• World
  • May 19
  • Sreesha V.M

FDA approves Novavax COVID-19 vaccine with new conditions

• The US Food and Drug Administration (FDA) approved Novavax’s COVID-19 vaccine, but limited its use to older adults and people over the age of 12 with conditions that put them at risk due to the illness.

• Nuvaxovid is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax's recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognise the virus, while Novavax’s Matrix-M adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation.

• The approval restricts the use of the vaccine, sold under the brand name Nuvaxovid, to individuals aged 65 and older, and those between 12 and 64 who have at least one underlying condition that increases their risk of developing severe illness from COVID-19.

US Food and Drug Administration (FDA)

• The Food and Drug Administration (FDA) is an agency within the US Department of Health and Human Services. 

• The FDA protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

• The agency also is responsible for the safety and security of the country’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

• Though FDA can trace its origins back to the creation of the Agricultural Division in the Patent Office in 1848, its origins as a federal consumer protection agency began with the passage of the 1906 Pure Food and Drugs Act. This law was the culmination of about 100 bills over a quarter-century that aimed to rein in long-standing, serious abuses in the consumer product marketplace.

(The author is a trainer for Civil Services aspirants.)

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