Category: Vaccine

(AP) The U.S. government will pay the vaccine maker Moderna $176 million to accelerate development of a pandemic influenza vaccine that could be used to treat bird flu in people, as concern grows about cases in dairy cows across the country, federal officials announced Tuesday.

Moderna already has a bird flu vaccine in very early-stage testing that uses the same mRNA technology that allowed rapid development and rollout of vaccines to protect against COVID-19. The new funds from the U.S. Department of Health and Human Services include continued development of the vaccine, including a late-stage trial next year if those early study results are positive.

But the project can be quicky redirected to target another form of influenza if a different threat than the H5N1 form of bird flu emerges, HHS officials stressed.

The award was made through the Biomedical Advanced Research and Development Authority, or BARDA, a program that focuses on medical treatments for potential pandemics.

The H5N1 virus was detected earlier this year in dairy cows and has spread to more than 135 herds in 12 states and infected three people to date, all with mild cases. Federal health officials stress that the risk to the wider population remains low.

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The US will pay Moderna $176 million to develop an mRNA pandemic flu vaccine - East Idaho News

The fact that the Democratic Republic of the Congo (DRC) last carried out a census about 30 years ago hasnt exactly made the countrys efforts to reach every child with essential vaccines easy, points out Dr Pierre Akilimali, a researcher at the Kinshasa School of Public Health. The definitive denominator the number of children the programme ought to be immunising has been lacking for a couple of generations now.

Fortunately, in the meantime, technology has become capable of leapfrogging logistical hurdles. Dr Akilimali works as a research coordinator on a Ministry of Health-led project called Mapping for Health (M4H), which uses granular geospatial data from high resolution satellite images, along with data collected on the ground with a smartphone app, to help health workers create detailed, thorough vaccination plans.

Broadly, the intention is to zero in on zero-dose children; specifically, the project supports a Ministry of Health aim to boost vaccine coverage by 15% per targeted province initially by 2020, then by end of 2024, translating to 220,000 additional children protected.

In 2020 and 2021, Mapping for Health, with Gavi funding, targeted five priority provinces: Kinshasa, Kasa, Kasa-Oriental, Haut Katanga and Lomami. In those provinces, during that time-frame, the health system recorded a significant increase in vaccine coverage.

Weve refined our approach to locating and reaching zero-dose children in our community, said Yves Mukendi, a community health worker (CHW) in Haut-Lomami, one of nine provinces in DRC where M4H has now been put into play. Prior to the Mapping for Health project, immunisation campaigns were scheduled using antiquated and insufficient data. Since it was difficult to pinpoint every childs specific location, some children particularly those who lived in isolated areas were frequently overlooked.

This indicates that more kids are going to receive vaccinations, and the general health of our community will significantly improve, Mukendi added.

The mapping process layers existing info such as satellite images with the knowledge that local health teams carry in their files, their phones and their heads.

In whats typically a ten-day process, according to a November 2023 research report published by Kinshasa School of Public Health and HealthEnabled, and funded by Gavi, two mappers work with health zone representatives to figure out the basic contours of the area: settlements, boundaries, and health facilities. The mappers train health workers to take their smartphones back to the communities they serve, and fill in the blanks with GPS coordinates.

Next, a mini-census survey is conducted in random sample areas of the province, and then integrated with the mapping data to build a spatial model that can produce good population estimates. Specifically, Dr Akilimali said, the population estimates cover areas of 100x100 metres, offering demographic estimates for age and gender.

M4H is not just a tool; it's a paradigm shift in how we approach health care planning, Dr Akilimali emphasised. There are cases, he said, in which M4H has helped to detect and record entire villages that were missing from the standard, outdated maps.

By harnessing the power of geo-spatial data, we can create targeted interventions that reach the most vulnerable populations, ensuring that no child is left behind, he said.

Getting granular about demographics also opened the door to targeted, progressive interventions. In some provinces, a gender-conscious approach was built into the planning process.

M4H prioritises gender equity in health care delivery, explained Emmanuel Rukengwa, a national coordinator with the larger GRID3 mapping project that encompasses Mapping for Health, explaining that the aim is to balance out social biases that may prevent girls from receiving immunisations at an equivalent rate to their male counterparts.

A set of gender toolkits for EPI workers and their partners were released as part of the project to help reduce barriers to vaccination linked to gender and social exclusion factors in the DRC. For example, said Rukengwa, male involvement is essential to improving maternal and child health outcomes. The toolkits provide methods for conducting gender-based analyses and for integrating gender dimension into vaccination intervention planning.

