CDC

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 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.

Stop Press: Watch Tucker Carlson react to this news.

NHS Told to Differentiate Between Patients in Hospital “For Covid” and Those in Hospital “With Covid” – and Not Before Time

After almost 15 months of various forms of lockdown, hospitals have finally been told to change the way they collect data on patients who test positive for Covid. They have been instructed to differentiate between those who are actually sick with Covid symptoms and those who test positive but are actually ill with something else. The Independent has the story.

NHS England has instructed hospitals to make the change to the daily flow of data sent by NHS trusts and told the Independent that the move was being done to help analyse the effect of the vaccine programme and whether it was successfully reducing Covid sickness…

One NHS source said the new data would be “more realistic” as not all patients were sick with the virus, adding: “But it will make figures look better as there have always been some, for example stroke [patients], who also had Covid as an incidental finding.”

In a letter to hospital bosses on June 7th, shared with the Independent, NHS England’s Covid Incident Director, Professor Keith Willett, said that from now on NHS England wanted “a breakdown of the current stock of Covid patients into those who are in hospital with acute Covid symptoms (and for whom Covid is the primary reason for being in hospital); and those who are primarily in hospital for a reason other than Covid (but for whom the hospital is having to manage and treat the Covid symptoms alongside their primary condition)”.

He added: “In lay terms, this could be considered as a binary split between those in hospital ‘for Covid’ and those in hospital ‘with Covid’. We are asking for this binary split for those patients newly admitted to hospital and those newly diagnosed with Covid while in hospital.”…

NHS England data on hospital admissions is published daily at a regional level and several days later on the Government’s dashboard. An internal daily dashboard of Covid data tracks infections across hospitals but is not made public.

Professor Ian Douglas from the London School of Hygiene and Tropical Medicine said: “I think there are good arguments for presenting these data separately – people in hospital ‘with’ vs ‘for’ Covid, as it does partly address the burden to health services due to the virus. Not completely though, because people in hospital with Covid will presumably also need to be treated differently to avoid further spread, which places some extra burden on the hospitals.

“I’ve got no idea what the split is like at the moment, and importantly we won’t know retrospectively what the trend is. Following on from that, there are only a few days before any announcement about June 21st, which may not give us long enough to be sure about what direction the ‘for Covid’ numbers are going.”

This change resembles the recent shift in the definition of a “case” by the CDC in America, where an infection in a vaccinated person is now only a “case” when the person is hospitalised or dies, whereas with the unvaccinated any positive PCR test still counts as a “case”, no matter how mild or asymptomatic.

Now, I’m all in favour of a more restrictive and conventional definition of case that gives a more realistic picture of the impact of the disease. But one can’t help suspect it’s more about politics than science when the kind of change many of us have been calling for since the start only comes once it helps to create the impression that the vaccines are working.

The Independent report is worth reading in full.

CDC Investigating Reports of Heart Inflammation in Young Covid Vaccine Recipients

The U.S. Centers for Disease Control and Prevention (CDC) is investigating several dozen reports of heart inflammation in teenagers and young adults after Covid vaccination. These cases occurred in people days after receiving an mRNA vaccine, though the agency did not specify whether this was linked to the Pfizer or the Moderna vaccine (or both). The New York Times has more.

The [agency’s vaccine safety] group’s statement was sparse in details, saying only that there were “relatively few” cases and that they may be entirely unrelated to vaccination. The condition, called myocarditis, is an inflammation of the heart muscle, and can occur following certain infections.

The CDC’s review of the reports is in the early stages, and the agency has yet to determine whether there is any evidence that the vaccines caused the heart condition. It has posted some guidance on its website for doctors and clinicians to be alert to unusual heart symptoms among young people who had just received their shots.

“It may simply be a coincidence that some people are developing myocarditis after vaccination,” said Dr Celine Gounder, an Infectious Disease Specialist at Bellevue Hospital Center in New York. “It’s more likely for something like that to happen by chance, because so many people are getting vaccinated right now.”

The cases seem to have occurred predominantly in adolescents and young adults about four days after their second dose of one of the mRNA vaccines, which are Moderna and Pfizer-BioNTech. And the cases were more common in males than in females.

“Most cases appear to be mild, and follow-up of cases is ongoing,” the vaccine safety group said…

“We look forward to seeing more data about these cases, so we can better understand if they are related to the vaccine or if they are coincidental,” said Dr Yvonne Maldonado, Chair of the American Academy of Pediatrics’ Committee on Infectious Diseases. “Meanwhile, it’s important for pediatricians and other clinicians to report any health concerns that arise after vaccination.” …

In the general population, about 10 to 20 of every 100,000 people each year develop myocarditis, or an inflammation of the heart, experiencing symptoms ranging from fatigue and chest pain to arrhythmias and cardiac arrest. Many others likely have mild symptoms and are never diagnosed, according to researchers.

