Pfizer to Seek FDA Approval for COVID-19 Vaccine After Election
Pfizer said their company will not ask for Food and Drug Administration (FDA) approval for their COVID-19 vaccine candidate until after the election.
As Pfizer CEO Albert Bourla said in an open letter, their COVID-19 vaccine cannot request for emergency FDA approval before the third week of November.
The timeline is only based on Pfizer's best estimates and does not account for delays on the COVID-19 vaccine, said an Associated Press report.
Bourla said that if they do ask for FDA approval, they will be putting forward a successful vaccine.
In asking for FDA approval, the company wants to meet three key requirements first: efficacy, safety and manufacturing.
FILE PHOTO: FILE PHOTO: A sign is pictured outside Pfizer Headquarters in the Manhattan borough of New York City, New York, U.S., July 22, 2020.
He stressed that while the world is rushing towards a COVID-19 vaccine, ensuring its safety is equally important.
To ensure public trust, Bourla explained the process and timeline that they are employing in making the vaccine.
He said Pfizer is "operating at the speed of science." This means the company will know if their vaccine works by the end of the month, but it's only part of a bigger equation.
The company will still go through "robust safety data" from their studies to make sure everything works fine, Bourla explained.
He added that their researchers are not the only ones involved in the vaccine study. An independent team will review their data efficacy and all data in their application will be reviewed by FDA's own scientists.
He also ensured that their company is meeting the high-quality standards it has been known for.
"Our purpose is to discover breakthroughs that change patients' lives," he said, adding that there is not greater breakthrough than an effective vaccine.
According to Pharmaceutical Technology, Pfizer's COVID-19 vaccine relies on mRNA technology. It is being developed with German BioNTech.
Their research is on its global Phase II/III study.
No COVID-19 Vaccine Before Election
There have been repeated promises by President Donald Trump that a COVID-19 vaccine will be ready before Election Day.
But scientists have cautioned that this is an unlikely scenario. At best, a leading shot may work by late November or December.
Even if a shot emerges effective by the end of the year, doses will be limited.
The government will decide who will get these doses first, and it's likely these will go to health care workers.
Politicizing for COVID-19 Vaccine
As the pressure ramped up on drug makers to have a vaccine ready by the Election Day, many grew doubtful of health agencies.
The FDA was not spared from this as in early September, Latin Post reported on a poll that concluded the public's loss of confidence in the FDA.
From there, drug makers have been making pledges left and right to assure people that they will only release reliable vaccines.
In another report, they added that they won't be affected by politics that surrounds the election, not to sacrifice safety for speed.
Officers from the Center for Disease Control and Prevention (CDC) also criticized the politicization, reported Business Insider.
In an open letter, they expressed concern about silencing the nation's health agency amid the ongoing pandemic. See the full letter here.
Check these out!
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