Moderna

Sweden Suspends Use of Moderna Covid Vaccine in Under-30s Due to Concerns about Side Effects

Swedish health authorities have suspended the use of the Moderna Covid vaccine in people aged 30 and under due to concerns about side effects, including inflammation of the heart muscle. The Independent has the story.

The reason for the pausing is “signals of an increased risk of side effects such as inflammation of the heart muscle or the pericardium” – the double-walled sac containing the heart and the roots of the main vessels, Sweden’s Public Health Agency said in a statement. “The risk of being affected is very small.” 

Anders Tegnell, Sweden’s Chief Epidemiologist, said they “follow the situation closely and act quickly to ensure that vaccinations against Covid are always as safe as possible and at the same time provide effective protection” against the disease.

In July, the European Medicines Agency recommended authorising Moderna’s Covid vaccine for children ages 12 to 17, the first time the shot has been authorised for people under 18.

Moderna’s vaccine was given the green light for use in anyone 18 and over across the 27-nation European Union in January. It has also been licensed in countries including Britain, Canada and the U.S., but so far its use hasn’t been extended to children. To date, the Pfizer vaccine is the only one approved for children under 18 in Europe and North America.

Hundreds of millions of Moderna doses already have been administered to adults. In a study of more than 3,700 children ages 12 to 17, the vaccine triggered the same signs of immune protection, and no Covid diagnoses arose in the vaccinated group compared with four cases among those given dummy shots.

Sore arms, headache and fatigue were the most common side effects in the young vaccine recipients, the same ones as for adults.

U.S. and European regulators caution, however, that both the Moderna and Pfizer vaccines appear linked to a rare reaction in teenagers and young adults — chest pain and heart inflammation.

The Swedish health authorities said that the heart symptoms “usually go away on their own,” but they must be assessed by a doctor. The conditions are most common among young men, in connection with, for example, viral infections such as Covid. In 2019, approximately 300 people under the age of 30 were treated in hospital with myocarditis.

Data point to an increased incidence also in connection with vaccination against Covid, mainly in adolescents and young adults and mainly in boys and men.

Worth reading in full.

Third Man Dies in Connection To Contaminated Moderna Vaccine Doses in Japan

The suspension of over two and a half million doses of the Moderna Covid vaccine in Japan following the discovery of contaminants in a number of batches did not come soon enough, with yet another death having been reported after vaccination of a potentially dodgy dose. This time, a man approaching his 50s died just one day after receiving his second dose. The Guardian has the story.

The 49 year-old man had his second shot on August 11th and died the following day. His only known health issue was an allergy to buckwheat, the Health Ministry said on Monday. As with the previous two deaths, the ministry said it had yet to establish if the latest fatality was linked to the vaccine.

The shot came from one of the three batches that were part of a recall of 1.63 million doses of the Moderna vaccine on August 26th, but not from one of the batches found to have fragments of stainless steel in them. The three batches were manufactured in Spain under contract by Moderna.

The company said: “This is a tragic event, and the loss of life is something that we take very seriously. We offer our sincerest condolences to their loved ones.”

Last week Moderna issued a joint statement with local distributor Takeda Pharmaceutical, saying: “The rare presence of stainless steel particles in the Moderna Covid vaccine does not pose an undue risk to patient safety and it does not adversely affect the benefit/risk profile of the product.”

Early last month, two men in their 30s with no underlying health conditions died within days of getting their second dose of the Moderna vaccine.

Contaminants believed to be pieces of rubber fragments from vial stoppers that entered the vaccine liquid due to incorrectly inserted needles were found in Okinawa, Gunma and Kanagawa in late August and early September. No problems were reported among those injected with the contaminated vaccines, which came from different batches to the previously recalled ones.

Worth reading in full.

Another Million Doses of the Moderna Covid Vaccine Suspended in Japan Over Contamination Fears

The recent deaths of two Japanese men in their 30s after being given potentially dodgy doses of the Moderna Covid vaccine was not the end of Moderna’s troubles in the country, with another million doses having now been temporarily suspended following the discovery of contaminants in more batches. Reuters has the story.

The suspension of Moderna supplies, affecting more than 2.6 million does in total, comes as Japan battles its worst wave of Covid yet, driven by the contagious Delta variant, with new daily infections exceeding 25,000 this month for the first time amid a slow vaccine roll-out.

The latest reports of vaccine contamination came from Gunma prefecture near Tokyo and the southern prefecture of Okinawa, prompting the suspension on Sunday of two more lots in addition to the 1.63 million doses already pulled last week.

