The FDA Has Authorized New Omicron Booster Shots

Pfizer and Moderna have released a new COVID booster shot that will target the highly contagious BA.4 and BA.5 omicron variant.
Posted at 8:41 PM, Aug 31, 2022

COVID boosters are getting an omicron makeover and could go into arms by the weekend.  

"I will be at the front of the line at the pharmacy getting my vaccination. I'm very confident about this," said Dr. Robert Califf, the FDA commissioner. 

The Food and Drug Administration has authorized a formula change to target the highly contagious omicron BA.4 and BA.5 variants. 

Anyone at least two months past their last COVID-19 shot is eligible. Moderna is authorized for those age 18 and older. For Pfizer and Biontech's it's 12 and up. 

Health officials say it's to get ahead for fall and winter when the virus has mutated and spread because more people are inside. 

"The idea here is the more up to date you are, the better chance we have of looking at what may come afterwards," said Dr. Peter Marks, the FDA vaccine chief. 

Pfizer and Moderna can now ship out the omicron formulated boosters. 

State and local health departments began placing pre-orders last month.  

The decision has faced some criticism though.  

Regulators say the new vaccine formula is similar enough that safety is sound.  

But how well it works in humans is unclear. 

Both Moderna and Pfizer submitted efficacy results from animal studies. 

That research did show a better antibody response to all the omicron subvariants compared to the original formula. 

Clinical trials on humans are set to begin next month. 

"f we wait for those data in human data, not just mice data, in human data we will be using what I would be using what I would consider to be a very outdated vaccine," said Dr. Rochelle Walensky, the CDCd director. 

The CDC still needs to sign off and officially recommend the new booster formula. Their advisors are meeting this week.