Though Moderna’s bivalent vaccine to counter the Omicron variant has cleared the initial hurdles in getting FDA authorization, the vaccine maker is moving on to the next step.
On Twitter, the company announced on Friday that it has filed a EUA for its bivalent vaccine for use in adolescents aged 12 through 17 and for smaller children aged six through 11.
We have submitted a request for emergency use authorization (EUA) for our Omicron-targeting bivalent #COVID19 #vaccine, mRNA-1273.222, in children and adolescents 12 to 17 years of age to the U.S. FDA. The EUA submission for children ages 6 to 11 years old was also completed. pic.twitter.com/8cj659zOU1
— Moderna (@moderna_tx) September 23, 2022
In another tweet, Moderna stated that the application for children aged six months through six years of age will likely be finished later in the year.
Regulatory bodies have been moving fast on the new boosters as Moderna got the OK from UK regulators in the middle of August, with the FDA also giving the thumbs up for both Moderna’s and Pfizer/BioNTech’s bivalent shots a few weeks later. However, those authorizations did not come with any new human data, and critics questioned the effectiveness of preventing deaths or hospitalizations.
The latest data from the CDC show that cases are trending downward, for the time being, but the US is still dealing with an average of over 54,000 cases and 347 deaths per day over the last week.
US reducing number of Pfizer/BioNTech vaccine donations as demand wanes
Last year, the Biden administration pledged to donate 500 million doses of the Pfizer/BioNTech vaccine to 92 low- and middle-income countries as part of a wider donation of 1 billion doses. However, that donation is being curtailed.
According to a report from Reuters, the US will cut down on the number of doses it will deliver by the end of 2022 to 600 million doses. Reuters said that Pfizer has enough supply to deliver the full order of 1 billion, but that it is seeing reduced demand in the delivery areas primarily due to hesitancy and “barriers in administration.”
Pfizer has reportedly delivered 400 million doses to 79 countries as part of the order thus far.
While the doses may be on the downswing, Pfizer is still boosting its donations of Paxlovid. The company, in a statement on Thursday, agreed to supply up to six million doses of the antiviral to the Global Fund. The fund plans to distribute doses to low- and middle-income nations as well.
It also has an agreement to supply four million doses of Paxlovid to UNICEF also.