After weeks of hazy timelines, Moderna and Pfizer-BioNTech’s omicron-adapted booster shots appear to be right around the corner.
The FDA could authorize the variant-targeted mRNA vaccines as early as Wednesday, Politico first reported, citing three people close to the decision.
In turn, the Biden administration would be poised to roll out the reformulated shots shortly after Labor Day in a bid to guard against a potential virus resurgence later this year, the news outlet explained. The shots are designed to offer greater protection against the BA.4 and BA.5 omicron subvariants plus the original SARS-CoV-2 strain.
The FDA declined to comment on Politico’s story. The publication's sources warned the exact timing of the emergency nods could shift as the U.S. regulator hustles to wrap up its reviews.
The regulatory premonition comes several days after Pfizer-BioNTech and Moderna finished submissions of their COVID-19 booster applications.
Pfizer and its German mRNA partner BioNTech submitted their filing last Monday, specifically seeking authorization for their booster in adults and teens ages 12 years and older. At the same time, the partners kicked off the application process with the European Medicines Agency, too.
Moderna, meanwhile, completed its application on Wednesday, submitting a bid for a 50-µg dose based on preclinical data and clinical trial data from the company’s BA.1 omicron-targeted booster candidate. Moderna’s retooled shot is expected to be authorized for adults ages 18 and up.
The federal government aims to deploy (PDF) a total 175 million doses combined of boosters from Moderna and Pfizer-BioNTech, the U.S. Centers for Disease Control and Prevention (CDC) said in a mid-August planning guide. Following the FDA’s emergency nod, the CDC would still need to endorse the shots for public distribution. The CDC has meetings of its external vaccine advisory panel scheduled to meet Thursday and Friday, Politico pointed out.
Some critics have taken issue with the pace Pfizer and Moderna’s reworked vaccines are apparently being put through the regulatory process, with a major point of contention being whether the administration should greenlight the boosters without the backing of in-human trials, Politico noted.
Biden administration health officials, for their part, argue there’s enough evidence behind the vaccines plus a growing sense of urgency to get them on tap before fall.
In lieu of human data on the bivalent boosters, the FDA will review real-world evidence from similar mRNA shots and human data from other bivalent vaccines as well as data from mice studies, Politico explained.
The news service compared the move to the process around the annually updated flu vaccine, which is only tested in animals before it rolls out each year given the tight turnaround time for manufacturers.
Even still, influenza shots aren’t based on relatively new mRNA technology, either.
Pfizer aims to kick off human safety and efficacy studies later this month, while Moderna has one such phase 2/3 study already underway, according to the companies’ filing releases from last week.
Even as Pfizer and Moderna’s vaccines continue to collectively combat COVID-19 in the U.S. and beyond, a sense of discord is brewing between the mRNA rivals.
Late last week, it came to light Moderna filed patent infringement lawsuits in the U.S. and Germany accusing Pfizer and BioNTech of treading on patents the Massachusetts-based biotech claims it filed between 2010 and 2016.
Moderna contends it’s trying to “protect the innovative mRNA technology that we pioneered, invested billions of dollars into creating, and patented during the decade preceding the COVID-19 pandemic," CEO Stéphane Bancel said in a statement.
Pfizer and BioNTech have vowed to “vigorously defend” against the lawsuit.
Moderna is not seeking to remove Pfizer and BioNTech’s vaccine from the market.
But in developed markets, Moderna says it expects mRNA rivals to "respect its intellectual property rights and would consider a commercially reasonable license." Pfizer and BioNTech have "failed" to seek such a license, Moderna argues.