Mamie Kabeya, a district-level health worker in Kasa, said, Being made more aware, we made extra efforts to deal with problems blocking girls access to vaccination. This implies that, regardless of a childs gender, we collaborate with communities to make sure that boys and girls are brought to immunisation clinics and that everyone is aware of the significance of vaccinating every kid.

Just three years in, users and researchers alike point to tangible impact. M4H has changed our immunisation approach in Haut-Lomami, said Mukendi. We have been able to discover 20% of new villages that were not in old maps.

Mukendi is far from alone in his enthusiasm: 86% of Haut Lomami workers who spoke to the KSPH and HealthEnabled surveyors said the geo-referenced tool was easy or very easy to use. A similar number described themselves as satisfied or very satisfied with its use.

It allows us to identify each population, each village and the distance, and the target population of each village, and even the vaccine to use, said one anonymous respondent from Haut Lomami. If I go somewhere in a small village that is, I dont know, 65 kilometres away with its target, I can already plan the vaccine I need to take, the tools I need to use, the means I need to use and how long I need to take. Its our map, it allows us to do a lot of things, and it makes it easier for us to do a lot of things.

The impact of the change on immunisation rates was traced in the KSPH research report. Comparing immunisation patterns in 2020, 2021 and 2022 in Haut Lomami with control provinces revealed that the GRID3 intervention and use of geospatial data for immunization may have contributed to a sustained increase in immunization coverage, increase in identification and immunization of zero-dose children, and minimal dropout.

The researchers elaborate: Data on initial vaccination coverage from the 2020 ECV [Vaccine Coverage Survey], and from ECVs carried out in 2021 and 2022, for BCG and OPV [oral polio vaccine] 0 antigens in the three provinces of Kasa, Kasa-Central and Haut-Lomami, show identical trends for all antigens, with clear progress on one side and stagnation on the other.

Clear progress arguably sells it short. Haut Lomamis coverage rates with the first dose of pentavalent vaccine, for example, rose from 9.9% in 2020, to a staggering 93.6% by 2022.

Kasa-Central, a control province for the study, made strides too but these were decidedly more modest. With a coverage rate of 26.3% for the first dose of pentavalent vaccine in 2022, 59.3% of Kasai Centrals eligible children had received that jab by 2022. Meanwhile, Kasas coverage of the same vaccine rose just slightly, from 51% in 2020, to 58.3% in 2022.

Several health structures have not yet begun to use geo-referenced data in routine immunisation and microplanning, noted sources, since in several provinces where the intervention has been implemented, validation and correction of maps or data is still ongoing. Another round of data collection is ongoing since October 2023 with different partners and in more provinces.

As we look to the future, initiatives like M4H serve as a testament to the transformative potential of technology in health care delivery, and the vital role it plays in safeguarding the health and well-being of our communities, said Emmanuel Rukengwa.

As DRC continues to catch up its post-pandemic immunity losses as of 2022, the countrys coverage with the third dose of the basic diphtheria, tetanus and pertussis-containing vaccine (DTP3) had slipped to 65% from 73% in 2019 thats encouraging indeed.

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Un-invisible: geospatial mapping effort a 'paradigm shift' for immunisation in DRC - Gavi, the Vaccine Alliance

Innovative vaccines are being developed that could potentially treat dangerous human papillomavirus (HPV) infections in adults and therefore reduce risks of cervical cancer, according to a new report released today by the World Health Organization (WHO).

Currently, vaccines exist to prevent, but not treat HPV infections, which are the main cause of cervical cancer. Using the latest immunotherapy advances, however, therapeutic vaccines are now also being developed that could clear HPV or treat precancerous cells in those already exposed to the virus.

To ensure maximum public health benefits, the report, WHO preferred product characteristics for therapeutic HPV vaccines calls on developers to ensure these products are designed to be used not only in wealthier contexts but also in low- and middle-income countries, where more than 90% of cervical cancer-related deaths occur.

To eliminate cervical cancer, it will be essential to expand access to existing interventions now lifesaving preventive vaccinations, timely screenings, and effective treatment all are critical for success, said Dr Sami Gottlieb, a medical doctor and epidemiologist within WHOs Department of Sexual and Reproductive Health and Research. Therapeutic HPV vaccines could be a catalytic innovation to complement these efforts, increasing options for the millions of women who have already acquired HPV and reducing their risks of developing life-threatening cancer in the future.

