Biontech founder and chief executive Ugur Sahin advocated having booster sensations done after just three months. "If Omicron continues to spread, as it looks like it will, it would make scientific sense to offer a booster as early as after three months," he said, pointing out that this is already being done in the United Kingdom. "However, that decision is not up to us."
Sahin further announced that this would probably make a fourth vaccination next summer necessary in some respects. One possibility among them is that the Omicron variant will prevail. "But the fourth vaccination could also be a vaccine adapted to an Omicron variant."
Biontech is working on a vaccine adapted to the new variant, which could then potentially be used in a fourth vaccination. "Whether we even turn the key to full production has not yet been decided. At the moment, there are different omicron variants on the way, and it is not yet clear which one will prevail and which one will then be in the vaccine," Sahin further told Der Spiegel. He added that it will be several weeks before it is clear whether a new vaccine is needed at all. So far, he said, the company expects to have to produce at least four billion doses of the vaccine in 2022. "Now we will think about whether it can be more," Sahin said.
The background of Sahin's statements are laboratory tests by Biontech and Pfizer, which were presented last Wednesday. According to them, at least three doses of their product are needed for sufficient protection against the Omicron variant of the coronavirus. However, Biontech/Pfizer believe that protection against severe disease is still available. One booster dose increases antibody levels sufficiently to neutralize the Omicron variant as well, they said. If needed, an adjusted vaccine could be made available starting in March, subject to regulatory approval.
The two pharmaceutical companies had tested in laboratory studies how well blood sera from vaccinated individuals with the antibodies they contain can neutralize the recently discovered omicron variant of the coronavirus. They used an artificially produced form of the virus for their study. From the results, insights into the protective effect can be derived, even though laboratory tests do not fully reflect real-world conditions.
According to the results, after two doses of the vaccine, the neutralization potential was reduced 25-fold compared to the wild-type of the pathogen. However, the T cells produced in response to the vaccination would not be affected by the mutations in the variant. Therefore, "the companies believe that vaccinated individuals may still be protected against severe forms of the disease."
Preliminary laboratory data suggested that "the first line of defense" against the omicron variant may be compromised after two vaccinations, but that the third vaccination restored that protection, Chief Medical Officer and Biontech co-founder Özlem Türeci said at an online press conference.
CEO Sahin did not specify when Biontech would decide on the need for a vaccine tailored to the new variant. First, he said, further results from laboratory tests and experience with the actual spread of the variant must be awaited in the coming weeks. Biontech continues to work "at full speed" on adapting the vaccine to Omicron, assuming that this may become necessary, he said. Production will not be more complicated than with the current vaccine, he said. Biontech is in constant contact with regulatory authorities regarding the new variant studies, he said.
In Sahin's view, it is more advisable for people who want to protect themselves against the Omicron variant to get boosted now rather than wait for a possible vaccine adjustment in a few weeks. In addition, if production starts up in March, the new vaccine will not immediately be available in large quantities. Biontech is expected to start production with 25, 50 and 75 million doses.
The booster dose increased antibody levels 25-fold, according to Biontech and Pfizer. These antibody levels would be associated with high efficacy against both the wild-type virus and previously emerged variants. "While two doses of the vaccine may continue to provide protection against severe disease, these initial data show very clearly that protection is enhanced with a third dose of our vaccine," said Albert Bourla, chief executive of Pfizer, the pharmaceutical company.
Blood sera for the manufacturers' trial were collected three weeks after the second vaccination or four weeks after the third vaccination. Data on the longevity of antibody titers induced by the booster are still being collected. Initial batches of an adapted vaccine could be shipped within 100 days if approved by regulators, according to Biontech. The expected production volumes of four billion doses of the vaccine in 2022 would not change even if an adjustment is necessary.
Image by Johaehn