Doctors involved in Operation Warp Speed and with Phase III of coronavirus trials discussed the safety of getting a vaccine.
With vaccines expected in the next few weeks, there is hope that the shots will have an impact on this pandemic and save lives.
There is still a lot of work to be done, not just with messaging about the vaccine’s safety but also with the clinical trials themselves.
Two doctors that have been very involved with Operation Warp Speed and two clinical trials gave a progress report of a coronavirus vaccine.
They discussed what many of you may be concerned about — vaccine safety.
They explained how no testing protocol was changed, there was no cutting corners, and trials were done in a deliberate speedy way, with resources to help in the process.
They also discussed the safety about getting a vaccine.
Dr. Kathleen Neuzil, Director at Center for Vaccine Development and Global Health and involved in Operation Warp Speed, said the clinical trials will continue and the FDA says they should continue for a minimum of 2 years. So the thousands of people enrolled in the trials will be followed for at least 2 years.
“So if there are any safety signal in that gold standard trial, those people will be 5 to 6 months ahead of where we are with vaccinating the public. And again, we would identify that,” says Dr. Neuzil.
She says there’s no reason to expect there to be an issue, and says they’ve never seen that with a vaccine at a late date like that.
So now, what about some of the issues?
The principal investigator for the Phase 3 trial of the Moderna and Johnson and Johnson trials, Dr. Buddy Creech says that will be the rollout of the vaccines.
“How do we ensure equitable access? How do we ensure that what will initially be a scarce resource we provide to as many people as possible given the high efficacy we are seeing in these studies.”
He also said it is very reassuring that we saw side effects common to other vaccines we already use like fever, headache, arm soreness or redness.
And we have not seen things that researchers would not expect.
That gives them confidence which is what is needed to roll out these vaccines in a very deliberate, staged manner.
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