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Pfizer (PFE) and partner BioNTech (BNTX) are expected to file a request with the FDA as early as today for emergency-use authorization of their COVID-19 vaccine for children 6 months to 5 years old. The data is based on an approach called "immunobridging," which is used to show that vaccines work and are safe among other age groups, and typically takes far less time than efficacy trials. An approval, which would be the first vaccine available for the demographic, could happen by the end of February.
Snapshot: The trial was designed to measure if immune responses were comparable to what was reported to be protective in teens and young adults. While the two-shot regimen did create a protective immune response in children 6 months to 2 years old, it was not the case in 2-, 3- and 4-year-olds. The vaccine was still found to be safe among the cohort, but the drugmakers added a third shot to the trial to try to improve the immune response (that data will only be available in late March).
"The idea is, let's go ahead and start the review of two doses," per the report in the Washington Post. "If the data holds up in the submission, you could start kids on their primary baseline months earlier than if you don't do anything until the third-dose data comes in."
Vaccine eligibility: In the trial of children between 6 months and 5 years old, recipients were inoculated with two doses of 3-microgram shots, three weeks apart. A child-sized version of Pfizer's vaccine (10 micrograms) is currently available for 5- to 11-year-olds, at a third of the dose given to everyone else 12 and older (30 micrograms). As of mid-January, around 28% of children aged 5 to 11 are at least partially vaccinated, according to the Kaiser Family Foundation.
In Europe, at midday, London +1%. Paris +1%. Frankfurt +1.1%.
Futures at 6:20, Dow -0.2%. S&P -0.3%. Nasdaq -0.2%. Crude -0.2% $87.95. Gold +0.6% at $1808.10. Bitcoin +2.7% to $38,268.
Ten-year Treasury Yield -2 bps to 1.76%
Exxon (NYSE:XOM) announces sweeping restructuring of its global operations.
Preliminary survey shows OPEC compliance increasing, up 132% in January.
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FTC to handle review of Microsoft-Activision Blizzard (MSFT, ATVI) deal.
Novavax (NASDAQ:NVAX) finally files for U.S. authorization of COVID vaccine.
Bitcoin, Ether close out rough month amid Fed pivot; cryptos nosedive.
Boeing (NYSE:BA) clinches deal with Qatar for 50 new freighter jets.
J.P. Morgan's Kolanovic says we're in a bear market, so buy the dip.


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