FDA Authorizes New COVID-19 Vaccine

Sept. 11, 2023 – The FDA as we speak licensed the latest COVID-19 vaccine, the primary to not goal the preliminary or “ancestral” pressure of the virus. 

Final 12 months, the FDA licensed a bivalent vaccine aimed toward each the outdated and the brand new. This time, it’s a “monovalent” or single-strain vaccine with one principal goal: to reduce well being dangers, hospitalizations, and deaths related to newer variants just like the XBB.1.5 Omicron subvariant. It’s also anticipated to supply some safety towards associated variants at the moment in circulation

The FDA emergency authorization applies to vaccines made by each Pfizer and Moderna. 

Two steps stay earlier than you will get the booster at your physician’s workplace or native pharmacy, nonetheless. The CDC’s Advisory Committee on Immunization Practices, or ACIP, is anticipated to vote on approving the brand new vaccine this week. Then the brand new director of the CDC, Mandy Cohen, MD, MPH, should log out. 

The FDA stated the vaccine is allowed for anybody age 5 and older no matter earlier vaccination standing so long as it’s been greater than 2 months because you’ve obtained a COVID shot. 

Kids 6 months by way of age 4 who’ve obtained not less than one earlier COVID vaccine are eligible for one or two doses of the brand new vaccine. You’ll want to talk to your pediatrician to verify dosage. 

Kids in the identical age group who’ve by no means obtained a COVID vaccine are eligible for 3 doses of the brand new Pfizer vaccine or two doses of the brand new Moderna system. 

“The FDA is assured within the security and effectiveness of those up to date vaccines and the company’s benefit-risk evaluation demonstrates that the advantages of those vaccines for people 6 months of age and older outweigh their dangers,” the company stated in a press release. 

The quantity of people that received the earlier booster fell in need of expectations. In most locations all through america, 20% or much less of the inhabitants obtained the up to date bivalent vaccine since its approval Sept. 1, 2022, for instance. Solely in seven states and the District of Columbia does the share go above 25%, in accordance with a CDC map

A significant unknown is how the price of the brand new boosters, not freed from cost, might have an effect on their uptake. The producers estimate that with out medical insurance they are going to value $110 to $130 for every dose.

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