Pharmaceutical Technology

FEBRUARY 3, 2023

Only a few weeks into the new year, the prospect of getting a successful advanced HIV vaccine shrank after the discontinuation of yet another late-stage trial. On January 18, Janssen, a Johnson & Johnson (J&J) subsidiary, stated that its vaccine was not effective in preventing HIV infections.

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pharmaphorum

JANUARY 10, 2024

Novavax is a leading pharmaceutical company dedicated to creating protein-based vaccines for diseases like COVID-19 and malaria. Learn more about their innovative vaccine development process and their commitment to creating a healthier future.

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Vaccination Vaccine Protein Development 124

Pharmaceutical Technology

JULY 6, 2022

The European Commission (EC) has granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years. A protein-based vaccine, NVX-CoV2373 is made from the genetic sequence of the SARS-CoV-2 virus’ first strain.

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Vaccination Vaccine Protein Clinical Trials 264

Pharmaceutical Technology

JUNE 24, 2022

Novavax has obtained emergency use authorization (EUA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), from the Taiwan Food and Drug Administration for use in people of the age 18 years and above. The protein-based vaccine is engineered from the genetic sequence of the SARS-CoV-2 virus’ initial strain.

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Vaccination Vaccine Clinical Trials Clinical Trials 263

Pharmaceutical Technology

SEPTEMBER 7, 2022

Indian company Bharat Biotech International has secured approval from Central Drugs Standard Control Organisation (CDSCO) under Restricted Use in Emergency Situation for its intranasal Covid-19 vaccine, iNCOVACC (BBV154), for usage in people aged 18 years and older. It is formulated to permit intranasal delivery via nasal drops.

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Vaccination Vaccine Clinical Trials Clinical Trials 263

XTalks

JULY 19, 2022

The US Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Novavax’s COVID-19 vaccine, making it the fourth authorized vaccine in the US against COVID-19. The vaccine is branded as Nuvaxovid outside the US with approvals/authorizations in Canada, the EU, UK, Australia and South Korea.

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Pharmaceutical Technology

FEBRUARY 14, 2023

The US Department of Health and Human Services (HHS) and the Department of Defense have modified their existing agreement with Novavax to secure additional doses of the Covid-19 vaccine, Adjuvanted (NVX-CoV2373). million additional doses of its Covid-19 vaccine. Under the modified deal, Novavax will deliver up to 1.5

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Vaccination Vaccine Protein Engineer 162

Bio Pharma Dive

NOVEMBER 11, 2020

The companies' early success helps validate an industry-wide bet to target the coronavirus' spike protein. But differences between each vaccine could still prove crucial.

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Pharma Times

NOVEMBER 12, 2021

Researchers have said that next generation vaccines for COVID-19 should aim to induce a response against ‘replication proteins’

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Protein Vaccination Vaccine Research 121

Pharmaceutical Technology

FEBRUARY 15, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Flavivirus vaccine components. The structural proteins include the capsid, pre-membrane/membrane proteins and envelope (E) proteins.

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Vaccination Vaccine Protein Immune Response 130

Pharmaceutical Technology

JULY 12, 2022

million doses of the company’s Covid-19 vaccine, NVX-CoV2373, in the initial stage. The order is contingent on the vaccine obtaining Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) as well as the Centers for Disease Control and Prevention (CDC) recommendation. The post US to procure 3.2

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Vaccination Vaccine Protein Pharmacy 162

Pharmaceutical Technology

JUNE 20, 2023

The World Health Organisation (WHO) has granted an emergency use listing (EUL) to SK bioscience’s Covid-19 vaccine, SKYCovione. SKYCovione is a self-assembled nanoparticle vaccine and the 12th Covid-19 vaccine to receive a EUL from the regulator.

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Vaccination Vaccine Protein Clinical Trials 363

Pharmaceutical Technology

FEBRUARY 15, 2023

In the last three years alone, there have been over 633,000 patents filed and granted in the pharmaceutical industry, according to GlobalData’s report on Innovation in Pharmaceuticals: Coronavirus vaccine components. The vaccine also contains other inactive ingredients such as cholesterol.

