Publications bias misleading research of COVID-19 vaccine protection data

By Catalina Jaramillo

A follow-up formula of ripassrous vaccines has shown that COVID-19 vaccines are and rarely have serious side effects. But an article shared on social media incorrectly says that CDC data shows that more than 18 million other people “were so severely injured”/BioNTech or Moderna COVID-19 vaccine “that they had to go to the hospital. “

More than 632 million doses of COVID-19 vaccine have been administered in the United States, what the Centers for Disease Control and Prevention calls “the most intense surveillance program” in U. S. history.

After receiving a vaccine, many other people experience mild to moderate symptoms, such as headache, fatigue, fever, or pain at the injection site. But those side effects go away within a few days and aren’t noticed as a protective issue, but as a sign that the vaccine is working.

Side effects that require medical attention may also occur, but they are the exception.

However, an online article incorrectly reported that “according to the CDC’s own internal data,” more than 18 million other people “suffered such severe injuries” from a dose of the Pfizer/BioNTech or Moderna COVID-19 vaccines “that they had to go to the hospital. “

“Court Orders CDC to Know of 18 Million Vaccine Injuries in U. S. ,” Oct. 14 headline in Technocracy News

The message refers to awareness of a CDC protective surveillance system, called v-safe, that the anti-vaccination organization Informed Consent Action Network received as a component of a Freedom of Information Act lawsuit. According to the organization’s knowledge review, of approximately 10. 1 million v-safe users, more than 780,000, or more than 7. 7 percent, “have had a medical condition that requires medical attention, emergency room intervention, or hospitalization. “This is “alarming,” he says, and “should have brought in the CDC to prevent its Covid-19 vaccination program. “

A website, Technocracy News

But v-safe collects knowledge on any fitness occasion, vaccine-related or not, and 7. 7%, even if taken literally, for any type of medical care, not just hospitalizations, up to a year after vaccination. It is wrong to say that the research recorded many hospitalizations after vaccination and it is misleading to recommend that each and every reported case was due to a vaccine. Importantly, published research on v-safe data shows that less than 1% of participants reported receiving medical care in the first week after receiving a vaccine.

The CDC said they may simply not comment on the analysis. But a spokesperson told us in an email that, to the CDC’s knowledge, in the first week after vaccination, “medical reports (including telehealth appointments) range from 1 to 3 percent (depending on vaccine, age group, and dosage). Knowledge of V-safe showed low rates of medical care after vaccination, i. e. hospitalization.

More than 10 million v-safe users have completed 146 million fitness surveys, the CDC told us.

“V-safe is designed to identify cause-and-effect relationships between vaccines and adverse events,” said Dr. Edward Belongia, director of the Center for Clinical Epidemiology and Population Health at the Marshfield Clinic Research Institute and an expert on vaccine safety. Telephone interview.

V-safe is a vaccine surveillance program that uses SMS and online surveys to monitor people’s fitness after receiving a COVID-19 vaccine. Every day for a week after each dose of the vaccine, participants who voluntarily enroll in the program receive messages asking them how to feel that day. They are also asked to report certain symptoms from a preloaded list, adding chills, headaches and nausea, or anything that is not on the list; and any impact on fitness, such as inability to work, inability to perform daily activities, or desire to seek medical care. Follow-up SMS messages are sent once a week for the next six weeks and at three, six and 12 months after vaccination. V-safe users are not requested to report only symptoms or fitness effects that could be similar to injections.

“It lacks the point of detail and granularity to assess whether those events are causally related. And you know, there’s no comparison organization there, everyone at v-safe is vaccinated. Therefore, it is highly unlikely to find out whether a vaccine caused a specific adverse event based on v-safe data alone,” Belongia told us.

The formula is part of a broader formula of early precaution reporting that allows experts to monitor vaccine safety. Belongia and other experts say v-safe has limitations: headache, muscle aches or fever.

“And what we’re seeing is largely consistent with what’s been observed in clinical trials: that those symptoms are very common, that they’re mild to moderate, that they go away in two or three days, so there’s nothing unexpected about that,” he said.

Data collected through v-safe is not publicly available, as are data from other systems, such as the vaccine adverse event reporting system. mortality report and other reviews, as well as in presentations to the Advisory Committee on Immunization Practices. According to the CDC, knowledge of v-safe has been presented at 11 meetings since the vaccines were released in December 2020; January, March, June, September and October 2021; and in January, April, May, June and September 2022.

