Tag Archives: Health Care/Life Sciences

Indigenous Australians are Skeptical About Covid-19 Vaccines, and They’re Hard to Reach | Instant News


SYDNEY – To reach indigenous clans in northern Australia, vaccinators must pass through monsoon rains which can make airplanes and waterways infested with crocodiles. Once they reach the community, they face another formidable challenge in convincing the group to take fire.

First Nations like the people of East Arnhem Land – more than 600 miles by road from the nearby city of Darwin and bastions of traditional Aboriginal culture – are next in line Australian vaccination program which started last month and focuses on prioritizing health and other workers on the front lines to keep Covid-19 out of the country.

In many ways, vaccination programs are a litmus test for countries with large indigenous groups who feel marginalized and distrust government policies. Nearly 150,000 indigenous Australians lived in remote areas in 2016, according to the latest available government data. In East Arnhem Land, the life expectancy is around 50 years and half of Aboriginal children experience severe hearing, lung or other health problems by age 4.

“What we hear now is probably 50-75% going to say no,” said Eddie Mulholland, chief executive of Miwatj Health Aboriginal Corp., an indigenous community controlled primary health service for about 8,000 people across East Arnhem Land.

Concern rose among indigenous Australians after it was reported rare cases of blood clots in people in Europe who have received the Covid-19 injection developed by AstraZeneca PLC and the University of Oxford, although regulators have found no link between blood clots and vaccines and recommend continued use.

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Opinion: Food or medicine? A dangerous choice that many seniors have to make | Instant News


You need to keep a roof over your head, refrigerate food and continue taking medication. But what if you can’t afford all three? What are you doing? The choices are tough – and potentially dangerous.

This is what many Americans experience, says a study by GoodRx, a Santa Monica. California-based health care company that tracks prescription drug prices across the country.

In 2020, note Amanda Nguyen, Ph.D., a GoodRx health economist, nearly 40% of those surveyed said paying for a prescription was financially difficult. Writing on the company blog, he adds that “over 20% said they struggled to pay for basic necessities such as food and shelter as a result.”

The COVID-19 pandemic, which has cost millions of Americans their jobs, is clearly making things worse. Job loss usually means loss of health insurance, forcing people to spend savings, take on debt “and (make) potentially dangerous changes to prescribed treatment regimens,” wrote Nguyen.

In January, a separate GoodRx survey reported that the price of 832 drugs increased by an average of 4.6%. Of these, says the company Tori Marsh MPH, 822 are brand-name drugs, 175 are specialty drugs (meaning they may be expensive at first), and the remainder are drugs administered by health care practitioners (available only under the supervision of a healthcare provider). The overall increase appears to be the biggest in years, he said.

Prices of some drugs are rising faster. The world’s best-selling drug, Humira – an anti-inflammatory drug used to treat rheumatoid arthritis, psoriasis and Crohn’s disease – was up 7.4% in January, and up 21% over the past three years, Marsh said. Humira is the ATM machine for its manufacturer, AbbVie Inc., which says that was responsible for a net income of $ 5.152 billion in the fourth quarter of 2020 only. The Food and Drug Administration has coincidentally approved five generic versions of Humira, but so far these “biosimilars” (as the industry calls generics) have not stopped AbbVie’s sauce train.

The GoodRx study covers all age groups, but there is no doubt that such price increases can be overwhelming for seniors, who tend to leave the workforce and rely too much on Social Security. As I mentioned earlier, files the average Social Security recipient earned $ 1,543 a month this year– An increase of only 1.3% from last year – and for millions of Americans, that’s the only source of income they have.

So, when the cost of required medical treatment is rising faster than that, tough choices will have to be made.

Marsh says this is what a lot of people do.

“In 2020, 20.7% of people reported taking on debt or declared bankruptcy because of the cost of their prescription medication. Borrowing from friends or family was the most common financial act (16.8%), followed by getting a loan (5.0%), taking out another mortgage (1.2%), and filing for bankruptcy (1.0%). “

Imagine: Having to mortgage your home or declare bankruptcy because the combined costs of maintaining the roof, food in the fridge, and medicine in the bathroom cupboards are too much. I feel that this is not what the term “golden years” mean.

