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AstraZeneca and Sanofi's today announced Beyfortus™ (nirsevimab-alip) has been approved in the United States for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season.
And for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Beyfortus is the first preventive option approved to protect a broad infant population, including those born healthy at term or preterm or with specific health conditions that make them vulnerable to severe RSV disease.
Furthermore, the single dose can be flexibly administered at the beginning of the RSV season or at birth for those born during the RSV season.
The companies confirmed on July 17, 2023, Beyfortus will be available for the 2023-2024 RSV season in the U.S.
Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said in a press release, "Beyfortus represents an opportunity for a paradigm shift in preventing serious respiratory disease due to RSV across a broad infant population in the U.S."
"The science that Beyfortus is built on demonstrates AstraZeneca's continued leadership in addressing the needs of the most vulnerable populations and reducing the burden on healthcare systems."
The Food and Drug Administration (FDA) approval followed the unanimous vote by the Antimicrobial Drugs Advisory Committee on the favorable benefit-risk profile of Beyfortus. It was based on the extensive clinical development program for Beyfortus, spanning three pivotal late-stage clinical trials.
Beyfortus was generally well tolerated, with a favorable safety profile consistent across all clinical trials.
Beyfortus has already been approved in the European Union and the United Kingdom.
According to the U.S. Centers for Disease Control and Prevention, RSV is a very contagious virus that can lead to serious respiratory illness in infants. Two out of three infants are infected with RSV during their first year of life, and almost all infants are infected by their second birthday.
The JAMA Network's Original Investigation in 2022 reported 6,549 respiratory fatalities were associated with RSV each year, including 96 (95% CI, 92-99) among children younger than one year.
RSV mAbs (Synagis) have been approved in the U.S. since 1998. Additionally, RSV vaccines have recently been approved by the FDA.
Invivyd, Inc. today announced additional positive initial data from its ongoing Phase 1 healthy volunteer clinical trial of its lead investigational monoclonal antibody (mAb) candidate, VYD222.
The results announced today add to the positive initial Phase 1 data reported by Invivyd in June 2023.
VYD222 is a broadly neutralizing, half-life extended mAb candidate in development for the prevention of symptomatic COVID-19 in vulnerable populations, such as immunocompromised people.
"We are pleased to see a favorable safety and tolerability profile as well as robust serum neutralizing titers against Omicron XBB.1.5 for all the VYD222 dose levels tested in our ongoing Phase 1 clinical trial," said Dave Hering, chief executive officer of Invivyd, in a press release on July 17, 2023.
"We believe these high neutralizing titer values and fold increases at this early timepoint are extremely encouraging as they indicate the potential for VYD222 to protect longer between doses and to provide additional protection from potential loss of neutralization activity as SARS-CoV-2 evolves."
The Phase 1 clinical trial of VYD222 enrolled 30 healthy volunteers across three dosing cohorts. In each cohort, participants were randomized 8:2 to VYD222 or placebo.
The initial Phase 1 data showed that a single administration of VYD222 was generally well-tolerated at all three dose levels tested, with no serious adverse events (SAEs) reported to date. At the middle VYD222 dose tested (2500 mg), geometric mean serum neutralizing titers were 9647.0 (95% CI: 6115.4, 15218.0) against Omicron XBB.1.5 at Day 7, with a geometric mean 92.82-fold rise (95% CI: 21.2, 406.6) from baseline to Day 7.
At the highest VYD222 dose tested (4500 mg), geometric mean serum neutralizing titers were 16864.7 (95% CI: 12825.5, 22176.1) against Omicron XBB.1.5 at Day 7, with a geometric mean 120.97-fold rise (95% CI: 31.4, 466.2) from baseline to Day 7.
The higher VYD222 dose levels tested in the Phase 1 clinical trial are designed to provide additional protection from potential loss of neutralization activity as SARS-CoV-2 evolves.
Analysis of the serum-neutralizing activity from samples collected at different time points across all dose cohorts in Phase 1 clinical trial is ongoing, as is detailed pharmacokinetic analysis and modeling.
Invivyd intends to use these analyses, combined with published clinical outcome data from prior clinical trials of vaccines and mAbs for the prevention of symptomatic COVID-19, including data from its Phase 2/3 clinical trial of adintrevimab for the prevention of COVID-19 (EVADE), to inform its VYD222 dosing strategy further.
