The government plans to jointly roll out 175 million doses of the new boosters developed by Moderna and Pfizer-BioNTech, with Moderna’s injection available to all adults and Pfizer’s ages 12 and older, according to a federal planning guide. published earlier this month.
The boosters, which officials hope will provide more protection against the BA.4 and BA.5 Omicron subvariants, in addition to protection against the original strain of the coronavirus, come as the government tries to stay ahead of a rapidly-changing virus that continues to infect tens of thousands of Americans every day. The actual number is unknown because so many people self-test at home and fail to report their cases to the government.
An FDA spokesperson declined to comment, and knowledgeable people, who were given anonymity to speak about matters they are not allowed to speak about publicly, warned the exact timing could change as the agency rushes to work. finalize.
Moderna and Pfizer-BioNTech each ready to submit their applications for approval last week.
Once the FDA approves the shots, the Centers for Disease Control and Prevention must still approve their distribution to the public. The CDC has scheduled meetings of its external vaccine advisory panel for Thursday and Friday — sessions traditionally held before the agency makes its final verdict. The CDC has not yet published a formal agenda.
The speed of the vaccine’s planned approval and rollout has sparked criticism from some public health experts, who questioned whether the administration should give the boosters green without human studies proving their effectiveness.
But health officials from the Biden administration have argued that there is ample evidence to support the vaccines and increasing the urgency to make them available before the fall.
The FDA will not convene its own group of outside advisors before approval, with Commissioner Robert Califf in a: Twitter thread citing “extensive discussion” on bivalent boosters in June.
While regulators don’t have human data on these bivalent boosters available to consider, Califf noted that they will evaluate real-world evidence from similar mRNA shots, human data from other bivalent shots, and data from mouse studies. The flu vaccine, which is also updated annually, is also only tested on animals for distribution due to the short lead time for manufacturers. However, it is not based on the relatively new mRNA technology.
Pfizer expects to start a human trial later this month on the safety and effectiveness of its booster; Moderna already has such an investigation underway.
The CDC also said it expects Omicron-specific boosters for children under 12 to be ready shortly after boosters for adults become available.