Updated COVID-19 booster vaccines must be designed to fight variants that weren’t in play when the original vaccines were made, the Food and Drug Administration has told drugmakers.
The FDA late last week asked vaccine manufacturers to add an omicron Ba.4/5 spike protein component to the current vaccine composition to create a two-component, or bivalent, booster shot. If all goes as planned, the idea is to have new boosters available in early to mid-fall 2022 to increase immunity in already-vaccinated recipients, it announced Thursday.
Vaccine immunity wanes over time, and a new generation of SARS-CoV-2 variants are now skirting the original vaccines’ defenses, the agency said. Its independent advisers last week voted to recommend the drug changes for the fall season to avoid a possible surge in infections.
Original shot still in play
Meanwhile, clinicians should continue to provide the original vaccine to eligible patients who have not yet gotten any COVID-19 shot, the FDA added.
“[W]e have not advised manufacturers to change the vaccine for primary vaccination, since a primary series with the FDA-authorized and approved COVID-19 vaccines provides a base of protection against serious outcomes of COVID-19 caused by circulating strains of SARS-CoV-2,” it stated.
In addition, eligible people who have yet to receive a first booster shot should do so, FDA added.
U.S. to re-up its stockpiles
The news comes as the United States moved to re-up its supply of COVID vaccines. Federal authorities last Wednesday said that Pfizer and partner BioNTech will receive $3.2 billion for 105 million doses of a new vaccine that may contain omicron-specific protections, Endpoints News reported.
In related news, Pfizer has also begun testing universal coronavirus vaccines. Such a vaccine is something of a “holy grail,” among drugmakers, and would in theory protect recipients against a range of coronaviruses, including COVID-19 and its variants, according to Axios.
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