Pittsburgh Doctor Addresses Concerns About Pfizer's COVID-19 Vaccine
PITTSBURGH (KDKA) - Several concerns were brought up in the FDA's coronavirus vaccine advisory panel deliberations about the Pfizer vaccine.
One is the cumbersome nature of the vaccine. It requires cold storage, but also careful mixing, and use within six hours. Training will be needed. Also, there's a minimum order of nearly 1,000 doses, which means people in rural areas may need to come to the city.
"The state has been preparing for this, and they've been working with hospitals and public health clinics to practice this," says Dr. Arvind Venkat, an emergency medicine physician at the Allegheny Health Network. "They recognize that it's not just receiving the vaccine into their facilities. It's also all the steps that it takes to get the vaccine into people's arms and get them protection.
During the public commentary, people expressed concerns that certain populations weren't adequately represented and that study hasn't been long enough.
"I think their concerns related to our public faith in the vaccine, as opposed to the science of the vaccine. This was one of the largest trials, and it frankly went quickly because we had such widespread transmission of COVID that they were able to rapidly assess whether the vaccine was protective or not," Dr. Venkat says.
"You never have a perfect study population that mirrors everything that happens in society," he adds.
Another concern involved the reports of allergic reactions.
"It's very likely this was a rare event. They did not see this widespread during the clinical trial. With a vaccine, they will always be monitoring for short, medium and long-term effects," says Dr. Venkat.
The biggest issue to Dr. Venkat was the loss of robust data from the placebo group, should those people want to leave the study and get the vaccine after EUA.
"We're weighing the individual good versus the good that comes to all of society through research. So certainly anyone who finds out they received a placebo and wants to remove themselves from the trial they can," Dr. Venkat explains. "The concern is that decision will reduce our societal understanding of what happens with the vaccine in terms of side effects compared to those who received a placebo."
All trial participants could receive the vaccine through alternative study designs. These were proposed to balance the science, the ethics, and practical issues.
