the difference between a vaccine that works and doesn’t) need to engage in solving global health problems, a critical mass coming together, [and] the R21 malaria vaccine is an example of this, indeed.”
The pandemic period
During the pandemic, Novavax was operating under a joint contract with the EU Commission, delivering the vaccine through that (which came to an end at the close of 2023) to different governments around the world. Now, the company has initiated a transition into a “new and normal commercial situation in Europe,” Jorgen Persson, VP of market access and customer engagement, told journalists.
In different countries, governments are still considering their management of the vaccine post-pandemic, and so Novavax is in discussions with those governments. There is, Persson said, a dialogue from the perspective of delivering an updated vaccine that covers the needs of the space as it is now. The vaccine is approved in over 40 countries and recommended by the WHO. Well-positioned with proven technology, pipeline assets, commercial execution, and a focus on corporate development, Novavax’s platform seems to stand it in good stead for its desired future.
The value of vaccines
Previously, pharmaphorum had spoken with Alvar Paz, general manager for Europe at Novavax, and Silvia Taylor, executive vice president and chief corporate affairs and advocacy officer for Novavax, at the Economist Impact Future of Health Europe Summit in London. Taylor later partook in a fireside chat at the conference with Michael Guterbock on the value and power of vaccines.
Taylor joined Novavax in June 2020, right as the pandemic was hitting. In the time since, she’s helped to build the company from a very small, development-stage company to a global commercial organisation with authorisations around the world and commercial operations and manufacturing in Europe. Paz, meanwhile, joined Novavax two years later, in June 2022.
When it comes to public health, education is key, insisted Taylor: the availability, the choice, the options of vaccines. It's about trust. And Novavax hopes to be among the first companies to commercialise a combination vaccine (COVID and influenza).
“That's almost the holy grail, right?” she said. “If you think about it, it's two seasonal vaccines given in one jab. I think the convenience and the adherence to vaccination will greatly improve when you do combination products like this, but that is a few years away. We're still in phase two, and so I think we've got a couple of years more of our clinical development before we go to that.”
“I think the uniqueness of what Novavax is bringing to market is that we're the only protein-based option,” she continued. “It has advantages in terms of not needing to be frozen, it's refrigerator stable. I think, speaking to demand, you've got the consumer demand, you've also got the healthcare providers who have to administer. It's a really attractive profile.”
Remembering that COVID isn’t ‘done’
In October 2023, Novavax was given the go-ahead by regulators in the US for an updated version of its COVID-19 vaccine, which targets the XBB.1.5 variant of the coronavirus.
“COVID isn't done with us. It continues [and] it continues to change,” explained Taylor. “It continues to be something that we see a need for. In fact, in markets like the US, the recommendations are even broader than what we see in Europe in terms of giving accessibility to everybody in the market to get vaccinated as they choose. We think that's a great model. It's not the way it is here in Europe.”
“When you're talking about infectious diseases, you're not just vaccinating yourself for yourself, you're doing it for your community, you're doing it for your country,” she added. “You literally see things spreading. What we say about, "Nobody is safe until everybody is safe," is very, very much true.”
“We should be grateful to the mRNA vaccine, which is a pandemic vaccine, but ours is the endemic vaccine,” Paz noted. “A protein-based vaccine has proven the features that much better fit an endemic situation, [including] supply stability, temperature stability, even the product features themselves: efficacy, longer duration and durability, and safety profile.”
The press conference in Sweden might have been missing the Scandinavian summer light, but it appears that the light of vaccine-protective hope is burning brightly at Novavax, from COVID to malaria, and beyond.
