Pfizer Inc and BioNTech SE said on Monday that their COVID-19 vaccine has induced a strong immune response in children aged 5 to 11, and they are using the vaccine in children in that age group in the United States, Europe and elsewhere. are planning to seek authorization to use. as soon as possible.
The companies said the vaccine produced an immune response in 5 to 11-year-olds in their Phase II/III clinical trial, similar to what they had previously seen in 16 to 25-year-olds. He added that the safety profile was also generally on par with that of the older age group.
“Since July, pediatric cases of COVID-19 in the US have increased by nearly 240 percent – underscoring the public health need for vaccinations,” Pfizer Chief Executive Albert Boerla said in a news release. “
“These trial results provide a strong basis for seeking authorization of our vaccine for children ages 5 to 11, and we plan to submit them to the FDA and other regulators immediately.”
Top US health officials believe regulators can make a decision on whether the shot is safe and effective in young children within three weeks of companies submitting requests for authorization, two sources said this month. told Reuters at the beginning.
The highly contagious Delta variant has led to an increase in COVID-19 hospitalizations and deaths in the United States in recent months. Pediatric cases are also increasing, especially as not all children under the age of 12 have been vaccinated, but there is no indication that, apart from being more transmissible, delta virus is more dangerous in children.
A speedy authorization could help mitigate a potential escalation of cases in the fall, especially with schools already open nationwide.
The companies vaccine, called Comirnati, is already authorized for use in children under the age of 12 in several countries, including the United States. The vaccine was originally authorized for use in the United States in December 2020 in people 16 or older and received full US approval in that age group last month.
Children ages 5 to 11 were given two shots of a 10-microgram dose of the vaccine, one-third the size of the dose given to those 12 and older. The companies expect data on how well the vaccine works in children 2 to 5 years old and 6 months to 2 years old in the fourth quarter of this year.
Unlike the large clinical trial previously conducted by drug manufacturers in adults, the 2,268 participant pediatric trial was primarily intended to measure the efficacy of the vaccine by comparing the number of COVID-19 cases in vaccine recipients to those receiving placebo. was not done for.
Instead, the test compares the amount of neutralizing antibodies induced by the vaccine in children to the response of older recipients in an adult trial.
A Pfizer spokesman said companies could disclose the vaccine’s effectiveness from a later trial, but that there were not yet enough cases of COVID-19 among participants to make that determination.
The vaccine was about 95 percent effective in adult clinical trials, but Pfizer says immunity wanes a few months after the second dose. US regulators are expected to authorize a third, booster dose of the vaccine for older and high-risk Americans earlier this week.
The companies said the vaccine was well tolerated, with side effects generally comparable to those seen in participants aged 16 to 25.
Both the Pfizer and Moderna vaccines have been linked by regulators to rare cases of heartburn in teenagers and young adults, especially young men. Pfizer said they saw no instances of heart inflammation in the trial participants.
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