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Initial safety data from the first month of COVID-19 vaccination shows injections to be as safe as studies suggest.
Although the rate of severe allergic reactions is higher than in the general population, all people with an allergic response have been treated successfully, and no other serious problems have emerged among the first 22 million people vaccinated, according to the reports. Centers for Disease Control and Prevention.
Data was collected from several tracking systems, including a voluntary system where vaccinated people report their symptoms by text. Another allows people who believe they have been injured by a vaccine to provide information, and a third collects reports from medical records.
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While it is never possible to prove that something is completely safe, data from these tracking systems suggests that vaccines do not cause a large number of unusual or dangerous results.
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In a meeting on Wednesday, Dr Tom Shimabukuro, deputy director of the CDC’s Office of Immunization Safety, briefed a CDC advisory committee of the agency’s review of the safety data collected so far on the two authorized vaccines.
Side effects remain a common result of Pfizer-BioNTech and Moderna vaccines, with 70% of people reporting pain.
Vaccinated people suffered serious health crises and even death within days of receiving a vaccine. But the rate of these events is not higher than one would expect in the general population and cannot be related to the vaccine, the review found.
He did not speak to several people who are believed to have died after receiving a vaccine, including a doctor from Florida and a radiologic technologist from California.
More than 22 million Americans have received at least one dose of vaccine
More than 2 million of the first 22 million to receive at least one dose of the vaccine reported to V-safe, a self-report system including online surveys and text messages.
Of these, over 70% reported pain, 33% fatigue, 30% headache, 23% muscle pain, and about 11% chills, fever, swelling or joint pain.
There was little difference in the side effects reported between the two vaccines, although people generally had more difficulty with the second dose than the first.
More than 9,000 people have reported side effects after vaccination with the CDC’s Vaccine Adverse Event Reporting System, or VAERS. Just under 1,000 of these reports were deemed serious. The majority of complaints were for headaches, fatigue, dizziness, nausea, chills, fever, and pain.
A third safety reporting system, called Vaccine Safety Datalink, examines the medical records of nine participating healthcare organizations, including data on more than 12 million people per year. More than 162,000 people in the system have received at least one injection of COVID-19.
In this group, there was “no signal as of January 16” of an increased risk for any of 20 common conditions, which included heart attack, appendicitis, emboli, and illnesses caused by low platelet counts. .
In the vaccinated group, four people reported Bell’s palsy, a form of facial palsy seen in a small number of people in each of the vaccine trials. In the unvaccinated group, there were 348 cases.
Nursing home deaths ‘don’t appear to be linked to COVID-19 vaccination’
One way to know if COVID-19 vaccines are killing people is to look at the number of people who are expected to die over a period of time and compare it to the actual deaths that have occurred within days of vaccination.
VAERS has received reports of 196 deaths from the COVID-19 vaccination.
Of these, 66% were residents of long-term care facilities. About 1.3 million nursing home residents were vaccinated between December 21 and January 18.
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In such a large group followed during this period, 11,440 people are expected to die from all causes. This led the CDC to conclude that the much lower number of deaths in nursing homes was not caused by vaccination.
Barbara Bardenheier, from Brown University School of Public Health, conducted a related study with residents of Genesis Healthcare, the largest retirement home company in the United States.
More than 7,000 Genesis residents at 118 facilities received their first dose of vaccine between December 18 and December 31. After excluding people with active COVID-19 infections, researchers found fewer deaths among vaccinated residents compared to unvaccinated.
“The results suggest that short-term death rates appear unrelated to COVID-19 vaccination among residents of skilled nursing facilities,” according to a slide summarizing the study’s findings.
The CDC also found no causal link between vaccination and deaths in younger, healthier people.
Among 13.7 million people under the age of 65, 168 people are expected to suffer from a sudden and fatal heart attack over a typical period of 35 days. By comparison, 18 such deaths have been reported to VAERS among recently vaccinated people.
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The risk of COVID-19 disease is greater than the risk of anaphylaxis
Both vaccines have been shown to trigger a relatively high – but still rare – rate of serious allergic reactions.
Of the 10 million people who received the Pfizer-BioNTech vaccine, 50 suffered anaphylactic shock, a rate of five serious allergic reactions per 1 million doses. Twenty-one in 7.6 million people who received the Moderna vaccine also went into shock, a rate of 2.8 per 1 million doses.
Ninety percent of these incidents occurred within half an hour of being shot and all of them have recovered.
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By comparison, for the seasonal flu vaccine, the rate of anaphylaxis is 1.3 per million shots, significantly lower than that of the two licensed COVID-19 vaccines.
Still, “the chances of getting sick from COVID-19 are much higher than the risks of anaphylaxis,” CDC director Dr Rochelle Walensky said in a separate meeting on Wednesday.
The CDC is investigating whether people who had previously had COVID-19 before being vaccinated were more likely to have an allergic reaction.
Contact Karen Weintraub at [email protected].
Patient health and safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial contributions.
This article originally appeared on USA TODAY: The first 22 million Americans have been vaccinated against COVID-19, and initial safety data shows all is well, according to CDC
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