WHAT YOU NEED TO KNOW:
- Pfizer said three doses of the Covid-19 vaccine give strong protection against the disease.
- Some American parents have been waiting for the FDA to authorize the third dose for kids under age 5.
- The FDA’s panel of independent experts will meet on June 15 to review Pfizer’s and Moderna’s applications to approve their vaccines for kids under 5.
Pfizer said Monday that three doses of their COVID-19 vaccine provide strong protection for children younger than five. If authorized, the young children can receive the third dose possibly beginning in early summer.
Pfizer will be submitting its data to U.S. regulators later this week. The Food and Drug Administration is currently evaluating an application by Moderna to offer two-dose vaccinations to kids below 5 years old. The FDA’s independent scientific advisers set June 15 to publicly debate the data from one or both companies.
Some parents are anxiously waiting to vaccinate their babies, toddlers and preschoolers, especially as COVID-19 cases are surging once again. There are 18 million youngsters under 5 in the U.S. – the only group who has not been eligible for COVID-19 vaccination.
According to Pfizer, it initially aims to give tots an extra low dose but found out during its trial that two shots didn’t seem strong enough protection for preschoolers. That’s when researchers gave a third dose to more than 1,600 children with ages ranging from 6 months to 4 years. The trial was conducted during the winter surge of the omicron variant.
Pfizer and BioNTech announced that the extra COVID-19 shot boosted the kids’ levels of antibodies enough to meet FDA criteria for emergency use of the vaccine. There were no safety issues reported.
Preliminary data revealed that the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned the calculation is based on just 10 cases diagnosed among study participants by the end of April. The study rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer promised an update as soon as more data is available.
While the vaccine effectiveness likely could change somewhat, “all of this is very positive for those parents who are looking forward to having a vaccine for their younger children in the coming months,” said Dr. William Moss of the Johns Hopkins Bloomberg School of Public Health, who was not part of the study.
If FDA confirms the data, the vaccine could “be an important tool to help parents protect their children,” agreed Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.
Moderna asked FDA to authorize two shots, each containing a quarter of the dose given to adults. While that spurred good levels of virus-fighting antibodies, Moderna’s study found effectiveness against symptomatic COVID-19 was just 40% to 50% during the omicron surge, much like for adults who’ve only had two vaccine doses.
If FDA clears either vaccine or both, the Centers for Disease Control and Prevention would have to recommend whether all kids under 5 should receive the shots or only those at high risk.
Generally, COVID-19 isn’t as dangerous to children as to adults, but some kids can become severely ill or even die. The omicron variant hit children hard. Kids under 5 were hospitalized at higher rates than at the peak of the previous delta surge.
Source: ABC News