PITTSBURGH (KDKA) – Even when the first coronavirus vaccine was given in England, the wait continues in this country.
Volunteers in Pittsburgh and beyond have rolled up their sleeves to test the vaccines and get them through the testing periods. However, the Food and Drug Administration has not yet approved them for use in that country.
Pfizer and its partner BioNTech filed for emergency clearance on November 20, but the FDA won’t hear their case until this Thursday.
Moderna’s hearing will come a week later.
CBS News medical expert Dr. David Agus, of the Keck School of Medicine at the University of Southern California, says the FDA will review a vaccine that hasn’t changed since the spring.
“I think we all know from the data reported today that the vaccines are being approved so that each day takes longer, which literally means lives are being lost,” said Dr. Agus. “At the moment the FDA said you have to wait until you have everything ready and then submit all of your data. We are reviewing them, and they are reviewing every case to make sure that exactly what was reported is exactly what happened. That thinks everything is good. Of course we want security. However, a longer review is not synonymous with certainty. “
If Pfizer gets its approval on Thursday, it will be almost three weeks since it applied.
Dr. Agus says: “You know that an external advisory board is not mandatory. So it is not absolutely necessary. It will potentially instill some trust with the public and I’m sure why they are. So I agree, and I agree, we need the vaccines as soon as possible. We have to introduce them so that we can protect the people of this country. You know, there is a limited supply of vaccines one by one, but the sooner we start vaccinating, the faster we will overcome the hiccups and the sooner we can keep some people safe. “
According to Dr. Agus, the British were able to give their approval quickly as they monitored the data from the trials throughout the process.
Dr. Agus says the FDA always considers risk versus 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 if you look at the risk of getting the vaccine out today compared to a week or two weeks. And what is the reward, I think the reward is really there. The vaccines have been shown to be safe as there was no serious adverse event related to the vaccine that was irreversible after a day or two. Fever, chills at the injection site. A little tired, but after a day or two it all goes away and then top three candidates Pfizer McDermott and AstraZeneca block 100% hospitalization and become seriously ill with this virus. So it couldn’t be better. “
Once the vaccine is available, people shouldn’t hesitate to get it, even if they have had COVID-19.
“No question,” he said. “Unfortunately, after you had the virus, immunity can be short-lived and we see that we don’t have good immunity tests now. Whether you’ve been exposed and sick before the virus, or have been asymptomatic or never been exposed to the virus, everyone must get the vaccine that promises some level of long-lasting immunity. ”
He says there is just no way of knowing. Dr. Agus is confident it will take at least a year, but it could be a lot longer. This is a case where literally “only time will tell”.