OUT OF MIND
Would you like to react to this message? Create an account in a few clicks or log in to continue.
Latest topics
» Enormous sinkhole swallows up the ground in Chile
Haven't the Children Been Through Enough?  EmptyToday at 9:42 am by PurpleSkyz

» Joe Biden Unleashes Machine Gun-Toting Agent on Trump’s Mar-a-Lago Residence
Haven't the Children Been Through Enough?  EmptyToday at 9:24 am by PurpleSkyz

» Aussie Doctor Risks Medical License to Tell the Truth About COVID Vaccine Injuries and Deaths
Haven't the Children Been Through Enough?  EmptyToday at 9:12 am by PurpleSkyz

» Since covid “vaccines” were unleashed, athlete deaths are up 1700%
Haven't the Children Been Through Enough?  EmptyYesterday at 10:05 am by PurpleSkyz

»  Cancer Explosion: Pathologist Reports on Rise of Aggressive Cancers Since mRNA Shots
Haven't the Children Been Through Enough?  EmptyYesterday at 9:59 am by PurpleSkyz

» ‘Revolution Has Begun’: 75,000 Brits To Stop Paying Power Bills Amid Inflation Storm
Haven't the Children Been Through Enough?  EmptyYesterday at 9:41 am by PurpleSkyz

» “Before You Inject Your Child” – Dr. Robert Malone
Haven't the Children Been Through Enough?  EmptyYesterday at 9:34 am by PurpleSkyz

» Unleashed by Democrats, the IRS ‘beast’ is coming for all with incomes under $200K a year
Haven't the Children Been Through Enough?  EmptyYesterday at 9:17 am by PurpleSkyz

» 24-Year-Old Irish Athlete Dillon Quirke Dies Unexpectedly After Collapsing Mid-Game
Haven't the Children Been Through Enough?  EmptySun Aug 07, 2022 6:48 pm by PurpleSkyz

» Ou Yang Li-hsing Found Dead in Hotel Room…After Pelosi’s Visit…Heart Attack?
Haven't the Children Been Through Enough?  EmptySun Aug 07, 2022 6:44 pm by PurpleSkyz

» Find Out if You’re Eligible for Part of the $90M Facebook Data Tracking Settlement
Haven't the Children Been Through Enough?  EmptySun Aug 07, 2022 10:03 am by PurpleSkyz

» The “Unvaccinated” Question (Revisited)
Haven't the Children Been Through Enough?  EmptySun Aug 07, 2022 8:48 am by PurpleSkyz

» These people are nuts: Reuters Links Deadly DC Lightning Strike To Global Warming
Haven't the Children Been Through Enough?  EmptySun Aug 07, 2022 8:44 am by PurpleSkyz

» Thousands of Jabbed Teenage Girls Are Developing Tics, Doctors Baffled
Haven't the Children Been Through Enough?  EmptySun Aug 07, 2022 8:34 am by PurpleSkyz

» EUDRA Stats thru July 30th 2022
Haven't the Children Been Through Enough?  EmptySun Aug 07, 2022 8:21 am by PurpleSkyz

» US Declares Monkeypox Public Health Emergency – Big Pharma Ready for Windfall Profits, Again
Haven't the Children Been Through Enough?  EmptySun Aug 07, 2022 7:56 am by PurpleSkyz

» Good Samaritans Fined, Threatened with Arrest for Pulling Government Litter Out of a River
Haven't the Children Been Through Enough?  EmptySun Aug 07, 2022 7:52 am by PurpleSkyz

» MRNA 'VACCINE' GENOCIDE 2021-2022: TESTIMONIES FROM THE VICTIMS AND MEDICAL STAFF
Haven't the Children Been Through Enough?  EmptyWed Aug 03, 2022 10:17 am by PurpleSkyz

» Mysterious metallic orb containing a secret code inside falls on Veracruz, Mexico
Haven't the Children Been Through Enough?  EmptyWed Aug 03, 2022 10:10 am by PurpleSkyz

» 10,000% Increase in Cancers Following COVID-19 Vaccines as Doctors and Scientists Worldwide Sound the Alarm
Haven't the Children Been Through Enough?  EmptyWed Aug 03, 2022 9:55 am by PurpleSkyz

» Good People Doing Good Things – Dr. Sanduk Ruit & Dr. Geoffrey Tabin
Haven't the Children Been Through Enough?  EmptyWed Aug 03, 2022 9:48 am by PurpleSkyz

» UK Government admits 19 million Brits remain Unvaccinated & 30 million Brits have refused the COVID Booster Jab
Haven't the Children Been Through Enough?  EmptyWed Aug 03, 2022 9:38 am by PurpleSkyz

You are not connected. Please login or register

OUT OF MIND » BREAKING NEWS & HOT TOPICS » THE GREAT DIE OFF » Haven't the Children Been Through Enough?

Haven't the Children Been Through Enough?

Go down  Message [Page 1 of 1]

PurpleSkyz

PurpleSkyz
Admin

Covid vaccines for children should not be authorized
Published on May 11, 2021
Written by British Medical Journal
Haven't the Children Been Through Enough?  Vaccine-image-2

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
Competing interests: The authors have read and understood BMJ policy on declaration of interests and declare the following interests: VP discloses research funding from Arnold Ventures; royalties from Johns Hopkins Press, Medscape, and MedPage; consulting fees from UnitedHealthcare; speaking fees from Evicore and New Century Health; and Patreon backers for Plenary Session podcast.
See more here: bmj.com

https://principia-scientific.com/covid-vaccines-for-children-should-not-be-authorized/?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+psintl+%28Principia+Scientific+Intl+-+Latest+News%29

Thanks to: https://principia-scientific.com



  

Back to top  Message [Page 1 of 1]

Permissions in this forum:
You cannot reply to topics in this forum