Pfizer & Moderna to roll out Omicron-specific COVID-19 boosters
FDA gave green light Wednesday to the country's first vaccine update
Updated boosters are expected to come out as soon as next week after the Food and Drug Administration authorized Pfizer-BioNTech and Moderna to modify their respective shots to better protect Americans against the Omicron strain of COVID-19.
Officials with the regulatory agency said updating the shots to protect against what is now the most common and contagious strain of coronavirus is a much-needed step ahead of an anticipated winter surge.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” FDA Commissioner Dr. Robert Califf said Wednesday alongside the announcement. “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.”
Both tweaked mRNA boosters are “bivalent formulations.” This means they will contain a piece of genetic material from the SARS-CoV-2 virus that instructs cells in the body to create the distinguishing “spike” protein of both the original virus strain as well as that of the Omicron variants, BA.4 and BA.5.
People who have already had their primary vaccination series and are at least two months out from their last shot are eligible for the new boosters. Pfizer-BioNTech’s will be cleared for those aged 12 and up, while Moderna’s are for adults. The FDA said Wednesday it will work quickly to evaluate bivalent shots for additional age groups. Pfizer has said it plans to ask the FDA to approve boosters for elementary-age kids in early October.
Dr. Ugur Sahin, CEO and co-founder of BioNTech, said in a statement released with Pfizer that the updates were made to stay top of the virus as it adapts.
“In less than three months, we were able to develop and manufacture an Omicron BA.4/BA.5-adapted vaccine,” Sahin said Wednesday. “This milestone further underlines the strength of rapidly adaptable mRNA vaccines against the this continuously evolving virus.”
Stéphane Bancel, CEO of Moderna, likewise emphasized that booster shots will be an important public health measure that people can take to help protect themselves and others “especially as we head into a season filled with indoor gatherings.”
Moderna's booster will be available at vaccination sites nationwide in the coming days, whereas Pfizer said it would be able to ship up to 15 million doses immediately.
While the U.S. has purchased a combined amount of around 170 million doses from the companies, one regulatory step remains before the shipments can begin. The Centers for Disease Control and Prevention, set to debate the evidence for the updated boosters Thursday, must first decide who should get the additional jab first. People at high risk for COVID-19 complications are just one example of such a class.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, assured the public that the updated booster shots are safe and efficient.
“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” Marks said.
After asking the companies to produce vaccines that protected against the newest versions of the Omicron variant, the FDA cleared the updated boosters based on animal studies that showed a good immune response, rather than waiting an additional few months for human studies. Before this move, the FDA also looked at human studies of previous Pfizer and Moderna updates, which targeted the Omicron strain that emerged last winter. The changes to these vaccine boosters showed to be safe and boost antibodies for the variant.
“Based on the data supporting each of these authorizations, the bivalent COVID-19 vaccines are expected to provide increased protection against the currently circulating Omicron variant,” the FDA noted Wednesday, referring to the BA.4 and BA.5 Omicron strains.
Marks emphasized, too, that the FDA has experience making these kinds of decisions.
“The FDA has extensive experience with strain changes for annual influenza vaccines. We are confident in the evidence supporting these authorizations,” he said Wednesday.
Current human studies will continue as the bivalent shots roll out in an effort to determine the value they provide.
It remains to be seen how many Americans will roll up their sleeves to get the additional jab. Only half of all vaccinated Americans have received their first recommended booster dose while just a third of those aged 50 and up have gotten a second booster.
While the primary vaccination series, and even more so with a booster, continues to provide strong protection against severe disease and death caused by COVID-19, it is unclear how much of a boost the bivalent boosters will offer.
Across the world, other countries have already updated boosters for citizens. In Britain, for example, those aged 50 and up can receive a Moderna booster designed to protect against the initial Omicron strain, BA.1. European regulators are still deciding whether to authorize Moderna and Pfizer’s latest booster.