Posts

Showing posts with the label Immunizations

Novavax updated Covid vaccine wins FDA, CDC backing, paving way to reach Americans within days

Image
[ad_1] A vial labelled "Novavax V COVID-19 Vaccine" is seen in this illustration taken January 16, 2022.  Dado Ruvic | Reuters Novavax 's updated Covid vaccine won the backing of U.S. regulators on Tuesday, putting the shot on track to roll out weeks after new jabs from Pfizer and Moderna reached Americans. The Food and Drug Administration authorized Novavax's single-strain vaccine, which targets omicron subvariant XBB.1.5 , for emergency use in people ages 12 and up. The Centers for Disease Control and Prevention is now including Novavax's shot in the same recommendation it issued last month for updated vaccines from Pfizer and Moderna. That recommendation says all Americans ages six months and older can receive an updated Covid jab. Novavax said in a statement that doses of the shot will likely be available within the next few days. "Novavax's authorization today means people will now have the choice of a protein-based non-MRNA option to help...

Pfizer RSV vaccine for infants has 'generally favorable' safety data, FDA staff say

Image
[ad_1] Blood sample for respiratory syncytial virus (RSV) test Jarun011 | Istock | Getty Images U.S. Food and Drug Administration staff on Tuesday said Pfizer's vaccine that protects infants from respiratory syncytial virus has "generally favorable" safety data. The FDA staff made the conclusion in briefing documents ahead of a meeting on Thursday when a panel of external advisors to the agency will discuss whether to recommend full approval of the RSV shot . The advisors will vote on whether Pfizer's late-stage clinical trial data on the vaccine supports its safety and efficacy. The FDA typically follows the advice of its advisory committees, but is not required to do so. The agency is slated to make a decision on whether to clear the shot in August before RSV season in the fall. If approved, Pfizer's jab would become the world's first vaccine that protects infants against RSV.  RSV usually causes mild, cold-like symptoms. But infants and older ad...

Pfizer, GSK RSV shots for older adults may prevent thousands of hospitalizations, CDC analysis says

Image
[ad_1] Respiratory syncytial virus vial. Manjurul | Istock | Getty Images Vaccinating one million adults ages 65 and above with a single RSV shot from Pfizer or GSK may prevent thousands of hospitalizations over two seasons of the virus, according to a Centers for Disease Control and Prevention analysis .  A CDC medical officer presented the analysis, conducted by researchers at the University of Michigan, at an advisory committee meeting on Wednesday. The committee recommended that adults ages 60 and older may receive one dose of Pfizer's or GSK's respiratory syncytial virus shot after consulting their doctor.  The analysis found that vaccinating one million adults 65 and older with a single dose of Pfizer's shot may prevent 2,500 hospitalizations and 25,000 outpatient visits over two seasons of the virus. RSV season typically lasts from October to March in the Northern Hemisphere.   The analysis also found that vaccinating one million adults in the same age gr...

Pfizer Group B strep vaccine for infants returns encouraging mid-stage trial results

Image
[ad_1] Streptococcus agalactiae bacteria, responsible for vaginal and urinary tract infections and newborn infections including meningitis and septicemia. Optical microscopy view. Cavallini James | BSIP | Universal Images Group | Getty Images Pfizer on Wednesday said its experimental vaccine targeting the potentially deadly bacterial disease Group B Streptococcus returned strong mid-stage clinical trial results , a promising step as the drug inches toward potential approval. Pfizer is among several drugmakers racing to develop the world's first shot targeting Group B strep disease, which is linked to nearly 150,000 infant deaths worldwide each year, especially in lower-income countries. The Food and Drug Administration in September granted breakthrough therapy designation to Pfizer's vaccine, which is intended to expedite the development and review of the shot.  Pfizer's single-dose shot generated antibodies that may provide infants with meaningful protection aga...