La vaccine against Covid-19 known as until now as the Pfizer-BioNTech vaccine, is renamed Comirnaty in the United States after its Food and Drug Administration (FDA) granted its full authorization, not only approved for emergency use (USA) as to date.
With this decision, the United States tries to give greater confidence to the population and convince the skeptics with the coronavirus vaccine. “You can be very sure that This vaccine meets the high standards of safety, efficacy and manufacturing quality“Janet Woodcock, Acting Commissioner of the FDA, said in her statement.
“Although millions of people have already received Covid-19 vaccines safely, we recognize that for some, FDA approval of a vaccine can now infuse a additional confidence to get the vaccine, “adds Woodcock.
Comirnaty, first vaccine against Covid-19 with total green light
Full FDA approval is currently only for the prevention of Covid-19 disease in people aged 16 years or ms, but the vaccine is still available under an emergency use authorization (US) for people 12-15 years of age, as well as for the administration of a third dose in certain immunosuppressed people.
“This is a crucial moment for our country in the fight against the coronavirus pandemic, as we are well aware that this vaccine is one of our greatest weapons against the virus“, apunta Woodcock.
For his part, the director of the FDA’s Center for Biological Evaluation and Research, Peter Marks, explained that this new phase has the objective of generating greater confidence in the population that has not yet been immunized. “We hope that those who have endured until now to get vaccinated will do so,” and indicated, according to Antena 3, that he hopes that this announcement scare “false claims”, such as that coronavirus vaccines “cause infertility, contain microchips, cause disease or that thousands of people have died from inoculation.”
What is the Pfizer or Comirnaty vaccine like?
Comirnaty contains Messenger RNA (mRNA), a kind of genetic material, which the body uses to mimic one of the proteins of the virus that causes Covid-19. When a person receives this vaccine it causes their immune system to react defensively to the virus that causes the coronavirus even though the mRNA is only present in the body for a short period of time and the genetic material of the individual is not incorporated or altered. Comirnaty has the same formulation as the vaccine formerly known as Pfizer-BioNTech approved for emergency use (USA), and is administered the same: two doses three weeks apart.
Of the 170 million people vaccinated against coronavirus in the United States, more than 92 million have received the one from Pfizer. According to ‘El Mundo’, the FDA is already reviewing the information provided by Modern (licensed for emergency use) to obtain full approval but the decision could take weeks, and it is expected that Johnson&Johnson, which developed the third vaccine to be approved for emergency use in the United States, apply soon for a full green light.
What is the FDA?
The United States Food and Drug Administration (FDA) is, according to the statement, an agency of the US Department of Health and Human Services and is responsible for protect public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human use and medical devices for human and veterinary use.
The agency is also responsible for the safety and security of the supply of food, cosmetics, dietary supplements, and products that emit electronic radiation, as well as for regulating tobacco products.