BioNTech has expanded an ongoing clinical trial program to develop new vaccines and patterns of administration for better protection against the dominant Omicron coronavirus variant as it reported a profit boost from its first-generation shot.
The enlargement of its trial program with partner Pfizer, initially unveiled in January, comes as global COVID-19 cases are on the rise and protection against infection from its established Comirnaty vaccine has waned, though protection against severe disease remains.
BioNtech boosted the number of participants in the trial – in which participants’ blood will be monitored for immune responses – to 2,150 from the 1,420 announced in January.
Data is expected in April, the company said in a statement on Wednesday.
“Our goal is to understand the protection these vaccines provide against Omicron, as well as the cross-protection they provide against previous variants of concern,” it said.
“Currently, there is no regulatory consensus on the need for Omicron-based vaccines,” BionNtech added.
The study was expanded to add several groups, including volunteers getting a sequence of an Omicron-based vaccine plus the established shot targeting the original Wuhan virus.
The company, which has delivered more than 3.1 billion vaccine doses globally with Pfizer, also said it added a subgroup getting a new vaccine targeting these two variants in one shot, a feature known as bivalent.
The European Medicines Agency had urged pharmaceuticals companies to explore not only shots tailored to the Omicron variant but also bivalent candidates.
Thanks to 10.3 billion euros ($11.48 billion) in net income in 2021, the German biotech firm plans to spend between 1.4 billion and 1.5 billion euros on research and development this year.
It also plans to buy back up to $1.5 billion worth of shares over two years and pay a special dividend of 486 million euro in total, or 2 euros per share.
It reiterated its 2022 vaccine revenue guidance of between 13 billion and 17 billion euros, on orders so far for about 2.4 billion doses in 2022.
Driven by demand for its vaccine, overall sales exploded to 19 billion euros in 2021 from 109 million euros a year earlier, far surpassing its previous guidance for vaccine sales of 16-17 billion euros for the year.
The prior outlook was based on estimated 2021 deliveries of up to 2.5 billion doses, but BioNTech said on Wednesday it delivered 2.6 billion doses.
The shot by the BioNTech-Pfizer was the mainstay of immunization campaigns of most high-income nations, but the two companies got a share of the blame from non-government campaign groups for poorer countries’ lack of access to the shots.
BioNTech said 1 billion doses of its shot were given to low- and middle-income countries last year. The tally reached 1.3 billion by early March and would exceed 2 billion by the end of 2022, it added.
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