A tiny black substance was found in a Moderna vaccine vial in Gunma, an official from the prefecture said, while in Okinawa, black substances were spotted in syringes and a vial, and pink material was found in a different syringe.

Japan’s Health Ministry said some of the incidents may have been due needles being incorrectly inserted into vials, breaking off bits of the rubber stopper. Other vials from the lots can continue to be used, the ministry said on Monday.

The contamination cases followed a Government report on Saturday that two people died after receiving Moderna shots that were among lots later suspended.

The Government had said that no safety or efficacy issues had been identified and that the suspension was a precaution. The causes of death are being investigated.

“It is unlikely, in my opinion, that contamination of foreign substances led directly to sudden deaths,” said Takahiro Kinoshita, a Physician and Vice Chair of Cov-Navi, a vaccine information group.

“If the contaminated substances were dangerous enough to cause death for some people, probably many more people would have suffered from some symptoms after the vaccination.

“However, further investigations are definitely needed to evaluate the harm of the particular doses in question.”

Worth reading in full.

Two Die After Taking Moderna Vaccine From Now-Suspended Batches

Two men in their 30s have died in Japan after being given a dose of the Moderna Covid vaccine from batches that have since been suspended following the discovery of contaminants. Reuters has the story.

The men in their 30s died this month within days of receiving their second Moderna doses, the [Japanese Health] Ministry said in a release. Each had a shot from one of three manufacturing lots suspended on Thursday. The causes of death are being investigated.

Japan halted the use of 1.63 million Moderna doses shipped to 863 vaccination centres nationwide, more than a week after the domestic distributor, Takeda Pharmaceutical Co, received reports of contaminants in some vials.

“At this time, we do not have any evidence that these deaths are caused by the Moderna Covid vaccine,” Moderna and Takeda said in a statement on Saturday. “It is important to conduct a formal investigation to determine whether there is any connection.”

The Government has also said no safety or efficacy issues had been identified and the suspension of the three Moderna batches was a precaution. …

The contaminants found in some vials in Japan are believed to be metallic particles, public broadcaster NHK reported, citing Health Ministry sources.

Worth reading in full.

U.S. Health Officials Reviewing Reports That Moderna Covid Vaccine Linked to Higher Risk of Heart Condition Than Previously Thought

Days after the U.S. Government announced its plans to begin a Covid booster vaccine roll-out, the Washington Post has revealed that American health officials are reviewing reports that the Moderna vaccine may be linked to a higher risk of a heart condition in younger adults than was previously thought – especially in young men. Reuters has the story.

The review was focused on Canadian data that suggests a higher risk from the shot than the Pfizer vaccine, especially in men below the age of 30, according to paper.

The Washington Post report quoted a source saying it was too early for the regulators to reach a conclusion, and that additional work was needed before any recommendation was made.

“While we won’t comment on internal meetings or discussions, we can say that FDA is absolutely committed to reviewing data as it becomes available to us,” the U.S. Food and Drug Administration said. Moderna did not immediately respond to Reuters’ requests for comment.

The possible review comes just two days after U.S. health officials said that Covid vaccine booster doses will be available to Americans from September 20th, over concerns that initial vaccinations may offer lower protection in the face of rising infections due to the Delta variant.

Health regulators in June had added a warning to the literature that accompanies mRNA vaccines produced by Moderna and Pfizer to flag a rare risk of heart inflammation seen primarily in young males.

Data from a Government agency’s safety monitoring system in that month suggested a rate of 12.6 cases of heart inflammation per million in 12 to 39 year-olds. …

If new information changes the risk-benefit profile of Covid vaccines, the FDA will update the public accordingly, the agency said in an email. …

Roughly 142 million shots of the Moderna vaccine have been administered in arms, according to U.S. Government data as of Thursday.

Worth reading in full.

Moderna Covid Vaccine Approved for Use in 12 to 17 Year-Olds by U.K. Regulator

The Medicines and Healthcare products Regulatory Agency says the Moderna Covid vaccine is safe for use in U.K. children aged 12 to 17 years. It is now up to the Joint Committee on Vaccination and Immunisation (JCVI) to advise the Government on whether the Moderna jab should be rolled out to children in this age group. Reuters has the story.

Moderna’s vaccine was recommended for use in adolescents by European regulators in July and is awaiting U.S. authorisation. It is already approved for people over the age of 18 in the U.K.

Britain’s JCVI gave the go ahead on August 4th for 16 and 17 year-olds to get their first dose of Pfizer’s Covid vaccine ahead of the reopening of schools for the new education year in September.

JCVI will make a decision on whether 12-17 year olds should be vaccinated with the shot made by Moderna as part of its deployment programme.

