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Israel reports link between rare cases of heart inflammation and COVID-19 vaccination in young men | Science

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A 16-year-old in Tel Aviv, Israel, receives a dose of the Pfizer-BioNtech COVID-19 vaccine on January 23.

JACK GUEZ / AFP via Getty Images

By Gretchen Vogel, Jennifer Couzin-FrankelJun. 1, 2021, 1:55 p.m.

Science’s COVID-19 reporting is supported by the Heising Simons Foundation.

The COVID-19 vaccine, made by Pfizer and BioNTech, appears to put young men at increased risk of developing an inflammation of the heart muscle called myocarditis, Israeli researchers say. In a report presented today to the Israeli Ministry of Health, they conclude that between 1 in 3,000 and 1 in 6,000 men aged 16 to 24 who received the vaccine developed the rare disease. However, most cases were mild and resolved within a few weeks, which is typical of myocarditis. “I can’t imagine medical professionals saying we shouldn’t vaccinate children,” said Douglas Diekema, pediatrician and bioethicist at Seattle Children’s Hospital.

Israeli health officials first reported the problem in April when they reported more than 60 cases, mostly in young men who had received their second dose of the vaccine a few days earlier. Around the same time, the US Department of Defense began pursuing 14 such cases. In mid-May, the U.S. Centers for Disease Control and Prevention announced that cases of myocarditis are also being reviewed. European Medicines Agency officials announced on May 28 that they had received 107 reports of myocarditis following the Pfizer BioNTech vaccine, or about one in 175,000 doses administered. But relatively few people under the age of 30 have been vaccinated in Europe.

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The results of the Israeli panel come from the debate between Israel and many European countries over whether younger youth should be vaccinated against COVID-19. Israel has been vaccinating adolescents aged 16 and over since late January, and the Ministry of Health is due to announce tomorrow whether vaccinations will be open to children aged 12 and over. Other countries, including the United States and Canada, began vaccinating children ages 12 and older in mid-May.

“From the parents’ point of view, it really depends on the risk perception and the evaluation of the data,” says Diekema, who examined the risk-benefit analysis. Even if a link between myocarditis and the vaccine remains, the condition is usually mild and requires treatment with only anti-inflammatory drugs, while COVID-19 infection can cause serious illness and long-term side effects in young people as well. “I don’t know many doctors who change their minds about vaccinating their children,” says Diekema.

In Israel, which relied almost entirely on the Pfizer BioNTech vaccine for its early and rapid vaccination campaign, the Ministry of Health convened a panel in January led by Dror Mevorach, director of internal medicine at Hadassah University Medical Center, to assess the problem examine. Mevorach shares with Science that he and his colleagues have identified 110 cases of myocarditis in 5 million people in Israel who received two doses of the Pfizer BioNTech vaccine in the month prior to their diagnosis. That’s roughly the equivalent of one in 50,000 vaccine recipients, a number that is not of concern given the background rate of myocarditis in the general population that is typically caused by viral or bacterial infections, including COVID-19.

However, the rate of myocarditis after vaccination was higher in young men. Ninety percent of the cases picked up in Israel occurred in men, and while myocarditis is usually more common in young men, the rate among those vaccinated was between five and 25 times the background rate, the report said. The analysis “is very causal in nature,” says Mevorach. “I believe there is a link” between the vaccine and the cases.

“It suggests that this is a real phenomenon, at least statistically,” says Peter Liu, cardiologist and scientific director of the Heart Institute at the University of Ottawa. Diekema says it is important to “investigate the evidence for a signal” but warns that “this report is suggestive … it will require validation in other populations by other investigators before we can be certain that the There is a connection “. Other factors could play a role, says Diekema. Now that the kids are socializing and exercising again, his hospital’s emergency department is seeing “more viral illnesses than we’ve seen in a year,” and as a result, “I would expect a small increase in myocarditis from a year.” “Ideally, scientists should compare cohorts of vaccinated and unvaccinated adolescents at the same time,” says Diekema, and he is encouraged that such studies be prepared now.

Cases of myocarditis after the Moderna vaccine, which is not used in Israel, are also being investigated in the United States. It’s not clear why the two vaccines, both based on messenger RNA (mRNA), could increase the risk. One possibility is that the very high levels of antibodies, both of which produce in young people, in rare cases also lead to some kind of immune overreaction that inflames the heart. “There is no question about that [vaccines] are extremely immune generating, ”says Liu. Mevorach suspects that the mRNA itself could play a role. The innate immune system recognizes RNA as part of the body’s defense against microbes – including RNA viruses like SARS-CoV-2, he notes. “I think the mRNA is actually a kind of natural adjuvant that boosts the immune response,” he says.

According to Diekema, the medical community is now on alert for teens with chest pain and other symptoms shortly after vaccination so they can be quickly identified, treated and reported to health officials. Mevorach agrees that the awareness of those vaccinated, their parents, and their doctors is important for prompt and effective treatment. He says he and his colleagues handled about 40 cases. Few needed corticosteroids, he said, and most would have made a full recovery.