What can be done about all of this? The US health care system is a big mess. We spend more on health care – twice as much as the developed world average – but have worse outcomes, said this sad report from the Commonwealth Fund. Trust me: It’s a downer.

Some proposals, however, center on the idea of ​​spending more money. As a candidate, Joe Biden suggests lowering the age of eligibility for Medicare by five years to 60.But most Americans – 85% Democrats and 69% Republicans – want to drop it even more, to be as young as 50, according to a 2019 Kaiser Family Foundation poll.

Where did the money come from? Medicare’s finances have faltered. Hospital Insurance Trust Fund, for example, will not have enough money to cover all support costs starting in 2024 – very close. What happens if millions of new beneficiaries are added to the system? A much higher tax seems to be a painful answer. Good luck getting a big tax hike through Congress.

And even if the Medicare eligibility age remains at 65, thousands of Americans qualify for it every day. Hard choices for millions – food, rent, medicine, and more – await. Tell your story. Do you have to make a choice like this? Between food / rent – and your medicine? I won’t identify you if you will. My email: [email protected].

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The European Gang That Can’t Shoot Straight | Instant News


A Red Cross volunteer prepares the AstraZeneca Covid-19 vaccine at the Saint-Jean-de-Luz vaccination center, southwestern France.


Photo:

Bob Edme / Associated Press

It’s hard to think of a recent failure that could match the EU’s Covid vaccine launch. Protectionism, mercantilism, bureaucratic incompetence, lack of political accountability, crippling security-ism – it’s all here. Keystone Kops in Brussels and European capitals would have been hilarious if the consequences weren’t so serious.

But hospitalizations and deaths increased again in Italy, Germany and France while successful vaccinations reduced illness and death in the US, UK and Israel. To date, the US has administered 34 doses per 100 population, the UK has entered 40 doses, and Israel has 111. Most vaccines require two doses. Compare that to about 12 in France, Germany and Italy.

As the pandemic moves into the reopening phase, Europe’s mistake will cost the entire world economically as the Continent struggles to emerge from lockdown.

***

Take the latest mistakes first. Various European regulators and politicians have spent this week claiming Oxford /

AstraZeneca

the vaccine – the only one currently widely available in the EU – may not be safe, just to be rethought and now begging people to start taking it.

This time the concern is that the puncture has caused blood clots or problems with blood platelets in some patients. Some people who receive the vaccine develop blood clots, but the European Medicines Agency (EMA) found the vaccine was not associated with an increased risk overall.

Among the 11 million or more vaccinated in the UK, serious freezing is less common than would be expected in the general population. People can develop clots for a variety of reasons including health conditions and other medications. Covid-19 can also cause clots, so any risk-benefit calculation supports vaccination.

This is part of the peculiar European safety-ism that has followed the vaccine program from the start. The introduction of the AstraZeneca jab was withheld even after the EMA approved it because bureaucrats in Germany claimed there was no evidence that the injection was successful in patients over 65 years of age.

Fewer elderly patients were included in the sample during the vaccine trial phase, but that is the extent of this claim. This was quickly debunked – real-world evidence available even then from Britain showed high efficacy in an older group – but not before French President Emmanuel Macron took up the theme.

Such sloppy talk prevented vulnerable European parents from receiving the vaccine last month. It also changes the priority list. Younger teachers and university professors in Italy received pre-sick injections and the elderly under a scheme developed when officials claimed it would not work for older people.

One problem is that no one appears to be entirely responsible for monitoring safety and efficacy. Nominally, that is the job of EMA, and the agency is handling it with the typical eurocratic self-confidence. The EMA approval process is more bureaucratic, requiring input from all EU member states. Imagine if the FDA consulted all 50 states.

But national governments are also allowed to make their own safety decisions on “emergency” grounds. Great Britain used this option to agree

Pfizer

and AstraZeneca fired quickly despite being a member of the EU late last year.

