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ACIP votes unanimously backs GSK’s shingles vaccine Shingrix for immunocompromised adults 19 and older

CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended two doses of GlaxoSmithKline’s (NYSE:GSK) Shingrix (a recombinant adjuvanted zoster vaccine) for adults 19 and older with immunodeficiency or immunosuppression as a result of disease or therapy.

CDC considers Shingrix to be an adult vaccine, and its recommendation is for the adult immunization schedule, which begins at the age of 19.

In addition, ACIP was unanimous in backing Merck’s (NYSE:MRK) and Pfizer’s (NYSE:PFE) pneumococcal vaccines in elderly and immunocompromised adults.

ACIP will share the recommendations with the director of the CDC and the US Department of Health and Human Services for review and approval.

Shingrix first won FDA approval in 2017 to prevent shingles in adults aged 50 and older. In July of this year, the agency extended approval to include adults aged 18 and older with an elevated risk of developing shingles as a result of immunodeficiency …

WHO endorses first malaria vaccine

Mosquito photo by Skyler Ewing from Pexels

The World Health Organization (WHO) has backed the first malaria vaccine, which could be especially beneficial in areas such as sub-Saharan Africa with moderate to high malaria transmission rates. In 2019, malaria caused 409,000 deaths, according to WHO.

The vaccine from GlaxoSmithKline (NYSE:GSK) specifically targets plasmodium falciparum, a malaria strain common in sub-Saharan Africa. Plasmodium falciparum tends to be more dangerous and resistant to antimalarial drugs than other plasmodium species.

“This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus in a statement. “Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.”

WHO recommended that el…

FDA approves GSK’s Shingrix to prevent shingles in immunocompromised adults

GlaxoSmithKline (NYSE:GSK) received permission from FDA to expand the use of its Shingrinx shingles vaccine to include immunocompromised and immunosuppressed adults 18 years old or older.

Having won initial FDA approval in 2017 for individuals 50 and older, the shingles (herpes zoster) vaccine is a non-live, recombinant subunit adjuvanted vaccine. Shingrix is the first shingles vaccine to win an indication for people who are immunodeficient or immunosuppressed.

Approximately 1 million people develop shingles in the U.S. each year, according to the CDC.

GSK has gained shingles vaccine market share since November 2020, when Merck (NYSE:MRK) discontinued Zostavax, a rival shingles vaccine. Zostavax initially won approval in 2017 and was previously the only shingles vaccine available in the U.S.

The FDA decided based on clinical studies involving adults 18 or older who had undergone an autologous hematopoietic stem cell transplant (auHSCT). Ad…

NVIDIA debuts supercomputer for healthcare and AI research

Santa Clara, Calif.–based NVIDIA has launched the Cambridge-1, which it hails as “the United Kingdom’s most powerful supercomputer.”

Developed with healthcare applications in mind, NVIDIA invested some $100 million in the supercomputer.

Initial applications of the Cambridge-1 include using AI to improve drug development, explore the causes of dementia and identify genomic-based disease risk factors.

Early users of the Cambridge-1 include AstraZeneca (LON:AZN), GSK (NYSE:GSK), Oxford Nanopore, King’s College London, St. Thomas’ NHS Foundation Trust and Oxford Nanopore Technologies.

AstraZeneca’s focus of the computer will be on creating an open-source transformer-based generative AI model for chemical structures. The model can be used to predict chemical reactions, optimize molecules and generate de novo molecules.

AstraZeneca and NVIDIA are also teaming up to use Cambridge-1 to facilitate digital pathology to accelerate the process of annot…

An inside look at GSK’s digital twin initiative

A GSK vaccine facility. Image courtesy of GSK.

Digital twins, functional computerized models of physical objects, are a staple of smart manufacturing. Their use in the pharmaceutical industry, however, is still in an early phase.

GlaxoSmithKline (LON:GSK) is one of the first pharmaceutical companies to announce a digital twin initiative. Partnering with Siemens (ETR:SIE) and Atos (EPA:ATO), GSK has created a real-time simulation of the entire vaccine manufacturing process.

A year in the making

The project, which launched a year ago, has already shown promise in reducing manufacturing timelines, optimizing product quality and other areas. The use of digital twins has enabled GSK to optimize vaccine-related experiments. “With digital twins, you’re able to do huge amounts of digital experiments and minimize the number of wet experiments that you do,” said Matt Harrison, head of sciences, digital innovati…

CureVac’s interim vaccine efficacy is 47% in Phase 2b/3 study

Germany-based CureVac (NSDQ:CVAC) announced that its mRNA vaccine was 47% effective against COVID-19 in a second interim analysis of a pivotal study involving approximately 40,000 participants in 10 countries.

The rise of COVID-19 variants played a role in the disappointing results. At least 13 COVID-19 variants were present in the study population who contracted the novel coronavirus. Some 57% of cases involved variants of concern.

