CLEVELAND (WJW) — The FDA followed its emergency-use approval of the Pfizer-BioNTech COVID-19 vaccination with a plea Saturday for confidence in the process behind the development, testing and approval of the vaccine.
“Efficiency does not mean cutting of corners. Medical products are still undergoing rigorous study and clinical trials, important safety checks remain in place,” said FDA Commissioner Dr. Stephen Hahn. “I know the meticulousness of the review that the FDA has done. I will absolutely take this COVID-19 vaccine, pending availability and distribution, because I have complete trust and confidence in the FDA’s career staff’s evaluation.”
Preparing for the arrival of its first doses is the Cleveland Clinic, where Dr. Daniel Culver echoed the commissioner’s statements with FOX 8 on Saturday.
“We have reviewed at Cleveland Clinic also the data that are publicly available and we agree that this does appear to be safe and effective,” said Culver.
Culver believes the first doses of the vaccine could be ready for administration at the Cleveland Clinic in less than a week and he says when it is his turn, he too will accept the shot. That having been said, Culver also says there remains some unknowns about the vaccine.
“We know right now it prevents the development of symptomatic disease and it seems right now to most likely prevent the development of severe disease but it’s not certain that it prevents any infection from occurring at all,” Culver said.
The FDA commissioner says although the emergency approval was expedited the process remained consistent with the high standards on which the FDA has always insisted.
“What we have seen this year is a historic partnership among the private sector, academic researchers and the federal government to find efficiencies in our scientific process as well as the dedication of time and energy toward a common goal, which has led to the rapid development of truly innovative medical products,” said Hahn.
“All the normal safeguards, all the normal assessment for safety was in the trial, and looking at those data, there are no surprises. The vaccine does appear to indeed be very safe and effective at least in the short term, and so I think this is a positive step,” said Culver.
The first limited doses are expected to be administered to healthcare providers. The Cleveland Clinic recently revealing its vaccination clinic and its freezer facility in preparation for distribution.
Culver says the expected approval of another vaccine being developed by Moderna in the coming days will add to its availability.
And even though the vaccine’s rollout is seen as a positive step, both the FDA chairman and Dr. Culver say it is likely to be a long while before we are all back to something that seems like “normal.”
“I think there is a light at the end of the tunnel, but we are still a very long way from the end of the tunnel and I hope that people keep their guard up right now,” said Culver.
“We remind the public to remain vigilant as inoculation will take time. Wear a mask, wash your hands and remain socially distant when possible. Protect yourself, the vulnerable and others.” said Hahn.
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