FDA said it has authorised bivalent formulations of the Moderna and Pfizer-BioNTech COVID-19 vaccines for use as a single booster dose at least two months after completing primary or booster vaccination.
US President Joe Biden has announced the launch of an annual COVID-19 vaccine for all Americans above 12 years of age, a move which he said would protect his fellow countrymen against this deadly disease and its variants.
“We are launching a new vaccine, our first in almost two years, with a new approach. For most Americans, that means one COVID-19 shot, once a year, each fall,” Biden said in a statement.
Starting this week, at tens of thousands of convenient pharmacies, doctor’s offices, and community health centers, and other places, Americans age 12 and older can go get this new fall COVID-19 vaccine, he said.
Biden said that the new vaccine provide the strongest protection from the new Omicron strain of the COVID-19 virus, which did not exist when the original vaccine was developed.
“As the virus continues to change, we will now be able to update our vaccines annually to target the dominant variant. Just like your annual flu shot, you should get it sometime between Labour Day and Halloween. It’s safe, it’s easy to get, and it’s free,” he said.
“It’s simple, and it’s easy to understand: If you are vaccinated and 12 and older, get the new COVID-19 shot this fall. This once-a-year shot can reduce your risk of getting COVID-19, reduce your chance of spreading it to others, and dramatically reduce your risk of severe COVID-19,” Biden said.
Last week, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, endorsed the CDC Advisory Committee on Immunisation Practices’ (ACIP) recommendations for use of updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older.
Updated COVID-19 boosters add Omicron BA.4 and BA.5 spike protein components to the current vaccine composition, helping to restore protection that has waned since previous vaccination by targeting variants that are more transmissible and immune-evading, CDC said.
“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant. They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants,” Walensky said.
FDA said it has authorised bivalent formulations of the Moderna and Pfizer-BioNTech COVID-19 vaccines for use as a single booster dose at least two months after completing primary or booster vaccination.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalisation and death) of COVID-19,” said FDA Commissioner Robert M. Califf.
“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants,” he said.
