Pfizer said on Friday it had forecast that the Covid-19 pandemic will not end until 2024, and that a lower-dose version of its vaccine, for children ages 2 to 4, has produced a weaker immune system response than expected, potentially delaying authorization.
The company said it is testing a three-dose vaccine treatment in all age groups under 16, including ages 2 to 4. It had previously expected data from this group later this year, but did not anticipate the delay would significantly change plans. to apply for emergency authorization in the second quarter of 2022.
“The data are illustrating the impact of a booster and that our vaccine works best with a basic three-dose regimen,” Scientific Director Mikael Dolsten said in a teleconference.
Pfizer developed the vaccine with BioNTech Germany. The companies have been developing a tailored version of their vaccine to fight the fast-spreading omicron variant, though they have not decided whether it will be needed. They hope to start a clinical trial of the updated vaccine in January, according to Pfizer executives.
The company said it currently expects the vaccine to generate $31 billion in revenue next year. Specific doses for variants, if necessary, could increase sales in 2022.
Pfizer and BioNTech tested a 3 microgram dose of their vaccine in children ages 2 to 5 years old, after using a 10 microgram dose in children ages 5 to 11 and 30 microgram doses in all ages 12 and older. 6 to 24 months, the low-dose version of the vaccine generated an immune response consistent with that of older vaccine recipients, the company said.
If the three-dose study is successful, Pfizer and BioNTech plan to submit the data to regulators to support an Emergency Use Permit for children 6 months to less than 5 years in the first half of 2022.
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