Thankful for VAERS

Here's something to be thankful for: The Vaccine Adverse Event Reporting System.

VAERS is designed to be a signaling system to detect potential safety problems with vaccines that were not detected during the clinical trials. 

All reports are accepted into the VAERS database without determining whether the event was caused by a vaccine. When experts see an unusual pattern of reports that could be a safety signal, they can then investigate; all reports of serious adverse events are reviewed.

The Centers for Disease Control and Prevention and the Food and Drug Administration have used VAERS to spot potential safety issues with the COVID-19 vaccines and, if necessary, issue warnings to health care providers and the public. 

The VAERS system is working, as we found out a few times in the past year. COVID-19 vaccines are safe and effective, but rare adverse events have been swiftly spotted, investigated and addressed.   

But VAERS has been one of the most misunderstood and misused tools during the pandemic.  As we wrote in March, too many social media users have used the raw data -- the unverified VAERS reports -- to make unsupported claims about vaccines causing injuries and deaths. 

It is happening again. This time the anti-vaccine messages target parents of young children, 5 to 11, who are now eligible for the Pfizer/BioNTech vaccine. (See our guide to the pediatric vaccine here.)

Managing Editor Lori Robertson and Science Editor Jessica McDonald team up to address the latest viral social media messages that use the VAERS data, and flawed calculations, to falsely claim that the Pfizer vaccine for children will cause many more deaths than it will prevent.

For their analysis, read "Benefits Outweigh Risks of Pediatric COVID-19 Vaccine, Contrary to Posts Misusing VAERS Data."

Reader: So factcheck can’t tell me what HCQ and Zinc dosage Aaron Rodgers took, and for how long, to make him and his Packers teammates winners against Russell Wilson and his Seahawks teammates? How sad.

FactCheck.org Managing Editor Lori Robertson: I haven't seen that Aaron Rodgers had advocated specific amounts of hydroxychloroquine and zinc. However, if he and others take those medications and don't die of COVID-19, that doesn't mean those medications cured COVID-19 or that we can tell that the medications helped. The best way to find out whether a treatment leads to better outcomes for patients is through a randomized controlled trial. And researchers have used those trials to evaluate both hydroxychloroquine and zinc. 

As we've written, in a randomized controlled trial, one group of patients is given the medication and another receives standard care. Such studies are considered the “gold standard” in evaluating whether treatments are effective because they reduce bias by randomly assigning participants to treatment or standard care/placebo groups. Participants can be “blinded,” meaning they won’t know to which group they’re assigned. Researchers, who also can be blinded, can more confidently evaluate whether a treatment led to different effects.

Large, randomized controlled trials haven't found a benefit to using HCQ for hospitalized patients. Two randomized controlled trials are still ongoing to evaluate whether HCQ could prevent COVID-19. 

For instance, in early June 2020, the chief investigators of the Recovery trial in the U.K. announced they had found no significant difference in mortality at 28 days and no evidence of benefits on other outcomes in using hydroxychloroquine. The study included 1,542 patients hospitalized in the U.K. with COVID-19 who were given hydroxychloroquine and 3,132 given usual care.

The results were peer-reviewed and published in the New England Journal of Medicine in early October. In the hydroxychloroquine group, 27% of the patients died within 28 days, and 25% of those in the usual-care group died.

Two other randomized clinical trials similarly found no benefit from the drug. 

As for zinc, clinical trials are continuing to study its use for COVID-19. So far, the National Institutes of Health says there is insufficient evidence to recommend for or against using it. You can see information on the ongoing clinical trials here. 

And as for the combination of zinc and HCQ, one randomized study in Egypt didn't find a significant difference between a patient group treated with zinc and HCQ, compared with a patient group treated with HCQ. The same researchers also found no benefit to using HCQ when evaluating a patient group receiving HCQ plus standard care and a group receiving only standard care. 

