The pharmaceutical companies Pfizer and BioNTech requested permission from the US Food and Drug Administration (FDA) to begin providing a COVID-19 vaccine "booster" dose in children between 5- and 11-years-old to target the virus's Omicron variant, the companies said on Monday
WASHINGTON (Pakistan Point News / Sputnik - 26th September, 2022) The pharmaceutical companies Pfizer and BioNTech requested permission from the US food and Drug Administration (FDA) to begin providing a COVID-19 vaccine "booster" dose in children between 5- and 11-years-old to target the virus's Omicron variant, the companies said on Monday.
"Pfizer Inc. and BioNTech SE today announced they have completed a submission to the (FDA) requesting Emergency Use Authorization (EUA) of a 10-microgram booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children ages 5 through 11 years of age," the companies said in a statement.
A similar authorization request will be submitted to the European Medicines Agency in the coming days, the statement said.
The companies are also initiating studies to evaluate the safety of the new Omicron booster vaccines in children six-months through 11-years of age, the statement said.
The EUA request is based on safety data from the companies' previous Omicron BA.1-adapted vaccine in the age group, the statement also said.
The updated Omicron booster vaccine currently holds an EUA for use in people 12-years old and up as a single dose administered at least 2 months after last COVID-19 vaccination.
The vaccine safety information warns potential recipients to tell their provider if they have had myocarditis or pericarditis, a bleeding disorder, are immunocompromised or pregnant.
Myocarditis and pericarditis, as well as severe allergic reactions, have been tied to the companies' COVID-19 vaccines, the statement said. The observed risk is higher among adolescent and young adult males, the statement added.
Last week, US President Joe Biden said that the COVID-19 pandemic is over, but some administration officials later said they were surprised with Biden's statement.