Federal officials finally approved the emergency use of the COVID-19 vaccine that Pfizer and BioNTech produced in a breakthrough decision that commits to drastically alter the fight against COVID-19 in the United States.
NPR reported, the Food and Drug Administration issued a letter to Pfizer indicating approval of the authorization on Friday evening.
In a statement, Alex Azar, Human and Health Services Secretary said, it is "nothing short of a medical miracle" to have authorization from the FDA of a COVID-19 vaccine for only more than 11 months from the time the virus became popular worldwide.
Azar also said these vaccines would help bring this global health crisis to an end, an all the more reason to "double down on the public health measures we need to stay safe in the coming months.
The Food and Drug Administration has finally approved emergency use of the COVID-19 vaccine that Pfizer and BioNTech produced, in a breakthrough decision that commits to alter the fight against COVID-19 drastically in the United States.
Decision of the FDA
The decision of the FDA, which comes just one day from an advisory panel's overwhelming endorsement, makes the said COVID-19 vaccine the first to get a go-signal for extensive distribution in the United States.
Several other nations have previously approved such authorization to the vaccine of Pfizer and BioNTech, which include the United Kingdom, where a far-reaching immunization program began earlier this week.
Earlier on Friday, Azar said he expects to see people in the US getting vaccinated early next week. In the first push following the authorization, the government expects 2.9 million doses of COVID-19 vaccines to go out.
According to the said report, shipments are expected to start within 24 hours after the official announcement of the FDA authorization.
Referring to this latest development, government officials said they would supply adequate doses of the Pfizer vaccine for 20 million people by the end of 2020.
Efficacy of the Vaccine
Director of the Vaccine Education Center at Children's Hospital of Philadelphia, Dr. Paul Offit said, they have clear evidence that the vaccine is highly efficient, at least three months from receiving the first dose.
More so, given the other data they reported, said Offit, who is also one of the 17 members of the panel who voted for the recommendation of the vaccine, thinks it is "likely to be effective for much longer.
Meanwhile, four of the advisers voted against the recommendation for emergency use of the vaccine, while one member abstained.
Offit also said they know that the vaccine has been administered safely to thousands of people. Therefore, "we can say, at least with comfort," that it does not result in an uncommon, severe side effect.
He also added the warning that this does not essentially rule out the probability that an uncommon or rare side effect may occur later. However, he explained, he thinks they know enough.
"You know," he elaborated, "when you agree to move forward" with something, "it is not whether you know everything." Rather, he said it is whether you know enough to claim that the benefits are outweighing what, at this point, are hypothetical risks.
Essentially, the Pfizer vaccine, which is given in a pair of doses with a three-week interval, has been presented to be 95-percent efficient in clinical tests.
However, it is not the only vaccine that shows promising results. Moderna, another vaccine candidate, has been presented to be more than 94-percent effective in tests and is presently waiting for its own FDA approval of authorization for emergency use.
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