BioNTech expects to begin deliveries of two Omicron-adapted vaccines as soon as October.
The German biotech firm, which makes the Pfizer COVID-19 vaccine, announced the update Monday as it reaffirmed its vaccine revenue forecast for the year, according to The Associated Press.
BioNTech is expanding its COVID-19 product pipeline to aim for "prolonged and broad protection," Ugur Sahin, MD, the company’s CEO and co-founder, said during the earnings call.
BioNTech and Pfizer have delivered 3.6 billion doses of the COVID-19 vaccine to 180 countries and territories. About 1.5 billion doses have gone to low- and middle-income countries.
Demand is decreasing in Western countries, where many people have received two to four shots by now, the AP reported.
But booster campaigns with updated shots that target Omicron variants are expected to increase demand this fall. Pending regulatory approval, both adapted vaccines will be available in time for fall booster campaigns, BioNTech said.
Company officials acknowledged some uncertainty about what a severe shortage of natural gas could mean for operations but said they don’t expect to be affected by it and are putting measures in place to reduce risks, the AP reported. (The company uses natural gas to produce the COVID-19 vaccine.)
BioNTech and Pfizer submitted one of the updated vaccines, which targets the BA.1 Omicron subvariant, to the European Medicines Agency last month, with delivery pending approval.
The other updated vaccine, which targets the BA.4 and BA.5 subvariants, will begin clinical trials this month, the AP reported, with first doses expected to be shipped as soon as October.
BioNTech studies have shown that the shot prompts a stronger immune response against the BA.4 and BA.5 subvariants, as well as other Omicron subvariants such as BA.2, according to the Financial Times.
The European Medicines Agency will require clinical data for the BA.4 and BA.5 shot, and the FDA has said it would be prepared to approve the shot while trials are ongoing, the newspaper reported.
BioNTech and Pfizer are also investigating next-generation vaccines that could create a longer-lasting immune response against the coronavirus as it evolves, company officials said. The goal is to deliver a pan-coronavirus vaccine that can protect against future variants of concern, which could better target the spike protein on the coronavirus and enhance T-cell immunity response.
During the second half of 2022 or early 2023, BioNTech is starting clinical trials to test other infectious disease vaccines, including shots designed to protect against shingles, herpes simplex virus type 2, tuberculosis, and malaria.
BioNTech also plans to invest a large part of its share of the earnings from COVID-19 vaccines into research and development for cancer treatments, company officials said. The company received positive data from an early-stage trial of a personalized cancer vaccine for pancreatic cancer, as well as a CAR T-cell therapy candidate in solid tumors, the Financial Times reported.
BioNTech is focused on "furthering our oncology pipeline, as well as driving our leadership in COVID-19 vaccine development," Jens Holstein, the company’s chief financial officer, said Monday.
"We are driving toward potential launches of multiple innovative products to address diseases with high unmet medical need in the coming 3 to 5 years," he said.
Reuters: "BioNTech expects Omicron-adapted vaccine deliveries as soon as October."
Financial Times: "BioNTech and Pfizer to begin clinical trial of vaccine for new Covid variants."
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Cite this: Omicron-Adapted Vaccine Delivery Expected in October, BioNTech Says - Medscape - Aug 08, 2022.