The MHRA said it did not identify any new side effects with the vaccine and that the safety data was comparable with that for young adults, with adverse events being mostly mild and moderate and including sore arms or fatigue. …

The vaccine developed by Pfizer… got MHRA’s nod for use in children aged 12 to 15 on June 4th.

Worth reading in full.

Slowing Vaccine Take-Up Means 170,000 Moderna Doses at Risk of Expiry

The NHS is looking to redistribute thousands of Covid vaccine doses as slowing take-up rates among young Britons, who don’t appear to be moved by petty bribes, could result in doses being thrown away after reaching their expiry dates. The Guardian has the story.

An internal email seen by the Guardian warned of 170,000 doses of the Moderna vaccine at risk of expiry within the next fortnight, as doctors across England have raised alarm at the unpredictability of vaccine take-up among young people meaning more doses will go to waste.

The Government is to unveil a raft of new initiatives to increase vaccine uptake among young people, including discounts on car-hailing companies such as Uber and Bolt, as well as the delivery service Deliveroo.

It is understood the NHS has managed to redistribute 40,000 of the spare Moderna jabs. However, concerns have been raised about the number of jabs wasted as uptake slows among younger people eligible for the Moderna and Pfizer jabs.

The Joint Committee for Vaccination and Immunisation recommends an interval of eight to 12 weeks between doses, initially as a way to offer more people first doses because of limited supply, but studies have since shown that the larger gap could give longer protection.

One NHS doctor in the north-east, Dr Alison George, said colleagues had been forced to routinely discard Pfizer doses, rather than give second shots early to people who requested them. “We have very high rates of infection here and the local hospital is already under significant pressure with some elective surgery cancelled,” the GP said. …

Beccy Baird, a Senior Fellow at The King’s Fund, said it was getting more difficult to predict vaccine uptake.

“Uptake is getting lower as the cohorts get younger and matching the supply of vaccines to demand will get harder as demand becomes less predictable. This is made all the harder as the vaccines have a limited shelf life,” she said. …

“In the early stages of the rollout, you could be confident that wherever vaccines were delivered there would be sufficient demand for them. Now that a majority of adults have been vaccinated, and with uptake getting lower as the cohorts become younger, demand for the vaccine is more unpredictable, making it harder to know exactly where the doses are needed.” …

Pfizer and Moderna vaccines are now mostly distributed to the under-40s, who cannot receive the AstraZeneca vaccine. Those vaccines have a shorter shelf life of up to one month in the fridge, compared with the AstraZeneca vaccine, which can last for up to six months.

Worth reading in full.

Man Dies from Blood Clot after Taking Moderna Covid Vaccine

Cases of blood clotting after vaccination have mainly been associated with the AstraZeneca Covid vaccine over recent months, but an American man, aged 65, has now died 12 days after his second dose of the Moderna vaccine in what is being reported as the first known death from blood clotting linked to this vaccine. The Sun has the story.

After getting the coronavirus jab, the man experienced pain in both legs, difficulty breathing and was diagnosed with thrombosis with thrombocytopenia syndrome (TTS) two days before he died.

Three days into his stay at Allegheny Health Network in Pittsburgh, Pennsylvania, the man developed cerebral venous sinus thrombosis, according to a report published on the Annals of Internal Medicine website.

This is a rare type of blood clot blocking the brain’s sinus channels of draining blood, which could lead to hemorrhages. 

Doctors searched to identify other causes behind his TTS including Covid, other viruses or thrombotic thrombocytopenia purport, a rare disorder that causes blood clots throughout the body.

The man had chronic underlying conditions including high blood pressure and hyperlipidemia, which presents itself when high levels of fat particles are in the blood.

Despite “rapid and exhaustive” treatment eliminating all other options, a solution could not be found leaving investigators believing the blood clots were caused by the vaccine.

Previously, research showed that the “rare but life-threatening” condition only occurred in individuals who received Johnson & Johnson or AstraZeneca vaccines.

Both vaccines combine genetic material taken from the coronavirus and genes of the adenovirus, producing an immune response.

The findings show that the side effects can also occur when someone gets a vaccine that has messenger RNA (mRNA).

Because blood clots do occur after vaccinations, the report claims, “it should not dissuade people from getting the Covid jab”.

Earlier this month, the U.S. Food and Drug Administration announced that it would add a warning to the Moderna vaccine – as well as the Pfizer vaccine – after the Centers for Disease Control and Prevention said there is a “likely link” between them and cases of heart inflammation, particularly in children and young adults.

The Sun report is worth reading in full.

