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Pfizer and German partner BioNTech have submitted initial data from the late-stage trial of their COVID-19 vaccine in children aged 5 to 12 to the U.S. Food and Drug Administration, raising hopes that a key patient group can be added to the program as soon as late October.
The companies are seeking an emergency-use authorization for that cohort, who are among the last to become eligible for inoculation, even as they’ve returned to school in person. Pfizer
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and BioNTech
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had said last week that the Phase 2/3 trial involving 2,268 participants had found that two doses of just 10 mg of vaccine had proved safe and effective in children.
“Topline immunogenicity and safety readouts for the other two age cohorts from the trial — children 2 to [less than] 5 years of age and children 6 months to [less than] 2 years of age — are expected as soon as the fourth quarter of this year,” the companies said in a statement.
Dr. Anthony Fauci, President Joe Biden’s chief medical adviser, told MSNBC that the hope is now for authorization by the end of October.
The move comes at a time when the U.S. is still suffering more than 2,000 COVID-19 deaths a day, according to a New York Times tracker, matching levels last seen in February, the majority of whom are in unvaccinated people. New cases and hospitalizations are falling, but the death toll remains stubbornly high. More than 690,000 Americans have died of COVID so far, according to data aggregated by Johns Hopkins University, and that number is on track to hit 700,000 within five days.
Alaska is still leading the nation by new cases measured on a per capita basis and hospitals there are rationing care, the tracker shows. Alaska has fully vaccinated just 50% of its population, below the national average that now stands at 55.4%, according to a CDC tracker.
A study released Tuesday by the Kaiser Family Foundation on vaccine attitudes found that the greatest motivator for unvaccinated people is fear of the highly transmissible delta variant, which has been dominant in the U.S. for months. Other factors, such as the FDA’s full approval of the Pfizer vaccine and mandates from governments and companies are less effective.
“Large gaps in vaccine uptake remain by partisanship, education level, age, and health insurance status,” the authors wrote.
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The study also found the debate around booster shots to be both confusing and a negative for unvaccinated people, who believe requiring a third dose so soon after primary vaccination means that the vaccines don’t work as well as experts claim.
“The top reason vaccinated adults see driving high caseloads is vaccine refusal, while the unvaccinated say the main reason is that the vaccines aren’t working as well as promised,” the study found.
Source: Kaiser Family Foundation
Elsewhere, Russia suffered its highest one-day death toll on Tuesday at 852, Reuters reported, beating the previous record set just last week. Daily cases started climbing in early September after millions of Russian students returned to schools and colleges.
India reported its lowest daily numbers of COVID-19 infections deaths in more than six months, Al Jazeera reported. The death toll of 179 COVID deaths, reported on Tuesday, is the lowest daily figure since the middle of March.
Japan is dropping its state of emergency on Thursday, as infections slow, the Associated Press reported. Prime Minister Yoshihide Suga is expected to announce a lifting of the emergency and subsequent plans later Tuesday.
French drug company Sanofi
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has halted the development of a COVID-19 vaccine candidate that used the same mRNA technology as used in the Pfizer/BioNTech and Moderna
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vaccines, MarketWatch’s sister publication Barron’s reported.
Sanofi said that interim results from a Phase 1/2 study of the vaccine had been positive, and that no safety concern had been observed, but it would drop the program given the competition. Sanofi will instead seek to develop other vaccines based on that technology.
Latest tallies
The global tally for the coronavirus-borne illness climbed above 232.4 million on Tuesday, while the death toll rose above 4.75 million, according to data aggregated by Johns Hopkins University.
The U.S. continues to lead the world with a total of 43.1 million cases and 690,706 deaths.
India is second by cases after the U.S. at 33.7 million and has suffered 447,373 deaths. Brazil has second highest death toll at 594,653 and 21.4 million cases.
In Europe, Russia has most fatalities at 201,854, followed by the U.K. at 136,569.
China, where the virus was first discovered late in 2019, has had 108,360 confirmed cases and 4,809 deaths, according to its official numbers, which are widely held to be massively underreported.