Wrapping Up

Here's what else we've got for you this week:

• "CBO: Build Back Better Not Quite ‘Fully Paid For’": For weeks, President Joe Biden has been saying the Build Back Better plan would be “fully paid for” and would not increase the deficit. But the official congressional scorekeeper in its long-awaited final analysis contradicted the president’s claims.
• "Pfizer/BioNTech’s COVID-19 Vaccine Formulation Tweaked to Improve Stability": With the release of its pediatric COVID-19 vaccine, Pfizer switched the buffer used in its formulation to increase the stability of the product, allowing it to remain at refrigerator temperatures for longer. The Food and Drug Administration OK’d the change, which is also being made to some doses for teens and adults. Social media posts, however, misleadingly suggest that the ingredient swap is dangerous or was added to prevent heart attacks in children. 
• "Facebook Post Spreads Bogus Claim About ‘Detox’ After Vaccination": A vaccination can’t be reversed through any “detox” process, medical experts say. Yet, a social media post is spreading the false claim that a bath with borax can “get rid” of a COVID-19 vaccine. The bath may remove some water from the body, but not the molecules associated with vaccines, a toxicologist told us. 
• "Posts Misidentify Man Shown in Photo with Ghislaine Maxwell": Ghislaine Maxwell, who is charged with assisting accused sex trafficker Jeffrey Epstein, is scheduled to go on trial on Nov. 29. Social media posts are circulating a photo that falsely claims to show Chief Justice John Roberts in an affectionate pose with Maxwell. The photo actually shows Maxwell with a French modeling agent facing sexual assault charges. 
• "Virginia Lt. Gov.-Elect Sears Distorts Facts on COVID-19 Vaccines:" In an interview on CNN’s “State of the Union,” Virginia Lt. Gov.-Elect Winsome Sears spread misinformation about COVID-19 vaccines that we have previously debunked.

• "Video que cuestiona la eficacia de la vacuna incluye falsedades sobre estadísticas israelíes": La tasa de mortalidad por COVID-19 para las personas no vacunadas ha sido sustancialmente más alta que la de personas vacunadas, tanto en Israel como en Estados Unidos. Pese a ello, el comentarista conservador Ben Swann afirma falsamente en un video que las cifras de Israel demuestran que las vacunas no son efectivas en la prevención de hospitalizaciones y muertes. Pero los gráficos que usa no diferencian entre pacientes vacunados y no vacunados. 
• "Decreto en Colorado aborda el aumento de las hospitalizaciones, no el estado de vacunación": En respuesta a un aumento de las hospitalizaciones por COVID-19, el gobernador de Colorado, Jared Polis, firmó una orden ejecutiva el 31 de octubre que permite a los hospitales que están en o cerca de su máxima capacidad, transferir o dejar de admitir pacientes. Mensajes en las redes sociales afirmaron sin fundamento que el decreto señala que los hospitales pueden “negarse a tratar a los no vacunados”. Pero la orden no menciona el estado de vacunación.
• "Publicaciones tergiversan datos para afirmar falsamente que Italia redujo su recuento de muertes por COVID-19": La gran mayoría de las personas que han muerto con COVID-19 tenían otras afecciones médicas que las ponían en riesgo de enfermarse gravemente, u otras afecciones causadas por el COVID-19. Pero publicaciones en internet tergiversan los datos sobre esas afecciones para afirmar falsamente que Italia ha reducido su recuento de muertes por COVID-19. Sin embargo, esto no es verdad. 
• "Publicaciones virales hacen afirmaciones infundadas después de que Newsom recibe la vacuna de refuerzo contra el COVID-19": Después de recibir la dosis de refuerzo de la vacuna contra el COVID-19, el 27 de octubre, el gobernador de California Gavin Newsom canceló un viaje y no participó en ningún acto público oficial durante 12 días. Publicaciones en medios sociales afirmaron, sin pruebas, que Newsom había sufrido efectos secundarios graves tras recibir el refuerzo. Pero su equipo negó que hubiera tenido una “reacción adversa” a la dosis, y durante este periodo de tiempo apareció dos veces en las redes sociales y se dice que asistió a una boda.