At the moment, the number of cases of myocarditis reported after vaccination does not appear to be greater than would normally be seen in young people, according to the CDC. But members of the agency’s vaccine safety group “felt that information about reports of myocarditis should be communicated to providers”, the report said.

Mancunian children as young as 16 are to be offered Covid mRNA vaccines due to fears about the Indian Covid variant. The CDC continues to recommend Covid vaccines for Americans aged 12 and over.

The New York Times report is worth reading in full.

CDC Says Americans Can Stop Wearing Face Masks Inside – but Only if They’re Fully Vaccinated

The Centers for Disease Control and Prevention (CDC) says that Americans can stop wearing face masks inside. The loosening of restrictions comes, as always, with a range of caveats – not least the fact that they only apply to those who are fully vaccinated against Covid. The New York Times has the story.

The advice from the CDC comes as welcome news to [fully vaccinated] Americans who have tired of restrictions and marks a watershed moment in the pandemic. Masks ignited controversy in communities across the United States, symbolising a bitter partisan divide over approaches to the pandemic and a badge of political affiliation...

The new advice comes with caveats. Even vaccinated individuals must cover their faces and physically distance when going to doctors, hospitals or long-term care facilities like nursing homes; when travelling by bus, plane, train or other modes of public transportation, or while in transportation hubs like airports and bus stations; and when in prisons, jails or homeless shelters.

In deference to local authorities, the CDC said vaccinated Americans must continue to abide by existing state, local, or tribal laws and regulations, and follow local rules for businesses and workplaces. Individuals are considered fully vaccinated two weeks after the one-dose Johnson & Johnson shot or the second dose of either Pfizer or Moderna vaccine series…

The CDC has been under fire recently for moving too gingerly to lift restrictions on public activities for those who are vaccinated. Some critics have said the Agency’s caution may suggest to Americans that officials lack confidence in the vaccines…

Only half of Americans said that they had a “great deal” of trust in the CDC, according to a new survey conducted in February and March by the Robert Wood Johnson Foundation and the Harvard T.H. Chan School of Public Health.

Officials are worried that herd immunity may not be reached in the U.S., partly due to the decline of daily vaccination rates.

As of Wednesday, about 154 million people have received at least one dose of a Covid vaccine, but only about one-third of the nation, some 117.6 million people, have been fully vaccinated.

But the pace has slowed: Providers are administering about 2.16 million doses per day on average, about a 36% decrease from the peak of 3.38 million reported in mid-April.

As demand for the vaccine continues to wane, some states are requesting small fractions of their allotted doses from the Federal Government to save them from having to throw unused doses away. It is hoped that the change in mask-wearing guidelines for the vaccinated will push those who haven’t yet been vaccinated to get a move on.

The New York Times report is worth reading in full.

Stop Press: “The rule is now simple,” says Joe Biden: “Get vaccinated or wear a mask.”

New York Times Fact Checks “Deceiving” CDC on Masks and Outdoor Transmission

When the New York Times weighs in to fact check the CDC, you know something is in the wind. On Tuesday, reporter David Leonhardt wrote a scathing criticism of the U.S. Federal Health Authority’s recent advice that “less than 10%” of COVID-19 transmission is occurring outdoors.

Leonhardt points out that while this is technically true, it is like saying “sharks attack fewer than 20,000 swimmers a year” when the actual number is around 150 worldwide. “It’s both true and deceiving,” he says.

He calls this “an example of how the CDC is struggling to communicate effectively, and leaving many people confused about what’s truly risky”. The CDC places “such a high priority on caution that many Americans are bewildered by the agency’s long list of recommendations”.

They continue to treat outdoor transmission as a major risk. The CDC says that unvaccinated people should wear masks in most outdoor settings and vaccinated people should wear them at “large public venues”; summer camps should require children to wear masks virtually “at all times”.

However, in reality, “there is not a single documented Covid infection anywhere in the world from casual outdoor interactions, such as walking past someone on a street or eating at a nearby table”.

Leonhardt digs into the studies that supposedly underpin the CDC’s advice and finds layers of conservative over-caution.

Many of the instances of “outdoor transmission” in the literature turn out to be from construction sites in Singapore. This appears to be a classification issue.

