Side effects feared from vaccine are more common in COVID cases — Israeli study

[overman]

https://www.timesofisrael.com/side-...are-more-common-in-covid-cases-israeli-study/​

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Side effects feared from vaccine are more common in COVID cases — Israeli study​

Research on 2 million Israelis fails to find high incidence of any serious side effect post-inoculation; coronavirus patient 4 times more likely to get myocarditis than vaccinee​

COVID is far worse than vaccines in elevating risk of myocarditis and other conditions that have been feared as post-inoculation side effects, Israeli research shows.

The authors of the peer-reviewed side effects study, thought to be the largest of its kind to date, say it offers new reassurance on the safety of the Pfizer vaccine. They believe that it should prompt a serious rethink among people who shun the shots because of the rare side effects.

“Anyone who has been hesitant to get vaccinated so far due to concerns about rare side effects such as myocarditis, should be aware that the risk is higher among unvaccinated people infected with the coronavirus,” said Prof. Ran Balicer, head of research at the Clalit Health Services, which produced the study.


The study looked at almost two million medical records, and failed to identify high incidence of any serious side effect post-vaccination — while finding that several conditions are less common than normal among the newly inoculated.

According to Balicer, it provides clear figures that put the incidence of side effects, which loom large in the minds of many, into perspective.

Balicer, a senior adviser to the Israeli government on the coronavirus, said: “So far one of the main motives for hesitation to get vaccinated has been a lack of information about possible vaccine side effects. This in-depth study provides reliable information on the safety of the vaccines, and we hope it will help those who have not yet decided on the vaccine.”

One of the most discussed vaccine side effects, a heart condition called myocarditis, was found to be elevated among vaccinated people, with 2.7 more cases per 100,000 people than would normally occur (known as surplus cases). But among people who didn’t vaccinate and subsequently caught COVID-19 and recovered, surplus cases stood at 11 per 100,000.

The study, just published in the New England Journal of Medicine, focused on people who received the Pfizer vaccine, and tracked patients’ health for six weeks. The study concluded that “the BNT162b2 vaccine was not associated with an elevated risk of most of the adverse events examined.”

The main exceptions were lymphadenopathy, which enlarges lymph nodes, and shingles. There were 78 surplus cases of lymphadenopathy per 100,000 vaccinated people but only 3 among the unvaccinated and infected.

There were nine fewer cases of shingles per 100,000 among the unvaccinated population than the norm, but 16 surplus cases among vaccinated patients.

The data indicates that the conditions feared as side effects were largely in the normal range — or even less common than normal — among vaccinated people, but elevated among those who caught COVID-19.

Acute kidney injury and arrhythmia turned out to be less common among the vaccinated than would be expected. Yet among the unvaccinated and infected patients, there were surplus cases — as many as 125 and 166 per 100,000 in the case of acute kidney injury and arrhythmia respectively.

There were other conditions that were more common among recovered patients, but in the broadly normal range among the vaccinated. These included pulmonary embolism (62 surplus events per 100,000 among the infected), deep vein thrombosis (43 events), myocardial infarction (25 events), pericarditis (11 events), and intracranial hemorrhage (7.6 events).

Appendicitis was found higher than the norm among both vaccinated people and the unvaccinated infected to a similar level — with five and four surplus cases per 100,000 people respectively.

The research was conducted in partnership with Harvard University, which chose to study Israeli data because it is comprehensive. Marc Lipsitch, director of Harvard’s Center for Communicable Disease Dynamics, a co-author of the study, said that a major challenge of vaccine safety research is comparing like-for-like patients.

“This is especially challenging when it comes to vaccines that are advancing so fast, but Clalit’s extraordinary database makes it possible to design research that addresses these challenges in a way that builds confidence in the reliability of the research’s conclusions.”

Since EDMW likes Israel as a case study so much here is another article

https://www.timesofisrael.com/israe...or-highly-allergic-patients-with-supervision/

Israeli study: Pfizer shot safe for highly allergic patients, with supervision​

Of 429 people with serious allergies, only 9 had a reaction to the COVID shot, and all of them recovered quickly and experienced no further issues​

People with serious allergies can safely be inoculated with the Pfizer coronavirus vaccine with supervision, an Israeli study has concluded.

Sheba Medical Center, Israel’s largest hospital, set up a special clinic to oversee administration of vaccines to highly allergic people, with medical assessments done first and doctors on hand to treat the patients in the case of any serious reactions.

The Pfizer-BioNTech vaccine by far is the shot most commonly used in Israel (Moderna has also been used but in a limited amount).


More than 8,000 people applied, and 429 with serious allergies were vaccinated under observation. Only nine of the 429 had allergic reactions, and all of them quickly recovered and were in good health through the study’s two-week follow-up period.

The team running the clinic wrote their findings in a peer-reviewed study in the Journal of the American Medical Association.

It concluded that, with the right expert oversight, “most patients with a history of allergic diseases and, particularly, highly allergic patients, can be safely immunized.”

Dr. Nancy Almog-Levin, Sheba’s head of clinical immunology who directed the research, told The Times of Israel that allergic reactions were more common than with other vaccines, but that the level was not concerning and all reactions were easily managed.

She noted that initially there had been concerns about the Pfizer vaccine for highly allergic people, and that the US Food and Drug Administration had recommended that such people not be vaccinated. This has since been revised, and now few people are excluded on allergy grounds.

“Now, our data clearly shows that seriously allergic people can be vaccinated safely, which is important,” she said.

“This is significant for people with allergies, and also for others. Because if we’re seeing that even among the most allergenic people the vaccine is safe, we can infer that it’s very safe in terms of allergic reactions for the rest of the population that doesn’t suffer badly from allergies.”

The authors suggested that their research is particularly significant as clinical trials for the Pfzer vaccine and several subsequent studies had excluded patients with a history of allergic reactions, and there is confusion about the impact of vaccines on highly allergic people.

The study describes how careful assessment of patients with allergies allowed them to be safely given vaccines. They were invited to apply to Sheba, and 8,102 people submitted their details. Some 6,883 were defined as low-risk and were vaccinated in normal settings.

The next level of screening involved an allergy questionnaire, after which 785 received regular vaccination and five were deferred from immunization. The remaining 429 were deemed in need of care from the high-risk clinic, with vaccines given under observation.

Nine had allergic reactions, all of them women. Six of them had mild immediate allergic reactions, like swelling of the tongue or a cough that was fixed with antihistamine.

Three patients had anaphylactic reactions that included shortness of breath. Two of those three had a prior diagnosis of multiple drug allergies. All three were successfully treated with adrenaline, antihistamines, and an inhaler.

The study stated: “All nine patients who experienced an immediate reaction to the first dose were followed up by our team within two weeks; none reported recurrent or ongoing allergic symptoms.”