Three doses of Pfizer’s COVID-19 vaccine provide strong protection for children under 5, the company announced Second. 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 desperate parents to vaccinate their babies, toddlers and preschoolers, especially as the number of COVID-19 cases in the United States continues to grow. States are once again rising. The 18 million children under the age of 5 are the only group in the US not yet eligible for the COVID-19 vaccine.
Health Canada has not yet approved a COVID-19 mRNA vaccine for children under the age of five.
Pfizer told CBC News on Monday morning that it is in discussions with Health Canada about vaccines for children under the age of 5, but could not comment on the timing.
The U.S. Food and Drug Administration has begun evaluating data from Pfizer’s rival Moderna, which hopes to begin offering two child-sized shots by the summer.
Pfizer had a harder time figuring out its approach. It aims to give children under the age of 5 as little as one-tenth of what adults receive – an even lower dose than the dosage for children aged 5 to 12. However, during testing. , the company found that two injections with that dose did not appear to be correct. enough for preschoolers. So the researchers gave the third shot to more than 1,600 teenagers — ages six months to four years — during the Omicron variant’s winter growth spurt.
In a media release, Pfizer and partner BioNTech said the supplement did the trick, increasing children’s antiviral antibody levels enough to meet FDA’s criteria for emergency use of vaccines without safety concerns.
The companies say preliminary data shows the three-dose series is 80 percent effective at preventing symptomatic COVID-19, but they caution 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.
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 dose sizes for children under 5 years of age. both Pfizer and Moderna.
The agency has set a scheduled 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 submitted data to the FDA showing that young children develop high levels of antibodies against the virus after two shots containing a quarter of the 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.
Last month, the company told CBC News that it hopes to complete a regulatory approval application for a COVID-19 vaccine in children 5 years of age and younger soon.
The FDA is expected to review Moderna’s data on both the youngest age group and its study of adolescents and elementary-age children. Health Canada authorized Moderna’s shots for children between the ages of six and 11 in March. Last fall, the company expanded the Pfizer shooting range to children aged 5 to 11 years old.
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 variant affects children especially severely, with a higher rate of hospitalizations for children under the age of 5 compared with the peak of the previous Delta surge.
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 received the two recommended initial doses. In Canada, 41% of the population between the ages of 5 and 11 are considered fully immunized.
Last week, US health authorities said elementary school-age children should get the same booster shot as everyone 12 and older is supposed to get, to best protect against the variants. latest coronavirus.
