COLUMBUS, Ohio — With a vaccine for COVID-19 on the way, medical experts said they’ve heard from many people with many questions about it.
“There’s a lot of misinformation out there when it comes to vaccines. There’s a lot of vaccine hesitancy,” Dr. Joseph Gastaldo said.
We spoke with OhioHealth’s Infectious Diseases doctor Joseph Gastaldo to get clarity on some of the most frequent questions.
For starters - the effectiveness of the vaccine.
“First of all, we don’t have the actual data and the details we need to see. It hasn’t been presented publicly to the FDA yet,” Dr. Gastaldo said.
He said what has been released is an interim announced in a press release, that outside of the drug company, has not been seen by anyone in the scientific of medical world.
“When we say effectiveness, it’s based on information given to us. So again, we have to wait for it to the televised open review at the level of the FDA,” Dr. Gastaldo said.
Studies have varied, but do have a common focus that was measured.
“Whether it be moderate or severe or people that were hospitalized, all the studies are measuring little bit different things, but what they say they measured is symptomatic COVID-19,” Dr. Gastaldo said.
Dr. Gastaldo said these vaccines may likely have little impact of those with asymptomatic or mild symptoms.
“They’re going to perform like an Influenza vaccination or flu shot,” Dr. Gastaldo said.
Another frequently asked question is whether or not a person who got the vaccine will have side effects or not.
“The short answer to that yes, again nothing in life, nothing in the COVID-19 world, nothing in medicine is zero risk,” Dr. Gastaldo said.
What medical experts know about the vaccine approval process is carefully done.
“The amount of people put in the vaccine studies are the same as traditional vaccine studies. The population and the amount of people are the same. We know that the vaccine companies are having a very diverse population represented in their studies,” Dr. Gastaldo said.
After the vaccination studies finished their enrollment, the FDA commissioner put a pause for 60 days.
“Why the 60 day pause? It's because most serious adverse reactions in studies have occurred within 6 weeks, so he decided to do a pause for 8 weeks,” Dr. Gastaldo said.
The doctor said there’s also a chance for people to have an allergic reaction. He also pointed out that peoples’ immune systems will react differently.
“When people have a headache, a fatigue or a fever after a vaccine, that’s not a side effect of the vaccine. That’s your body’s immune system working and recognizing and processing the vaccine. That’s a good sign,” Dr. Gastaldo said.
Historically, he mentioned that vaccines approved by the FDA have taken around 11 years to go through all of the studies, research and safety measures.
This vaccine has gone through all of those. Nothing has changed, except for the fact it went through Operation Warp Speed.
“Operation Warp Speed allowed the approval process to be happening in a much more efficient basis,” Dr. Gastaldo said.
The FDA will start the approval process on Dec. 10, the recommendation will go to the FDA commissioner and then to the CDC.
Experts know not everyone is for the vaccine or will trust getting it.
However, Dr. Gastaldo said that’s where health providers come in. He said they need to be as educated as possible on the efficiency and safety of the vaccine.
Once that is done, they can then have open, honest and informal conversations with their patients to help answer questions or concerns.
“Celebrities, social influencers, people who don’t have any training or scientific understanding of the approval process should not be giving information,” Dr. Gastaldo said.