Eliminating cervical cancer which kills one woman every 90 seconds is a major public health initiative for WHO. The key goals of WHOs Cervical Cancer Elimination Initiative are, by 2030, to:

A therapeutic vaccine for HPV could supplement these existing approaches. Such vaccines aim to boost the bodys immune response so that it can either fight and clear high-risk strains of the virus or abnormal precancerous cells. It is likely to be especially beneficial for adult women who did not receive the HPV vaccination before contracting the virus and in poorer countries, where millions of women still lack access to effective cervical screening and cancer treatments.

There are currently over 20 therapeutic HPV vaccine candidates at different stages of development, with several in clinical trials. The new report aims to guide vaccine developers to ensure their products meet global public health needs and to enable vaccines to be rolled out more quickly if approved. It considers medical indications for potential use of such a vaccine, target populations, safety and efficacy criteria, as well as practical considerations such as delivery strategy, storage and dosage schedules, and affordability.

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Vaccines to treat human papillomavirus could be a significant innovation in the fight against cervical cancer - World Health Organization (WHO)

The rollout of the vaccine will be announced at a later date Syda Productions/Shutterstock

Frances public health authority has issued a recommendation that people aged 75 and over should make an appointment for an anti-bronchitis vaccine this autumn.

The Haute Autorit de sant also recommends that over 65s who have respiratory or cardiac conditions also get the vaccine.

It advises that people take the jab against RSV, the respiratory syncytial virus that is responsible for bronchitis, as vaccines against this have recently received authorisation and can be given for the first time this year.

Every year, between 15,000 and 20,000 elderly people in France are hospitalised with bronchitis.

In previous years, a triple-epidemic of bronchitis, flu, and Covid hit French hospitals during winter, saturating hospital beds.

Read more: Covid-19: Advice for tests, masks, isolation as cases rise in France

Further information regarding the vaccine calendar will be available later in the year but it means older people will be able to take vaccines against bronchitis, flu, and Covid simultaneously.

European authorities gave two vaccines against RSV one from Pfizer and one from GSK the green light to be used from this autumn.

A third, by US group Moderna, is currently also being assessed but is waiting further EU confirmation before it can be used on the public.

The choice of which vaccine to use will be up to the medical professional giving the vaccine.

Read more: CALENDAR: Check to see you are up to date with vaccinations in France

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Anti-Bronchitis Vaccine for Over 75s in France: New Public Health Recommendation - The Connexion

- Vivian Wan/Bloomberg News

GSK struck a deal to buy the rights to CureVacs Covid-19 and flu vaccines for up to 1.45 billion euros ($1.56 billion), in a bid to regain ground lost to newcomers to the vaccine market during the pandemic.

The deal bolsters the U.K. pharmaceutical companys vaccine portfolio at a time when bird-flu concerns are boosting demand. Vaccines accounted for roughly a third of GSKs sales last year.

GSKs deal with CureVac follows in the footsteps of a vaccine licensing agreement between Sanofi and Novavax in May valued at up to $1.4 billion.

Both GSK and Sanofi were among the biggest makers of vaccines before the pandemic, but fell behind rivals and new entrants that launched shots based on messenger RNA, or mRNA, technology as Covid-19 turbocharged demand. The mRNA-based vaccines that were widely used to combat Covid-19 use messenger ribonucleic acid instead of an actual bacteria or virus in the production process.

For GSK, the deal with CureVac is all about securing control of those vaccines the company considers most promising and relevant for the development of mRNA vaccines, a spokesperson said. Alongside the deal, GSK will continue to explore the potential of its own mRNA technology, the spokesperson said.

Under the licensing agreement, GSK will assume full control of developing, manufacturing and commercializing globally the candidate vaccines it and CureVac developed through a collaboration. These include shots for seasonal flu and Covid-19 that are currently in mid-stage trials and for avian flu in early-stage clinical development, the companies said.

CureVac will receive EUR400 million upfront and up to EUR1.05 billion in additional paymentssubject to reaching development, regulatory and sales milestoneas well as royalties, the companies said. It will also retain exclusive rights to the additional undisclosed infectious disease targets from the prior collaboration that havent yet been validated in clinical trials.

The deal restructures an existing collaboration between the two companies that began in 2020, at the height of the pandemic, when CureVac sought partners to develop its Covid-19 vaccine candidate. At the time, GSK took a stake of around 10% in CureVac. As of March, GSKs stake in CureVac amounted to 7.4%, according to FactSet.

