The Pfizer COVID-19 vaccine was approved by the US Food and Drug Administration (FDA) on Monday.
Following the FDA’s approval, the Pentagon announced it will require the US military to get vaccinated, Reuters reported. The approval is expected to lead to more vaccine mandates for government employees.
The FDA said its approval of the vaccine “signifies a key achievement for public health” and Acting FDA Commissioner Janet Woodcock added that it “is a milestone as we continue to battle the COVID-19 pandemic”.
From now on, the vaccine will be marketed under its brand name Comirnaty.
The vaccine was already available under emergency use authorisation (EUA), and had been administered tens of millions of times, as the FDA recognised that its potential benefits outweighed the potential risks of the product.
Based on the agency’s standard process for reviewing the quality, safety and effectiveness of medical products, full approval was granted.
This process includes preclinical and clinical data and information, details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made.
For people aged 16 years and older, the vaccine was tested on a group of 40,000 participants, half of which were given the vaccine while the other received a placebo. Moreover, 12,000 recipients have been followed for at least 6 months.
Based on the results of this trial, the vaccine was 91% effective in preventing COVID-19 disease. It is effective in preventing COVID-19 and potentially serious outcomes including hospitalisation and death.
The FDA and Centres for Disease Control and Prevention will continue monitoring to identify and evaluate safety concerns in a timely manner.
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