Jiangsu Recbio Technology Co. Ltd. has received clinical trial approval for its novel adjuvanted recombinant shingles vaccine, REC-610, from the Food and Drug Administration of the Philippines. A phase I trial will be conducted in healthy volunteers.
Both neutralizing antibodies and antibody effector functions are needed for protection against re-infection with respiratory syncytial virus (RSV), which may explain why it has been challenging to design an effective vaccine against the virus. As reported in the Dec. 12, 2022, issue of Cell, researchers carried out a human challenge study where volunteers were given a candidate vaccine for RSV, Ad26, or placebo.
Emergex Vaccines Holding Ltd. has generated a chikungunya virus (CHIKV) ligandome, the first major milestone in the development of the company's CD8+ T-cell CHIKV adaptive vaccine candidate. Using an immunoproteomics approach, naturally presented MHC Class I-restricted peptides on the surface of a human leukocyte antigen (HLA)-typed cell line infected with CHIKV virus were extracted and identified.
Pfizer Inc. and Biontech SE have initiated a phase I study to evaluate the safety, tolerability and immunogenicity of BNT-162b4, a next-generation COVID-19 vaccine candidate that aims to enhance SARS-CoV-2 T-cell responses and potentially broaden protection against COVID-19.
Arizona State University scientists have discovered an unprecedented pathway in a fungus to produce telomerase RNA (TER) from a protein-encoding messenger RNA (mRNA). Unlike in animals and other fungi, this fungal TER is transcribed by RNA polymerase III, lacks a protective 5′ cap and it is processed from the 3′-untranslated region of an mRNA transcript. This telomerase has two essential structural domains that keep it active. For now, scientists have only observed this process in the fungus Ustilago maydis, or Mexican truffle. “In animals, and even in Ascomycota, which is another fungal phylum, the telomerase RNA is transcribed by RNA polymerase II as an independent gene. This is the only case among all different kingdoms in eukaryotes that the telomerase RNA is processed from the mRNA molecule. It is a very unusual biogenesis pathway.” Julian Chen told BioWorld.
Although U.S. President Joe Biden suggested in September that the pandemic is over, health officials insist there is still much to do in preparation for an endemic stage of the SARS-CoV-2 virus. The number of weekly COVID-19 confirmed cases both globally and in the U.S. is similar with each of the last two years, but deaths from the virus are at some of the lowest levels since the pandemic began. Still, the virus will continue to evolve and circulate, and the biopharma industry will need to develop new booster vaccines, antivirals and monoclonal antibodies, among other candidates, to prepare for upcoming battles.
Valneva SE’s share price plummeted May 16 after the European Commission decided to terminate an advance purchase agreement for millions of doses of its COVID-19 vaccine candidate VLA-2001 because of delays in development. The company’s shares (Paris:VLA) fell more 19% to €9.65 (US$10.07) after it said it would reconsider its financial guidance for 2022.
Pharma CEOs have pushed back strongly against intellectual property (IP) waivers for COVID-19 vaccines and therapies, saying that pricing is not the reason why middle- and low-income countries have not received pharmaceutical countermeasures against the pandemic. Senior execs from Pfizer Inc., Eli Lilly and Co., and Roche Holding AG, also expressed concerns about the latest funding package from the U.S. government, which at $10 billion is less than half that originally requested by the White House.
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