The Singapore data originally comes from a Government database there. That database does not categorise the construction-site cases as outdoor transmission, Yap Wei Qiang, a spokesman for the Ministry of Health, told my colleague Shashank Bengali. “We didn’t classify it according to outdoors or indoors,” Yap said. “It could have been workplace transmission where it happens outdoors at the site, or it could also have happened indoors within the construction site.”

The decision that they were outdoors was made by researchers making conservative assumptions.

“We had to settle on one classification for building sites,” Quentin Leclerc, a French researcher and co-author of one of the papers analysing Singapore, told me, “and ultimately decided on a conservative outdoor definition.” Another paper, published in the Journal of Infection and Public Health, counted only two settings as indoors: “mass accommodation and residential facilities.” It defined all of these settings as outdoors: “workplace, health care, education, social events, travel, catering, leisure and shopping.”

Even with this conservative definition, however, the studies still found only a maximum of 1% of infections were caught outdoors.

So where did the CDC get 10% from? Leonhardt enquired and received this statement:

CDC Finds More Clotting Cases After Johnson & Johnson Covid Vaccine

The Centers for Disease Control and Prevention (CDC) has said there is a “plausible causal association” between the Johnson & Johnson (J&J) Covid vaccine and blood clotting after finding more U.S. cases of the condition among people who received the vaccine. Reuters has the story.

The CDC said in a presentation the Agency has now identified 28 cases of thrombosis with thrombocytopenia syndrome (TTS) among the more than 8.7 million people who had received the J&J vaccine. TTS involves blood clots accompanied by a low level of platelets – the cells in the blood that help it to clot.

So far, three of the 28 have died. Previously, as of April 25th, the CDC had reported 17 cases of clotting among nearly eight million people given vaccines.

The Advisory Committee on Immunisation Practices (ACIP), which advises the U.S. CDC, recommended on April 23rd that the U.S. lift a 10-day pause on the J&J vaccinations imposed to review safety data on the clotting issue. The panel will review the new data later on Wednesday…

Scientists are working to find the potential mechanism that would explain the blood clots. A leading hypothesis appears to be that the vaccines are triggering a rare immune response that could be related to these viral vectors.

The syndrome does not appear to be associated with either of the Covid vaccines produced by Pfizer or Moderna.

Most of the cases were among women aged 18 to 49, the CDC said, with rates among women aged 30-39 at 12.4 cases per million and those aged 40-49 at 9.4 cases per million…

Symptoms typically occur several days after vaccination to up to two weeks.

Norway, which has stopped using the AstraZeneca Covid vaccine because of fears over blood clotting, has delayed a decision on whether to include vaccines made by J&J in its national rollout efforts. A Government-appointed commission recently recommended that neither vaccine should be used in the country due to their harmful side effects.

The Reuters report is worth reading in full.

CDC Says Fully Vaccinated Americans Can Now Go Maskless Outside – but Not in Crowds

When Joe Biden became the President of the U.S., he asked Americans to wear face masks for his first 100 days in office. Thursday marks his 100th day as President, but new guidance from the U.S. Centers for Disease Control and Prevention (CDC) says that only fully vaccinated Americans can do away with face masks outdoors – and even then, only when not in crowds. The Mail has the story.

Fully vaccinated Americans can now safely go without masks outside, the CDC said on Tuesday.

“If you are fully vaccinated, things are much safer for you,” said CDC Director Dr Rochelle Walensky during a Tuesday White House press briefing. 

“There are many situations in which Americans do not need to wear masks if they are fully vaccinated, particularly outdoors.”

As long as they are outside, people who are fully vaccinated can now exercise, go to small gatherings or restaurants with people who are vaccinated or unvaccinated. 

It comes amid mounting evidence – finally acknowledged by the CDC on Tuesday – that outdoor transmission of coronavirus is exceedingly rare, accounting for less than 10% of cases. Those risks are mainly linked to crowded events that can turn into super-spreader events, or people who were in close range of one another. 

However, in crowded places like concerts, parades or sporting events, even vaccinated people should still wear masks, the CDC’s new guidance says. 

The guidance is merely that – advice about what the health agency has deemed safe – and is not enforceable. It’s up to states, counties and cities to issue mask mandates and other restrictions. 

Several states, including Massachusetts and Kentucky rolled back their guidelines on mask-wearing outdoors on Tuesday morning, in anticipation of the update to the guidelines. 

Unvaccinated people can shed their masks too, if they are outside exercising or at small outdoor gatherings with vaccinated friends and families.  

In order to “make a point” about the new mask-wearing guidelines, President Biden took off his mask when giving a speech at the White House on Tuesday and kept it off until he was back inside.

Worth reading in full.

