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Pfizer’s experimental Covid-19 Omicron-targeting vaccines prompted strong immune responses in a study that may pave the way for the use of next-generation Covid-19 shots better tailored to fight new variants.
Pfizer and its partner, Germany-based BioNTech, said a booster dose of a vaccine designed to target Omicron, as well as a hybrid shot that that fights the original strain and Omicron, both elicited a “substantially higher” immune response against Omicron subvariant BA.1 when compared with their existing Covid-19 vaccine.
The companies reported data from a late-stage study of the two vaccine candidates on Saturday before a meeting of advisers to the US Food and Drug Administration, who will discuss on Tuesday how to modify vaccines to fight emerging and future variants.
To secure an emergency-use authorisation for the adapted boosters, Pfizer and BioNTech must demonstrate that they are superior against Omicron and remain safe.
Both Omicron-modified vaccine candidates have safety and tolerability profiles similar to the original shot, according to Pfizer and BioNTech. The data will be discussed with regulators with the aim of quickly introducing a more tailored booster shot to address current and future variants, they said.
“Based on these data, we believe we have two very strong Omicron-adapted candidates that elicit a substantially higher immune response against Omicron than we’ve seen to date,” said Pfizer CEO Albert Bourla in a statement.
In a late-stage trial of 1,234 participants age 56 years and older, an omicron-adapted booster shot increased neutralising antibody levels by 13.5 to 19.6-fold, depending on the dose, against omicron subvariant BA.1.
The bivalent shot, which combines the original Covid-19 vaccine and a candidate that targets the spike protein of the Omicron BA.1 variant, led to a 9.1 and 10.9-fold increase in antibodies against omicron.
Ugur Sahin, the CEO of BioNTech, said that Omicron had new sublineages that continued to evolve and exhibit the potential to evade the protections of vaccines.
“We will therefore remain vigilant and are prepared to rapidly adapt our Omicron-adapted vaccine candidates to emerging sublineages if epidemiological and laboratory data suggest,” he said.
Pfizer and BioNTech said that early laboratory research showed that both Omicron-adapted vaccine candidates neutralised omicron subvariants BA.4 and BA.5, though to a lesser extent than BA.1.
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