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Covid vaccines for children should not get emergency use authorization


Emergency use authorization for mass child vaccination presents a different balance of risks and benefits than it did for adults, say Wesley Pegden, Vinay Prasad, and Stefan Baral


The rapid development of highly effective covid-19 vaccines is a triumph of science and, with equitable implementation strategies, represents humanity’s path out of this pandemic. To expedite deployment in the United States, the US Food and Drug Administration (FDA) provided three covid-19 vaccines with emergency use authorization while they concurrently went through the traditional review process. Pfizer has asked the FDA to amend the existing emergency use authorization for its vaccine to allow eligibility for children aged 12 to 15. Further clinical trials of covid-19 vaccines, including for younger children, are underway. Unlike for adults, however, the likelihood of severe outcomes or death associated with covid-19 infection is very low for children, undermining the appropriateness of an emergency use authorization for child covid-19 vaccines.


Emergency use authorization in the US requires that an intervention address a serious or life threatening condition, and for known and potential benefits of the intervention to be balanced against the known and potential harms. The emergency use authorizations for covid-19 vaccines were implemented at the height of the second wave in the US, enabling around 100 million American adults, who would otherwise be at significant risk of severe outcomes or death from covid-19 infection, to be vaccinated on an accelerated time frame.


Significant adverse events to vaccines are sometimes detected during wider distribution; for example, such events were investigated for the Johnson & Johnson covid-19 vaccine. But phase III trials of covid-19 vaccines in adults have demonstrated reductions in both infections and severe disease, and even if one reasoned conservatively from data on infections alone, these trials showed a large benefit for adult populations that convincingly offset the potential for harms from any side effects rare enough to be missed in phase III trials. Collectively, covid-19 vaccination in adults met emergency use authorization criteria given the positive balance of risks and benefits at the individual level.

Trials for covid-19 vaccines are also underway for children as young as 6 months. These trials are not powered to measure decreases in severe covid-19 infections, due to their rarity in this age group. Instead, these trials are examining safety, the immune response, and, as a secondary outcome, the impact on the incidence of covid-19 infections. As for adults, these trials are not designed to assess rare or delayed adverse events. Unlike for adults, the rarity of severe covid-19 outcomes for children means that trials cannot demonstrate that the balance of the benefits of vaccination against the potential adverse effects are favorable to the children themselves. In short, given the rarity of severe clinical courses and limited clarity of risks, the criteria for emergency use authorization do not appear to be met for children.


Emergency use authorizations for child vaccinations can make sense for children for whom the benefits are greatest, and thus for whom it is clearest that the benefits outweigh any unknown harms. In the near term, emergency use authorizations should be considered for children at genuinely high risk of serious complications from infection. It is also worth considering whether emergency use could be authorized for children whom especially concerned caregivers are sheltering from school or social interactions. The small risk posed to children by covid-19 does not merit restrictions on any regular child activities in a context where adults are protected by vaccines, but individual children who find their lives curtailed in this way may obtain significant benefits from vaccination.


One might hope to achieve population level benefits with broader child vaccination for covid-19, even while the relative benefits and risks for children themselves remain unclear, but this is inconsistent with the conditions for emergency use authorization. Fortunately, covid-19 vaccines have shown very high effectiveness across the adult population, and future trajectories of hospitalizations and deaths will largely be determined by vaccination rates in adults.

In 1976, the vaccination campaign in anticipation of a deadly swine flu (H1N1) epidemic inoculated 45 million Americans before being derailed by very rare cases of Guillain-Barré syndrome. That year saw less flu-related morbidity and mortality than scientists and politicians had expected when they began the vaccine campaign, and these few hundred adverse events cast a long shadow on American vaccination programs, affecting attitudes towards influenza vaccines for years to come. This highlights an important tradeoff when accelerating approval of pharmaceutical interventions in the context of an emergency. Specifically, that the risk of rare adverse events remains and, if the benefit achieved by an intervention is insufficient, any serious, yet rare, adverse effects can prove to be the lasting legacy of a regulatory decision.


For adults, the benefits of covid-19 vaccination are enormous, while for children they are relatively minor. Rare side effects from adult covid-19 vaccination are unlikely to lead to future vaccine hesitancy whose public health impact could be comparable to the benefits of the adult covid-19 vaccination program itself. But accelerated mass child vaccination under emergency use authorization—perhaps even spurred by school mandates and “vaccine passports”—presents a different balance of risks and benefits. The possibility that rare adverse events could emerge as the more durable public health legacy of an emergency use authorization for child covid-19 vaccines is much greater.


