Category: Vaccine

Novavax, Inc. today announced that Singapores Health Sciences Authority (HSA) has granted full approval for Novavaxs prototype COVID-19 vaccine Nuvaxovid (NVX-CoV2373) for active immunization to prevent COVID-19 inindividuals aged 12 and older.

The company announced the approval in an Oct. 18 press release.

NVX-CoV2373 is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavaxs unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavaxs 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.

For the 2023-2024 vaccination season,Novavax has developed an updated COVID-19 vaccine which has been authorized for use in the U.S.The updated vaccine induces neutralizing antibody responses against currently circulating variants XBB.1.5, XBB.1.16, XBB.2.3,BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6.Additional non-clinical data demonstrated that Novavaxs vaccine induced CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavaxs vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.

Todays full approval of our prototype vaccine will enable us to file for approval of our updated protein-basednon-mRNA COVID-19 vaccine in the coming weeks. We continue to work closely with HSA to ensure a protein-based vaccine is part of the portfolio for Singaporeans to protect themselves against COVID-19.

In clinical trials, the most common adverse reactions associated withNovavaxs prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.

About the PREVENT-19 Phase 3 TrialThe PRE-fusion protein subunitVaccineEfficacyNovavaxTrial COVID-19 (PREVENT-19) was a randomized, placebo-controlled, observer-blinded Phase 3 trial conducted in the U.S. and Mexico to evaluate the efficacy and safety of NVX-CoV2373 as a primary series and as a booster in adults and adolescents to prevent SARS-CoV-2 infection. As a primary series, the primary endpoint was the first occurrence of polymerase chain reaction (PCR)-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least seven days after the second dose in 29,960 adult participants aged 18 and older at baseline without protocol violations prior to illness. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Full results of the trial were published in The New England Journal of Medicine.

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Vaccine maker Novavax Inc (NVAX.O) on Monday said it has shipped millions of doses its updated COVID-19 shots to distributors after receiving the go-ahead from U.S. regulators. The U.S. FDA authorized the updated vaccine last week for emergency use in individuals aged 12 years and older, but batches of the shots needed additional clearance from the FDA before they could be released. Novavax said it expects the shots to be available at U.S. pharmacies this week. Reuters

The Medicines and Healthcare products Regulatory Agency or MHRA in the United Kingdom has granted full marketing authorization for its prototype COVID-19 vaccine Nuvaxovid or NVX-CoV2373 for individuals aged 12 and older. Business Insider

As the updated COVID vaccines roll out around the country, one more competitor has joined the mix. In early October the U.S. Food and Drug Administration authorized a new booster shot made by the company Novavax. Like the mRNA-based Pfizer and Moderna shots, it targets a SARS-CoV-2 variant, XBB.1.5, which is a descendant of Omicron. It is the first protein vaccine to appear in more than a year, which some public health experts say is encouraging news for people who are hesitant the mRNA vaccines that have been widely used throughout the pandemic. Scientific American

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Novavax's Prototype COVID-19 Vaccine Nuvaxovid Receives Full Approval in Singapore - Global Biodefense

Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (U.K.) has granted full marketing authorization for its prototype COVID-19 vaccine Nuvaxovid (NVX-CoV2373) for individuals aged 12 and older for active immunization to help prevent COVID-19.

"Full marketing authorization of our prototype COVID-19 vaccine in the U.K. is a stepping stone to enable authorization of updated strains of our vaccine in the future," said John C. Jacobs, President and Chief Executive Officer, Novavax. "We are working with the MHRA to provide the information needed for the rapid review of our updated protein-based non-mRNA COVID-19 vaccine as an important step to ensuring access to vaccine options in the U.K. this coming vaccination season."

Authorization was based on two Phase 3 trials, PREVENT-19 conducted in the U.S. and Mexico and a Phase 3 trial in the U.K., as well as a Phase 2a/b trial in South Africa. In these trials, Novavax demonstrated the efficacy and safety of its prototype vaccine as a primary series in individuals aged 12 and older, and the immunogenicity and safety of the vaccine as a booster in individuals aged 18 and older.

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. If you are concerned about an adverse event, it should be reported on a Yellow Card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. When reporting please include the vaccine brand and batch/Lot number if available.

i. Additional efficacy and safety data are being collected.

Trade Name in the U.S. The trade name Nuvaxovid has not been approved by the U.S. Food and Drug Administration.

Important Safety Information: U.K.

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following websites:

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Novavax (NVAX) Receives Full Marketing Authorization for Prototype COVID-19 Vaccine Nuvaxovid in United Kingdom - StreetInsider.com

Analyzing data from the shingles vaccine, Brandyn Churchill, assistant professor of resource economics at UMass Amherst, and Laura E. Henkhaus, health economist and data scientist with Hill Physicians Medical Group, found that the number of people taking the vaccine nearly doubled after the Affordable Care Act (ACA) required private insurers to cover vaccinations recommended by the Centers for Disease Control and Preventions Advisory Committee on Immunization Practices, as part of preventive care coverage.