An important question is whether delaying the second dose of vaccine could reduce the potential risk. Maybe there is an opportunity to find out: Several countries have increased the interval between the two doses from the 3 weeks tested and recommended by Pfizer to 12 or even 16 weeks because they want to give at least one injection to as many people as possible. A decline in myocarditis cases in those whose second dose was delayed could show in the months’ data. Lowering the dose in young people could also be worth considering, says Liu. Pfizer and Moderna vaccines are now being tested at lower doses in children under the age of 12, with results expected in the coming months.

Even if the link between the syringes and myocarditis solidifies, the vaccine’s benefits – providing good protection against COVID-19 – outweigh the risks, even for young people, who are generally less at risk of developing serious illnesses, according to Liu. However, Mevorach says the compromises in Israel could possibly be different given the extremely low number of SARS-CoV-2 infections – only 15 new cases were diagnosed yesterday. He hopes the Ministry of Health will leave the decision on vaccinating younger adolescents to their parents and doctors. “We don’t have an emergency at the moment,” he says.

Pandemic

Kremlin blames ‘nihilism’ as Moscow sees record COVID-19 infections

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A specialist wearing personal protective equipment (PPE) sprays disinfectant while disinfecting Rizhsky train station, one of the measures taken to contain the spread of coronavirus disease (COVID-19), in Moscow, Russia, June 17, 2021. Moscow Department for Russian Emergencies Ministry / Handout via REUTERS

MOSCOW, June 18 (Reuters) – The Kremlin on Friday blamed a surge in COVID-19 cases on reluctance to get vaccinated for “nihilism” after fears raised a record of 9,000 new infections in the capital third wave had stoked.

Russia, the largest country in the world, reported 17,262 new coronavirus infections nationwide.

Moscow Mayor Sergei Sobyanin extended the restrictions he had previously imposed, including a ban on public events with more than 1,000 people, the closure of cafes and restaurants at 11 p.m. and the closure of fan zones set up for the European Football Championship. Continue reading

Sobyanin said earlier this week that Moscow, home to 13 million people, was facing a new, more aggressive and contagious variant of the coronavirus and that the situation in the city was rapidly deteriorating.

It was not clear if he was referring to the Delta variant, which was first identified in India and which led to a resurgence of cases in the UK.

Kremlin spokesman Dmitry Peskov said President Vladimir Putin is closely monitoring the situation.

When asked to explain the increase in cases, Peskov blamed the virus’ “cunning nature”, an indication of its mutations, and “total nihilism and low vaccination rate”. Continue reading

At a briefing, he rejected the idea, postulated by some critics, that Russians were reluctant to vaccinate because they mistrusted the authorities.

As of June 2, the latest available census, only 18 million Russians had received at least one dose of vaccine: that is far less than most western countries for one eighth of the population.

The Moscow authorities this week ordered all workers with public functions to be vaccinated. Continue reading

Sobyanin said Friday he expected the city government to begin vaccinating migrant workers with Sputnik Light – a single dose of the Sputnik-V vaccine – early next month.

But he also said it was “vital” to give more booster doses – a third dose, in effect. He said he had just received a booster himself after being fully vaccinated twice a year ago.

He said the third dose offered was a repeat of the first dose of the double Sputnik-V vaccine.

Several Russian officials and members of the business elite, as well as some members of the public, have already secured third and fourth doses of Sputnik V, Reuters reported in April. Continue reading

How long a vaccine will protect against COVID-19 will be crucial as countries assess when or if re-vaccination is needed, and Russia’s results are closely monitored elsewhere.

Reporting by Gleb Stolyarov; Letter from Olzhas Auyezov; Editing by Maria Kisselyova

Our Standards: The Thomson Reuters Trust Principles.

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Global COVID-19 death toll exceeds 4 million

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June 18 (Reuters) – Coronavirus-related deaths worldwide passed a dismal 4 million milestone on Thursday, as many countries struggle to get enough vaccines to keep their populations safe, according to a Reuters tally.

While the number of new cases and deaths has declined in countries like the United States and the United Kingdom, several countries are experiencing vaccine shortages as the Delta variant becomes the dominant strain worldwide.

According to a Reuters analysis, it took over a year for the COVID-19 death toll to hit 2 million, while the next 2 million were recorded in just 166 days.

The five largest countries by total deaths – the United States, Brazil, India, Russia, and Mexico – account for about 50% of all deaths worldwide, while Peru, Hungary, Bosnia, the Czech Republic, and Gibraltar have the highest death rates when populations adjust is. (Chart on worldwide cases and deaths)

Countries in Latin America are facing the worst outbreak since March, with 43 out of 100 infections reported in the region worldwide, according to a Reuters analysis. The nine countries that reported the most deaths per capita in the past week were all in Latin America.

