BILLIONThree doses of Pfizer’s COVID-19 vaccine provide strong protection for children under the age of 5, the company announced Monday. Pfizer plans to make the data available to US regulators later this week in a step towards allowing the youngest children to be vaccinated.
The news comes after months of anxious waiting by parents desperate to vaccinate their babies, toddlers and preschoolers, especially as one-off COVID-19 cases more is increasing. The 18 million children under the age of 5 are the only group in the United States not yet eligible for the COVID-19 vaccine.
The Food and Drug Administration has begun evaluating data from rival Moderna, which it hopes will begin offering two child-sized shots by the summer.
Pfizer had a harder time figuring out its approach. It aims to give children an even lower dose — a tenth of what an adult receives — but during testing it was found that two injections did not appear to be strong enough for children. Kinder Garten. So the researchers gave a third shot to more than 1,600 teenagers — ages 6 months to 4 years — during the winter spike in the omicron variant.
In a press release, Pfizer and partner BioNTech said this additional round of injections did the trick, increasing the drug’s levels of anti-viral antibodies enough to meet FDA criteria for use with the vaccine. Urgent request without safety problem.
The companies say preliminary data shows the three-dose series is 80 percent effective in preventing symptomatic COVID-19, but they warn that the calculation is based on only 10 diagnosed cases among people participated in the study at the end of April. Study rules state that at least 21 cases are needed to formally determine efficacy, and Pfizer promised to update as soon as more data becomes available.
Read more: Risk of COVID-19 for children under 5: What parents should know
The companies have already submitted data on the first two doses of the drug to the FDA, and BioNTech CEO Dr Ugur Sahin said final data on the third dose will be submitted this week.
“This study shows that our low dose, 3 micrograms of vaccine, carefully selected based on tolerability data, provides young children with a high level of protection,” he said in a statement. high against recent strains of COVID-19.
What’s next? FDA vaccine director Dr. Peter Marks has pledged the agency will “move quickly without compromising our standards” in assessing overall doses from both Pfizer and Moderna.
The agency has set up expected date next month for its scientific advisers to publicly debate data from each company.
Moderna is looking to be the first to vaccinate the youngest children. It data sent with the FDA saying that the larvae develop high levels of antiviral antibodies after two injections containing a quarter of an adult dose. Moderna research shows 40% to 50% effectiveness against symptomatic COVID-19 during Omicron elevation, the same as for adults with only two doses of the vaccine.
Complicating Moderna’s progress, the FDA has so far allowed their vaccine to be used only in adults.
The FDA is expected to review Moderna’s data on both the youngest age groups, plus its study of adolescents and elementary school-age children. Other countries have extended Moderna’s reach to children under the age of 6.
Although COVID-19 is generally not as dangerous for young children as it is for adults, some children become seriously ill or even die. And the omicron variation affects children especially severely, with a higher rate of hospitalizations for children under 5 years old than the peak of the previous delta spike.
It is not clear what the youngest child’s immunization needs will be. Pfizer shots for 5 to 11 year olds opened in November, but only about 30% of that age group have had the two recommended initial doses. Last week, US health authorities said elementary-age children should be booster shot Like everyone 12 years of age and older needs the best protection against the latest coronavirus variants.
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