PITTSBURGH (KDKA) – Even as the first coronavirus vaccine was administered in England, the wait continues in this country.
Volunteers in Pittsburgh and beyond rolled up their sleeves to help test the vaccines and get them through the trial periods and yet in this country, the Food and Drug Administration has not yet approved them for use.
Pfizer and its partner BioNTech applied for its Emergency Use Authorization on November 20th but the FDA will not hear its case until this Thursday.
Moderna’s hear will come a week later.
CBS News Medical Expert Dr. David Agus from the Keck School of Medicine at the University of Southern California says the FDA will be reviewing a vaccine that hasn’t changed since the spring.
“So I think all of us know from seeing the data that have been reported today that the vaccines will be approved so every day longer it takes, literally means lives lost,” said Dr. Agus. “So right now the FDA had said, you got to wait till you finish everything and then submit all of your data, and we review it, and they’re reviewing down to each case, making sure what was reported is exactly what happened. That’s all finding good. Certainly, we want safety. But, reviewing it longer does not equal safety.”
If Pfizer gets its approval Thursday it will be almost three weeks since it applied.
Dr. Agus says, “You know, having an outside advisory committee is not mandatory. So it’s not necessarily needed. It will potentially instill some public confidence which is I’m sure why they’re doing it, and so it is, and I agree, we need the vaccines out as soon as possible. We need to roll them out so we can start protecting people in this country. You know, one by one, there’s a limiting supply of vaccines, but the sooner we start to vaccinate, the sooner we’ll get over the hiccups the distribution and the sooner we’ll enable some people to be safe.”
Dr. Agus says the Brits were able to give its approval quickly because it’s been monitoring the data from the trials throughout the process.
Dr. Agus says the FDA always considers the risk versus the reward.
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“We have record numbers of cases, record numbers of hospitalizations, and record numbers of deaths in many places across the country,” he said. “So I think when you start to look at what is the risk of getting the vaccine out today versus a week versus two weeks from now. And what is the reward, I think the reward is really there. The vaccines are proven safe in that there has not been one serious adverse event related to the vaccine that has not been reversible after a day or two, fever, chills pain at the injection site. Some fatigue but it all goes away after a day or two, and then, each of the three leading candidates Pfizer McDermott and AstraZeneca 100% they block hospitalization and getting seriously ill from this virus, so you can’t do better than that.”
Once the vaccine is available Dr. Agus says people should not hesitate to get it, even if they’ve had COVID-19.
“No question about it,” he said. “Unfortunately, immunity, after you’ve had the virus can be short-lived and we’re seeing that now, we don’t have good tests for immunity. So everybody, whether you’ve been exposed prior to the virus and gotten some degree of sickness, or been asymptomatic, or have never been exposed to the virus, needs to get the vaccine, which will promise, some degree of long-lasting immunity.”
He says there is simply no way to know. Dr. Agus is confident it will be at least a year but it could be much longer. This is a case where literally “only time will tell.”