The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend COVID-19 vaccines for the 2023-2024 vaccination campaign be monovalent vaccines that target the XBB variants, currently the most prominent variants of the SARS-CoV-2 virus.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Hipra Human Health SLU’s recombinant COVID-19 vaccine, Bimervax, as a booster in people ages 16 and older who have been vaccinated with an mRNA COVID-19 vaccine.
Limited data exist on checkpoint inhibition that targets the early activation phase of adaptive immunity. B-and T-lymphocyte attenuator (BTLA) blockade is known to enhance and broaden CD8+ T-cell responses to a target antigen.
The Biden administration has determined that the public health emergency (PHE) for the COVID-19 pandemic will not be renewed and thus will come to an end in the second week of May. While the end of the PHE will affect some Medicare telehealth provisions that have not been memorialized in legislation, the U.S. FDA’s ability to issue emergency use authorizations (EUAs) will not be immediately affected as that authority was invoked by a separate mechanism.
Two companies who needed partners have found each other, as privately held Elicio Therapeutics Inc. will merge with Angion Biomedica Corp. in an all-stock deal.
One of the big regulatory and pandemic stories of 2022 with global impact was the June 17 World Trade Organization’s (WTO) agreement on a five-year intellectual property (IP) waiver for COVID-19 vaccines and their components.
One of the big regulatory and pandemic stories of 2022 with global impact was the June 17 World Trade Organization’s (WTO) agreement on a five-year intellectual property (IP) waiver for COVID-19 vaccines and their components.
Minervax Aps has closed a €72 million (US$76.6 million) financing round, enabling it to accelerate phase II development of its group B streptococcus (GBS) vaccine for the prevention of stillbirth and serious infections in newborns and complete the program next year.
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.
A new vaccine that uses the native-like HIV-1 envelope (Env) trimer CH505 and a Toll-like receptor (TLR) 7/8 agonist adjuvant, successfully evaluated in macaques, generated potent polyclonal neutralizing antibodies (nAbs) and a high protection against the infection of the homologous simian-human immunodeficiency virus (SHIV).