Hospitals in Bolivia, Chile and Uruguay mostly see COVID-19 patients between the ages of 25 and 40 as the trend towards younger patients continues. In Sao Paulo, Brazil, 80% of intensive care unit (ICU) inmates are COVID-19 patients.

Rising deaths are straining the operating capacity of crematoriums in developing countries, and gravediggers in several countries have been forced to add a number of new graves to cemeteries.

India and Brazil are the countries with the highest number of reported deaths on a seven-day average each day and are still facing cremation issues and shortage of burial sites. According to a Reuters analysis, India is responsible for every third death reported worldwide on a daily basis.

Many health experts believe the official death toll is underestimated worldwide, with the World Health Organization (WHO) estimating the death toll as much higher last month.

Last week, the Indian state of Bihar significantly increased its COVID-19 death toll after discovering thousands of unreported cases, adding weight to concerns that India’s total death toll is well above the official figure.

As poorer countries struggle to vaccinate their populations due to vaccine shortages, wealthier countries have been urged to donate more to help contain the pandemic.

“The main problem in America is access to vaccines, not vaccine acceptance,” said Carissa Etienne, director of the Pan American Health Organization, on Wednesday, urging donor countries to send vaccinations as soon as possible.

The Group of Seven (G7) rich nations had pledged to provide 1 billion COVID-19 vaccinations to help poorer countries vaccinate their populations.

(Corrects the day of the week in the first paragraph)

Reporting by Roshan Abraham and Ahmed Farhatha in Bengaluru; Additional coverage from Lasya Priya M; Edited by Lisa Shumaker and Karishma Singh

Our Standards: The Thomson Reuters Trust Principles.

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CureVac Shares Plunge Premarket on Disappointing Covid-19 Vaccine Trial

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Shares in Germany’s CureVac CVAC -3.47%

NV fell nearly in half in pre-trading hours, suggesting significant losses for investors as the market reopened after the drug company reported disappointing results from a study on its experimental Covid-19 vaccine.

Nasdaq-listed CureVac said late Wednesday that its vaccine was 47% effective against the disease in an interim analysis of a large clinical trial, a disappointing result that will likely cloud the vaccine’s prospects for wider use.

For the main listing in the US, shares fell 45% in over-the-counter trading. The shares of the Frankfurt-listed company traded 43% lower on Thursday.

The setback could hamper vaccination campaigns in Europe because the German company has a contract with the European Commission to supply up to 405 million doses, one of the bloc’s largest deals with a single company. CureVac has partnered with major pharmaceutical company GlaxoSmithKline GSK 0.22%

SPS and Novartis AG

NVS -0.13%

to help make cans.

CureVac was once considered one of the most hopeful candidates for developing a successful Covid-19 vaccine. It received support from the German government, which had a 17% stake in the company, and the company was listed in the US last August. The company had a market valuation of $ 18.29 billion at the close of trading on Wednesday.

The share price had already declined in the past few days due to growing doubts about the study and the company’s ability to get its vaccine approved in Europe in the second quarter as planned.

A government spokesman declined to comment on the interim analysis, but said it would not affect the German vaccination schedule. On its website, the German Ministry of Health no longer includes CureVac in its vaccine delivery forecasts for the remainder of 2021.

CureVac’s vaccine uses a gene-based technology, messenger RNA, similar to that used by Moderna Inc.

and Pfizer Inc.,

with his partner BioNTech SE,

Manufacture Covid-19 vaccines.

In comparison, these vaccines were at least 94% effective in large clinical trials last year before new virus variants spread significantly. The Moderna and Pfizer shots have formed the backbone of mass vaccination campaigns in the US and other countries.

CureVac’s vaccine is slightly different from the Pfizer and Moderna shots, with a formulation that allows for storage at higher temperatures than the other shots.

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CureVac, together with its partner Bayer AG, carried out a combined clinical phase 2/3 study with its vaccine from December, in which around 40,000 people in 10 countries in Latin America and Europe took part.

The study volunteers received two doses of either the CureVac vaccine or a placebo, and the researchers tracked how many in each group got Covid-19.

The proliferation of new coronavirus variants may have played a role in the disappointing effectiveness, CureVac said.

Approximately 57% of Covid-19 cases for which virus sequence data was available were caused by variants of concern – those that are more easily transmitted or can cause more serious illness – and most of the remaining cases were caused by other, less characterized variants, announced the company.

“Although we had hoped for a stronger interim result, we are aware that demonstrating high efficacy in this unprecedented variety of variants is a challenge,” said Dr. Franz-Werner Haas, CEO of CureVac.

The company said the effectiveness of the vaccine in the study varied based on age, with results suggesting effectiveness in younger people but not conclusive effectiveness in those over 60 years of age.

CureVac’s early work on a Covid-19 vaccine last year first caught the attention of then-President Donald Trump. In March 2020, the German government accused the US of tricking CureVac into moving to the US to work on a vaccine.

The company continued to develop the shot after its founder, who returned as CEO, suffered a debilitating stroke and took medical break.

Write to Peter Loftus at peter.loftus@wsj.com

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