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The agreement comes as governments around the world are stepping up efforts to prevent the potential spread of the avian flu virus to people. In the U.S., there have been outbreaks of the virus in dairy-cow farms in 12 states, with three dairy workers infected, according to the Centers for Disease Control and Prevention.

Vaccine maker Moderna on Tuesday received $176 million from a U.S. government program to accelerate development of avian flu vaccines for humans. Australias CSL last month got an order for more than 40 million doses of bird flu vaccines from the European Union.

Germany-based biotechnology company CureVac said the licensing agreement with GSK is part of a strategic overhaul that will see it reduce its workforce by around 30% in a bid to streamline its operations. The company in May said it had more than 1,100 employees.

The news sent CureVac shares sharply higher in U.S. premarket trading. GSKs stock edged slightly higher in European morning trading.

The payments from GSK and CureVacs expected savings in personnel costs from its own restructuring mean the company will have cash to run its operations until 2028, CureVac said.

CureVac said the restructuring will allow it to focus resources on mRNA projects in oncology and other areas. The company aims to create a leaner organization refocused on technology innovation, research and development, it said.

Helena Smolak contributed to this article

Write to Anthony O. Goriainoff atanthony.orunagoriainoff@dowjones.com

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GSK to Buy CureVac's Covid-19, Flu Vaccine Rights for Up to $1.56 Billion - Yahoo Finance

Novavax's COVID-19 vaccine would be the only protein-based option available in Canada, if authorized

Novavax's filing is aligned with NACI, U.S. FDA, EMA and WHO recommendations on vaccine composition

GAITHERSBURG, Md., July 2, 2024 /CNW/ --Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant,announced that it has filed for authorization with Health Canada for its 2024-2025 FormulaCOVID-19vaccine (NVX-CoV2705) for individuals aged 12 and older. The submission follows the National Advisory Committee on Immunization (NACI) guidance to use the latest selected strain and the guidance from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and World Health Organization (WHO).1-4

"Novavax is working closely with Health Canada to have an updated protein-based COVID-19 vaccine option approved for all eligible Canadians this fall," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Our updated COVID-19 vaccine is active against JN.1, KP.2 and KP.3, in addition to other JN.1 sublineage strains."

Nonclinical data have demonstrated that Novavax's updated COVID-19 vaccine induces broad neutralization responses to JN.1 lineage viruses, including those containing the F456L and R346T mutations, to "FLiRT" variants and to "FLuQE" variants such as KP.3.4-6 Novavax's vaccine also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a wide range of JN.1 lineage variants.4 These responses indicate that Novavax's vaccine technology induces broadly neutralizing responses against multiple variant strains, including responses to circulating forward drift variants.

Novavax intends to have its vaccine available in Canada for immediate release post-authorization, should public health programs choose to provide this option. Novavax has filedwith the U.S. FDAand EMA, and is working with other regulatory authorities globally on authorization or approval of its updated COVID-19 vaccine.

About the Novavax COVID-19 2024-2025 Formula (NVX-CoV2705)NVX-CoV2705 is an updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the JN.1 variant. 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 8C, enabling the use of existing vaccine supply and cold chain channels.

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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.7 The Matrix-M adjuvant stimulates the entry of antigen-presenting cells at the injection site and enhances antigen presentation in local lymph nodes.

About NovavaxNovavax, 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. The Company's portfolio includes its COVID-19 vaccine and its pipeline includes a vaccine for influenza and COVID-19 and influenza combined. In addition, Novavax's adjuvant is included in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine. Please visit novavax.comand LinkedIn for more information.

Forward-Looking StatementsStatements herein relating to the future of Novavax, its operating plans and prospects, the immunogenic response of its vaccine technology against variant strains and the scope, timing and outcome of future regulatory filings and actions, including any Health Canada, EMA or FDA recommendations, the timing of its delivery for a JN.1 protein-based COVID-19 vaccine this fall, 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, antigenic drift or shift in the SARS-CoV2 spike protein, 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 a JN.1 protein-based COVID-19 vaccine 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; 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, 2023, 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 http://www.sec.gov and http://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.

