Ciara Linnane
Positive results from a trial of the COVID-19 vaccine developed by Pfizer and German partner BioNTech in children aged 5 to 11 was tempered Monday by a rising average death rate, with the U.S. now seeing more than 2,000 fatalities a day for the first time since March 1.
Pfizer /zigman2/quotes/202877789/composite PFE -1.60% and BioNTech /zigman2/quotes/214419716/composite BNTX +0.26% said a Phase 2/3 trial involving 2,268 children found the vaccine was safe, well-tolerated and produced “robust” neutralizing antibody response. Children were given a two-dose regimen of 10 micrograms administered 21 days apart, a smaller dose than the 30 micrograms given to people aged 12 and older.
“The antibody responses in the participants given 10 µg doses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age immunized with 30 µg doses,” the companies said in a joint statement.
They will now submit data to the U.S. Food and Drug Administration, the European Medicines Agency and other global regulators with some urgency. Results from a trial involving children younger than 5 are expected “as soon as later this year.”
The news comes at a time when pediatric cases in the U.S. have climbed some 240% since July, “underscoring the public health need for vaccination,” said Pfizer CEO Albert Bourla.
The data was released just days after an FDA advisory committee reframed a proposed approval of BioNTech and Pfizer’s COVID-19 booster for the general population, and instead recommended authorization of an additional dose of the vaccine to people 65 and older and those at high risk for severe disease.
The committee voted against a broader FDA approval of the booster for people who are at least 16 years old and vaccinated six months ago. The FDA isn’t required to follow the advice of the committee but often does. A decision could come a soon as today.
Dr. Anthony Fauci, President Joe Biden’s chief medical adviser, took to the Sunday chat shows to clear up any confusion over boosters, which Biden had promised would be rolled out from Sept. 20 for all fully vaccinated people.
“I don’t think they made a mistake,” Fauci told CNN , adding that a third shot may still be approved if new data shows it’ll be effective.
“The goal of this particular decision was to prevent people from getting serious disease who are at risk, such as the elderly and those that have underlying conditions,” Fauci told ABC News in a separate interview Sunday.
The U.S. is averaging 2,011 deaths a day, according to a New York Times tracker, which shows cases and hospitalizations gradually easing in some hot spots after a surge that started in July, driven by the highly transmissible delta variant.
COVID-19 has now killed about as many people in the U.S. as the 1918-19 Spanish flu pandemic did, or about 675,000 , according to the Associated Press, which added that it shows the virus’s lethality despite modern-day medical advances even as the U.S. population a century ago was just one-third of what it is today.
Texas and Florida account for more than 30% of those deaths. Florida, which has vaccinated 56% of its population, is averaging 353 deaths a day and Texas, where 50% of the population is inoculated, is seeing 286 deaths a day, according to the Times.
The CDC’s vaccine tracker shows that 54.6% of the overall U.S. population is fully vaccinated, meaning they have had two doses of the vaccines developed by Pfizer and BioNTech and Moderna /zigman2/quotes/205619834/composite MRNA -2.58% , or one of Johnson & Johnson’s /zigman2/quotes/201724570/composite JNJ -1.85% one-shot vaccine. Some 211.8 million Americans have received at least one dose, equal to 63.8% of the population.
The U.S. is planning to relax travel restrictions on the U.K. and E.U for vaccinated passengers, according to media reports.
Elsewhere, actor and comic Chris Rock said he has been diagnosed with COVID-19 and sent a message to anyone still on the fence: “Get vaccinated,” t he Associated Press reported.
The 56-year-old comedian wrote on Twitter : “Hey guys I just found out I have COVID, trust me you don’t want this. Get vaccinated.” Rock had a single shot of the J&J vaccine earlier this year, he told “The Tonight Show” in May .
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