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Product Development

BioNTech’s Sahin doubts need for adapted vaccine to address SARS-CoV-2 variant, but could create one in weeks

Dec 22, 2020 | 6:34 PM GMT

If it turns out that mutations in a newly identified variant of the SARS-CoV-2 virus allow it to evade protection offered by the Comirnaty vaccine for COVID-19 from Pfizer and BioNTech, the German biotech believes it could create a modified vaccine within about six weeks.

At a press briefing Tuesday, BioNTech SE (NASDAQ:BNTX) CEO Ugur Sahin said such a scenario is relatively unlikely, since there are only nine mutations in the variant, among more than 1,270 amino acids in the virus’ spike protein. Comirnaty (BNT162b2) has already shown efficacy against other SARS-CoV-2 variants, with similar neutralization.

Still, the company will run a two-week experiment to compare the vaccine’s immune response to the variant against the wild-type virus. The experiment would use pseudoviruses under laboratory conditions, Sahin said.

“We have scientific confidence that the vaccine might protect, but we will know it only if the experiment is done, and we will need about two weeks from now to get the data, and we will of course publish the data as soon as possible,” Sahin said.

“If the mutant virus is inactivated in the same manner, we will say there is no difference,” he said. “If we see a reduction, we can quantify that.”

“There is no reason to be concerned or worry until we get the data.,” added Sahin, who said if it were deemed necessary to create an adapted version of the vaccine, BioNTech could do so quickly. “In principle, the beauty of the messenger RNA technology is that we can directly start to engineer a vaccine which completely mimics this new mutation, and we could be able to provide a new vaccine, technically, within six weeks.”

But, he cautioned, questions remain as to how regulators would respond. “Since this new vaccine would not have efficacy and safety data, there would be a lot of discussion whether a vaccine with this new variant could be applied or not applied. So this is a more complex discussion.”

“In principle what we would do is to change the insert and replace the virus variant — the one we are using now with a different one — without touching the platform as such,” added CMO Özlem Türeci. “It will depend on the extent regulators would accept the platform data we have produced with the current variant as being indicative for the new insert, basically, into this platform. That would define how long it would take to approve that variant vaccine.”

FDA has granted an emergency use authorization for Comirnaty, while EMA’s CHMP has recommended it be given conditional approval.

Pfizer Inc. (NYSE:PFE) is BioNTech’s development and commercialization partner.

Paul Stoffels, the CSO of Johnson & Johnson (NYSE:JNJ), told BioCentury on Monday that the pharma had not yet gained access to the new variant. Efficacy results are due in mid-January from a Phase III trial of J&J’s COVID-19 vaccine.

Other mutations seen earlier in 2020 did not cause a “change in the potency of the vaccine,” and there is no reason to believe the new strain will be resistant to J&J’s vaccine, Stoffels added.

If necessary, J&J could quickly engineer a new vaccine or a multivalent vaccine, he said.

If SARS-CoV-2 drifts and requires changes to vaccines, regulators are likely to take a “pragmatic” approach and allow manufacturers to modify authorized COVID-19 vaccines without requiring full development programs, Stoffels said.

The alternative, requiring vaccine developers to start from scratch, would be “catastrophic because then you need another year to do a clinical trial,” he said.

Washington Editor Steve Usdin contributed to this report.

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