Why FDA Should Not Authorize COVID Vaccines for Kids, Teens

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 the COVID-19 pandemic. To expedite deployment in the U.S., three COVID-19 vaccines were provided Emergency Use Authorization (EUA) while concurrently undertaking the traditional review process.

Article by Stefan Baral, Wesley Pegden, and Vinay Prasad from Medium.

Pfizer has requested the FDA amend the existing EUA for its vaccine to allow eligibility for children aged 12 to 15, and 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 EUA for child COVID-19 vaccines.

Emergency Use Authorization in the U.S. 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 EUA for COVID-19 vaccines were implemented at the height of the second wave in the U.S., enabling 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 and Johnson COVID-19 vaccine. But Phase 3 trials of COVID-19 vaccines in adults 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 3 trials. Collectively, COVID-19 vaccination in adults met EUA 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. 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, EUA’s 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 normal 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, 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 expected, 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 risk of rare adverse events remains. And if the benefit achieved by an intervention is insufficient, 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 EUA — perhaps even spurred by school mandates and “vaccine passports” — presents a different balance of risks and benefits. Rare adverse events really could prove to be the most durable public health legacy of an EUA for child COVID-19 vaccines.

Even in the likely scenario that no significant adverse events materialize, we may pay a price for the pursuit of EUA’s for COVID-19 vaccines in children. Controversy surrounding mass child vaccination under EUA’s could feed vaccine hesitancy in the U.S. 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.

‘The Purge’ by Big Tech targets conservatives, including us

Just when we thought the Covid-19 lockdowns were ending and our ability to stay afloat was improving, censorship reared its ugly head.

For the last few months, NOQ Report, Conservative Playbook, and the American Conservative Movement have appealed to our readers for assistance in staying afloat through Covid-19 lockdowns. The downturn in the economy has limited our ability to generate proper ad revenue just as our traffic was skyrocketing. We had our first sustained stretch of three months with over a million visitors in November, December, and January, but February saw a dip.

It wasn’t just the shortened month. We expected that. We also expected the continuation of dropping traffic from “woke” Big Tech companies like Google, Facebook, and Twitter, but it has actually been much worse than anticipated. Our Twitter account was banned. Both of our YouTube accounts were banned. Facebook “fact-checks” everything we post. Spotify canceled us. Medium canceled us. Apple canceled us. Why? Because we believe in the truth prevailing, and that means we will continue to discuss “taboo” topics.

The 2020 presidential election was stolen. You can’t say that on Big Tech platforms without risking cancellation, but we’d rather get cancelled for telling the truth rather than staying around to repeat mainstream media’s lies. They have been covering it up since before the election and they’ve convinced the vast majority of conservative news outlets that they will be harmed if they continue to discuss voter fraud. We refuse to back down. The truth is the truth.

The lies associated with Covid-19 are only slightly more prevalent than the suppression of valid scientific information that runs counter to the prescribed narrative. We should be allowed to ask questions about the vaccines, for example, as there is ample evidence for concern. One does not have to be an “anti-vaxxer” in order to want answers about vaccines that are still considered experimental and that have a track record in a short period of time of having side-effects, including death. One of our stories about the Johnson & Johnson “vaccine” causing blood clots was “fact-checked” and removed one day before the government hit the brakes on it. These questions and news items are not allowed on Big Tech which is just another reason we are getting canceled.

There are more topics that they refuse to allow. In turn, we refuse to stop discussing them. This is why we desperately need your help. The best way NOQ, CP, and ACM readers can help is to donate. Our Giving Fuel page makes it easy to donate one-time or monthly. Alternatively, you can donate through PayPal as well. We are on track to be short by about $4100 per month in order to maintain operations.

The second way to help is to become a partner. We’ve strongly considered seeking angel investors in the past but because we were paying the bills, it didn’t seem necessary. Now, we’re struggling to pay the bills. We had 5,657,724 sessions on our website from November, 2020, through February, 2021. Our intention is to elevate that to higher levels this year by focusing on a strategy that relies on free speech rather than being beholden to progressive Big Tech companies.

During that four-month stretch, Twitter and Facebook accounted for about 20% of our traffic. We are actively working on operating as if that traffic is zero, replacing it with platforms that operate more freely such as Gab, Parler, and others. While we were never as dependent on Big Tech as most conservative sites, we’d like to be completely free from them. That doesn’t mean we will block them, but we refuse to be beholden to companies that absolutely despise us simply because of our political ideology.

We’re heading in the right direction and we believe we’re ready talk to patriotic investors who want to not only “get in on the action” but more importantly who want to help America hear the truth. Interested investors should contact me directly with the contact button above.

As the world spirals towards radical progressivism, the need for truthful journalism has never been greater. But in these times, we need as many conservative media voices as possible. Please help keep NOQ Report going.

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