The Safety monitoring data of 6.2 million mRNA vaccinators is released!

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The safety monitoring data of 6.2 million mRNA vaccinators is released!

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The safety monitoring data of 6.2 million mRNA vaccinators is released!

Regarding whether to vaccinate, the three most basic points are: the necessity of vaccination, the effectiveness of the vaccine, and the safety of the vaccine.

The necessity of vaccination is beyond doubt. Starting from December 2019, the new coronavirus disease (COVID-19) caused by the new coronavirus (SARS-CoV-2) has spread globally. According to the Johns Hopkins University database, as of September 7, 2021, Eastern Time, there are 220 million confirmed cases worldwide and 4,581,038 deaths.

More importantly, it is not yet possible to predict when this century’s plague will end. . .

(Source: arcgis.com)

The effectiveness of the vaccine is also well-documented. At present, 18 vaccines have been approved for marketing, of which two mRNA vaccines have shown outstanding vaccine protection efficacy.

Only the safety of the vaccine has always made me worried.

Theoretically, I fully believe in the safety of mRNA vaccines; however, as far as we, family members, and relatives and friends are concerned, they are vaccinated with mRNA COVID-19 vaccine. This prompts us to review the safety of the vaccine with a magnifying glass every day, lest there be any omissions.

We have also posted a lot of tweets on the safety of mRNA vaccines for this purpose, and we will not miss any clues.

However, most of the previously published studies involved tens of thousands of subjects in clinical trials; who knows what other rare adverse events are?

Finally  the research data of millions of vaccinators came out.

On September 3, 2021, JAMA magazine published data on the safety of mRNA vaccines that many people are concerned about. This study was completed by an independent Vaccine Safety Data Link (VSD), which monitored 6.2 million vaccinators of mRNA COVID-19 and 11.8 million doses, focusing on 23 potential serious adverse events.

Vaccinators’ data:

• The researcher is the Vaccine Safety DataLink (VSD), which was established in 1990 and owns America’s premier active monitoring system for vaccine safety.
• The included data comes from Kaiser Permanente, the largest medical system in the United States, and three other related medical systems, covering a population of 12.5 million.
• Starting from December 14, 2020, the data on vaccine side effects will be updated weekly through active monitoring of medical records; the data in this research paper will be updated until June 26, 2021.
• This monitoring only involves two mRNA vaccines, namely Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273.

Observation indicators:

Monitor 23 serious adverse events, including:

1) Routine monitoring of diseases: acute disseminated encephalomyelitis, allergic reactions, encephalitis/myelitis, Guillain-Barré syndrome, immune thrombocytopenia, Kawasaki disease, narcolepsy, epilepsy, transverse spinal cord inflammation;

2) COVID-19 vaccine related diseases: appendicitis, Bell’s palsy;

3) COVID-19 infection related diseases: acute myocardial infarction, acute respiratory distress syndrome, diffuse intravascular coagulation, multiple system inflammatory syndrome in children and adults, myocarditis/pericarditis, pulmonary embolism, stroke (hemorrhagic/ischemic ), thrombotic thrombocytopenic purpura and venous thromboembolism;

4) Diseases newly discovered during surveillance: cerebral venous sinus thrombosis, thrombosis with thrombocytopenia syndrome, myocarditis/pericarditis.

Main results:

1. Demographic characteristics of subjects:

The vaccinated population is dominated by young adults aged 18-59, reaching 5.12 million; in terms of race, the white population is the most with 4.13 million, and 1.23 million Asians who have received the mRNA vaccine are also included.

(Image source: JAMA)

2. Inoculation of mRNA vaccine for 1 to 21 days does not increase a series of health risks.

As shown in Table 3, the study compared the observed 23 potential adverse events, and found no statistically significant differences in the occurrence of these adverse events within 1 to 21 days of the mRNA vaccine. Including myocarditis/pericarditis, which is widely concerned.

(Image source: JAMA)

3. In the adolescent group, the risk of myocarditis/pericarditis increases after vaccination with mRNA vaccine.

Given that pericarditis and myocarditis mainly occur in the adolescent group, the researchers specifically analyzed the 12-39-year-old vaccinators. The results are similar to previous reports: mRNA vaccination is associated with an increased risk of pericarditis/myocarditis.

(Image source: JAMA)

Specifically, from 0-21 days after mRNA vaccination, 34 cases of myocarditis/pericarditis occurred in 12-39 year-old vaccinators, of which 85% were males, which mainly occurred in the first week after vaccination. It is common after the second vaccination; 82% of patients with pericarditis/myocarditis were admitted to the hospital, with a median hospital stay of 1 day, and all 34 patients with myocarditis/pericarditis were discharged (Annex Table 4).

(Image source: JAMA)

From this, the researchers concluded that no serious health effects related to BNT162b2 or mRNA 1273 vaccination were found.

This result was quickly reported by the major media. In response, Dr. Nicola Klein, the lead researcher of the project, said:

“These results from our safety surveillance are reassuring,”

Regarding the myocarditis/pericarditis, the only myocarditis/pericarditis associated with the mRNA vaccine in adolescents, the researchers specifically emphasized: in the first week of vaccination, for every 1 million doses, there is an additional risk of 6.3 cases of myocarditis/pericarditis.

To be honest, this ratio is much lower than we expected, and it is consistent with the previous report: the median hospitalization was only 1 day, and all patients recovered and discharged; this result actually helps strengthen our confidence in letting children receive mRNA vaccination. .

This result is also consistent with a real-world study published by Israel in the New England Journal of Medicine (NEJM) on August 25, 2021.

In this study, the Clait Institute cooperated with Harvard University to analyze the Israeli health database, a total of 880,000 vaccinators, to test the safety of the BNT162b2 mRNA vaccine. It was also found that myocarditis was related to vaccination, but it was very rare, every 10 years. There were 2.7 excess cases out of 10,000 vaccinators.

More importantly, the researchers compared the probability of these rare adverse reactions in people vaccinated with the mRNA vaccine and those infected with the new coronavirus. The results showed that among those with the BNT162b2 mRNA vaccine, except for the increased risk of lymphadenopathy, other risks were far lower than those of the new coronavirus. People infected with the virus.

This result further demonstrates the protection of population health by vaccination (BNT162b2).

(Image source: NEJM)

Summary:

Studies targeting 6.2 million people who received mRNA vaccines (BNT162b2 and mRNA-1273) in the United States and 880,000 BNT162b2 mRNA vaccinations in Israel have shown that mRNA vaccines have extremely high safety and no serious health effects related to mRNA vaccination have been found.

(source:internet, reference only)

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Important Note: The information provided is for informational purposes only and should not be considered as medical advice.