12 Deadly Diseases Cured in the 20th Century
Heart Inflammation Link To Pfizer And Moderna Jabs
Heart inflammation is a "very rare" side-effect of the Covid vaccines made by Pfizer and Moderna, according to regulators in Europe.
The medicines safety body said the benefits of Covid vaccines continue to far outweigh any risks.
But doctors and patients have been advised to be aware of the symptoms of heart inflammation.
These include chest pain, a feeling of breathlessness and a pounding or fluttering heartbeat. Anyone with these symptoms should see a doctor.
Two conditions were linked to the vaccines - inflammation of the heart muscle itself, known as myocarditis, and inflammation of the fluid-filled sac the heart sits in, known as pericarditis.
The EMA analysis of cases found:
Five people died. The review said they were all either elderly or had other health conditions.
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has also been investigating the link.
It reported: "A consistent pattern of cases occurring more frequently in young males and shortly after the second dose of the vaccines.
"These reports are extremely rare, and the events are typically mild with individuals usually recovering within a short time with standard treatment and rest," it added.
Most cases are thought to be within 14 days of vaccination.
While the risk is very rare, it is more likely to develop in young people - who are currently the focus on the vaccination campaign in the UK.
"The chance of these conditions occurring is very low, but you should be aware of the symptoms so that you can get prompt medical treatment to help recovery and avoid complications," the EMA said.
The link with heart inflammation was found only in the vaccines that rely on mRNA technology to train the immune system.
There was no link found for vaccines such as Oxford-AstraZeneca or Janssen, which use a genetically modified virus.
However, the EMA has advised anyone with a history of capillary leak syndrome should not be given the Janssen vaccine. This is a rare but serious syndrome in which fluid leaks from blood vessels in the body.
EMA Panel Probes Heart Inflammation With Pfizer/BioNTech COVID Vaccine
A review of side effects reported with coronavirus vaccines by the EMA's safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot.
The Pharmacovigilance Risk Assessment Committee (PRAC) says it is aware of cases of myocarditis and pericarditis – inflammation of the heart muscle and membrane around the heart – with the vaccine.
At the moment, there's no indication that the cases are linked to the vaccine itself, but the EMA has asked the companies to provide "further detailed data, including an analysis of the events according to age and gender," as it looks into the signal.
It is also asking for similar data from Moderna, which manufacture a COVID-19 vaccine that like Comirnaty is based on mRNA.
While still very preliminary, the investigation will be a worry to the EU, which made the Pfizer/BioNTech vaccine the mainstay of its COVID-19 vaccination programme. On Saturday, the bloc extended its contract with the companies to provide up to 1.8 billion doses through 2023.
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Pfizer has already said it will be able to provide the EU with an extra 50 million doses in the second quarter of this year, to help compensate for missed deliveries of AstraZeneca's adenovirus-based shot.
The move signals a further shift away from the AZ and Janssen adenoviral vaccines, which are both being investigated over a potential link to rare blood clots, particularly in people with low platelet counts (thrombocytopenia).
An update on the Janssen jab at the PRAC's latest meeting concluded that the benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects, but its labelling will be updated to recommended increased vigilance in people with thrombocytopenia and a recent history of blood clots.
The PRAC also looked at clotting risks with Comirnaty and the Moderna jab, and concluded that for the moment there does not seem to be any evidence of a safety signal for the mRNA shots.
The meeting did however recommend a change to the label for Comirnaty to include a risk of facial swelling with the jab. The committee said there is "at least a reasonable possibility" that the vaccine can cause the side effect in people previously treated with dermal fillers, often used for cosmetic purposes.
Also in the spotlight is a possible link between the AZ vaccine and Guillain-Barre syndrome (GBS), an immune system disorder that causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking.
It is too early to draw any conclusions, according to the committee, but it has asked AZ for more data including an analysis of all reported cases of GBS after dosing with its vaccine.
BridgeBio Heart Drug Approved By FDA, Setting Up Battle With Pfizer
The Food and Drug Administration has approved a new medicine for a deadly genetic heart condition, boosting its developer, BridgeBio Pharma, and teeing up a battle for control of a lucrative market targeted by several drugmakers.
The agency on Friday cleared Attruby, known scientifically as acoramidis, for people with a cardiac form of transthyretin amyloidosis, a progressive disease that leads to heart failure and death.
In testing, Attruby helped keep people alive and out of the hospital longer than those who'd received a placebo. Treatment was also associated with improvements in quality of life as well as markers of heart health.
Notably, the drug is approved to prevent hospitalization or death resulting from heart complications of transthyretin amyloidosis with cardiomyopathy. Investors had been skeptical BridgeBio would earn such a distinction from regulators, leading to doubts about Attruby's commercial prospects.
