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The government resumed distributing the antibody combination earlier this month after pausing shipments over concerns about the treatment’s effectiveness against coronavirus variants. Read More
The FDA has indicated that it will be asking Pfizer-BioNTech to perform more studies on the COVID-19 vaccine Comirnaty’s booster shot before approving the companies’ supplemental biologics license application (BLA). Read More
Gaithersburg, Md.-based Emergent BioSolutions has struck a five-year deal with Providence Therapeutics to help manufacture the Canadian company’s COVID-19 vaccine candidate. Read More
COVID-19 vaccine booster shots may be necessary to sustain waning immunity, said Center for Biologics Evaluation and Research (CBER) Director Peter Marks in remarks at the RAPS Convergence annual conference, which is being held virtually this week because of the pandemic. Read More
Two outgoing vaccine experts at the FDA as well as experts from the World Health Organization (WHO) are arguing that providing COVID-19 booster shots to the general public isn’t warranted at this time. Read More
Moderna is working on a new booster vaccine, mRNA-1073, that combines the drugmaker’s COVID-19 shot with its experimental flu vaccine in a single dose. Read More
“We need to fight today’s pandemic but also ensure we are prepared with new drugs to combat viruses with future pandemic potential,” said Exscientia CEO Andrew Hopkins. Read More
Approved vaccines and the diminishing numbers of unexposed individuals are making placebo-controlled trials for COVID-19 vaccines a thing of the past, so researchers will have to rely on active comparators to develop second-generation shots. Read More
Neutralizing antibody activity against Delta was not observed in samples obtained from vaccinated individuals six months following a second dose, the researchers said. Read More