Sunday, October 10, 2021

Finland joins Sweden and Denmark in pausing use of the Moderna COVID-19 vaccine in young people over fears the shots are causing rare heart inflammation

Finland has become the latest Nordic nation to pause use of the Moderna COVID-19 vaccine in young people due to fears that the shots are causing rare heart inflammation.

The Finnish Institute for Health and Welfare said on Thursday that authorities won't give the vaccine to males under age 30, and they will be offered the Pfizer-BioNTech immunization instead.

The government agency said it found that young men and boys were at a slightly higher risk of developing myocarditis.

It comes after health officials in Sweden and Denmark made a similar decision earlier this week.

In Sweden, the Moderna jab will no longer be available to any one born after 1990, or those aged 30 and younger.

Denmark has restricted access to the vaccine to anyone under the age of 18.

Norway, another Nordic country, has not taken as drastic action as its neighbors, with health officials urging people under 30 to opt for the Pfizer vaccine instead.

All four countries based their decision on an unpublished study with Sweden's Public Health Agency saying that it signals 'an increased risk of side effects such as inflammation of the heart muscle or the pericardium'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.

It added: 'The risk of being affected is very small.'

Myocarditis and pericarditis, both types of inflammation of the heart, are known side effects of the Covid vaccines, and the Centers for Disease Control and Prevention (CDC) even warns that the condition may develop in young males after vaccination.

Heart inflammation is also a symptom of many viral infections like COVID-19, though, and the likelihood of developing the inflammation after infection is much higher than it is after vaccination.

The Swedish health agency said it would pause using the shot for people born in 1991 and later as data pointed to an increase of myocarditis and pericarditis among youths and young adults who had been vaccinated.

'The connection is especially clear when it comes to Moderna's vaccine Spikevax, especially after the second dose,' the health agency said.

A Moderna spokesperson said in an email the company was aware of the decisions by regulators in Denmark and Sweden to pause the use of its vaccine in younger individuals because of the rare risk of myocarditis and or pericarditis.

'These are typically mild cases and individuals tend to recover within a short time following standard treatment and rest,' they wrote.

'The risk of myocarditis is substantially increased for those who contract COVID-19, and vaccination is the best way to protect against this.'

According to one U.S. study that has yet to undergo peer review young males under 20 are up to six times more likely to develop myocarditis after contracting COVID-19 than those who have been vaccinated.

Denmark said that, while it used the Pfizer-BioNTech vaccine as its main option for people aged 12 to 17 years, it had decided to pause giving the Moderna vaccine to people below 18 according to a 'precautionary principle'.

In June, the CDC issued a warning that young males were at an increased risk of myocarditis after receiving the vaccine.

The label for both the Pfizer and Moderna vaccines were changed in the U.S. to reflect the warning, though usage was never paused.

Cases of inflammation after vaccination are rare, though they do occur often enough to concern regulators.

A recent study from Kaiser Permanente Southern California found that around seven out of every one million people that receive a two-shot COVID-19 vaccine will develop myocarditis.

The same study found that 47.5 out of every one million Covid patients experience heart inflammation.

While myocarditis will often resolve itself, it can be dangerous. Heart inflammation can often lead to fatigue, shortness of breath and chest pain for patients. People with inflamed hearts are at a higher risk for heart failure, heart attacks and strokes.

Attempting strenuous physical activity with an inflamed heart could also potentially lead to sudden cardiac arrest, or even death.


Fumento Misdiagnoses Remdesivir

Lawyer and author Michael Fumento recently argued in an AIER article that the FDA’s approval of the Covid-19 treatment remdesivir has failed patients and provides another example of the failure of the “Do something, anything” approach to combat the pandemic.

Referencing several critical studies and a condemning statement from the WHO, Mr. Fumento argues that remdesivir “doesn’t work.” However, since it remains the only fully approved Covid-19 treatment, and the FDA hesitates to retract drugs it already approved, remdesivir remains on the market. The agency’s wrongdoing in approving it also allows remdesivir’s producer Gilead to charge an alarmingly high price for treatment ($3,000 above production cost).

Frustrated but not surprised, Mr. Fumento concludes his article by stating, “At best, this can be a lesson to us all about pandemic drug approvals. But as noted we’ve had those lessons and they didn’t stick. Don’t expect this to have any impact, either.”

Having studied the FDA’s approval process for eight years and the history of remdesivir for the past two, I’m afraid I have to disagree with his assessment.

Mr. Fumento correctly notes that remdesivir previously struggled to receive FDA approval. But he neglects to mention why the drug remained off the market.

Beginning in 2014, remdesivir entered a clinical trial to help combat the Ebola outbreak in West Africa. Reviewing data, an article published in Drugs and Context found that remdesivir, “performed well in pre-clinical studies.” However, Gilead later withdrew the drug for financial reasons, fearing it could not afford to continue with the FDA’s approval process (which often requires over $1 billion to complete) after underperforming in a small-sample efficacy test (which wouldn’t have counted in its approval application).