Mr. Hering continued, "As a point of reference, we find it encouraging to observe that even our lowest VYD222 dose tested in our Phase 1 clinical trial resulted in higher titers against Omicron XBB.1.5 than the maximum titers against XBB.1.5 from investigational XBB-containing mRNA vaccines tested in humans that were shared at the FDA's recent vaccines advisory committee meeting."
"Higher VYD222 doses tested in our Phase 1 clinical trial have resulted, as expected, in higher titer levels that were well above those reported mRNA COVID-19 vaccine titer levels."
"We believe these initial Phase 1 clinical trial results support the potential for VYD222 to provide safe, meaningful, durable protection for vulnerable populations, such as immunocompromised people who may not generate adequate protection from COVID-19 vaccines, and we look forward to advancing VYD222 as fast as possible in collaboration with global regulators, starting with the FDA."
As of July 2023, mAbs targeting COVID-19 are in use globally.
Genentech today announced that the Phase III OCARINA II clinical trial evaluating Ocrevus® (ocrelizumab) as a twice-a-year 10-minute subcutaneous injection met its primary and secondary endpoints in patients with relapsing forms of Multiple Sclerosis (MS) or primary progressive MS (RMS or PPMS).
In this clinical trial, Ocrevus subcutaneous injection was shown to be non-inferior to Ocrevus given by intravenous infusion (IV), as measured by pharmacokinetics (levels in the blood) over 12 weeks.
Additionally, Ocrevus subcutaneous injection was comparable with Ocrevus IV in controlling brain magnetic resonance imaging lesion activity over 12 weeks.
“These results give people living with MS the possibility to receive the transformational benefits of Ocrevus in the way best suited to their lives while freeing up time and healthcare resources,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, in a press release on July 13, 2023.
“This new subcutaneous injection will allow Ocrevus to be administered in 10 minutes twice a year, helping people living with MS to spend less time in treatment for this disease.’’
Ocrevus is not a vaccine but is a humanized monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to nerve cell insulation and support and nerve cell damage.
The Ocrevus 10-minute injection is designed to be administered without the need for IV infrastructure. Hence, it can potentially expand the usage of Ocrevus in MS centers without IV infrastructure or those with IV capacity limitations.
It also retains the twice-yearly dosing regimen of Ocrevus IV that has shown high persistence and adherence since becoming a standard of care MS treatment.
This provides an additional delivery option so that the administration of Ocrevus can be matched to the individual needs of patients and healthcare professionals.
The investigational subcutaneous formulation combines Ocrevus with Halozyme Therapeutics’ Enhanze® drug delivery technology.
Ocrevus remains the first and only therapy approved for RMS and PPMS, and more than 300,000 people have been treated globally.
The future vaccination plans for U.S. travelers and those living in dengue-outbreak areas, such as Puerto Rico, were disrupted yesterday.
Takeda announced on July 11, 2023, that the Company had voluntarily withdrawn the U.S. Biologics License Application (BLA) for its dengue vaccine candidate, TAK-003, following discussions with the U.S. Food and Drug Administration (FDA).
Takeda's press release stated that aspects of data collection could not be addressed within the current BLA review cycle.
On November 22, 2022, Takeda announced that the FDA had accepted and granted priority review of the TAK-003 BLA.
TAK-003, known internationally as QDENGA®, is approved in multiple endemic and non-endemic countries, such as the United Kingdom, Europe, and Brazil.
Gary Dubin, M.D., president of Takeda's Vaccines Business Unit, commented in a related press release, "The urgent global need to combat the growing burden of dengue remains, and we will continue to progress regulatory reviews and provide access for people living in and traveling to dengue-endemic areas while we work to determine next steps in the U.S."
QDENGA® is a tetravalent dengue vaccine preventing Dengue Fever or Severe Dengue caused by any of the four serotypes of the dengue virus.
During 2023, locally-acquired dengue has been confirmed in Florida and Texas.
While other second-generation dengue vaccine candidates are in development, the initial FDA-approved dengue vaccine Dengvaxia® remains available in the U.S. but has specific pre-vaccination requirements.
