Search Results for “vaccine” – Page 15 – media

Valneva Reports Strong Phase III Chikungunya Vaccine Data After Merck’s Exit from Race

By Tristan Manalac Pictured: Syringe pulling vaccine from a vial / Adobe Stock, weyo Data from a Phase III study showed Valneva’s chikungunya vaccine candidate VLA1553 can elicit a strong immune response and could be an effective protective option against the mosquito-borne disease caused by the chikungunya virus, the French company announced Tuesday. This news follows a February 2023 report from Fierce Biotech revealing that Merck had dropped out of the chikungunya race. Citing a company spokesperson, Fierce noted that the decision to discontinue the chikungunya program was part of the company’s “routine pipeline prioritization.” Published Monday in the medical journal The Lancet, Valneva’s double-blinded and randomized Phase III study enrolled more than 4,100 participants who were given either VLA1553 or placebo. In the per-protocol analysis, the investigational shot induced neutralizing antibody titers above the protective threshold in 263 of 266 participants with evaluable findings. This corresponded to a 28-day ...
- Source: drugdu
- 116
- June 15, 2023
BioNTech to defend itself against COVID-19 vaccine injury claim in Germany

Two years after the initial COVID-19 vaccine push swept across the globe, Pfizer’s COVID-19 vaccine partner BioNTech is heading to court in its home country of Germany to defend itself against allegations that its shot caused injuries. This lawsuit comes from a German healthcare worker who seeks at least 150,000 euros ($161,500) in damages for alleged bodily harm, plus compensation for unspecified material damage, Reuters reports. The woman claims she suffered from upper-body pain, swollen extremities, fatigue and a sleeping disorder as a result of taking the Comirnaty vaccine. The plaintiff’s attorneys at the firm Rogert & Ulbrich will challenge the vaccine’s positive risk-benefit profile as assessed by European Union regulators and vaccine assessment agencies, according to the news service. Under German drug laws, drugmakers are only liable for side-effect damages if “medical science” can prove their meds have an incorrect label or cause disproportionate harm relative to their benefits, ...
- Source: drugdu
- 93
- June 14, 2023
Updated Covid vaccines need to target XBB omicron variants this fall, FDA staff says

U.S. Food and Drug Administration staff on Monday said updated Covid boosters should target XBB omicron subvariants for the upcoming fall and winter vaccination campaign. The U.S. should use a monovalent vaccine targeting either XBB.1.5, XBB.1.16, or XBB.2.3, collectively the dominant strains nationwide, the staff said in a briefing document. The FDA staff made the conclusion ahead of a meeting on Thursday, when a panel of external advisors to the agency will recommend a strain for new Covid shots to target later this year. There is no set date for when the vaccination campaign will begin. Vaccine manufacturers will be expected to update their shots once that strain is selected. Pfizer, Moderna and Novavax are already developing versions of their respective vaccines targeting XBB.1.5 and other circulating variants. The upcoming strain selection will be crucial to those companies’ abilities to compete in the fall, when the U.S. is expected to ...
- Source: drugdu
- 102
- June 14, 2023
China Approves the World’s First Vaccine against XBB Descendent Lineages of SARS-CoV-2 for Emergency Use

CHENGDU, China, June 8, 2023 /PRNewswire/ — On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 cell) developed by WestVac Biopharma/ West China Medical Center, Sichuan University was approved for EUA by relevant authorities in China. This is the first COVID-19 vaccine in the world approved for EUA against XBB descendent lineages of SARS-CoV-2. It demonstrates that China is leading the world in the development of COVID-19 vaccines. WestVac Biopharma and its subsidiary company WestVac Biopharma (Guangzhou) leveraged the rapid response of the insect cell expression platform on constructing the vector for Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 Cell), which is of high purity and high quality for human use. The subunit vaccine antigen is precisely designed based on the structure of the targeting S-RBD and HR proteins of the COVID-19 subvariants XBB.1.5 and BA.5 and self-assembled into stable trimeric protein particles with ...
- Source: drugdu
- 151
- June 12, 2023
GSK’s RSV vaccine approved by EC for older adults

GSK’s respiratory syncytial virus (RSV) vaccine has been approved by the European Commission (EC) for the prevention of RSV-caused lower respiratory tract disease (LRTD) in adults aged 60 years and older. The EC’s decision, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, makes Arexvy the first RSV vaccine for older adults to be granted European Marketing Authorisation. RSV is a common contagious virus characterised by several mild, cold-like symptoms. Although most people can recover within a week or two, older adults are at a high risk for severe disease. This is partly due to age-related decline in immunity. RSV can also exacerbate other conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure. Overall, RSV infections in older adults account for over 270,000 hospitalisations and approximately 20,000 in-hospital deaths each year in Europe. GSK’s EU application was supported by positive results from its phase ...
- Source: drugdu
- 116
- June 9, 2023
Moderna, Pfizer Hit with New COVID Vaccine Patent Lawsuits