JoeForkeyBolo
4 months ago
NEWS: Novavax's Updated COVID-19 Vaccine Now Authorized in Canada
https://ir.novavax.com/press-releases/2023-12-05-Novavaxs-Updated-COVID-19-Vaccine-Now-Authorized-in-Canada
December 5, 2023
• Novavax's updated protein-based non-mRNA COVID-19 vaccine will be available in Canada for individuals aged 12 and older in the coming days
GAITHERSBURG, Md., Dec. 5, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that Health Canada has granted expanded authorization for Nuvaxovid™ XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. The Public Health Agency of Canada's National Advisory Committee on Immunization recommended XBB COVID-19 vaccines that target more recent, immune-evasive variants of the virus.1
"Today's expanded authorization will support the Canadian government's strong commitment to provide its citizens with effective options, such as our protein-based non-mRNA vaccine, in the campaign against currently circulating COVID-19 variants," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We look forward to helping to protect Canadians in time for the upcoming holiday season and, pending vaccine batch release, have doses in market for access across the country."
The expanded authorization was based on non-clinical data showing that Novavax's COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.2,3
In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.
Novavax's updated COVID-19 vaccine is also authorized in the U.S., the European Union and by the WHO, and is under review in other markets.
chrismiss_everyday
5 months ago
Wish it were available at CVS or Walgreens!
Novavax's Updated Protein-based COVID-19 Vaccine Now an Option for All 194 Member States of the World Health Organization
GAITHERSBURG, Md., Nov. 28, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that Nuvaxovid™ XBB.1.5 COVID-19 Vaccine (NVX-CoV2601) has been granted Emergency Use Listing (EUL) by the World Health Organization (WHO) for active immunization to prevent COVID-19 in individuals aged 12 and older. The EUL assists WHO member states in assessing vaccines with the aim of expediting availability and enables the WHO's 194 member states to expedite regulatory approvals to import and administer the vaccine.
"The WHO Emergency Use Listing of our updated protein-based non-mRNA COVID-19 vaccine enables expedited regulatory approvals for its 194 member states and UN procurement agencies, such as UNICEF, thereby supporting equitable access to our vaccine around the world," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Rural or hard-to-reach areas can benefit from our vaccine's ease of transport and storage profile. As part of a diversified vaccine portfolio, our vaccine can play an important role in helping to protect people around the globe against the latest variants."
Novavax's vaccine can be stored at 2 to 8 degrees Celsius and has a 12-month shelf life, simplifying delivery, decreasing the carbon footprint and reducing wastage.1-4
The EUL was based on non-clinical data showing that Novavax's COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to subvariants BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.5,6
In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.
Novavax's updated COVID-19 vaccine is also authorized in the U.S. and the European Union, and is under review in other markets.
Trade Name in the U.S.
The trade name Nuvaxovid™ has not been approved by the U.S. Food and Drug Administration (FDA).
NOVAVAX COVID-19 VACCINE, ADJUVANTED (2023-2024 FORMULA) AUTHORIZED USES
Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. Refer to the full Fact Sheet for information about the Novavax COVID-19 Vaccine, Adjuvanted.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
IMPORTANT SAFETY INFORMATION
What should you mention to your vaccination provider before you or your child get the Novavax COVID-19 Vaccine, Adjuvanted?
Tell your vaccination provider about all of your or your child's medical conditions, including if you or your child:
have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects your immune system
are pregnant or plan to become pregnant
are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection
Who should not get the Novavax COVID-19 Vaccine, Adjuvanted?
A person should not get the Novavax COVID-19 Vaccine, Adjuvanted if they had:
a severe allergic reaction after a previous dose of any Novavax COVID-19 Vaccine, Adjuvanted
a severe allergic reaction to any ingredient of these vaccines
What are the risks of the Novavax COVID-19 Vaccine, Adjuvanted?
There is a remote chance that the vaccine could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose. For this reason, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
Difficulty breathing
Swelling of the face and throat
A fast heartbeat
A bad rash all over your body
Dizziness and weakness
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within 10 days following vaccination. The chance of having this occur is very low. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the vaccine:
Chest pain
Shortness of breath
Feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported in clinical trials with the Novavax COVID-19 Vaccine, Adjuvanted include:
Myocarditis (inflammation of the heart muscle)
Pericarditis (inflammation of the lining outside the heart)
Injection site reactions: pain/tenderness, swelling, redness and itching
General side effects: fatigue or generally feeling unwell, muscle pain, headache, joint pain, nausea, vomiting, fever, chills
Allergic reactions such as hives and swelling of the face
Swollen lymph nodes
Side effects that have been reported in post-authorization use with the Novavax COVID-19 Vaccine, Adjuvanted include:
Severe allergic reactions
Myocarditis (inflammation of the heart muscle)
Pericarditis (inflammation of the lining outside the heart)
Paresthesia (unusual feeling in the skin such as tingling or a crawling feeling)
Hypoesthesia (decreased feeling or sensitivity, especially in the skin)
These may not be all the possible side effects. Serious and unexpected side effects may occur. The possible side effects are still being studied.