Contacts:InvestorsErika Schultz 240-268-2022 ir@novavax.com

MediaGiovanna Chandler 240-720-7804 media@novavax.com

References

Public Health Agency of Canada. Guidance on the use of COVID-19 vaccines during the fall of 2024. May 5, 2024. Available at:https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-guidance-covid-19-vaccines-fall-2024

U.S. Food and Drug Administration. Updated COVID-19 Vaccines for Use in the United States Beginning in Fall 2024. June 13, 2024. Available at: https://www.fda.gov/vaccines-blood-biologics/updated-covid-19-vaccines-use-united-states-beginning-fall-2024

European Medicines Agency.ETF recommends updating COVID-19 vaccines to target new JN.1 variant. April 30, 2024. Available at:https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-new-jn1-variant

World Health Organization. Statement on the antigen composition of COVID-19 vaccines. April 26, 2024. Available at:https://www.who.int/news/item/26-04-2024-statement-on-the-antigen-composition-of-covid-19-vaccines

U.S. Centers for Disease Control and Prevention. Variant Proportions [Data set]. In COVID Data Tracker. 2024. Available at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions

Focosi D, Spezia PG, Gueli F, Maggi F. The Era of the FLips: How Spike Mutations L455F and F456L (and A475V) Are Shaping SARS-CoV-2 Evolution. Viruses. 2023;16(1):3. Published 2023 Dec 19. doi:10.3390/v16010003.

Stertman L, Palm AE, Zarnegar B, et al. The Matrix-M adjuvant: A critical component of vaccines for the 21st century. Hum Vaccin Immunother. 2023;19(1):2189885. doi:10.1080/21645515.2023.2189885.

SOURCE Novavax, Inc.

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Novavax Submits Application to Health Canada for Updated Protein-based 2024-2025 Formula COVID-19 Vaccine - Yahoo Finance

When you think of Moderna (NASDAQ:MRNA) and its efforts to develop a next-generation COVID-19 vaccine, what do you think of? Chances are, you probably have the same concern that its simply a rehash, a sophomore album put out by a musical act to fulfill contract requirements. However, a more robust vaccine may be exactly what society needs at this hour. Therefore, I am bullish on MRNA stock.

At first glance, MRNA stock might not seem particularly compelling, especially with the acute fear of the virus well in the rearview mirror. As I mentioned last month, the Associated Press reported in February 2022 that anxieties associated with the virus began fading. You can also refer to the technical chart of Moderna stock at that time.

Indeed, MRNA stock suffered its first warning that not all was well in September 2021. However, the stock left no doubt in December to early January 2022. An effort by the bulls was made to restore confidence later that year. Unfortunately, this market initiative failed, leading to greater erosion.

Even now, the circumstances surrounding MRNA stock dont seem that compelling. On a year-to-date basis, shares gained under 6%. Thats not a particularly exciting statistic. Nevertheless, the endemic nature of COVID-19 may give Moderna much-needed relevance.

According to MedlinePlus, endemic means a disease that is always present in a population within a geographic area, typically year-round. In other words, impacted communities must learn to live with COVID rather than eradicate it completely.

Because of the vast resources available that biotechs including Moderna have forwarded, living with COVID-19 doesnt seem so terrible. However, one must consider the framework multidimensionally. The virus is still a threat. And COVID isnt just a matter of the sniffles but can be a temporarily debilitating disease.

That raises broader economic concerns. For example, one study shows that missing work leads to productivity losses that amount to $225.8 billion for U.S. employers, or $1,685 per employee.

On the other end of the scale, theres a risk called presenteeism. This circumstance describes workers who are legitimately sick but show up for work anyway due to various incentives. These could range from not wanting to fall behind to financial concerns such as lack of sick time.

Whatever the cause, presenteeism can also be disruptive in the form of healthy workers becoming sick.

To address COVIDs endemic threat, Moderna is developing a next-generation vaccine. More strains of the virus are appearing, which means that first-gen vaccines are not as effective. By protecting more people, Moderna can be an accretive benefit for the wider economy. Not only that, but the relevance of a new vaccine has likely risen due to the accelerated threat of serious COVID-19 complications.

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While the medical machinery has largely addressed or has frameworks in place to combat manageable COVID, the threat of serious infection that can lead to devastating results such as organ failure lingers. Thats because the virus is especially dangerous to people who already have chronic conditions.

Per the Mayo Clinic, those who have serious conditions such as heart disease are at risk of contracting severe COVID-19. Among the risk factors is obesity. Heres the problem: Americas waistline is expanding.

Data from various health agencies report that a worrying number of adults and children are obese. According to one analysis conducted in late 2022 to early 2023, 19 states have incurred obesity rates of over 35%. This figure increased by three states from just the year prior.

Whats more, this isnt just a problem that materialized overnight. Back in 2004, a medical journal sounded the alarm with its article title, Fat land: how Americans became the fattest people in the world.

Its not just the endemic threat of COVID-19. Rather, its that Americans are at greater risk of serious infection, and thats a powerful narrative for MRNA stock.

