On 23 August 2021, the US Food and Drug Administration approved the first Covid-19 vaccine.
The Pfizer-BioNTech Covid-19 vaccine has now been approved for use in individuals 16 and older. Previously, the vaccine was available under emergency use authorisation, a status which remains for use on those aged 12 to 15.
“The FDA’s approval of this vaccine is a milestone as we continue to battle the Covid-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorisation, as the first FDA-approved Covid-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received Covid-19 vaccines, we recognise that for some, the FDA approval of a vaccine may now instil additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the US”, said Woodcock.
The vaccine contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes Covid-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes Covid-19. The mRNA in it is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material.
On 25 August 2021, Switzerland’s federal government announced it had signed another contract with biopharma firm Pfizer ensuring access to a sufficient supply of mRNA vaccine for the Swiss population for the next two years. The new contract provides for the delivery of 7 million doses in both 2022 and 2023, with an option of an additional 7 million doses each year. The use of any modified Pfizer/BioNTech vaccines will require authorisation by Swissmedic.
FDA statement (in English)