Monovalence

New CDC Respiratory Guidance Ignores Kidney Patient Concerns

Retrieved on: 
Thursday, March 7, 2024
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WASHINGTON, March 7, 2024 /PRNewswire/ -- Today, the American Association of Kidney Patients (AAKP), the largest and oldest independent kidney patient organization in the nation, issued an Official Statement (appears below) in response to the Center for Disease Prevention and Control's (CDC) new Respiratory Virus Guidance, publicly announced on March 1, 2024. The CDC announcement occurred on the first day of National Kidney Month. March traditionally unites kidney stakeholders and people of goodwill in efforts to raise awareness of kidney diseases, address ongoing unmet patient needs, and advocate for removal of federal regulatory and payment barriers that impede access to, and development of, new kidney diagnostics, drugs, and devices.

Key Points: 
  • Mortality rates among kidney patients occurred at historic levels at the start of the COVID pandemic, devastated the kidney patient community and families, and this community's ongoing risks remain a strategic concern among patient advocates and allied kidney professionals.
  • AAKP also raised kidney patient health and safety concerns to CDC officials in stakeholder briefings prior to the March 1, 2024, CDC Respiratory Virus Guidance announcement.
  • The American Association of Kidney Patients (AAKP), the nation's largest and oldest independent kidney patient organization in the nation, is deeply concerned about the Center for Disease Prevention Control's (CDC) Respiratory Virus Guidelines, including for COVID, announced on March 1, 2024.
  • https://www.cdc.gov/mmwr/volumes/73/wr/mm7308a5.htm
    Since 1969, The American Association of Kidney Patients has been a patient-led organization driving policy discussions on kidney patient care choice and medical innovation.

Pfizer and BioNTech's Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster Receives Health Canada Authorization for Individuals 12 Years of Age and Older

Retrieved on: 
Friday, October 7, 2022
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An application for an Omicron BA.4/BA.5-adapted bivalent vaccine for children 5 through 11 years of age is also being planned for submission to Health Canada for review.

Key Points: 
  • An application for an Omicron BA.4/BA.5-adapted bivalent vaccine for children 5 through 11 years of age is also being planned for submission to Health Canada for review.
  • The authorization of COMIRNATY Original & Omicron BA.4/BA.5 is based on clinical data from Pfizer and BioNTech's Monovalent ("original" vaccine), Omicron BA.1-adapted bivalent vaccine as well as pre-clinical and manufacturing data from their Omicron BA.4/BA.5-adapted bivalent vaccine.
  • A clinical study investigating the safety, tolerability, and immunogenicity of the Omicron BA.4/BA.5-adapted bivalent vaccine in individuals 12 years of age and older is currently underway.
  • Apart from the addition of the mRNA sequence of the Omicron BA.4/BA.5 spike protein, all other components of the vaccine remain unchanged.

$185+ Bn Vaccine (Inactivated, Live Attenuated, Subunit Vaccines) Markets, 2028 by Indication, Route of Administration, Type, Valence - ResearchAndMarkets.com

Retrieved on: 
Tuesday, December 14, 2021
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The vaccine market's growth is mainly attributed to the high prevalence of diseases, technological advancements in the vaccines industry, increasing government initiatives towards immunization, and a strong pipeline for vaccines.

Key Points: 
  • The vaccine market's growth is mainly attributed to the high prevalence of diseases, technological advancements in the vaccines industry, increasing government initiatives towards immunization, and a strong pipeline for vaccines.
  • In addition, emerging markets are expected to offer significant growth opportunities for players operating in the vaccines market.
  • However, product recalls and inadequate access to vaccines are the key factors expected to hinder the growth of the vaccines market.
  • Based on the disease indication, in 2021, the COVID-19 vaccines segment is estimated to account for the largest share of the total vaccines market.