US panel recommends Pfizer COVID-19 vaccine for younger children
WASHINGTON, United States — A medical panel of US government advisors endorsed the Pfizer Covid-19 vaccine in five-to-11-year-olds Tuesday, paving the way for younger children to get their shots within weeks.
The independent experts concluded the known benefits — both directly to kids' health but also in ending school and other disruptions — outweighed the known risks.
After a day of presentations and debate, the final vote was 17 in favor and one abstention.
The Food and Drug Administration, which convened the meeting, is expected to give its formal green light soon, making 28 million young Americans eligible for the shot by mid-November.
"It is pretty clear to me that the benefits do outweigh the risk when I hear about children who are being put in the ICU, who are having long term outcomes after their COVID, and children are dying," said Amanda Cohn of the Centers of Disease Control and Prevention (CDC), who voted yes.
"It's never when you know everything — the question is when you know enough," said Paul Offit, a pediatrician at the Children's Hospital of Philadelphia, who also voted yes but reflected on the fact that more complete safety data would become available over time.
He added that many children who are at high risk stand to benefit, and that the theoretical risk of myocarditis, the most worrisome side-effect, would probably be very low, given the lowered dose of 10 micrograms, compared to 30 micrograms in older ages.
Nevertheless, several experts partly caveated their votes by saying they would not favor broad vaccine mandates in schools and the shot should remain a personal decision for families.
Earlier, top FDA vaccine scientist Peter Marks said younger children were "far from being spared harm of Covid-19," adding that, in this group, there had been 1.9 million infections and 8,300 hospitalizations, roughly a third of which required intensive care.
There have also been around 100 deaths, making it a top 10 leading cause of death, he added.
Rare side-effects
An analysis by Pfizer posted by the FDA before the meeting showed the vaccine was 90.7 percent effective at preventing symptomatic Covid-19.
FDA scientist Hong Yang presented a risk-benefit model that showed at current infection rates, the vaccine would prevent far more hospitalizations from Covid than they might cause from myocarditis.
If community transmission was brought down to very low levels, this may change -- but even then vaccination might be worthwhile because of long term risks linked to non-hospitalized cases, she added.
These include multisystem inflammatory syndrome in children (MIS-C), a rare but highly serious post-viral complication, which has affected more than 5,000 children of all ages and claimed 46 lives.
In its clinical trial, Pfizer evaluated safety data from a total of 3,000 vaccinated participants, with the most common side-effects mild or moderate, including injection site pain, fatigue, headache, muscle pain and chills.
There were no cases of myocarditis or pericarditis (inflammation around the heart), but experts agreed there were not enough study volunteers to be able to detect highly rare side-effects.
Matthew Oster, a CDC researcher, gave a presentation on what is known so far about these side-effects among groups already eligible for vaccines.
Of 877 vaccine-induced myocarditis cases in under 29s, 829 were hospitalized, according to official data. The vast majority were discharged but five remain in intensive care.
The rate will probably be lower in the five-to-11 age group than among adolescent males, because it is thought to be linked to testosterone.
The panel weighed this theoretical risk against preventing Covid, which may cause more frequent and severe myocarditis.
The meeting comes as the United States is emerging from its latest wave driven by the Delta variant.
Overall, 57 percent of the total population is now fully vaccinated.
Vaccine confidence has risen in recent months, but the United States remains behind every other G7 nation in percent of population fully vaccinated.
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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