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The designation addresses the unmet need for prevention of H5N1, which remains a global health risk, and a phase 1 trial of the vaccine was initiated in November 2024.
In 2023, the FDA approved six vaccines, including 2 for respiratory syncytial virus (RSV), and the first vaccine to prevent the mosquito-borne virus chikungunya.
Innovation in the vaccine area continues. In 2023, the FDA approved six vaccines, including several important firsts. But they face a difficult landscape where federal policies dictate coverage.
Ixchiq contains a live, weakened version of the chikungunya virus and may cause symptoms in the vaccine recipient similar to those experienced by people who have chikungunya disease.
WASHINGTON — Vinay Prasad, an academic and fierce critic of the medical mainstream, will be the next director of the Food and Drug Administration center that oversees the regulation of vaccines, gene therapies, and the blood supply.
Currently, there is no vaccine to prevent chlamydia, but treatment includes regimens of antibiotics, including doxycycline, azithromycin, and levofloxacin.
The Food and Drug Administration canceled an upcoming vaccine advisory committee meeting to discuss influenza virus strains, according to committee member Paul Offit. “Vaccine makers look to this meeting to determine which strains to include in this year’s vaccine.”
Following a meeting of the Vaccines and Related Biological Products Advisory Committee, the FDA announced their recommendation of COVID-19 vaccines targeting LP.8.1, a strain of the JN.1 1 variant that has become dominant in the US.
The FDA is advising health care professionals who administer the vaccine to make sure the correct volume of the vaccine is withdrawn from the vial and the correct dose is administered to the patient.
Two RSV vaccines for seniors have completed phase 3 trials and demonstrated beneficial results. The public still awaits FDA decisions on potential approvals for both.
FDA and CDC halt Ixchiq chikungunya vaccine for adults 60 years and older due to severe adverse events, including fatalities, urging caution in vaccination practices.
The US Food and Drug Association (FDA) has granted fast track designation to Sanofis mRNA vaccine candidate for the prevention of chlamydia infection. The chlamydia vaccine candidate has been designed to protect against primary genital tract infection and reinfection caused by the bacterium Chlamydia trachomatis.
A new booster shot of the Pfizer-BioNTech COVID-19 vaccine is now available for children aged 6 months to 4 years, in an effort to continue to curb the effects of COVID-19
The Food and Drug Administration on Friday expanded the approval for GSK’s vaccine to protect against respiratory syncytial virus, or RSV, authorizing its use for at-risk adults as young as 50. Arexvy, which was the first RSV vaccine approved , now becomes the first to be available to adults under the age of 60 who are not pregnant.
The Food and Drug Administration on Tuesday authorized Novavax’s updated Covid-19 vaccine, giving Americans seeking to update their protection against the SARS-CoV-2 virus another option. based company, which has struggled to claim a share of the now dwindling Covid vaccine market — globally and within the United States.
The Food and Drug Administration announced Monday that it had greenlit two updated Covid-19 booster shots in people as young as 6 months old, triggering a process that could see the Moderna and Pfizer-BioNTech vaccines become available in doctors’ offices, clinics, and pharmacies later this week. Read the rest…
FDA grants updated Moderna and Pfizer-BioNTech COVID-19 vaccines with emergency use authorization to target currently circulating variants of the virus.
The vaccine, indicated with a restriction on use for those younger than 65 years and without comorbidities, was proven safe and effective in a series of large clinical trials, and marks the first protein-based vaccine to be approved in the United States.
The Food and Drug Administration’s expert vaccine advisory panel on Thursday unanimously endorsed the idea of taking a strain of influenza viruses that no longer appears to circulate out of flu shots as quickly as possible, pressing the FDA and manufacturers to try to get the work done on an expedited timeline.
When Americans line up for flu vaccines next fall, they will almost certainly be getting vaccines that no longer contain protection against a family of flu viruses that appears to be extinct.
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