Adults are very price sensitive when it comes to their vaccine decision making, Churchill says. Cost matters. Age-targeted vaccine recommendations alone dont appear to do a lot for vaccine take-up among adults if the cost is coming out of their wallet.

Churchill and Henkhaus show that prior to the ACA preventive care insurance mandate, adults aged 60 and over, who were recommended to receive the shingles vaccine, were no more likely than their 59-year-old counterparts to be vaccinated. After the ACA mandate took effect in 2010, shingles vaccination increased from 3.1 to 5.9 percentage points for people aged 60 and over.

The research finds a similar increase for people aged 50 to 59 after recommendations for the shingles vaccine were expanded to cover adults aged 50 and over, and private insurance was required to cover it beginning in 2019. This coincided with a more effective and more costly version of the vaccine. Currently, the recommended two doses cost about $200 each.

Churchill notes people with a college education and those who had more contact with the health care system were more likely to take the shingles vaccine after it was fully covered by insurance. This might say something about an awareness that they knew they were eligible to get it without patient cost sharing, he says.

Caused by a reactivation of the chickenpox virus, shingles is an infection that can produce a painful rash with fluid-filled blisters. It affects more than one million people in the U.S. each year.

While shingles is not a communicable disease and its mortality rate is very low, the studys findings provide important guidance for policies promoting vaccination against communicable diseases, such as influenza and COVID-19.

With the COVID vaccines, clearly cost is not the only factor at play, but anything that would increase the cost to adults would likely further reduce vaccine take-up among that group resulting in potentially serious public health effects, Churchill concludes. COVID vaccines continue to be available with no out-of-pocket cost for most Americans.

The full paper, The Roles of Cost and Recommendations in Driving Vaccine Take-Up, appears in the American Journal of Health Economics.

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UMass Amherst Research Finds Adult Vaccination Rates Increase ... - UMass News and Media Relations

Washington, D.C., 18 October 2023 (PAHO) The Pan American Health Organization (PAHO) and the Government of Canada announced today the launch of a joint initiative to support Haiti to expand vaccination against potentially lethal vaccine-preventable diseases, including polio, measles, diphtheria and tetanus

The partnership, which is part of Canadas Global Initiative for Vaccine Equity (CanGIVE), will inject over 6 million Canadian dollars (around US$4,4 million) into the Haitian health system to bolster vaccination outreach and operations throughout the country. The contribution was announced by Canadian Prime Minister Justin Trudeau during the first Canada-Caribbean Community (CARICOM) summit, scheduled for 17-19 October 2023 in Ottawa.

Our national immunization programs have suffered serious setbacks over the last decade, PAHO Director Dr. Jarbas Barbosa said recently. We have witnessed decreases in vaccination coverage rates, inadequate sustainable financing for immunizations, and increasing vaccine hesitancy linked in part to misinformation.

With the COVID-19 pandemic further exacerbating this decline, the risk of vaccine-preventable disease outbreaks is now at a 30-year high, he added.

The risk of disease outbreaks in Haiti is compounded by a precarious security situation which has recently pushed thousands into improvised shelters and is impeding the proper functioning of health facilities, with several hospitals and clinics struggling to provide essential health services.

Through CanGIVE, PAHO and Canada will work together to help Haiti vaccinate its population against COVID-19 as well as against the diseases included in the regional immunization program, such as polio, rubella, congenital rubella syndrome, measles, diphtheria, and neonatal tetanus.

CanGIVE will focus on reaching marginalized communities in Haiti, including people living in deep urban and rural poverty. The program will bolster gender-sensitive vaccination operations that meet the needs of women and girls, who are often likewise marginalized.

In addition, the CanGIVE collaboration will support communications efforts to build vaccine confidence among the general population and increase vaccine uptake in the country.

CanGIVE is also being carried out in Jamaica and Colombia with similar objectives: address vaccine hesitancy, increase equitable access to vaccination, and protect the lives and health of the most vulnerable population groups.

With the contribution from CanGIVE, we can help Haiti begin to reverse the decline in routine vaccination, Dr. Oscar Barreneche, PAHO Representative in Haiti, said.

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PAHO joins forces with Canada to reverse declining immunization ... - Pan American Health Organization

Despite COVID-19 numbers peaking nationally two weeks ago, Dr. Peter Hotez said transmission of the virus is still occurring and could increase in the coming months amid low uptake of the updated COVID-19 vaccination.

Hotez,co-director of the Texas Childrens Hospital Center for Vaccine Development and dean of the National School of Tropical Medicine at Baylor College of Medicine, said individuals may not be receiving this vaccine because of continued availability issues and/or suggestions from their physicians to wait until later in the season when they may need immunity more.

