Vaccination & COVID 19

The virus is inactivated using formaldehyde before or after the primary purification step, depending on the manufacturer. This is repeated for three or four strains of virus, and the individually tested and released inactivated viral concentrates are combined and diluted to final vaccine strength. Vaccine approval comes under FDA authority through the Federal Food, Drug, and Cosmetic Act and is also governed by the Public Health Service Act, which regulates biological products.

Regulatory issues are involved in nearly every aspect of vaccine development, manufacturing, and marketing approval. Regulations come into play from the time of vaccine design and clinical testing, through manufacturing, to when the final product is distributed for widespread use.

Section 351 of the Public Health Service Act (P.L 78-410) requires a manufacturer of biological products to first obtain a license to ship the product (vaccine) in interstate and/or foreign commerce or to import the vaccine into the United States. To obtain a license, manufacturers must make a vaccine by an approved procedure, in approved facilities, and by an approved staff. Standards and requirements for vaccine licensure in the United States are generated and enforced by the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA). The licensing regulations are published in the Code of Federal Regulations, Title 21, Part 600.