MRNA isnt what you would call a discounted stock at the moment. Right now, shares trade at 8.9x trailing-year revenue. However, the biotech sector runs an average sales multiple of 6.92x. Whats worse, analysts anticipate that Fiscal 2024 sales may only reach $4.15 billion. Thats down 39.5% from last years tally of $6.85 billion.

Stated differently, you can expect the multiple to rise unfavorably on a forward basis.

Nevertheless, the market appears to have priced in much of the pessimism. In the trailing month, MRNA stock lost about 16% of its equity value. Once the volatility is fully baked in, Moderna looks compelling. Fundamentally, COVID-19s endemic threat poses a societal and economic threat. Someone has to address it. Modernas next-gen vaccine may help.

Turning to Wall Street, MRNA stock has a Moderate Buy consensus rating based on eight Buys, seven Holds, and two Sell ratings. The average MRNA stock price target is $143.19, implying 22.3% upside potential.

With public fears of COVID-19 in the rearview mirror, Modernas efforts in developing a next-gen vaccine might seem superfluous. However, its actually surprisingly relevant. Due to the endemic threat of the virus, more people may suffer infections, which could impact economic productivity. Whats worse, the fading health of the American public raises the threat of serious COVID-19 symptoms. That means investors shouldnt ignore the potential opportunity for Moderna.

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Moderna Stock (NASDAQ:MRNA): Next-Gen COVID-19 Vaccine Is More Than a Rehash - Yahoo Finance

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There is no evidence of major birth defects in babies born to mothers vaccinated against COVID-19 during the first trimester of pregnancy, according to new research published in JAMA Pediatrics on Monday, underscoring the safety of vaccination during pregnancy amid mounting evidence of the severe health risks infections can cause for mothers and babies.

The study adds to data supporting the safety and effectiveness of Covid vaccines during pregnancy.

Exposure to Pfizer and Modernas mRNA Covid vaccines during the first trimester of pregnancy was not associated with an increased risk of major birth defects including problems with the eyes, ears, neural tube, kidneys, respiratory system and musculoskeletal system, according to a team of researchers from across the U.S.

The findings come from an analysis of healthcare data covering more than 42,000 pregnancies linked to live births between early March 2021 and late January 2022 that were registered in the Vaccine Safety Datalink database from eight healthcare systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin.

Nearly a fifth of the pregnant people, around 7,600, received a dose of an mRNA Covid vaccine during the first trimester one of the most vulnerable periods of pregnancy for harmful exposures and birth defects the researchers said, with 19,000 not receiving a vaccine before or during pregnancy and 13,500 getting a dose in their second or third trimesters but not in their first.

The dose was the second vaccine for around 1,350 of the pregnant people vaccinated in their first trimester, the researchers said, with around 46% of the group going on to get their second dose during the second or third trimesters and 20% getting a third booster dose.

The researchers said their findings indicate no increased risk for major structural birth defects following first-trimester vaccination, adding this is in line with the handful of other studies from Scotland and Israel to comprehensively assess the association between maternal vaccination and birth defects in infants.

The findings, which only cover Pfizer and Modernas COVID-19 vaccines, should provide reassurance to pregnant people and their obstetric care practitioners, the researchers said.

Researchers and officials are naturally very cautious about giving newly approved healthcare products to pregnant people due to the risks for parent and child. This is especially true early on in pregnancy, when the risks of exposure to potential hazards is higher and for newer technology, like mRNA vaccines, that have been less widely studied in the population compared to more established products, and drugmakers routinely exclude pregnant people from trials over safety concerns. This caution was on full display during the early stages of vaccine rollout during the COVID-19 pandemic, when the shots were new and less was known about the virus and risks it posed to pregnant people and infants. There was little to no data about vaccination in pregnant people then and both experts and leading health agencies around the world, including the World Health Organization, were divided over how to proceed, sometimes discouraging and sometimes encouraging pregnant people from getting vaccinated. Experts and top health authorities now widely encourage pregnant people to get vaccinated without delay and there is an increasing array of evidence highlighting the serious health risks to mother and baby from Covid infections, including respiratory issues, preterm birth, stillbirth and neurological and developmental issues. Research also suggests maternal vaccination can protect the baby in the first six months of life after birth.

