Washington, May 23 (BUS): The company announced Monday that three doses of Pfizer’s COVID-19 vaccine provide strong protection for children under 5 years old.
Pfizer plans to submit the data to US regulators later this week in a move toward allowing young children to get the shots, according to the Associated Press.
This news comes after months of anxious waiting by desperate parents to vaccinate their children, toddlers and preschoolers, especially as cases of COVID-19 are on the rise again.
The 18 million children under the age of five are the only group in the United States not yet eligible for the coronavirus vaccination.
The Food and Drug Administration has begun evaluating data from competitor Moderna, which hopes to start offering two child-sized shots by summer.
Pfizer had a hard time figuring out its approach. She aimed to give children a lower dose – just a tenth of the amount adults receive – but she discovered during her trial that the two shots didn’t seem strong enough for preschoolers.
So the researchers gave a third dose to more than 1,600 young adults — from ages 6 months to 4 years old — during a winter wave of the omicron variant.
In a press release, Pfizer and partner BioNTech said the extra shot did the trick, increasing levels of virus-fighting antibodies enough to meet Food and Drug Administration standards for emergency use of the vaccine without any safety issues.
Preliminary data indicated that the three-dose series is 80% effective in preventing symptoms of COVID-19, the companies said, but they cautioned that the calculation is based on only 10 cases diagnosed among study participants by the end of April.
Study rules state that at least 21 cases are needed to formally determine efficacy, and Pfizer has promised an update once more data is available.
The companies have already submitted data on the first two doses to the Food and Drug Administration, and BioNTech CEO Dr. Ugur Şahin said the final phase three data will be submitted this week.
Dr. Jesse Goodman of Georgetown University, a former vaccine chief at the US Food and Drug Administration, said Pfizer’s conclusion that toes produce antibodies similar to levels that protect young people was encouraging.
If the FDA confirms the data, Goodman said, the vaccine could be an “important tool to help parents protect their children.” But he cautioned that it is necessary to keep track of how long the protection lasts, especially against serious diseases.
What’s Next? The FDA’s head of vaccines, Dr. Peter Marks, pledged that the agency would “move quickly without sacrificing our standards” in evaluating high-volume doses from both Pfizer and Moderna.
Moderna strives to be the first to vaccinate young children. It submitted data to the US Food and Drug Administration saying that children develop high levels of anti-virus antibodies after two injections containing a quarter of the dose given to adults.
The Moderna study found that efficacy against symptomatic COVID-19 ranged from 40% to 50% during a rush of the omecon, just like adults who received only two doses of the vaccine.