I disagree with this. We dont know if it is going to continue to get better or whether its going to worsen again, Hotez said. But, I wouldnt hold off. It may be necessary to get another booster in six months, but I would get immunized now if youre eligible.

According to Hotez, in areas where demand for the vaccine has been high, more people are having issues accessing it especially if they prefer which vaccine they receive, as some pharmacies may only have certain vaccines available.

Hotez said the inconsistency of supply is not the only issue for people wanting to get vaccinated. Insurance coverage has also created an obstacle, as it varies depending on an individual's provider.

He added that his daughter, a Medicaid recipient, had to pay $190 out-of-pocket after being told she was "out of network" when vaccinated at a CVS.

Hotez's daughter should not have had to pay for the vaccine, as Texas Medicaid currently covers all of the updated COVID vaccines since they were first made available, according to the Texas Health and Human Services Commission.

The disappointment weve had early on is people without certain types of insurance having to cover the cost, and not everyone can afford that, so they just walk away, Hotez said. I think thats a big mistake.

There may also be a lack of understanding, Hotez said, that the updated COVID vaccine is different from past vaccinations, which could deter people from getting vaccinated.

Unlike previous boosters, the updated COVID vaccines by Pfizer and Moderna are monovalent mRNA vaccines and are meant to protect against one variant, an earlier dominant subvariant of Omicron, XBB 1.5.

Initial reports indicate that because these vaccines target the single variant, they should increase immunity against other related variants, including BA.2.86, EG.5 and others in the XBB family.

The more recently approved Novavax updated COVID vaccine recommended by the CDC in early October is a non-mRNA vaccine but is also made to provide immunity against XBB1.5 and other circulating variants.

Hotez said clinics and hospitals have not seen an uptick in other common respiratory viruses such as RSV and influenza this season yet; however, healthcare professionals expect an increase in cases going into November and December.

This is why, Hotez said, those vaccinated against COVID should also consider receiving the RSV vaccine if eligible and their annual flu shot.

The updated COVID vaccine is available through the Houston Health Department at four of the departments vaccination sites at no cost to those who are underinsured or do not have health insurance:

La Nueva Casa de Amigos Health Center 1809 North Main St., 77009

Monday: 9 a.m.-5:30 p.m. Tuesday Thursday: 8:30 a.m.-4:30 p.m. Friday: 8:30 a.m.-11:30 a.m.

Northside Health Center 8504 Schuller Rd., 77093

Monday: 9 a.m.-5:30 p.m. Tuesday Thursday: 8:30 a.m.-4:30 p.m. Friday: 8:30 a.m.-11:30 a.m.

Sharpstown Health Services 6201 Bonhomme Rd., 77036

Monday: 9 a.m.-5:30 p.m. Tuesday Thursday: 8:30 a.m.-4:30 p.m. Friday: 8:30 a.m.-11:30 a.m.

Sunnyside Health and Multi-Service Center 4410 Reed Rd., 77051

Monday: 9 a.m.-5:30 p.m. Tuesday, Thursday, Friday: 8:30 a.m.-4:30 p.m. Wednesday: 8:30 a.m.-11:30 a.m.

Local Walgreens and CVS pharmacies are also accepting appointments; however, appointment and walk-in availability may vary per location. The updated COVID-19 vaccine is now available at no-cost at these pharmacies through most insurance plans and through the CDC's Bridge Access program which provides freeCOVID-19 vaccinations to uninsured adults and underinsured adults.

Walgreens Schedule a Vaccination Appointment

CVS Schedule Your COVID-19 Vaccine Today

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Availability of Updated COVID-19 Vaccine Continues to Lag - Houston Press

Scotland's papers: Gaza braced for invasion and Covid vaccine injuries  BBC.com

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Scotland's papers: Gaza braced for invasion and Covid vaccine injuries - BBC.com

HSA approves updated Covid-19 vaccine by Moderna as Singapore sees another infection wave  AsiaOne

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HSA approves updated Covid-19 vaccine by Moderna as Singapore sees another infection wave - AsiaOne

Aaron Rodgers Challenges Travis Kelce To Debate Vaccine Safety With RFK Jr. And Fauci  Forbes

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Aaron Rodgers Challenges Travis Kelce To Debate Vaccine Safety With RFK Jr. And Fauci - Forbes

Project NextGen Selects Initial Vaccine Candidates and Awards Over $500 Million to Advance Development of ...  HHS.gov

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Project NextGen Selects Initial Vaccine Candidates and Awards Over $500 Million to Advance Development of ... - HHS.gov

First on CNN: HHS awards more than $500 million to study Covid-19 vaccine nasal sprays and more  CNN

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First on CNN: HHS awards more than $500 million to study Covid-19 vaccine nasal sprays and more - CNN