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Pharmaceutical Technology

NOVEMBER 20, 2022

Health Canada has granted expanded authorisation for Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted) [Nuvaxovid; NVX-CoV2373] as a homologous booster for usage in adults aged 18 and above. The vaccine is indicated for active immunisation to prevent the disease.

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Pharmaceutical Technology

FEBRUARY 15, 2023

Clover Biopharmaceuticals has launched its recombinant SARS-CoV-2 subunit vaccine , a protein-based Covid-19 vaccine, in China. In December last year, Clover’s Covid-19 vaccine received emergency use authorisation in the country. 5, in a separate Phase III trial.

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Pharmaceutical Technology

MAY 29, 2023

Novavax has received positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for full marketing authorisation (MA) of its Covid vaccine, Nuvaxovid (NVX-CoV2373) , in the European Union (EU). The safety and efficacy of Nuvaxovid was evaluated as a primary series.

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Vaccination Vaccine Protein Immune Response 130

Pharmaceutical Technology

JUNE 24, 2022

As regulatory agencies gear up for another round of Covid-19 vaccine deliberations centered on emerging variants, Moderna has released data on its booster’s efficacy against Omicron subvariants. The mRNA-1273.214 booster contains the original Spikevax vaccine and a candidate targeting Omicron BA.1 1 variant of concern.

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Pharmaceutical Technology

AUGUST 2, 2022

The Health Emergency Preparedness and Response Authority (HERA) of the European Commission (EC) has entered a co-procurement framework contract for HIPRA HUMAN HEALTH’s bivalent recombinant protein Covid-19 vaccine. billion doses of Covid-19 vaccines. An increase in vaccination and boosting is essential over the coming months.

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Vaccination Vaccine Protein Medicine 162

XTalks

FEBRUARY 19, 2024

Moderna has been testing an experimental mRNA vaccine aimed at combating the human cytomegalovirus (CMV), which poses significant health risks to newborns and immunocompromised patients. The team used the data and patient samples from a gB/MF59 Phase II trial in adolescent girls as a benchmark to assess the new mRNA-based vaccine.

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Vaccination Vaccine Trials Clinical Trials 59

Pharmaceutical Technology

SEPTEMBER 14, 2022

Novavax and Serum Institute of India (SII) have reported that the former’s Covid-19 vaccine, NVX-CoV2373, has received full product registration from the South African Health Products Regulatory Authority (SAHPRA), with conditions. The vaccine showed efficacy, with an encouraging safety and tolerability profile, in the trials. .

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Pharmaceutical Technology

JULY 14, 2022

Novavax has obtained the US Food and Drug Administration (FDA) emergency use authorization (EUA) for its Covid-19 vaccine. The EUA for the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has been granted for providing a two-dose primary series for active immunisation aimed at preventing the disease in individuals aged 18 years and above.

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Vaccination Vaccine Clinical Trials Clinical Trials 162

Bio Pharma Dive

JULY 20, 2022

Health officials argue a new type of shot could help to persuade unvaccinated people, although some surveys suggest that might not be the case.

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Protein Vaccination Vaccine 280

Pharmaceutical Technology

OCTOBER 3, 2022

Indonesia has granted Emergency Use Authorization (EUA) for the patent-free Covid-19 vaccine, IndoVac, developed by the Texas Children’s Hospital Center for Vaccine Development (CVD) and Baylor College of Medicine, US. PT Bio Farma will manufacture 20 million doses of the vaccine this year.

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Drug Discovery World

JANUARY 16, 2024

Dr Masaru Kanekiyo On Tuesday 6 February at 11.30am, the speaker will be Masaru Kanekiyo, DVM, PhD, Investigator and Chief of Molecular Immunoengineering Section of the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), NIH. See the full programme and register your interest in this event.

