A new engineered glycated vaccine induced production of neutralizing antibodies against severe acute respiratory coronavirus 2 (SARS-CoV-2) and other coronaviruses in mice, scientists at The University of Osaka and the RIKEN Center for Integrative Medical Science in Yokohama have reported.
More than 21 months since the SARS-CoV-2 virus was first identified in Wuhan, China, the questions just keep coming, and the longer they go unanswered, the more divisive the opinions become. Controversies over the efficacy of current vaccines, over whether boosters are necessary for the general population, over the safety of COVID-19 vaccines for young children, over how to distribute the shrinking supply of highly effective monoclonal antibodies, and over how the virus originated in the first place – all of these looming questions have created a firestorm of uncertainty that will not stop burning.
When the SARS-CoV-2 virus first emerged in the U.S., the knee-jerk reaction by biopharma researchers was to make the best vaccines and therapeutics possible and to do so quickly. Since then, the number of those that have entered development has reached 1,001, more than for any other viral infection aside from HIV.
Constrained by the U.S. FDA’s authorized conditions of use for a booster dose of Pfizer Inc. and Biontech SE’s COVID-19 vaccine, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled with making recommendations Sept. 23 for the use of the booster, with several members questioning the need for a third dose in some of the populations the FDA identified.
LONDON – Self-amplifying RNA (saRNA) specialist Vaxequity Ltd. has sealed a commercialization deal with Astrazeneca plc after delivering safety data in a phase I/II trial of the technology in a COVID-19 vaccine.
Five days after an FDA advisory committee recommended a booster dose of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty, for people 65 and older or those who are at high risk of a serious infection, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled Sept. 22 with what a U.S. booster program would look like if only one booster is available when three different COVID-19 vaccines are being used in the country.
Fresh data from Johnson & Johnson show COVID-19 protection dramatically increased with a booster shot of its single-dose vaccine, adding momentum to the U.S. drive for boosters.
Minhai Biotechnology Co. Ltd. has won approval from the NMPA for its 13-valent pneumococcal conjugate vaccine, which makes it the third company with such a vaccine to be greenlighted in China.
SK Bioscience Ltd. has won approval from the South Korean Ministry of Food and Drug Safety (MFDS) to begin a phase III trial for its COVID-19 vaccine candidate GBP-510, making the recombinant protein antigen vaccine the first domestically developed candidate to make it to late-stage testing. “We aim to begin the phase III trials within August and to have the data ready by early 2022,” a company spokesman told BioWorld.
Novavax Inc. now says it plans to submit an emergency use authorization (EUA) to the FDA for its highly efficacious COVID-19 vaccine, NVX-CoV2373, sometime in the fourth quarter, backing off previous plans of a second-quarter and then a third-quarter filing.