Pfizer and BioNTech said On Monday, preliminary findings from a clinical trial of children under the age of 5 found that three doses of the coronavirus vaccine provided a strong immune response sufficient to meet regulatory approval criteria. Shown.
In a news release, the two companies released results from a subset of trials involving 1,678 children aged 6 months to 4 years, stating that a triple-dose regimen was 80% effective in preventing symptomatic infections. Said. No supporting data has been disclosed and the company has not disclosed how many children there are in the subset. A Pfizer spokesman said the comprehensive results of the trial will be disclosed next month.
Both Pfizer and Modana want to get permission to vaccinate the youngest children in the country soon. Only about 18 million children under the age of five are Americans who are not yet eligible for coronavirus vaccination, and parents’ expectations of when shots will be offered have been repeatedly shattered.
Pfizer and its partner BioNTech said the number of children on trial for Covid’s illness was too small to make a clear statement about its effectiveness. After the children in the vaccination group received the third dose, only 10 children who participated in the study became ill with Covid. The clinical trial protocol specified that at least 21 Covid cases were required for vaccine efficacy analysis. The two companies said that final data on efficacy, a secondary endpoint of clinical trials, will be shared “when available.”
The Biden administration wanted to provide vaccine doses to people under the age of five as early as February. The Food and Drug Administration initially pressured Pfizer to provide data on how effective the two doses were in infants, but Pfizer’s two doses were due to the highly contagious Omicron variant. Withdrawn after stating that it was not effective enough to prevent symptomatic infections.
But Pfizer said the new results showed that the third dose stimulates the immune system at least two months after the second dose and provides strong protection from the virus without safety concerns. .. The researchers stated that the immune response of a subset of study participants, measured one month after the third dose, was better than the immune response of 16-25 people who received the second dose. I did.
Dr. Albert Bourla, Pfizer’s Chief Executive Officer, said: statement. Dr. Ugur Sahin, CEO of BioNTech, said the two companies will complete an FDA application for an emergency permit for pediatric vaccines this week.
New discoveries intensify competition between Moderna and Pfizer over which companies produce the best vaccines for the youngest Americans. Moderna proposes a two-dose regimen for children under 6 years of age, using a quarter dose for adults. The company expects a third dose to be needed as a booster shot, but has not yet submitted data on it to the government.
The question of which vaccine is more effective is submitted to the FDA’s Board of External Advisors. At a meeting scheduled for June 15th.. With both Pfizer and Modana proposing different dosing schemes to the youngest children and presenting different clinical trial results, the Commission is responsible for whether the vaccine should be approved or both are worthy of approval. May shake.
of In late April, Moderna sought an emergency permit for a pediatric vaccine After the interim results, participants in the clinical trial showed an immune response similar to that of young adults when given a quarter dose.
Like Pfizer, the company said its results meet clinical trial criteria for success. According to Moderna, the vaccine is 51% effective against symptomatic infections in children under 2 years of age and 37% effective in children 2-5 years of age.
If Pfizer’s results are supported by subsequent data, its effectiveness is superior to that of Moderna. Both companies say their vaccine causes side effects similar to other pediatric vaccines that have been used for decades.
Adil Hassan Report that contributed.