What should I do about side effects?
If you or your child experience a severe allergic reaction, call 9-1-1, or go to the nearest hospital.
Call the vaccination provider or your healthcare provider for any side effects that bother you or your child or do not go away.
Report vaccine side effects to the FDA and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 18008227967 or report online to https://vaers.hhs.gov/reportevent.html . Please include "Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) EUA" in the first line of box #18 of the report form.
In addition, you can report side effects to Novavax, Inc., using the following contact information: Website: www.NovavaxMedInfo.com, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829).
What about pregnancy or breastfeeding?
If you or your child are pregnant or breastfeeding, discuss the options with your healthcare provider.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy. Women who are vaccinated with the Novavax COVID-19 Vaccine, Adjuvanted during pregnancy are encouraged to enroll in the registry by visiting https://c-viper.pregistry.com .
Please see the Fact Sheet for Recipients and Caregivers for more information. Reporting Adverse Events and Vaccine Administration Errors
Adverse events can also be reported to Novavax, Inc. using the following contact information or by providing a copy of the VAERS form to Novavax, Inc. Website: https://www.novavaxmedinfo.com/, Fax Number: 1-888-988-8809, Telephone Number: 1-844-NOVAVAX (1-844-668-2829).
About Nuvaxovid™ XBB.1.5 2023-2024 Formula (NVX-CoV2601)
NVX-CoV2601 is an updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the Omicron XBB.1.5 subvariant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M™ adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.
About Matrix-M™ Adjuvant?
When added to vaccines, Novavax's patented saponin-based Matrix-M adjuvant enhances the immune system response, making it broader and more durable. The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.??
About Novavax??
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. Focused on the world's most urgent health challenges, Novavax is currently evaluating vaccines for COVID-19, influenza and COVID-19 and influenza combined. Please visit novavax.com and LinkedIn for more information.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, including the availability of its updated XBB version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) and the timing of delivery and distribution of its vaccine are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for its product candidates, including its updated XBB version of its COVID-19 vaccine in time for the fall 2023 vaccination season or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
JoeForkeyBolo
6 months ago
Science: Should you pick Novavax’s COVID-19 shot over mRNA options?
Limited data and lack of head-to-head studies make comparisons tricky
October 6, 2023
For cardiologist Eric Topol, this week’s vaccine news presented a personal dilemma. Topol, who directs the Scripps Research Translational Institute and is a popular commenter on COVID-19 research, had hoped to get an updated COVID-19 vaccine from Novavax, rather than a messenger RNA (mRNA) shot from Pfizer or Moderna. Novavax relies on an older, protein-based approach that has shown long-lasting effects against other pathogens, and Topol wondered whether it might produce more durable protection. On Tuesday, it seemed he might get his chance: a drugstore he visited for an mRNA vaccine ran out of doses, and hours later the U.S. Food and Drug Administration authorized a Novavax shot well-matched to current COVID-19 variants. The green light marks the first time Novavax will be widely available to teens and adults.
“It’s hard to know how it compares” to mRNA vaccines, Topol admits; there are no head-to-head studies to rely on. In clinical trials, Novavax appeared less likely than mRNA shots to cause side effects like headache and fatigue. But how does it stack up against mRNA vaccines when it comes to protection against SARS-CoV-2? The question has been vexingly difficult to answer.