U.S. Medicines Regulator to Add Warning to Pfizer and Moderna Vaccines Over Link to Heart Inflammation

The U.S. Food and Drug Administration (FDA) is set to add a warning to the Covid vaccines made by Pfizer and Moderna after the Centers for Disease Control and Prevention (CDC) said there is a “likely link” between them and cases of heart inflammation, particularly in children and young adults. The MailOnline has the story.

The CDC made the announcement Wednesday during a presentation. 

The Covid Vaccine Safety Technical (VaST) Work Group discussed nearly 500 reports of heart inflammation, known as myocarditis, in vaccinated adults under the age of 30.

The group of doctors said the risk of myocarditis or pericarditis following vaccination with the mRNA-based shots in adolescents and young adults is notably higher after the second dose and in males  

It comes as the Advisory Committee on Immunisation Practices (ACIP) is set to meet this week to assess the possibility of a link between the heart condition and the mRNA vaccines. 

The Moderna and Pfizer vaccines use mRNA technology, while the Johnson & Johnson vaccine uses the more traditional virus-based technology. 

According to the presentation, there have been 484 preliminary reports of myocarditis or pericarditis in young people under age 30 as of June 11th.

So far, 323 have been confirmed by CDC and 148 are still under review.

In total, 309 patients were hospitalized, of which 295 were discharged and 79% have since recovered.

Nine patients are still hospitalized with two in intensive care units. There was no data available for five patients. 

Males were much more likely to report heart inflammation after receiving a second dose than women.

As of June 11th, there were 9.1 per million reported cases of myocarditis/pericarditis in females ages 12-to-17 compared to 66.7 per million in males of that age group.

What’s more, rates among females ages 18-to-24 and ages 25-to-29 were 5.5 per million and 2.6 per million respectively.

Ang [among] males, rates were 56.3 per million for the 18-to-24 age group and 20.4 per million in the 25-to-29 group.

In Australia, the AstraZeneca Covid vaccine is facing further criticism over its links to a variety of side effects. The vaccine will have been almost completely phased out of the country’s roll-out by October.

Worth reading in full.

CDC to Hold Emergency Meeting Over 226 Cases of Heart Inflammation in American Teens Who Have Had Pfizer or Moderna Vaccines

The U.S. Centers for Disease Control is set to hold an emergency meeting over a greater than expected number of cases of heart inflammation among young Americans who have received two doses of either the Pfizer or Moderna Covid vaccine. The MailOnline has the story.

[CDC leaders] will gather on June 18th to discuss 226 plausible cases of heart inflammation in young people – mainly affecting teenage boys and young men – after they have received their second doses of the vaccines. 

CDC bosses said Thursday the number of cases is higher than expected, although still rare.

[CNBC reports that, according to the CDC, scientists expected only between 10-102 cases of myocarditis or pericarditis.]

A total of 226 cases have been reported that may meet the CDC’s “working case definition” of myocarditis and pericarditis following the shots, the agency said. 

Myocarditis is inflammation of the heart muscle, and pericarditis is inflammation of the outer lining of the heart.

Among the 226, three are in intensive care, 15 are hospitalised, and 41 have ongoing symptoms. The rest – 167 – have recovered.  

It is not clear if either condition is caused by the shots and the reports of cases are extremely rare. 

The CDC continues to urge everyone aged 12 and older to get vaccinated.

These types of heart inflammation can be caused by a variety of infections, including a bout of Covid, as well as certain medications…

Cases are reported through the U.S. Vaccine Adverse Event Reporting System (VAERS).

The system accepts reports from everyone regardless of the plausibility of the vaccine causing the symptom.

In total, VAERS received 573 reports of myocarditis and pericarditis after the patient had received their second dose. 

A total of 372 reports were from people who had the Pfizer vaccine, while the remaining 201 had Moderna.

Another 216 cases of the heart inflammation were also reported after dose one of the vaccines. 

More than half of the cases reported after people had received their second dose were in people between the ages of 12 and 24, the CDC said.  

This group accounts for less than nine per cent of doses administered.  

Almost four-fifths of cases were in males. 

The overwhelming majority of the cases have occurred within a week of vaccination. 

Symptoms included chest pain and breathing difficulties. 

This comes just one day after Moderna asked the U.S. Food and Drug Administration to extend the emergency use of its Covid vaccine to American children aged 12 and over.

The U.K. Medicines and Healthcare products Regulatory Agency approved the use of the Pfizer vaccine in British children aged 12-15 earlier this month, though the Joint Committee on Vaccination and Immunisation said that the decision on whether or not to vaccinate children against Covid is down to the Government given that it is a “political” matter. So far, the petition on the Gov.uk website against the vaccination of children has been signed by over 50,000 people.

Worth reading in full.

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