Then, the virus-containing fluid is collected from the cells and the virus antigen is purified. Next, the vaccine manufacturer inoculates the CVVs into cultured mammalian cells (instead of into chicken eggs) and allows the CVVs to replicate (i.e., make copies) for a few days. First, CDC or one of its laboratory partners, uses influenza viruses that have been grown in cultured mammalian cells to make CVVs, which are then provided to a vaccine manufacturer. The process of creating cell culture-based flu vaccines involves several steps. Currently, cell culture-based manufacturing is used to make inactivated flu vaccines (e.g., flu shots), not LAIV (nasal spray flu vaccine). However, on August 31, 2016, FDA issued an approval for Seqirus, the sole FDA-approved cell culture-based flu vaccine manufacturer in the United States, to begin using cell culture-grown CVVs. Originally, this production process also began with chicken egg-grown CVVs per FDA regulations. ![]() There also is a cell culture-based production process for flu vaccines that was approved by FDA in 2012. This production method requires large numbers of chicken eggs to produce vaccine and may take longer than other production methods. There are several different manufacturers that use egg-based production technology to make flu vaccines for use in the United States. FDA tests and approves all flu vaccines prior to release and shipment. For the nasal spray flu vaccine (i.e., the live attenuated influenza vaccine – LAIV), the starting CVVs are used to make live, but weakened viruses that are then used in vaccine production. The manufacturing process continues with quality testing, packaging and distribution. For inactivated influenza vaccines (i.e., flu shots), the vaccine viruses are then inactivated (killed), and the virus antigen is purified. The fluid containing virus is harvested from the eggs. These CVVs are then injected into fertilized chicken eggs and incubated for several days to allow the viruses to replicate. The egg-based production process begins with CDC or another laboratory partner in the WHO Global Influenza Surveillance and Response System providing private sector manufacturers with candidate vaccine viruses (CVVs) grown in chicken eggs per current FDA regulatory requirements. Egg-based vaccine manufacturing is used to make both inactivated (killed) vaccine (usually called the “flu shot”) and live attenuated (weakened virus) vaccine (usually called the “nasal spray flu vaccine”). ![]() That has been used for more than 70 years. ![]() The most common way that flu vaccines are made is using an egg-based manufacturing process See Different Types of Flu Vaccines for more information. Different vaccines have different indications. Different manufacturers use different production technologies, but all flu vaccines meet FDA safety and effectiveness requirements. Food and Drug Administration (FDA) :Īll commercially available flu vaccines in the United States are made by private sector manufacturers. For the United States there are three different flu vaccine production technologies approved by the U.S.
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