Some hints are emerging, including the first large study of Novavax in the real world, published this week by a team in Italy. The results are far from definitive, but they suggest “there aren’t massive differences” between the vaccines, says Alberto Mateo Urdiales, an epidemiology and infectious disease researcher at the Italian National Institute of Health, who led the study.
Whereas mRNA vaccines carry instructions for making a SARS-CoV-2 protein, Novavax directly delivers a fragment of that viral spike protein with an adjuvant for boosting immune response. Such protein subunit vaccines have yielded durable protection against various pathogens including hepatitis B and shingles, along with some respiratory ailments such as pneumonia. A version of the Novavax vaccine targeting the original SARS-CoV-2 variant was approved as a primary vaccination series and first booster in the United States in 2022; it also became available in Europe that year. Its tried-and-true technology appealed to some people wary of the new mRNA approach. And unlike the more fragile mRNA shots, it lasts for months in the refrigerator. But uptake has been low and the company is banking on more shots in arms this fall.
The Italian team tried to pin down how well the shot actually works, analyzing data on more than 20,000 Italians who had received two doses as their primary vaccine series in 2022. After 4 months, the vaccine was 55% effective at staving off symptoms from a SARS-CoV-2 infection and 28% effective at preventing infection altogether, the researchers reported in JAMA Network Open. That’s roughly comparable to how the mRNA vaccines have performed, Mateo Urdiales says. He cautions that the emergence of SARS-CoV-2 variants, repeated boosting, and swelling numbers of infections make it hard to compare numbers across the studies of effectiveness conducted to date.
Smaller studies, meanwhile, have tried to address another reason a Novavax booster appeals to people like Topol: the possibility that “mixing and matching” various COVID-19 vaccines might provide better protection than any single vaccine brand. “There was theoretical hope that since these vaccines work in slightly different ways, they would have different strengths in terms of which part of the immune system they activate best,” says Angela Branche, an infectious disease specialist at the University of Rochester. She co-chairs a mix-and-match study called COVAIL that includes another protein subunit vaccine from the company Sanofi, which is not available in the U.S.
At the University of Maryland School of Medicine, infectious disease specialist and vaccine researcher Kirsten Lyke is leading a mix-and-match study in which 67 of the roughly 830 participants got the original Novavax vaccine as a first booster, having received Pfizer, Moderna, or Johnson & Johnson as their primary vaccination. Three months after that booster, their levels of neutralizing antibodies were similar to those in people who got an mRNA booster instead, the team reported in July in NPJ Vaccines. (Neutralizing antibodies may help protect against infection and illness.)
Mixing and matching has sometimes produced superior immune responses, both for COVID-19 and other vaccines. But Branche notes that protein and mRNA vaccines may be more similar, immunologically, than they appear at first blush, because both rely on the same SARS-CoV-2 spike protein to trigger an immune response.
Researchers also want to know how long protection lasts with Novavax versus mRNA vaccines. Mateo Urdiales found that protection from infection dropped in the first 4 months after Novavax vaccination, but it seemed to hold steady against symptoms; other studies have shown that with mRNA vaccines, protection against symptoms also declines in that time frame.
Lyke’s analysis hinted that levels of neutralizing antibodies waned more slowly after a Novavax booster than after an mRNA booster. But that doesn’t prove Novavax’s protection is more durable, she stresses: Novavax hit the scene much later, when many recipients had enhanced immunity from a previous infection. “This durability question is influenced by many different factors other than what the vaccine does,” Branche notes.
Ultimately, “I’m not sure that on their face any of the vaccines are particularly better than the other,” Lyke says.
Comparisons of safety are uncertain, too. A key concern for mRNA vaccines is myocarditis, an inflammation of the heart, which occurs, rarely, after vaccination, especially in young men. In Novavax trials, there were four cases of myocarditis in the vaccine arm within 20 days of vaccination and none in the placebo group during that time frame. June data from the Australian government noted myocarditis reports for three to four of every 100,000 Novavax doses, a rate roughly similar to what Australia reports for the mRNA vaccines.
