The chief executive of Pfizer Inc. said the company is expecting to submit data from late-stage trials of its COVID-19 vaccine in children ages 5 to 11 to the U.S. Food and Drug Administration within days, raising hopes that another key patient group will soon be eligible for shots.
Albert Bourla said on ABC’s “This Week” on Sunday that if the FDA authorizes its use, Pfizer
and its German partner BioNTech
will be ready to produce a vaccine aimed at children.
“It is a different formulation,” Bourla said. “It’s one-third of the dose that we are giving to the rest of the population.”
Last week, the two companies said a study found that the lower dose was safe and effective in younger children. The news comes as children have returned to in-person classrooms with only those 12 and older eligible for vaccination.
Separately, Pfizer said Monday that it is starting a Phase 2/3 trial involving 2,660 healthy adults aged 18 and older of its investigational novel oral antiviral candidate to treat adults living in a household with someone who has tested positive for and has symptoms of COVID-19. The candidate is called PF007321332 and is co-administered with a low dose of ritonavir to prevent infection.
“If successful, we believe this therapy could help stop the virus early — before it has had a chance to replicate extensively — potentially preventing symptomatic disease in those who have been exposed and inhibiting the onset of infection in others,” said Mikael Dolsten, MD, PhD., chief scientific officer and president, Worldwide Research, Development and Medical of Pfizer.
The U.S. is still averaging more than 2,000 COVID deaths a day, according to a New York Times tracker, most of whom are in unvaccinated people. The high fatality rate has persisted even as cases and hospitalizations are declining in some of the states that were recent hot spots. Florida, for example, is averaging around 7,000 cases a day, down from as many as 20,000 a day in August, while hospitalizations have more than halved.
But Alaska is still the state with the highest number of new cases measured on a per capita basis and its hospitals are still overwhelmed and rationing care. Alaska has vaccinated jut 50% of its population, lagging the national average of 55.3%, according to a Centers for Disease Control and Prevention tracker.
New York City healthcare workers are facing a Monday deadline to get vaccinated for risk losing their jobs by defying a state mandate, the Times reported. Gov. Kathy Hochul has said she is prepared to mobilize the National Guard or bring in temporary workers from the Philippines or Ireland to replace workers who refuse to get their shots, if needed.
Elsewhere, Australia’s biggest city Sydney will lift its lockdown gradually and allow vaccinated people more freedom than unvaccinated ones under a two-tiered system, Reuters reported. Movement restrictions across New South Wales will be lifted between Oct. 11 and Dec. 1 as vaccination rates push through 70%, 80% and 90%, while unvaccinated people will be barred from community sports, dining out and other activities.
A study published Sunday in the International Journal of Epidemiology found that the pandemic caused the biggest decrease in life expectancy since World War II. The study covered 29 countries.
“The COVID-19 pandemic triggered significant mortality increases in 2020 of a magnitude not witnessed since World War II in Western Europe or the breakup of the Soviet Union in Eastern Europe,” the authors wrote. “Females from 15 countries and males from 10 ended up with lower life expectancy at birth in 2020 than in 2015.”
Yet another Brazilian who accompanied unvaccinated President Jair Bolsonaro to the United Nations General Assembly last week has tested positive for COVID, Reuters reported. Pedro Guimaraes, head of state lender Caixa Economica Federal, became the fourth person from the delegation to test positive. The right-wing Bolsanaro had COVID last year and has been widely criticized for his cavalier attitude to the pandemic.
The global tally for the coronavirus-borne illness climbed above 231.9 million on Monday, 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 42.9 million cases and 688,051 deaths.
India is second by cases after the U.S. at 33.7 million and has suffered 447,194 deaths. Brazil has second highest death toll at 594,443 and 21.4 million cases.
In Europe, Russia has most fatalities at 201,015, followed by the U.K. at 136,529.
China, where the virus was first discovered late in 2019, has had 108,313 confirmed cases and 4,809 deaths, according to its official numbers, which are widely held to be massively underreported.