In the U.S., COVID-19 vaccines are widely available to all age groups apart from children under the age of five. However, that could change this month now that FDA has signaled that three doses of the Pfizer-BioNTech (NYSE:PFE/Nasdaq BNTX) COVID-19 vaccine are likely effective against COVID-19 in an analysis ahead of a June 15 Vaccines […]
COVID-19 vaccine
FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11
The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine. The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said […]
Moderna seeks authorization for COVID-19 vaccine in children as young as 6 months old
While a portion of the public is now eligible to receive a second booster dose of COVID-19 vaccine, the FDA has not yet authorized a vaccine for children aged 6 months to 5 years old. Moderna (Nasdaq:MRNA) is vying to be the first. The company announced today that it is filing a request for emergency […]
Takeda wins approval to distribute Novavax’s COVID-19 vaccine in Japan
Takeda (NYSE:TAK) has announced that it has won manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid, a novel COVID-19 vaccine. Nuvaxovid (NVX-CoV2373) was initially developed by Novavax (Nasdaq:NVAX). The approval covers the use of the vaccine as both a primary and booster immunization in adults at least […]
Pfizer-BioNTech COVID-19 vaccine booster spurs strong immune response in kids 5–11
Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have shared positive data from a Phase 2/3 clinical study testing a third 10-µg dose of the Pfizer-BioNTech COVID-19 vaccine in healthy children aged 5 through 11. The most recent data show that a booster dose of the BNT162b2 vaccine led to increased neutralizing titers for the omicron variant […]
FDA’s Woodcock reassures about COVID-19 tests, vaccines under Omicron
Acting FDA Commissioner Dr. Janet Woodcock thinks many COVID-19 tests will continue to work with the new Omicron variant — with information coming soon on vaccine efficacy. In a statement posted yesterday, Woodcock said she thought the agency is well-positioned to work with companies to address the potential impact of viral mutations on COVID-19 tests, […]
FDA advisory panel recommends boosters only for older and high-risk individuals
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously supported emergency use authorization to administer the Pfizer-BioNTech Comirnaty vaccine as a booster to those 65 years of age and older individuals at high risk of developing severe COVID-19. The panel, however, resoundingly rejected a plan to administer the vaccine as a booster to individuals […]
COVID-19 vaccine booster tensions mount between White House, CDC and FDA
Facing the second-biggest wave of COVID-19 infections and waning popularity, President Biden has promised to launch an initiative to begin providing vaccine boosters starting September 20. But the plan hinges upon FDA and CDC support, and some officials at the agencies remain unconvinced that boosters are immediately necessary. Two departing senior FDA vaccine officials recently co-wrote […]
FDA outlines plan to ‘follow the science’ as it mulls over COVID-19 vaccines for children
FDA leaders have issued a statement regarding the agency’s plan moving forward with regards to authorizing COVID-19 vaccines for children. The FDA plans to “follow the science” with eyes on COVID-19 vaccines for children younger than 12 as schools begin to get back in session around the country, the agency said in a news release […]
Moderna submits initial data to FDA for COVID-19 vaccine booster
Moderna (NSDQ:MRNA) announced that it initiated its submission to the FDA for a booster dose of its COVID-19 vaccine. Cambridge, Massachusetts-based Moderna expects to submit data to the European Medicines Agency and other regulatory authorities around the world in addition to the FDA in the coming days for the booster shot at a 50 µg dose […]
Pfizer seeks FDA blessing for COVID-19 vaccine booster
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) aim to expand the recent FDA approval of their COVID-19 vaccine to include booster doses for individuals 16 and older. The companies have submitted a supplemental Biologics License Application to the FDA, including Phase 3 data drawn from participants aged 15 to 55. The latest data indicate that […]