Novavax Inc. announced yesterday that it had reached an agreement with Canada, under which the country would pay $349.6 million to settle the forfeiting of certain doses of the company’s protein-based COVID-19 vaccine.
Novavax COVID-19 vaccine brands include Nuvaxovid™, CovoVax, NVX-CoV2373, and TAK-019.
Since authorization, over 100 million doses of Nuvaxovid have been distributed globally in about 40 markets.
As reported by BNN on July 7, 2023, this development results from a significant decrease in global demand for COVID-19 vaccines, leading to a surplus of unused doses.
The World Health Organization weekly epidemiological update edition #150 confirmed that during the previous 28 days, the COVID-19 pandemic has declined since mid-2022.
In addition to the settlement, Novavax also entered into a revised contract with Canada’s public works and government services department.
The terms of the advance purchase contract were amended to reflect the reduced number of vaccine doses due for delivery and the revised schedule for the remaining doses.
On June 6, 2023, the U.S. Food and Drug Administration confirmed Novavax COVID-19 Vaccine, Adjuvanted, was available in the U.S. for certain people. And on July 6, 2023, Nuvaxovid received Full Marketing Authorization in Europe as a primary series in individuals aged 12 and older and booster in adults.
The Lancet Infectious Diseases recently published results from a phase 1 clinical trial of a Lyme disease vaccine candidate, showing that Valneva's VLA15 produces a strong but waning immune response against six common strains of the Borrelia burgdorferi bacterium found in Europe and the United States.
Valneva Austria researchers led this company-sponsored, partially randomized, observer-masked study of the novel, multivalent outer surface protein A (OspA) subunit vaccine candidate.
OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick.
VLA15 produced immune responses for all strains, but responses were greater in the higher-dose adjuvanted groups. And one month after the third dose, responses declined, reaching baseline by one year.
And a booster dose given 13 months after the first dose triggered a strong immune response for about six months.
This study's findings are good news since Lyme borreliosis is the most common tick-borne disease in the northern hemisphere.
In Europe, there are estimated to be more than 200,000 cases each year. And in the U.S., approximately 30,000 patients per year.
In a related commentary also published by The Lancet, Nicole Bézay, and colleagues reported Valneva's novel vaccine represents a milestone in our fight against Lyme disease."
Initially developed by France-based Valneva SE, New York-based Pfizer, Inc. is VLA15's current development and commercialization collaboration.
Pfizer previously indicated it could submit a Biologics License Application in 2025 and Marketing Authorization Application in Europe in 2026, subject to positive data.
Local media today reported Moderna Inc. intends to establish its Chinese headquarters in Shanghai to promote the research, development, production, and sales of messenger RNA vaccines and drugs in China.
Yicai Global confirmed on July 6, 2023, Moderna signed a memorandum of understanding and a land deal with Shanghai's Minhang district government, marking the Massachusetts-based firm's first investment in China.
Sources told Yicai Global that Moderna's investment will total USD1 billion.
Additionally, Moderna will build a plant in China to make respiratory disease vaccines, such as those against respiratory syncytial virus (RSV) and influenza.
As the recent global pandemic fades, there is market pressure on Moderna to find new vaccine products for its foraying into China, wrote Yicai.
The European Commission (EC) recently confirmed it will facilitate the uptake of the EU Digital COVID certificate by the World Health Organization (WHO) and contribute to its operation and further development.
The EU Digital COVID certificate has been issued to over 2.3 billion people.
This means about fifty-one countries can begin accessing the WHO's Global Digital Health Certification Network (GDHCN) on July 1, 2023.
This global verification of health document system is designed to deliver better health for all.
The GDHCN's digital capabilities may include verification of vaccinations and prescriptions across country borders, verification of vaccination certificates within borders, the International Patient Summary, and certification of public health professionals through the WHO Academy.
And these capabilities include using EU privacy standards and validating digital signatures to prevent fraud.
However, the WHO will not have access to any underlying personal data, which would continue to be the exclusive domain of national governments.
This digital infrasctrure was initially presented on January 27, 2021, and confirmed in June 2023.
As of July 5, 2023, the U.S. government has not announced its official participation in the GDHCN.
