URMC doctors discuss safety concerns over Moderna pediatric COVID-19 vaccine trial | WHEC.com


URMC doctors discuss safety concerns over Moderna pediatric COVID-19 vaccine trial

Raven Brown
Updated: March 17, 2021 06:38 PM
Created: March 16, 2021 03:08 PM

ROCHESTER, N.Y. (WHEC) — Moderna is now studying its COVID-19 vaccine for children and URMC confirms it will participate.

The trial will test the safety and effectiveness of the two-dose vaccine in kids six months to 11-years-old.

Moderna says it plans to enroll more than 6,000 kids in the U.S. and Canada.

The first participants have already been dosed.

Moderna started testing the vaccine in adolescents between 12 and 17-years-old in December.

The URMC trial will start in the spring of 2021.

Anyone interested in joining the trial can call URMC at 585-276-5212 or visit its website.

Researchers said they are looking about 100 volunteers and told News10NBC this is one of the many steps to reaching herd immunity in our community.

"[We're] very excited. A little bit cautiously nervous about the job ahead,” URMC professor of pediatrics and infectious disease Dr. Mary Caserta said.

Caserta told News10NBC they are still waiting for more details—but the trials will include two doses of the vaccine beginning in Spring 2021.

“The trials are built in to have screening, enrollment, observation after and they are placebo-controlled so at least the phase 2 and phase 3 will be blinded," Caserta said.

URMC professor of pediatrics and infectious disease Dr. Jennifer Nayak described what they are looking for. 

“We're looking for children who are between the ages of 6 months and less than 12 years old so 6 to 11 who are overall healthy,” Nayak said. 

Nayak stressed that inclusion is a key part of the trial.

“When we conduct these studies there are a list of inclusion and exclusion criteria that we specifically go through who we expect to get children who are able to represent the whole populations,” Nayak said. 

While they are looking for healthy children, Dr. Caserta said those with chronic diseases can participate.

“Children are allowed to have things like asthma or diabetes as long as they're basically well controlled and have been stable for a period of time,” Caserta said. 

She noted children make up 22% of the population and the trials are critical when it comes to reaching herd immunity.

“We know the priority has been on older people because they've suffered the most consequences and we know that children acquire the infection and that children transmit the infection there are more than 75 million children in the United States and we need to include them in their plans for protecting,” Caserta said. 

“When you read the study, the number one objective is safety and intolerability so that is the upper most concern for everyone,” Caserta said.

Caserta hopes this trial will give families a sense of comfort when it comes to getting their kids vaccinated.

“The studies have built-in stopping points to evaluate safety before moving forward with their children so they're very mindful before moving to each stop that safety is the primary issue,” Caserta said. 

Nayak said they don't expect any concerns. 

News10NBC asked if there is any evidence that it would be unsafe for children to use this Moderna vaccine.

“So far looking at the adult data and the Pfizer goes down to age 16. These vaccines have been shown to be very safe in the population” Dr. Nayak said. 

Nayak tells me they will start with the older children first and monitor their reaction.

“Who we expect to be more like the vaccine has been tested in and then as we get some safety data and some dosage data we're able to move down to the next population and then down to the youngest population,” Nayak said.

Both said they do think it's important to study children as COVID-19 manifests differently in them compared to adults with the goal to provide parents some level of comfort.

“We are focusing on safety. These trials are designed to make sure that these vaccines are safe to go to be used in the pediatric population so that when that time comes there hopefully will be less hesitancy,” Nayak said. “By that point a lot of adults will have already been vaccinated."

Caserta says they believe the vaccine won't be ready and approved for all children until late 2021.

As part of the rollout URMC has a screening tool where volunteers can sign and click on the ‘get started’ link to register. 

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