The Centers for Disease Control and Prevention recommends vaccination at any point in pregnancy and says studies from around the world involving hundreds of thousands of people show vaccination both before and during pregnancy is safe and effective and beneficial to both the pregnant person and the baby. mRNA vaccines reduce the risk of severe illness and other health effects from COVID-19 during pregnancy, the CDC said, as well as helping to build protective antibodies that can protect the baby. The agency stresses the benefits of receiving a COVID-19 vaccine outweigh any potential risks of vaccination during pregnancy.

Data on side effects, especially rare ones, can take a while to emerge and it is hard to capture on relatively small sample sizes like pregnant people. The researchers said their findings only considered single births, as well as pregnancies ending in live birth, which would naturally exclude any defects resulting in stillbirth or similar outcome, as this data was not captured in the database available. Some other issues can take time to emerge, the researchers acknowledged, and though they were only able to evaluate defects up to four months from birth they said this time frame has proven to have a solid predictive value in the past.

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Pfizer And Moderna Vaccines Not Linked To Birth Defects, Study Finds - Forbes

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Its been a tough few weeks for the GSK (LSE:GSK) share price. Even news of a major vaccines agreement on Wednesday (3 July) hasnt helped it to recover ground.

At 15.03 per share, the FTSE 100 firm was last trading marginally lower in mid-week trading. It has now lost all the gains it had earlier enjoyed in 2024.

I think GSK shares might now be a brilliant dip buy. Heres why I think value investors should give it serious consideration right now.

To build its position in the lucrative vaccines market, GSK has announced a deal with German company, CureVac. It plans to pay up to 1.4bn to the cash-strapped company to take development control for certain vaccines.

GSK said it will acquire full rights to develop, manufacture and commercialise globally mRNA candidate vaccines for influenza and COVID-19, including combinations.

It will pay 400m up front, and up to another 1.05bn as certain development, regulatory, and sales milestones are met. The two companies have been working closely together since 2020 to develop mRNA vaccines for infectious diseases.

The agreement could significantly boost the profits GSK makes in a fast-growing marketplace.

Analysts at Statista, for instance, think total revenues from vaccine products will soar 28% between 2025 and 2028, to $88.6bn. Demand will driven by increased government promotion of vaccination programs and heightened consumer awareness of their life-saving benefits following the Covid-19 crisis.

Encouragingly, GSK is already establishing itself as a star player here. Sales of its vaccines like the blockbuster Shingrix treatment soared 16% in the first quarter of 2024 (at constant currencies), to 2.3bn.

Turnover was also helped by new product rollouts in the quarter. While getting product from lab bench to market can be a bumpy ride, a strong product pipeline suggests GSK is in good shape to keep this momentum going.

Investing in GSK doesnt come without peril, however. The pharma sector is strictly governed, and an adverse decision from regulators can cost a fortune in lost revenues and extra R&D costs.

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Last month, for instance, the US Centers for Disease Control and Prevention (CDC) pledged to restrict rollout of the respiratory syncytial virus (RSV) vaccine across older age groups. Jefferies analysts have said the decision could reduce the addressable market to 55m doses from a prior projection of 93m.

Another worry for GSK is the possibility of huge penalties related to Zantac. A judge in Delaware ruled last month that expert witnesses could be permitted in jury trials in cases claiming the heartburn drug causes cancer.

But all things considered, I still think the drugs giant has significant investment appeal. And particularly at current rock-bottom prices.

Its recent slump leaves GSKs share price trading on a forward price-to-earnings (P/E) ratio of just 9.4 times. This makes it one of the cheapest companies in the pharma sector (AstraZeneca, for example, trades on a multiple of 18.8 times).

Investors can now also grab a 4% dividend yield from the drugs giant. As a whole, I think its an excellent value share for investors to consider this July, with Wednesdays update providing even more reason to be optimistic.

The post Is GSKs share price a brilliant bargain after this new vaccines deal? appeared first on The Motley Fool UK.

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Royston Wild has no position in any of the shares mentioned. The Motley Fool UK has recommended AstraZeneca Plc and GSK. Views expressed on the companies mentioned in this article are those of the writer and therefore may differ from the official recommendations we make in our subscription services such as Share Advisor, Hidden Winners and Pro. Here at The Motley Fool we believe that considering a diverse range of insights makes us better investors.

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Key Takeaways

The Centers for Disease Control and Prevention (CDC) on Wednesday updated its recommendations for respiratory syncytial virus (RSV) vaccination for older adults who did not get vaccinated last season.

The agency now suggests that all adults older than 75 get the vaccine. People ages 60 to 74 who are at high risk for severe RSV are also recommended to get the shot. This includes people who have chronic conditions like lung or heart disease and those living in nursing homes.