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Medical Xpress

APRIL 13, 2023

The current COVID-19 vaccines are designed to trigger an antibody response to the SARS-CoV-2 spike protein, which is vulnerable to mutations that could make the vaccine less effective over time.

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Vaccination Vaccine Protein Antibody 98

Pharmaceutical Technology

JULY 27, 2022

Novavax has r eceived expanded approval for provisional registration from the Australian Therapeutic Goods Agency (TGA) for its Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use in adolescents aged 12 to 17 years. It is the first protein-based vaccine to be offered in Australia for adolescents aged 12 to 17 years.

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Vaccination Vaccine Clinical Trials Clinical Trials 147

Pharmaceutical Technology

JANUARY 25, 2023

It was an exceptional year for Moderna’s vaccine Spikevax, with forecast sales of $19.5bn in 2022. Spikevax is an mRNA vaccine that is approved in 20 geographies including the US, EU, and, the UK. The vaccine first gained Emergency Use Approval in December 2020 in response to the Covid-19 pandemic.

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Pharma Mirror

SEPTEMBER 11, 2022

Bandung, W Java, Indonesia, PT Bio Farma, the holding company for state-owned pharmaceutical companies in Indonesia, announced a new milestone in the manufacturing of IndoVac, a Covid-19 vaccine brand it has developed since November 2021.

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XTalks

MAY 7, 2021

As Novavax awaits emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its protein-based COVID-19 vaccine NVX-CoV2373, the company shared new data this week on the vaccine’s efficacy against the South African B.1.351 That analysis also showed that the Novavax COVID-19 vaccine was 96.4

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Protein Vaccination Vaccine Trials 97

Pharmaceutical Technology

DECEMBER 6, 2022

Evaxion Biotech and ExpreS 2 ion Biotechnologies have entered a vaccine discovery collaboration agreement to co-develop a new cytomegalovirus (CMV) vaccine candidate. CMV represents a critical unmet medical need, and I believe our two companies have the potential to deliver a truly differentiated vaccine.”.

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Vaccination Vaccine Development Immune Response 130

pharmaphorum

OCTOBER 4, 2023

Novavax has been given the go-ahead by regulators in the US for an updated version of its COVID-19 vaccine that targets the XBB.1.5 The FDA has signed off on the new protein-based shot, which joins two XBB.1.5-directed variant of the coronavirus.

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Pharmaceutical Technology

OCTOBER 20, 2022

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Novavax ’s adjuvanted Covid-19 vaccine, NVX-CoV2373, as a booster for use in people aged 18 years and above. The booster is indicated for use after a minimum of six months following a vaccine regimen with an authorised or approved Covid-19 shot.

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Pharmaceutical Technology

AUGUST 14, 2022

Novavax and its partner SK bioscience have obtained a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), to be used in adolescents of the age 12 to 17 years. It enrolled 2,247 adolescents across 73 US sites.

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Pharmaceutical Technology

AUGUST 23, 2022

5-adapted bivalent vaccine for Covid-19 in people aged 12 years and above. 1-adapted vaccine. The FDA also sought the vaccine’s pre-clinical and manufacturing data for addressing the SARS-CoV-2 virus’ evolution. 5-adapted bivalent vaccine will be made readily available for shipping. 5 variant spike protein.

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Medical Xpress

JANUARY 4, 2023

Myocarditis, a condition in which the heart muscle becomes inflamed, is a rare complication that can occur after mRNA COVID vaccination. It's estimated that roughly 18 cases occur in every 1 million vaccine doses administered, making it so rare that it is challenging to find cases to investigate.

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Scienmag

NOVEMBER 16, 2021

Despite great progress with SARS-CoV-2 vaccines, there is still a need to accelerate vaccination in low- and middle-income countries and a need for more effective vaccine strategies in older adults, who tend to have weaker immune responses to vaccination.

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Protein Vaccination Vaccine Immune Response 84

pharmaphorum

MAY 19, 2022

Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. There are hopes that its mRNA approach, which proved so effective against COVID-19, could succeed where traditional vaccine technologies have failed in HIV.

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