Remdesivir later entered clinical trials to help treat MERS during a 2016 outbreak in the Middle East. This time, the drug received financial and other support from the NIH and several medical schools. Here again, medical scientists noted the drug’s usefulness in “providing evidence to support new indications for this compound against human viruses of significant public health concern.” But the FDA’s burdensome approval process again prevented the promising experimental drug from advancing due to an inadequate number of patients in the clinical trials.

Far from being “a drug in search of a cure,” as Mr. Fumento suggests, medical literature suggests remdesivir was a promising treatment that helped patients during two previous epidemics. Its greatest challenge was regulatory, not clinical.

Mr. Fumento also fails to mention that there was a considerable demand to use remdesivir well before the FDA approved it. The first patient formally diagnosed with Covid-19 in the US received remdesivir. As cases spread, physicians and other medical establishments petitioned the FDA to grant patients access through the agency’s Compassionate Use program—giving dying patients a chance to try an experimental (unapproved) treatment to prolong their lives. Nearly two dozen US citizens tried remdesivir from January 25th—March 1st, 2020. Many more patients in 70 other countries were able to access remdesivir to treat Covid-19 despite many drug supply channels being shut down to prevent disease spread.

As patients recovered, the FDA issued its first Emergency Use Authorization (EUA) for the drug on May 1st, 2020, for severe cases of Covid-19. After nearly half a million doses of remdesivir reached patients, the FDA issued an EUA to treat milder cases of Covid-19. By late October, the agency fully approved remdesivir despite the drug never undergoing the full approval process.

Over the same time period, the FDA withdrew two EUAs for other drugs to treat Covid-19 (chloroquine and hydroxychloroquine), and several Covid-19 tests passed with EUA. If remdesivir is ineffective, why wasn’t it also withdrawn?

I have been critical of Mr. Fumento’s analysis of remdesivir. But I take the message of his article seriously. Policy changes enacted out of desperation to address a crisis can be wasteful, counterproductive, and harmful. His concerns are justified.

But remdesivir provides no such cautionary tale. Instead, it gives a story of the triumph of innovation during a difficult period. The lesson we should take away is not “Do something, anything,” it is to get government out of the way so we can find solutions.


Don’t freak out: Catching Covid after you are vaccinated improves immunity

For 20 months we’ve cowered behind masks, scrubbed ourselves with hand sanitiser and socially distanced to avoid Covid — now most people are vaccinated, experts are telling us we need to prepare to catch the virus.

It sounds counterintuitive but the argument is if you are vaccinated and catch Covid, you are unlikely to get seriously ill or go to hospital and getting the virus will further boost your immunity.

The new message comes as infections in the US and worldwide appear to have peaked and some scientists are noticing the virus has a wave pattern — two months of high infections followed by a decline then two months of high infections.

With lockdowns in three states due to ease in coming weeks Australian National University’s infectious diseases expert Professor Peter Collignon and University of Newcastle’s Professor Nathan Bartlett said fully vaccinated people needed to change their attitude to the virus.

Prepare yourself to be infected and don’t “freak out” if you do catch it when lockdowns end, they said.

“You might want to get it, you definitely want to get it. You definitely want to be vaccinated before you get it, because if you’re vaccinated your risk of death goes down,” said Prof. Collignon.

Prof. Bartlett said: “It’s immunity you want supported by the vaccine but then sort of topped up, by circulation and that’s really is what’s going to ultimately lead to make this turn this virus into basically an endemic, common cold causing virus, and that’s what you want it to be”.

The head of the Australian Society of Infectious diseases (ASID) Allen Cheng said he expected “everyone will probably be exposed, eventually.”

“We want to be vaccinated, so we have the best defences against it when it happens that we meet the virus,” he said.

A study by the US Centers for Disease Control and Prevention and another by one of Israel’s largest health providers found people who’d recovered from Covid and were later vaccinated had half the risk of reinfection compared with unvaccinated people who’d previously had Covid.

The Kaolinska Institute’s Charlotte Thalin told The Conversation combining natural infection with protection from a vaccine may work better because natural infection exposes our immune system to several viral proteins while vaccines introduce a single antigen: the spike protein.

But, like the other experts, she cautions you want to be vaccinated before getting infected because getting a natural infection first exposes you to the risks of death, blood clots and long Covid.

Many vaccinated people are likely to get infected because vaccines are less effective at preventing infection with the Delta variant.

Pfizer’s protection plunges from 93 per cent to 53 per cent after four months, a study published in The Lancet this week found.

However, the vaccines are still good at preventing 80-90 per cent of infected people from needing a hospital bed and are almost 100 per cent protective against death.




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