BridgeBio priced Attruby at just under $19,000 for a 28-day supply, translating to an annual list cost of about $244,000.
The approval represents another step forward in treatment of transthyretin amyloidosis, which has become a top target of drugmakers over the last decade. The condition is caused by the toxic buildup of a misfolded protein, transthyretin or TTR, that the body typically uses to transport vitamin A. It primarily affects the nerves, the heart or both, and worsens with time.
Since 2018, multiple treatment options have emerged for patients with nerve damage, or polyneuropathy, a rarer form affecting an estimated 30,000 to 50,000 people in the U.S. And Europe. Progress has been slower for those with cardiac symptoms. Until recently, this form was often mistaken for other heart problems and only properly diagnosed by the time patients already had advanced heart failure. But the 2019 approval of the first treatment — a Pfizer pill called tafamidis — and adoption of less invasive diagnostic techniques have accelerated progress.
Since then, awareness of ATTR amyloidosis with cardiomyopathy has grown, driving sales of tafamidis and boosting estimates of disease prevalence. Worldwide tafamidis sales last year reached $3.3 billion and may surpass that total in 2024, making it one of Pfizer's fastest-growing products.
In an interview, Neil Kumar, BridgeBio's CEO, noted how those sales were achieved even as only about 50,000 people in the U.S. Have been diagnosed. While an increase from a few years ago, that figure still only represents a fraction of the 250,000 to 300,000 in the country thought to have the condition. Research firm Global Market Insights estimated earlier this year that the overall market for transythretin amyloidosis treatments will surpass $11 billion by 2032, with the cardiomyopathy form accounting for the bulk of drug sales.
BridgeBio's drug is designed to "stabilize" the misfolded TTR protein, as tafamidis does, but more completely. Vutrisirian, a competing drug from Alnylam Pharmaceuticals that could get to market next year, interferes with TTR production by silencing expression of the related gene. Others from Ionis Pharmaceuticals and Intellia Pharmaceuticals could follow.
The rush of programs has positioned ATTR amyloidosis cardiomyopathy as one of drug industry's next commercial battlegrounds. Such a development will also mean physicians could soon have tough choices to make. While Bridgebio and Alnylam have revealed data in recent months pointing to the possible advantages of their drugs, their medicines weren't tested directly against tafamidis or each other, meaning doctors will have to figure out which treatment is best for each patient.
"It's going to be hard for us clinicians," said Mazen Hanna, a cardiologist at the Cleveland Clinic, in an interview earlier this year. "The experts in the amyloidosis community are going to be left with tough decisions to make, without clear data to support our decisionmaking."
At least so far, Wall Street has bet against BridgeBio. The company's share price has lost most of its gains since Attruby succeeded in Phase 3 testing in July 2023, while rival Alnylam has added billions in market value after triumphing in its own late-stage trial. Investor expectations are "far lower" for BridgeBio's drug than tafamidis or vutrisiran, wrote Cantor Fitzgerald analyst Josh Schimmer, earlier this month.
Kumar, the company's CEO, said the company's valuation implies Attruby will end up with a market share that would equate to "the worst second-mover launch of all time."
"Honestly I'm perplexed by it," he said, "and I think everyone on my board is perplexed."
One reason for investors' dim view is that BridgeBio has to compete against one similar, entrenched therapy and, likely within a year, another distinct alternative. Another is the company doesn't have a track record launching medicines, having only recently transitioned to a commercial-stage enterprise. Pfizer, by comparison, has a massive salesforce and Alnylam, one of biotech's most valuable companies, has been selling medicines for neuropathy tied to transthyretin amyloidosis for several years.
Yet Kumar think the negativity is misplaced. Some 20% to 40% of people either don't respond to tafamidis or end up progressing after treatment, he says, making Attruby the "obvious" choice for them. While acknowledging the caveats in comparing drugs across trials, he also noted how testing showed a benefit on survival and hospitalization that appeared to materialize more quickly — as early as three months — and have a greater effect size than tafamidis.
BridgeBio expects to compete with Pfizer for newly diagnosed patients, and ultimately claim a market share of about 30%, he says. The company plans to run a head-to-head trial against tafamidis in the future as well.
"There's probably a degree of skepticism around 'can a bunch of science nerds launch a drug'? I get that, and I'm going to show that we can do that," he said.
"Fundamentally, I think people will say, for a certain fraction of patients, I want to use a more potent drug that seems to have action earlier than we've seen before, and seems to have a greater magnitude of action."
Bayer holds rights in Europe to Attruby through a collaboration the companies signed in March. The drug could be approved there in 2025.
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