US halts use of GSK/Vir monoclonal in 8 states as FDA says it can't defeat new Omicron subvariant
With the emergence of the new but not necessarily more dangerous Omicron subvariant BA.2, the FDA on Friday announced that GlaxoSmithKline and Vir’s blockbuster monoclonal antibody to treat Covid-19 will no longer be used in 8 states in the Northeast and two US territories.
New data included in the FDA’s health care provider fact sheet show how sotrovimab is unlikely to be effective against the BA.2 sub-variant, the agency said. And based on CDC data, the BA.2 sub-variant is estimated to account for more than 50% of cases across 8 states — Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont, New Jersey, and New York — as well as Puerto Rico and the Virgin Islands.
The pause for sotrovimab, of which the US bought about $1.9 billion worth of doses, comes after several other mAbs were paused when Omicron initially emerged, including mAb combos from Regeneron and Eli Lilly.
The FDA notes that there are several other effective treatments against this BA.2 subvariant, including Pfizer’s pill Paxlovid, Merck’s molnupiravir, Gilead’s Veklury (remdesivir) and Eli Lilly’s bebtelovimab. But supplies of those treatments are likely to run thin as Congress has dropped the ball on providing additional funds for further purchases.
A senior Biden official said earlier this month that the government had planned to purchase additional monoclonal antibodies (from GSK and Lilly) but, “Without additional funding, we are canceling those plans,” the official said, noting shipments of monoclonal antibody treatments sent to states were reduced by 30%.
The call to break the funding stalemate comes as Congress punted on including about $15 billion — Biden initially wanted almost $23 billion — in pandemic funds in a larger annual spending package earlier in March.
On the antiviral front, the Biden administration noted that because pills like Pfizer’s Paxlovid can take more than 6 months to manufacture, the US will “likely not have enough of these treatments by the end of the year. And being unable to make additional purchase commitments now likely means that fewer treatments will be available next year as well.”
