A woman holds a small bottle labeled "COVID-19 Vaccine" and a medical syringe in front of the Pfizer logo. DADO RUVIC / Reuters
A panel of experts from the FDA, the drug regulator in the United States, has given the green light to the vaccine against covid-19 developed by Pfizer and BioNTech.
Following the experts' verdict, it is expected that, in the next few hours or days, the agency will formally announce its authorization for the emergency use of the vaccine.
It will be then that the United States follows in the footsteps of the United Kingdom and Canada and begins mass vaccination against covid-19.
The panel's decision came after a meeting that started this Thursday morning and has lasted for about nine hours.
At the end of the meeting, the FDA (Federation of Food and Drug Administration, for its acronym in English) asked its experts: “Based on the totality of the scientific evidence available, do the benefits of the Pfizer-BioNTech vaccine outweigh? What are the risks for its use in individuals 16 years of age or older?
The panel has voted yes.
In the past, experts have painstakingly reviewed the data from the Pfizer study for any red flags recommending against proceeding with the mass distribution of doses of a vaccine that, in clinical trials, has demonstrated extremely strong protection against a disease that already it has claimed more than 289,000 lives in the United States.
Approval comes at a critical time.
The country is going through the worst scourge of the pandemic.
Hospitals throughout the United States have their intensive care units on the brink of collapse, and we are waiting to see the effect on hospital admissions of the Thanksgiving holiday, celebrated two weeks ago, in which Americans are accustomed to travel from one state to another and traditionally meet as a family.
In addition, in just two weeks the Christmas season and the end of the year celebrations arrive.
The operation of the FDA panel, whose deliberations have been broadcast live for the first time, is like a sort of scientific tribunal examining the data and trying to determine if the vaccine is safe enough to authorize its emergency use. dramatically shortening the usual deadlines for drug approval.
The more than 20 members of the panel are experts in vaccines and infectious diseases.
His verdict is not binding on the FDA, but the agency usually follows his advice.
The authorization is not, therefore, immediate: it has to be decided by the FDA after the verdict of the panel.
Once the agency's decision has been announced, as General Gustave Perna, in charge of logistics, explained on Wednesday, the federal government is ready to distribute 2.9 million doses of the vaccine throughout the national territory in 24 hours.
The emergency authorization means that the FDA will allow a portion of the population to receive the vaccine while continuing to analyze the trial data.
A full authorization can take up to several months.
In the United Kingdom, the same vaccine began to be administered to the population last Tuesday.
On Wednesday, the Canadian regulator also gave the green light to proceed with mass vaccination in the country.
British authorities, however, have recommended that the vaccine not be given to people with a severe allergic history, after two health workers suffered anaphylactoid reactions after receiving their injections.
But the fact that the FDA published an unusually positive initial review of the vaccine a few days ago already made it possible to anticipate that the panel would recommend its approval.
The agency found no complications or safety threats in its review of the phase 3 clinical trial conducted by Pfizer with 44,000 people.
They also concluded that the vaccine was highly effective in various demographic groups.
The expectation about the panel meeting, and the fact that it had been decided to broadcast it live, are also part of an effort to convey confidence to the population about the vaccine, and avoid the reluctance of some, partly due to the unusual rapid development of the drug, cause a rejection that does not allow a herd immunization.
Just a month and a half after the replacement in the White House, after Democrat Joe Biden won the elections on November 3, the FDA has received pressure to accelerate the process by the still President Trump, eager to approval occurs within its mandate.
Information about the coronavirus
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