Even in the likely scenario that no significant adverse events materialize, we may still pay a price for the pursuit of emergency use authorizations for covid-19 vaccines in children. Controversy surrounding mass child vaccination under emergency use authorizations could feed vaccine hesitancy in the United States at a time when public attitudes towards vaccination are critical. A wide rollout of child covid-19 vaccines should follow the standard regulatory process as for most children, unlike adults, covid-19 vaccination is not addressing an emergency.


Wesley Pegden is an associate professor in the Department of Mathematical Sciences at Carnegie Mellon University. He tweets @WesPegden

Vinay Prasad is a practicing hematologist-oncologist and an associate professor in the Department of Medicine and the Department of Epidemiology and Biostatistics at University of California, San Francisco. He tweets @VPrasadMDMPH


Stefan Baral is a physician epidemiologist and an associate professor in the Department of Epidemiology at the Johns Hopkins School of Public Health. He tweets @SDBaral

 
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The top vaccine official for the state of Tennessee said she was fired after an argument over vaccinating children against coronavirus.

 

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Very good news about kids and Covid. Figures show the risk of death is negligible, meaning there is little reason to vaccinate children.

 

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17 Children Dead, More Than 2000 Suffering From Multi System Inflammatory Syndrome Due To COVID Vaccine​


17ChildrenDead2CMoreThan2000SufferingFromMultiSystemInflammatorySyndromeDueToCOVIDVaccine.jpg


Young children are becoming victims of Multi System Inflammatory Syndrome (MIS), due to the increase in the number of antibodies being made in the body from the COVID-19 vaccine which is causing damage to the immune system which is attacking other organs. Atleast 17 children have died in Jaipur and more than 2000 around India are suffering from MIS caused due to exccess antibodies from the COVID vaccine


The clinical trials of COVID-19 vaccine for children aged between 2 and 18 started last month in June at 525 centers in India.



The vaccine being given to the children to fight COVID-19 has now become a big problem. In children battling covid, high covid antibodies are now becoming the enemy of children’s lives. The tragic news was reported from Jaipur, Rajasthan by Bhawani Singh for News18 (archive link).

Due to hyper-activation of high antibodies or immune system, children are becoming victims of Multi System Inflammatory Syndrome. In Jaipur, in the last two months, 17 children have died due to this disease and more than 2 thousand children are suffering from MIS in the country.

In the JK Lone Hospital in Jaipur, the number of children suffering from MIS is increasing continuously. According to the information, so far 154 children have come to the hospital after suffering from this disease and out of these 17 have lost their lives.

In simple terms, if the body start making more antibodies in the body, then they are saved from corona but other parts of the body are harmed. In a way, it is an outbreak of antibodies. The body’s immune system itself starts harming the body.

Dr. Ashok Gupta, Pediatrician of Jekelon Hospital told that MIS is so dangerous that if not brought to the hospital on time, the risk of death increases.



So far 17 children have died due to this. And according to the Indian Academy of Pediatrics Intensive Care, more than two thousand children across the country are suffering from MIS.

Recently, a 12 year old girl Maddie in the US suffered severe memory loss and is now consigned to a wheelchair after getting Pfizer’s COVID-19 vaccine.


Meanwhile, a group of doctors have penned an “urgent open letter” to Singapore’s expert committee on Covid-19 vaccination, calling for the vaccination of youths in Singapore to be stopped until the US CDC clarifies why a teenage jab recipient died.

As reported by GreatGameIndia earlier, a 13-year-old boy died from heart problems after getting his second dose of Pfizer’s Covid-19 vaccine, as health officials begin to link cases of heart inflammation in kids to the jabs

 

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Vaccinating 1 million kids to prevent 2 COVID deaths. Now what is the side effect risks?

 

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Deaths From COVID Incredibly Rare Among Children – STUDY​

A comprehensive analysis of hospital admissions and reported deaths across England suggests that COVID-19 carries a lower risk of dying or requiring intensive care among children and young people than was previously thought.


In a series of preprints published on medRxiv, a team of researchers picked through all hospital admissions and deaths reported for people younger than 18 in England. The studies found that COVID-19 caused 25 deaths in that age group between March 2020 and February 2021.

About half of those deaths were in individuals with an underlying complex disability with high health-care needs, such as tube feeding or assistance with breathing.

The studies did not evaluate rates of less-severe illness or debilitating ‘long COVID’ symptoms that can linger months after the acute phase of the infection has past.

more here

 

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Malaysia ade ambik maklum x side effect ni semua... Macam aku sendiri pun tahu dari forum ni je...

Yang lain luar sana tu xtahu apa2 pun tentang ni...
 

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How College COVID Vaccine Mandates Put Students In Danger: The excessively narrow medical exemptions for COVID vaccine mandates at many colleges put students at unnecessary risk of serious complications, including hospitalization and death.




 
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