Some conclusions from these studies are that the momentary dose of series number one caused more participants to report mild and transient symptoms or to be unable to perform general activities, and that momentary reinforcement caused fewer expected side effects, such as pain at the injection site, than the first. According to the CDC, when COVID-19 vaccines began to be administered, v-safe was instrumental in identifying early reports of a severe allergic reaction that rarely occurs after vaccinations.

One study, published in the Lancet Infectious Diseases in March, analyzed v-safe reports between Dec. 14, 2020, and June 14, 2021, after handling the Pfizer/BioNTech and Moderna COVID-19 vaccines. It found that less than 1% of v-safe users reported receiving medical care within the first week of receiving a dose of the number one series of either vaccine, and a very small proportion (0. 2% or less) reported an emergency room visit or hospitalization. Again, even those doctor visits aren’t necessarily caused by the vaccine and may just be a coincidence.

The Informed Consent Action Network is a Texas-based organization founded through Del Bigtree, an anti-vaccination activist. The organization has filed several vaccine-related lawsuits against the CDC, the Food and Drug Administration and the National Institutes of Health. CDC in December 2021 and again in May 2022, following FOIA requests to download all knowledge submitted to v-safe since January 1, 2020. The v-safe program only started after COVID-19 vaccines became legal in December 2020.

In August, the CDC agreed to publish knowledge collected from more than 10 million v-safe participants on its online page through Sept. 30. any non-public identifiers. The firm told Reuters that “technical and administrative” disorders prevented it from releasing consciousness in time. Instead, the CDC sent the knowledge directly to ICAN, which published its own research on Oct. 3.

On its website, ICAN does not mention the strategies used for its analysis. But he mentions that knowledge is limited to v-safe’s 10 million users and the pre-populated fields verified through them, not the data users can load into text boxes. According to the company’s dashboard, data is pulled from records that have occurred up to a year after a vaccine dose. The company also released five downloadable files containing raw v-safe data.

FactCheck. org contacted Aaron Siri and Siri representatives

We were able to access one of the files containing symptoms and impacts on fitness, which included 116,294 reports. Of those reports, 1046, or 0. 9%, were health care reports of any kind, and this included reports from the same user over time. Of those, only seven corresponded to hospitalizations, adding two for the same user for two consecutive days.

Belongia, the vaccine protection expert, told us that the numbers through ICAN, adding up to the more than 780,000 users who reported needing medical attention of any kind, are “uninterpretable. “

“We don’t know what the background rate is in the v-safe population. What would that number have been in an organization of other people who hadn’t won the vaccine? Said.

Because fitness problems, in addition to hospitalizations, occur in the population every day, it is not unusual for them to occur after vaccination for reasons unrelated to the vaccine. That’s why it’s vital to see if a specific occasion occurs more after vaccination, which may involve a problem.

The research doesn’t mention how long after vaccination a user needed medical attention, but it did get answers up to a year after vaccination, which could be the difference between ICAN figures and data released by the CDC. Siri told Reuters that ICAN’s idea was vital to look beyond a week, as some potential vaccine-like side effects may appear only weeks after vaccination. But peak side effects occur some time after vaccination, so the inclusion of longer periods would come with more events that are not similar to the vaccine.

A user may have consulted a doctor for a completely different explanation of why six months after a vaccine and, if they correctly comply with v-safe commands, will inform the system. This user would receive an update call from v -safe, for the firm to get more information. But as we said, v-safe doesn’t have the ability to know whether a specific event, adding hospitalization, is caused by the vaccine or not.

“So to answer questions like that, in terms of relative threat, you need something like Vaccine Safety DataLink or VSD, which uses the medical records of millions of other people across the country and vaccination records to implement scientifically valid studies to whether there is a primary threat of specific adverse events after vaccination. ” Belongia said, referring to a network of nine built-in fitness care organizations, adding his own, which actively monitors vaccine safety.

“What we see in the knowledge is precisely the opposite of what is advised through teams like ICAN: these vaccines are very safe. With some very rare known exceptions,” Belongia said. But overall, it’s very transparent that the benefits of vaccines far outweigh the risks. “

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