FDA authorized additional dose of SARS-CoV-2 mRNA Vaccines…..

By August 17, 2021Covid-19 News

The FDA on August 12 authorized the administration of an additional dose of SARS-CoV-2 mRNA vaccines for certain people with compromised immune systems, “specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.” The FDA amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech and Moderna vaccines to allow for a third dose for this population, which is estimated to be about 2.7% of the US adult population. Several studies, including one published this week in the New England Journal of Medicine, show that immunocompromised people experience a significant increase in their immune response after a third dose of vaccine. The agency noted that other fully vaccinated people do not need an additional dose at this time, but several US health officials believe extra doses might be needed in the future. The US CDC’s Advisory Committee on Immunization Practices (ACIP) is meeting today to further discuss and vote on clinical recommendations regarding who will be eligible for extra shots and how they will be administered, with CDC Director Dr. Rochelle Walensky expected to sign off on any decisions later in the day. The ACIP also is expected to discuss what type of evidence is needed to inform a decision about whether additional vaccine doses are needed for a larger portion of the population and, if so, which populations should get them first.

 

In severely affected areas of the country, hospitals are being forced to implement emergency plans to manage the influx of COVID-19 patients. In Florida, which represents 22% of the national daily incidence, state health officials requested 200 ventilators and 100 high-flow nasal cannula kits from the federal Strategic National Stockpile (SNS). The state is not yet experiencing a shortage of this equipment, but statewide hospitalizations continue to set new records. Reportedly, officials in Brevard County, Florida, are emphasizing that the 9-1-1 telephone number should be used only for emergencies and encouraging residents to seek care through other means for less urgent conditions in order to reduce the burden on ambulance services and emergency departments. Daily incidence among children continues to increase, setting new records nationally and in severely affected states. In Mississippi, one school district—notably, with no mask mandate—is transitioning to virtual learning only 1 week into the school year, after 40% of students at one high school were required to quarantine. As of August 12, at least 10 cohorts of students at the high school are under quarantine, but the school elected to resume in-person classes and continue quarantining students following exposures prior to the district order to go virtual beginning August 16.

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