US approves Omicron vaccines from Moderna and BioNTech/Pfizer
US drug regulators have approved applications by Moderna and BioNTech/Pfizer to release a Covid-19 vaccine that specifically targets the dominant strain of the Omicron coronavirus variant.
The Food and Drug Administration on Wednesday gave the companies the go-ahead to roll out their “bivalent” shots, which target both the original strain of Covid and the fast-spreading BA.4 and BA.5 subvariants, ahead of a national booster programme this autumn.
US officials had resisted pushing ahead with variant-specific vaccines, but have been persuaded by the fact that many people with two or more shots are still susceptible to infection. They have taken this next step with the new vaccines despite a lack of clinical evidence about how they will work in an attempt to head off a huge spike in infections this winter.
The FDA insisted it was confident the new vaccines would prove safe and effective enough to prevent the kind of peak in cases seen last winter. The original vaccines will no longer be offered as booster shots.
Peter Marks, head of the unit that authorises vaccines at the FDA, said: “The hope here is that by increasing the amount of antibodies we have to that particular variant, we will restore the kind of protection that we had when we first saw these vaccines launched in the late part of 2020, early part of 2021, where we had very good protection against symptomatic disease.
“We don’t know for a fact yet whether we will get to that same level, but that is the goal here.”
The Moderna shot is authorised for anyone aged 18 and over, while the BioNTech/Pfizer vaccine can be given to anyone aged 12 or older. The vaccines are designed to be administered as a single booster at least two months after a previous jab.
This story originally appeared on: Financial Times - Author:Kiran Stacey
