Pfizer / BioNTech say data shows COVID-19 vaccine to be safe and protective in children

September 20 (Reuters) – Pfizer Inc (PFE.N) and BioNTech SE said on Monday that their COVID-19 vaccine elicited a robust immune response in 5 to 11 year olds, and they plan to seek regulatory clearance as soon as possible to use shooting in children of this age group in the United States, Europe and elsewhere.

The companies said their two-dose vaccine elicited an immune response in ages 5 to 11 in a Phase II / III clinical trial that matched what had previously been seen in ages 16 to 25. The safety profile was also generally comparable to that of the older age group, they added.

“Since July, pediatric cases of COVID-19 have increased by approximately 240% in the United States, underscoring the public health need for vaccinations,” Pfizer chief executive Albert Bourla said in a statement. Press release.

“These trial results provide a solid basis for seeking approval of our vaccine for children aged 5 to 11, and we plan to submit them urgently to the FDA and other regulatory agencies,” said added Bourla.

The Pfizer / BioNTech vaccine has already obtained U.S. regulatory clearance for people 12 years of age and older, including full approval from the Food and Drug Administration last month for those 16 and older.

Senior U.S. health officials believe regulators could decide whether the vaccine is safe and effective in young children within three weeks of companies submitting an application for authorization, two sources told Reuters this month. -this. Early clearance could help mitigate a potential increase in cases this fall, with schools already open across the country.

Hospitalizations and deaths from COVID-19 have increased in the United States in recent months due to the highly contagious Delta variant, especially in areas with low vaccination rates, even as President Joe Biden implores people who resist vaccines to get vaccinated. Pediatric cases are also on the rise, especially since not all children under 12 are vaccinated, but there is no indication that in addition to being more transmissible, the Delta virus is more dangerous in children. .

Acting FDA Commissioner Janet Woodcock said that once the agency receives the request, its process for determining whether the vaccine is safe and effective for children in the younger age group includes checking manufacturing processes for the lowest concentrations of injections and any study of its safety. .

“We will review the clinical data and make sure the children responded to the vaccine the way we expected,” Woodcock said during a podcast appearance by former Biden administration official Andy Slavitt. .

Pfizer shares fell 1.3% to $ 43.28 ahead of the bell Monday amid widespread market weakness.

DATA FOR YOUNG CHILDREN

The Pfizer / BioNTech vaccine, called Comirnaty, is licensed for use in children as young as 12 years old in many countries besides the United States. It was initially cleared for emergency use in people 16 years of age or older in the United States in December 2020.

Children 5 to 11 years old received two injections of a 10 microgram dose of vaccine, one third of the dose given to people 12 years of age and older.

In addition, the companies said they were awaiting data on the vaccine’s effectiveness in children aged 2 to 5 and children aged 6 months to 2 years as early as the fourth quarter of this year.

Unlike the larger clinical trial that drugmakers have previously conducted in adults, the pediatric trial of 2,268 participants was not primarily designed to measure vaccine effectiveness by comparing the number of COVID cases. -19 in those vaccinated to those who received a placebo.

Instead, it compares the amount of vaccine-induced neutralizing antibodies in children to the response of older recipients in the adult trial.

A Pfizer spokesperson said the companies may later disclose the efficacy of the vaccine from the trial, but there have not yet been enough cases of COVID-19 among participants to take this decision.

The vaccine was around 95% effective in the adult clinical trial, but Pfizer said immunity worsened a few months after the second dose. U.S. regulators are expected to authorize a third booster dose of the vaccine for older, 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.

The Pfizer / BioNTech vaccine is one of three vaccines licensed in the United States, along with Moderna’s two-dose vaccine (MRNA.O) and Johnson and Johnson’s single-dose vaccine (JNJ.N). The Moderna and J&J shots have yet to receive full FDA approval for any age group.

The Pfizer and Moderna vaccines have been linked by regulators to rare cases of heart inflammation in adolescents and young adults, especially young men. Pfizer said it saw no cases of heart inflammation in the trial participants.

Reporting by Michael Erman in New Jersey; Additional reporting by Manojna Maddipatla in Bengaluru; Editing by Will Dunham and Edmund Klamann

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