US gives final approval of Pfizer's COVID-19 vaccine for children aged 5-11
WASHINGTON, United States — The United States can now start giving children aged 5-11 the Pfizer-BioNtech Covid vaccine, US health authorities said Tuesday in a move hailed by President Joe Biden as a "turning point" in the fight against the pandemic.
Days after gaining authorization from the Food and Drug Administration, the vaccine was endorsed by the Centers for Disease Control and Prevention, clearing the way for the vaccination of up to 28 million children.
The government was well ahead of the decision, procuring enough doses for the children in the 5-11 age group and beginning to ship them across the country.
"Today, we have reached a turning point in our battle against Covid-19," Biden said in a statement released by the White House.
Vaccinating younger children will "allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus," the president continued.
The government has already secured enough vaccine for every child in America, he said, adding that over the weekend officials began the process of packing and shipping millions of doses.
"The program will ramp up over the coming days, and (be) fully up and running during the week of November 8," he said.
The vaccine will still be given in two injections, three weeks apart. The dosage has been adjusted to 10 micrograms per injection, compared to 30 micrograms for the older age groups.
The caps on the children's vials will be orange, making them easily recognizable compared to the purple caps on the vials for older groups.
'More worried' about Covid
The CDC had convened a panel of independent scientists on Tuesday to review the available data on the status of the outbreak in children, the effectiveness of Pfizer's vaccine, and its possible side effects during a day of live-streamed discussions.
The panel unanimously recommended the vaccine, and the CDC then endorsed that recommendation.
The main concern was the risk of myocarditis, an inflammation of the heart muscle, detected in adolescents and young adults (mostly males) after vaccination with the Pfizer or Moderna shots.
Health authorities have confirmed nearly 880 cases in people under 30 years of age, of which approximately 830 required hospitalization.
Nine deaths are suspected to have been related to myocarditis after the vaccine.
But of six cases so far reviewed, vaccine-related myocarditis was ultimately not identified as the cause of death, pediatric cardiologist Dr. Matthew Oster said in a presentation.
"I'm much more worried about what would happen to their child if they get Covid, for patients who don't have heart disease, than I am if they were to get this vaccine," he added.
There have been more than 1.9 million cases of Covid-19 among five- to 11-year-olds in the United States, and more than 8,300 hospitalizations, more than 2,300 cases of MIS-C (pediatric multisystem inflammatory syndrome), and about 100 deaths.
The expected benefits of vaccinating children also include fewer school closures, and a possible reduction in transmission of the epidemic into the general population.
According to a survey of 1,000 parents presented Tuesday by the CDC, 57 percent said they would "definitely" or "probably" get their child vaccinated.
"If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible," said Beth Bell, an infectious disease specialist and committee member.
"We have excellent evidence of efficacy and safety. We have a favorable risk benefit analysis."
Pharma giants Sanofi and GSK said on July 29, 2020, that they have agreed to supply Britain with up to 60 million doses of a potential COVID-19 vaccine. The agreement covers a vaccine candidate developed by France's Sanofi in partnership with the UK's GSK and is subject to a "final contract."
This thread collects some of the major developments in the search for a vaccine to ease the new coronavirus pandemic. (Main photo by AFP/Joel Saget)
As negotiations towards a new pandemic treaty pick up pace, observers warn of watered-down efforts to ensure equitable access to the medical products needed to battle future Covid-like threats.
Shaken by the pandemic, the World Health Organization's 194 member states are negotiating an international accord aimed at ensuring countries are better equipped to deal with the next catastrophe, or even prevent it altogether.
The process is still in the early stages, with the aim of reaching an agreement by May 2024.
But critics warn that revisions being made to the preliminary negotiating text are weakening the language -- notably in a key area aimed at preventing the rampant inequity seen in access to vaccines and other medical products during the Covid pandemic.
"I think it is a real step backwards," Suerie Moon, co-director of the Global Health Centre at the Geneva Graduate Institute, told AFP. — AFP
Africa's first mRNA vaccine hub is ceremonially launched on Thursday to acclaim from the UN's global health chief, who hailed it as a historic shift to help poor countries gain access to life-saving jabs.
The facility was set up in the South African city of Cape Town in 2021 on the back of the success of revolutionary anti-Covid vaccines introduced by Pfizer/BioNTech and Moderna.
"This precious project... will bring a paradigm shift in addressing the serious problem we faced, the equity problem, during the pandemic, so (that) it's not repeated again," World Health Organization (WHO) head Tedros Adhanom Ghebreyesus tells a media briefing to mark the inauguration. — AFP
China has approved its first locally developed messenger RNA (mRNA) vaccine against Covid-19, its manufacturer said Wednesday, months after the relaxation of strict Covid-zero regulations sparked a surge in cases.
The vaccine, developed by CSPC Pharmaceutical Group Ltd, has been approved for "emergency use" by Beijing's health regulator, the company said in a statement.
It showed high efficacy in a trial in which it was used as a booster shot for people who have been given other types of vaccines, the company added, without offering further details. — AFP
COVID-19 vaccine maker Novavax raises doubts about its ability to continue its business, announcing plans to cut spending after struggles in rolling out its coronavirus jab.
Shares of Novavax plummeted 25 percent in extended trading, after the company reported fourth-quarter earnings that missed analyst estimates.
While the firm should have enough money to fund operations, the situation is "subject to significant uncertainty," it says in a statement. — AFP
The protection against Covid-19 from being previously infected lasts at least as long as that offered by vaccination, one of the largest studies conducted on the subject says.
Ten months after getting Covid, people still had an 88% lower risk of reinfection, hospitalisation and death, according to the study published in the Lancet journal.
That makes this natural immunity "at least as durable, if not more so" than two doses of Pfizer or Moderna's vaccines, the study says.
The authors nevertheless emphasized that their findings should not discourage vaccination, which remains the safest way to get immunity. — AFP
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