But because the side effect is so uncommon and Novavax has been much less widely used, “I don’t think anyone can know the true rate yet of myocarditis from Novavax,” says Walid Gellad, a physician who studies drug safety at the University of Pittsburgh. “I would not assume yet that Novavax is the solution to the myocarditis issue of mRNA” vaccines, he adds.
Scientists hope more data on Novavax will come. Lyke is examining immune responses 6 months and 12 months after the original Novavax booster in her small cohort. Meanwhile, a rare head-to-head clinical trial began in February in Melbourne, Australia. It includes almost 500 people who already received three vaccine doses. Some are being randomized to get either a Moderna bivalent booster, which became available last fall, or the original Novavax vaccine. Others who opted against any booster will serve as a control group. “We want to determine the best vaccine for ongoing boosters,” says Claire von Mollendorf, who co-leads the study at the Murdoch Children’s Research Institute. Von Mollendorf expects initial results from a month after vaccination to be published around the end of the year. Results from a 12-month follow-up won’t come until early 2025.
The best time to pit Novavax head-to-head against the other COVID-19 vaccines may be right now, with updated boosters becoming available that all target the same version of Omicron, called XBB. This fall, “I think most people will take what they are offered, and then you can compare,” Mateo Urdiales says. He’s hoping to launch such a study, using the Italian registry data on vaccination.
As for Topol, upcoming travel and uncertainty about Novavax’s availability led him to opt against waiting. He got a Pfizer shot at a nearby grocery store this week—though he still wonders whether and how a dose of Novavax might have been different.
Source: https://www.science.org/content/article/should-you-pick-novavax-s-covid-19-shot-over-mrna-options
JoeForkeyBolo
6 months ago
CNBC: Novavax’s updated Covid vaccine can still catch up to Pfizer, Moderna shots this fall
October 7, 2023
KEY POINTS
• Novavax’s updated Covid vaccine is arriving nearly three weeks after new jabs from Pfizer and Moderna reached Americans — but analysts aren’t worried about that delay.
• It still appears well positioned to compete with the other companies in the U.S. Covid vaccine market this fall, particularly after logistical issues hampered the rollout of the other shots.
• That’s good news for Novavax, which is working to strengthen its financial position after raising doubts about its ability to stay in business at the beginning of the year.
Americans can finally get their hands on Novavax’s newest Covid vaccine after U.S. regulators greenlighted the shot this week.
The vaccine’s arrival comes nearly three weeks after new jabs from Pfizer and Moderna reached the public, and after more than 4 million patients rolled up their sleeves to get a shot in September. But Wall Street analysts aren’t worried about that delay.
They said Novavax appears well positioned to catch up and compete this fall with the other companies in the U.S. Covid vaccine market, particularly after logistical issues hampered the rollout of the other shots and a Food and Drug Administration label that allows for wide accessibility to Novavax’s jab, among other factors.
“I’m really not concerned about the timeline or lag relative to the other shots,” B. Riley Securities analyst Mayank Mamtani told CNBC. He added that regulators cleared Novavax’s new shot only slightly later than what the company had estimated, which was late in the third quarter.
That’s good news for Novavax, which is working to strengthen its financial position after raising doubts about its ability to stay in business at the beginning of the year. The biotech company is banking on sales of its updated Covid vaccine — its only commercially available product — and a broad cost-cutting push to help it stay afloat.
Public health officials see Novavax’s vaccine as a valuable alternative for people who don’t want to take messenger RNA shots from Pfizer and Moderna, which teach cells how to make proteins that trigger an immune response against Covid. Novavax’s shot fends off the virus with protein-based technology, a decades-old method used in routine vaccinations against hepatitis B and shingles.
Silvia Taylor, Novavax’s chief corporate affairs and advocacy officer, told CNBC that the company has collected data showing that 25% to 30% of people prefer a protein-based vaccine.
“We look forward to meeting this demand and more in the wake of new variants and rising COVID cases,” Taylor said in a statement.
Shares of Novavax jumped more than 10% on Tuesday after the FDA cleared its new shot. But the company’s stock is still down more than 25% year to date after shedding more than 90% of its value last year.
