Disease expert ‘not worried’ that COVID-19 vaccine was rushed process
Are health care officials sacrificing safety for speed when it comes to a COVID-19 vaccine?
Pfizer announced on Wednesday that it will apply "within days" to the FDA for emergency use approval. Pfizer's CEO said the company wouldn't take that step until it's COVID-19 vaccine met three key criteria.
- It had to be proven effective – meaning it can prevent COVID-19 in majority of patients.
- It had to be proven safe with data from thousands of patients.
- It could be manufactured consistently at highest quality standards.
Dr. Bettina Fries, the chief of infectious diseases at Stony Brook Medicine, says she’s “not worried that this was rushed.”
“I am not concerned that the FDA will not apply the same safety standards to this vaccine that they would apply to any vaccine,” says Dr. Fries.
The FDA has said it would not grant emergency use approval to any COVID-19 vaccine unless it had an efficacy rating of at least 50%.
Experts say manufacturing and distribution will happen faster than usual because, as part of Operation Warp Speed, companies were in trial and preparing for production at the same time. That usually doesn't happen because the financial risk is too great.
The FDA will look at results from the clinical trial in addition to two months of safety data and manufacturing records. The agency will also convene an outside panel of experts to consider Pfizer's application. That could take several weeks.