FDA generally requires that a vaccine be at least 50% effective in a placebo-controlled trial to win emergency use authorization.

CureVac’s stock dropped 3.47% to $94.79 per share after the company announced the news.

The company anticipates that a final analysis will be ready in a matter of weeks. Based on available data, the vaccine appears to have a favorable safety profile.

CureVac is partnering with GSK (NYSE:GSK) to develop a next-gen COVID-19 vaccine. That vaccine could potentially protect against multipl…

CureVac’s COVID-19 vaccine candidate inches forward to Phase 2b/3 efficacy readout

CureVac (NSDQ:CVAC) has announced that its first-generation COVID-19 vaccine has passed its first interim analysis but has chosen not to share efficacy data until a statistically significant efficacy analysis is ready.

The Tübingen, Germany–headquartered company is developing two mRNA-based vaccines. The mRNA vaccines from Moderna (NSDQ:MRNA) and Pfizer (NYSE:PFE) are currently two of the most popular COVID-19 vaccines in the world.

The data and safety monitoring board also concluded that there were no safety concerns linked to the CVnCoV in the HERALD study.

The company’s second-generation vaccine is known as CV2CoV, which it is developing in collaboration with GSK.

Sanofi and GSK start Phase 3 trial of COVID-19 vaccine

Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate.

The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according to a news release.

Get the full story at our sister site, Drug Discovery & Development.

Sanofi and GSK start Phase 3 trial of COVID-19 vaccine

Sanofi and GlaxoSmithKline announced today that they began enrollment in the Phase 3 clinical trial for their COVID-19 vaccine candidate.

The companies will evaluate the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate in a global, randomized, double-blind, placebo-controlled Phase 3 study of more than 35,000 participants aged 18 and older, according to a news release.

Prevention of symptomatic COVID-19 in SARS-CoV-2 naive adults constitutes the primary endpoint, while the prevention of severe COVID-19 disease and prevention of asymptomatic infection makes up the secondary endpoints.

Stage one of the study will investigate the efficacy of the vaccine formulation targeting the original D.614 virus (Wuhan) while a second stage will evaluate a second formulation targeting the South African (B.1.351) variant. The global study offers a chance to evaluate the vaccine candidate against a number of circulatin…

CureVac and GSK announce promising preclinical data for next-gen COVID-19 vaccine

As CureVac (NSDQ:CVAC) awaits European authorization for its mRNA COVID-19 vaccine, it is conducting preclinical research on a second-generation vaccine candidate known as CV2CoV, which it is developing with GSK.

In a study involving rats, the new mRNA vaccine candidate yielded high levels of antigen and strong neutralizing antibody titers after the first vaccination.

Tübingen, Germany–based CureVac also said the vaccine candidate led to high levels of antibodies against several variants of concern, including B.1.1.298, B.1.1.7 and B.1.351.

“To successfully fight the COVID-19 pandemic in the long term, we will need different vaccines, and we need to be able to respond effectively to emerging variants,” GSK Global Vaccines President Roger Connor said in a statement.

CV2CoV uses a new mRNA platform than CureVac’s first COVID-19 vaccine candidate known as CVnCoV. The new platform intends to bolster intracellular mRNA stability and translation to y…

Pharma 50: Here’s how the world’s largest pharma companies are doing

The global pharmaceutical industry held up well during the pandemic, with 10 of the largest businesses only seeing a roughly –3% drop in revenue in 2020. Eight of the 10 even came out ahead.

That’s one of the big takeaways from Drug Discovery & Development’s inaugural Pharma 50, a compilation of data on the largest pharma companies in the world. (Browse data on all 50 companies here.)

Overall, the 50 largest pharma companies brought in $851 billion in sales in 2020. Pharma companies also overcame COVID-19-related clinical trial disruption and staffing hurdles, driving unprecedented R&D advances to introduce novel vaccines and therapies to battle the pandemic. The resulting shift in public perception could benefit the industry for years to come.

One of the most notable achievements involved the mRNA vaccines from Pfizer/BioNTech and Moderna, according to analyst Mani Foroohar at SVB Leerink.

Other achievements, according to Foroohar, includ…

Pharma 50: Here’s how the world’s largest pharma companies are doing

The global pharmaceutical industry held up well during the pandemic, with 10 of the largest businesses only seeing a roughly –3% drop in revenue in 2020. Eight of the 10 even came out ahead.

That’s one of the big takeaways from our sister publication Drug Discovery & Development’s inaugural Pharma 50, a compilation of data on the largest pharma companies in the world. (Browse data on all 50 companies here.)

Overall, the 50 largest pharma companies brought in $851 billion in sales in 2020. Pharma companies last year overcame clinical trial disruption and staffing hurdles to drive unprecedented R&D advances to introduce novel vaccines and therapies to battle the pandemic. The resulting shift in public perception could benefit the industry for years to come.

Get the full story on our sister site Drug Discovery & Development.