Novavax’s shot has a broad authorization label
The FDA authorized Novavax’s updated vaccine — which targets the omicron subvariant XBB.1.5 — for emergency use in people ages 12 and older. Patients previously vaccinated with an older Covid vaccine are eligible to receive one dose of Novavax’s new jab, while unvaccinated people can receive two doses, according to the authorization.
The FDA similarly approved the new shots from Pfizer and Moderna for people ages 12 and older, but the agency also authorized those vaccines for emergency use in children ages 6 months through 11 years old.
Still, Mamtani said the authorization label for Novavax’s new vaccine is “broad and without any notable restrictions for the first time,” which will likely make the shot as widely accessible to teens and adults as the new mRNA jabs. That puts Novavax on more of a level playing field with Pfizer and Moderna this fall, even as a late entrant to the game.
The label for Novavax’s last Covid booster was far more restrictive. Last year, the FDA authorized it as a first booster dose for people ages 18 and older who couldn’t receive a new mRNA shot for accessibility or clinical reasons. That “basically disqualified a lot of people” from getting it last fall, according to Mamtani.
“Finally, after three years, Novavax has a label that puts its vaccine at parity with the mRNA shots,” Mamtani said. “I think the most powerful words on that label was that people can get it regardless of their previous Covid vaccination history.”
Logistical issues slowed down Pfizer, Moderna
Novavax’s vaccine is entering the market after Pfizer and Moderna had a bumpy start to the rollout of their shots. Insurance and supply-related issues left many Americans unable to find or access the new mRNA vaccines for free, which may give Novavax an opportunity to catch up and get more people to take its shot.
“We know that a lot of people have tried to get an mRNA vaccine, but they aren’t able to because of logistical challenges of access and distribution,” Jefferies analyst Roger Song told CNBC. “So, that’s one reason why the two or three weeks delay won’t necessarily be a hurdle for Novavax.”
There’s no way of knowing whether the rollout of Novavax’s new shot will see similar logistical snags or if it will have a smoother launch. The federal government shifted Covid vaccine distribution and coverage to the private market for the first time this fall. That has proved to be a tricky transition for the U.S. health-care system.
However, health-care providers and pharmacies have signaled that they are ironing out logistical issues and will be better equipped to handle them in the future.
Last week, a group of insurers told the Biden administration they were “largely, if not completely,” done with fixing delays in insurance coverage for the new Covid shots. Those delays had resulted in some patients getting charged up to $190 for a shot at pharmacies.
“Should further issues arise, we stand ready to swiftly implement system improvements,” the insurers said in a letter.
Some pharmacies, like Walgreens
, also appear to be resolving supply disruptions, which left many stores without any new Covid shots for patients to receive.
Covid vaccinations could peak later this fall
What’s more, Novavax’s new shot might actually be arriving at just the right time: a month before Covid vaccine demand is expected to peak in the U.S. this fall and winter.
Jefferies’ Song said the peak could follow a similar pattern as last season when most Covid boosters were administered in November. That’s partly because there is “less urgency” among Americans when it comes to Covid shots compared to early on in the pandemic, which could cause them to get vaccinated later rather than earlier.
“During the first season of Covid, everyone rushed to get vaccinations because it was really an emergency state. But now people have a mindset where they’re saying, ‘OK, I will wait and see how bad Covid really gets,’” Song said.
By November, Novavax’s new shot will likely be as widely available as shots from Pfizer and Moderna at pharmacies, doctor’s offices and other vaccine distribution sites.
But the biggest uncertainty this fall for all three companies is how many Americans will decide to get another Covid vaccine, Song said.
Last year’s uptake was already feeble: Only about 17% of the U.S. population — around 56 million people — received last year’s boosters, according to the Centers for Disease Control and Prevention.
“We don’t know how big the overall pie will be because we’ve never been in a commercial market for Covid vaccines,” he told CNBC. “This fall will set a new benchmark for the entire Covid vaccine space.”
Source: https://www.cnbc.com/2023/10/07/novavax-covid-vaccine-can-still-catch-up-to-pfizer-moderna-shots.html
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