The United States authorities took a further step on Monday to try to convince skeptics to get vaccinated against COVID-19 with the full authorization of the serum from Pfizer, which will now be called Comirnaty.
The United States Food and Drug Administration (FDA) granted its full authorization to the Pfizer vaccine, which thus becomes the first serum of its kind in the country to achieve it, since until now it was only approved for emergency use.
Following this FDA approval, President Joe Biden said in a White House speech that this “is the time” that unbelievers “have been waiting” to get vaccinated.
Biden argued that this news is very relevant because it comes just when the delta variant, which he described as “very dangerous”, is spreading in the United States.
“Although we are beginning to see initial signs that cases may be declining in some places, nationally cases continue to increase, especially among the unvaccinated,” added Biden.
THE VACCINE, ONE OF THE GREATEST WEAPONS
In a press conference, the acting commissioner of that regulator, Janet Woodcock, said that with this final approval the US population “can be sure that this vaccine meets the FDA’s gold standards in terms of safety, efficacy and manufacturing quality ”.
“This is a crucial moment for our country in the fight against the pandemic, as we are well aware that this vaccine is one of our greatest weapons against the virus,” said Woodcock.
The vaccine was licensed for emergency use in the US in mid-December for those over 16 years of age and was expanded in May for those over 12.
But it was not until today that its full approval was made official, which only applies to those over 16 years of age, because Pfizer has to provide more data on the use of the vaccine in children between 12 and 15 years of age to achieve the full authorization, which could take months.
DISMISS FALSE CLAIMS
In that same press conference, the director of the FDA’s Center for Biological Evaluation and Research – in charge of supervising vaccines -, Peter Marks, explained that this new phase has the objective of generating greater confidence in the population that has not yet been has immunized.
“After following our rigorous processes to evaluate this vaccine, we hope that those who have waited until now to get vaccinated will do so,” said Marks.
He also indicated that he hopes that this green light will scare away “false claims” such as that covid-19 vaccines “cause infertility, contain microchips, cause disease or that thousands of people have died from inoculation.”
“Let me be clear, these claims are simply not true: receiving a vaccine can save your life,” he remarked.
THE STATES INSIST WITH THEIR CAMPAIGNS
With the announcement of the FDA, several state governors of the country took the opportunity to insist on their immunization campaigns and ask the part of their population that has not yet been vaccinated to approach the inoculation points of their cities.
Through his social networks, the governor of California, Gavin Newsom, stressed that this authorization “confirms that the Pfizer vaccine protects against serious diseases, possible hospitalizations and death.”
“With the increase in COVID-19 cases across the country due to the delta variant, I encourage all Californians to trust science and protect themselves and their community by getting vaccinated,” he said.
For his part, the governor of Louisiana, John Bel Edwards, expressed his “fervent hope” that any resident in the state who is awaiting approval of the vaccine by the FDA “will take steps to receive their injection immediately.”
THE FDA REVIEWS OTHER VACCINES
So far, more than 170 million Americans in the US are fully vaccinated against COVID-19, of which more than 92 million have received serum from Pfizer.
The FDA is now reviewing the information provided by Moderna, the other drugmaker that has developed a messenger-RNA vaccine, like Pfizer’s, to get full approval, as it only has emergency use. The decision could take weeks.
Johnson & Johnson, which has developed the third vaccine to be approved for emergency use in the US (in this case from an adenovirus, like traditional vaccines), is expected to apply soon for full authorization.
The FDA’s decision on Monday is released as cases and hospitalizations have skyrocketed in the last month due to the expansion of the delta variant in the US.
The FDA is also now reviewing the possibility of giving a booster dose of Pfizer and Moderna vaccines to already immunized people, which the government wants to start administering as of September 20 due to the spread of the delta variant.
–