By Tristan Manalac Pictured: Scales of justice/Kanizphoto, iStock Tuesday, New York-based Promosome filed separate lawsuits against Moderna and Pfizer, accusing both companies of violating patent protections related to mRNA technology, according to a report by Reuters. In the filings submitted to the Southern District Court of California, Promosome claims that in 2009 company-affiliated scientists “discovered a method for increasing protein expression by making small changes to the mRNA that could affect the amount of protein produced without altering the amino acid sequence encoded by the mRNA.” This method is protected by U.S. Patent No. 8,853,179, also known as the ’179 Patent. Promosome scientists, including Nobel laureate Gerald Edelman, gave the company exclusive license to the ’179 Patent. Promosome eventually disclosed the protected technology to Moderna—which ultimately declined to license it—and to Katalin Karikó, who served as senior vice president and top mRNA scientist at BioNTech at the time of the ...
- Source: drugdu
- 104
- June 9, 2023
Moderna and Merck cancer vaccine used with Keytruda reduces risk of deadly skin cancer spreading

Moderna and Merck’s experimental cancer vaccine, used in combination with Merck’s Keytruda, reduced the risk of the most deadly form of skin cancer spreading to other parts of the body in a clinical trial, according to the midstage trial results published Monday. Moderna and Merck’s cancer vaccine reduced the risk of melanoma spreading to other parts of the body or death by 65% in patients with stage 3 or 4 of the disease compared with patients who received Merck’s immunotherapy treatment alone, the trial has found. Moderna and Merck will present the data at the American Society of Clinical Oncology’s annual conference in Chicago at 5 p.m. ET. The clinical trial has enrolled 157 patients who have had their cancer surgically removed. Patients in the treatment group receive 1 milligram injections of the vaccine every three weeks for nine total doses and 200 mg intravenous infusions of Keytruda every three ...
- Source: drugdu
- 129
- June 7, 2023
Look out, GSK. Pfizer has its adult RSV vaccine approval and is raring to launch

About a month after GSK won the world’s first approval for a respiratory syncytial virus (RSV) vaccine, rival Pfizer has followed suit. Late Wednesday, the New York drugmaker said its Abrysvo won FDA approval to prevent against lower respiratory tract disease caused by RSV in adults 60 and older. Both companies are looking to launch their offerings ahead of the upcoming RSV season, which typically starts in the late fall. Before the launch, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will meet later this month to discuss recommendations for the newly approved RSV shots. Pfizer expects to make the vaccine available in the third quarter, should ACIP members put their support behind the vaccine. The FDA approved Abrysvo based on data from a phase 3 trial called RENOIR, which enrolled about 37,000 participants. In the study, the vaccine achieved 66.7% protection against RSV-associated lower ...
- Source: drugdu
- 125
- June 5, 2023
While Pfizer, BioNTech agree to cut COVID vaccine supply to Europe, Moderna sets up shop in China

With demand plummeting for COVID-19 vaccinations, the EU has cut a deal with Pfizer and BioNTech to alter their contract, reducing purchases of the companies’ Comirnaty vaccine by roughly 35%, EU sources told Bloomberg. The companies provided little information on the adjusted contract, calling it a “rephrasing of delivery doses annually through 2026,” in a release. “The agreement includes an aggregate volume reduction, providing additional flexibility for EU Member States,” the companies wrote. “The EC [European Commission] will maintain access to future adapted COVID-19 vaccines and the ability to donate doses.” Some member states opted out of the deal, according to a statement from the EU. Meanwhile, the world’s other premier producer of COVID-19 vaccines, Moderna, is looking to advance sales of its mRNA shot in China, as it has established a unit called Moderna Biotech Ltd. in Shanghai, Reuters reports. Moderna CEO Stephane Bancel visited Shanghai last month, according ...
- Source: drugdu
- 141
- May 31, 2023
European Commission to receive fewer Pfizer-BioNTech vaccine doses under amended contract

Nicole DeFeudis Editor The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.” The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third. Some member states have opted out of the amendment, and “will continue to be bound by current contractual obligations,” the Commission said. The news comes weeks after the World Health Organization ended its three-year global health emergency for Covid-19, while warning that “the virus is ...
- Source: drugdu
- 121
- May 30, 2023

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