US Calls For Pause on Johnson & Johnson Vaccine Due to Clotting Fears

Federal health agencies in America have called for the rollout of the Johnson & Johnson (J&J) vaccine to be paused immediately due to some recipients developing rare blood clotting disorders within two weeks of being vaccinated. So far, nearly seven million people in the US have received shots of the J&J vaccine, which is not currently used in the UK. Six US recipients of the vaccine have developed disorders involving blood clots, all of them women aged 18-48. The New York Times has the story.

Federal health agencies on Tuesday called for an immediate pause in use of J&J’s single-dose coronavirus vaccine after six recipients in the US developed a rare disorder involving blood clots within about two weeks of vaccination.

All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalised in critical condition. …

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr Peter Marks, Director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement. “Right now, these adverse events appear to be extremely rare.”

While the move was framed as a recommendation to health practitioners in the states, the Federal Government is expected to pause administration of the vaccine at all federally-run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same.

Scientists with the FDA and CDC will jointly examine possible links between the vaccine and the disorder and determine whether the FDA should continue to authorise use of the vaccine for all adults or limit the authorisation. An emergency meeting of the CDC’s outside advisory committee has been scheduled for Wednesday.

While the majority of the US’s vaccine supply comes from other sources, it is expected that this pause could “substantially complicate” the nation’s vaccination efforts. The move comes after Europe’s medicines regulator announced last week that it was reviewing possible links between the vaccine and rare blood clots. The jab is expected to be approved for use in the UK “within days“, with 30 million doses having already been ordered by the Government.

J&J said the following in a news release:

We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid vaccines. At present, no clear causal relationship has been established between these rare events and the J&J Covid vaccine.

The New York Times’s article is worth reading in full.

Stop Press: The European rollout of the vaccine has now been paused, according to a statement released by Johnson & Johnson. The company said: “We have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe.”

Why Does Wikipedia Claim a Fifth of Covid Infections Are ‘Severe’?

There’s been a lot of worry about ‘misinformation’ around COVID-19, with numerous calls to suppress anything that doesn’t agree with the WHO’s current line, and news and social media companies all too happy to oblige.

Sometimes, though, the worst offenders are the mainstream sources themselves.

Take Wikipedia. On its main COVID-19 page – a page which cannot be edited by mere mortals as it is “protected to prevent vandalism” – it states the following in the second paragraph:

Of those people who develop noticeable symptoms, most (81%) develop mild to moderate symptoms (up to mild pneumonia), while 14% develop severe symptoms (dyspneahypoxia, or more than 50% lung involvement on imaging), and 5% suffer critical symptoms (respiratory failureshock, or multiorgan dysfunction).

This is claiming that almost a fifth of symptomatic COVID-19 infections are severe, and 1 in 20 are critical. If these are the statistics that people are reading then no wonder they’re scared.

Wikipedia is many people’s first port of call when looking up a subject, and often comes out near the top of internet searches. So the fact that it grossly exaggerates the seriousness of COVID-19 should be concerning. Even more concerning is why it does so.

Where did Wikipedia get its stats from? Alarmingly, the reference is to the U.S. Centers for Disease Control (CDC). In its latest clinical guidance, in a section headed “Illness Severity”, the U.S. federal health agency states:

A large cohort that included more than 44,000 people with COVID-19 from China, showed that illness severity can range from mild to critical:

– Mild to moderate (mild symptoms up to mild pneumonia): 81%

– Severe (dyspnea, hypoxia, or more than 50% lung involvement on imaging): 14%

– Critical (respiratory failure, shock, or multiorgan system dysfunction): 5%

In this study, all deaths occurred among patients with critical illness, and the overall case fatality ratio (CFR) was 2.3%.

These statistics come straight from an early study on the first 44,000 Covid patients in China, published on February 24th 2020. The study does not mention hospital admissions and it appears that all of these cases were in fact hospital patients. At any rate, the figures suggest a sample heavily skewed towards serious illness.

A more accurate estimate of severity comes from the ONS. In the December peak, the ONS estimated around 2% of the population of England were infected with COVID-19 and around 0.04% of the population were being admitted to hospital each week with the virus. This means about 2% of infections were leading to hospital admission, or 1% if we allow for the estimated half of serious infections caught in hospital. This is about 20 times lower than the nearly 20% serious infections in the Chinese study.

Why is the CDC still using this early study as its main source of statistics on the severity of COVID-19 when we’ve found out so much more about the illness since February 2020? Why is Wikipedia featuring these figures at the top of its COVID-19 page? Don’t they realise how misleading and unnecessarily frightening they are?