After the approval of the first RSV vaccine last summer, the agency said that all adults ages 60 and older should get the vaccine if they speak with a healthcare provider and decide together that vaccination is right for them.

However, that guidance confused patients and complicated the administration of the vaccine. The CDC updated the recommendation to simplify the decision-making process for clinicians and the public.

We believe this updated recommendation for people 60 and older provides healthcare providers with a clearer recommendation for those who will benefit most from RSV vaccine and will be easier to implement in healthcare settings, a spokesperson for the CDC told Verywell in an email.

For most people, an RSV infection feels like a bad cold. However, older adults and infants are more likely to develop pneumonia and respiratory failure. Each year, RSV leads to an estimated 60,000 to 160,000 hospitalizations and more than 6,000 deaths in adults 65 years and older.

About a quarter of older Americans have had a dose of the RSV vaccine.

The RSV vaccine is not currently an annual vaccine, so older adults do not need to get a dose every RSV season, according to the CDC spokesperson. This means if you have already gotten an RSV vaccine, you do not need to get another one at this time.

The best time to get an RSV vaccine is in the late summer or early fall for protection during the colder months. Adults can also get their RSV shot at the same time as some other vaccines, like those for flu, COVID-19, and pneumonia.

The RSV vaccines have only been available for a year. Wednesdays meeting was the first time the advisory committee discussed real-world data on how well and safely the vaccines are working.

That data showed that people older than 75 have over twice the rate of RSV-associated hospitalization compared to adults ages 6074 years.

Moving to a standard recommendation, as opposed to a shared decision, shows that weve now got more clear data on what are the benefits of this vaccine. We know that it reduces the risk significantly, particularly for folks 75 and older, of being hospitalized or dying from RSV illness, Robert Hopkins, Jr., MD, medical director of the National Foundation for Infectious Diseases, told Verywell.

There are three vaccines approved to prevent RSV in older adults. GlaxoSmithKlines Arexvy is FDA-approved to immunize people 60 years and older, as well as those 50 to 59 who are at an increased risk of lower respiratory tract disease from RSV. Abrysvo, made by Pfizer, can be given to adults ages 60 and older. Its also approved for use in people who are 32 to 36 weeks pregnant to protect their babies in infancy.

Even though the GSK shot is authorized for people 50 to 59 years old, the CDC declined to recommend it for that group.

An RSV vaccine from Moderna, which gained FDA approval last month, will be given under the same guidance as the other vaccines.

The main safety concern associated with the vaccines is Guillain-Barr syndrome, a rare condition in which the immune system attacks the nerves. Based on the current data, the risk of someone developing Guillain-Barr from the vaccines is about 10 in a million.

The earlier shared clinical decision-making recommendation was made in part to help people weigh the benefits, risks, and costs of vaccination with help from their health provider.

However, a survey found that 76% of internal medicine physicians and 64% of family practitioners who responded either strongly or somewhat agreed that shared clinical decision-making creates confusion. Besides, about 80% of older adult vaccines were given in pharmacies, so it can be unnatural for a patient to work in a conversation with their physician before getting the shot.

Hopkins said the recommendations will likely change again as scientists collect more data about the side effects and duration of protection from vaccination.

While the goal is to vaccinate as many high-risk people as possible, Hopkins said the rollout is pretty darn amazing so far.

Under the Affordable Care Act, private insurers dont have to cover a new vaccine thats been on the market for less than a year. Now that GSKs RSV vaccine has been approved for a year, there may be a lower barrier to accessing it.

The CDC also highlighted disparities in the demographics of older adults who have been vaccinated so far. Adults who are Hispanic, are uninsured, live in rural areas, and/or have a lower income have the lowest vaccination rates. CDC advisors said that clarifying the messaging about who would benefit most from vaccination could help remove barriers to access.

People ages 60 to 74 years old can still get the vaccine if they want it, but private insurers wont be required to cover the cost, the CDC said.

Getting vaccinated against RSV is especially important for people at high risk for respiratory infections because there are no antiviral medications to help treat people who are sick with RSV.

This is not an insignificant virus. Its a virus that causes significant disease, Hopkins said.

If you are older than 75 or have chronic conditions and are between the ages of 60 to 74, getting the RSV vaccine can significantly reduce your risk of severe illness, hospitalization, and death from RSV. The new CDC recommendations make it easier to decide if the vaccine is right for you, so consider discussing it with your healthcare provider, especially before the colder months.

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CDC Strengthens RSV Vaccine Recommendations for People 75 and Older - Verywell Health