Other governments are using this policy to slow down vaccine rollouts. EU capitals refuse to follow Britain in authorizing emergency use, apparently out of fear of hurting European solidarity. But some governments are happy to impose unilateral blocks on vaccines, such as the AstraZeneca blood clot riot. European regulators live by the adage “it’s better to be safe than sorry,” but in this they apologize with no added security.

At least now, millions of doses are available for Europeans who want it. This is not always the case, after a procurement negligence has delayed deliveries and nearly sparked several trade wars. Brussels officials last year seized the opportunity to push for the general procurement of vaccines to increase the EU’s credibility with European voters. Buying on behalf of 500 million Europeans should also give the bloc more influence with pharmaceutical companies.

There’s been chaos. The EU bureaucracy has little experience with procurement on this scale, and is also struggling to reach a block-wide agreement for ventilators and protective equipment. Brussels officials signed vaccine contracts months after the US and UK did so last year – and only after several European governments threatened to arrange their own procurement.

Washington and London understand that it is essential for mass procurement to waste large sums of R&D money on many companies in the hope that some will succeed. Brussels focuses on haggling cost-per-dose. Europeans pay a few dollars less per dose but end up near the back of the delivery line.

The EU response – a combination of threatened export restrictions, boisterous commercial clashes with pharmaceutical companies, and delusional efficacy issues – has undermined Europe’s credibility on trade matters. It also risks fueling vaccine nationalism and trade restrictions elsewhere.

***

Could everything be different? The Trump Administration’s Operation Warp Speed ​​demonstrates how a major government can use its fiscal resources to fund R&D in a crisis. Britain and Israel have shown that small countries can take advantage of regulatory agility to move forward. But somehow the European Union – a continent-wide political bloc made up of smaller nation-states – managed to get the worst of both worlds. It suffers from sluggish bureaucracy from big governments and quarrelsome inefficiency.

Europeans can debate in their spare time who is to blame for this and how to prevent it from happening again. The whole world can only hope they get their vaccination action soon.

Potomac Watch: Rather than reopening classrooms, the new president continues the work of his predecessors. Image: Oliver Contreras / Zuma Press

Copyright © 2020 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

Appears in the print edition of March 20, 2021.

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Catalents to Expand Production of the J&J Covid-19 Vaccine in Italy | Instant News


Contract drug manufacturers

Catalens Inc.

CTLT -2.95%

is planning a massive expansion of production of the Covid-19 vaccine in Europe, allowing it to make more doses

Johnson & Johnson‘s

JNJ 0.59%

shot, said people familiar with the matter.

Catalent will present a second J&J vaccine production line at its plant in Anagni, Italy, during the fourth quarter, the sources said. The expansion has the potential to double the production of the Covid-19 vaccine factory, said one source.

This increase will help increase the supply of the Covid-19 vaccine in European Union, which is stuck with late signing of contracts, delivery problems and difficulty distributing shots in some member states.

European regulators recently phased out the J&J vaccine, although distribution is not expected to start until next month.

J&J has agreed to give the EU 200 million doses this year, and the EU has the option to buy another 200 million. The company said it was confident it would meet its full year target.

NIAID director Anthony Fauci said it was risky to pull back on public health measures, as cases can peak and then recover, as has happened in Europe.

Johnson & Johnson declined to comment. The company has registered nearly a dozen companies to helped produce Covid-19 shots, including

Merck

& Co. and

Sanofi TO

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Catalent, from Somerset, NJ, is one of the world’s largest contract drug makers.

The company agreed to buy a 300,000 square foot facility in Italy in 2019 and take over ownership in January 2020. The company adapted it over the past year to help make a Covid-19 vaccine.

Catalent is currently helping to manufacture the vaccine developed by

AstraZeneca

PLC and the University of Oxford at the facility.

Initial production of the J&J vaccine at the facility is scheduled to begin in the second quarter, according to people with knowledge of the matter. Catalent hopes to eventually produce hundreds of millions of doses.

The expansion will increase the plant’s ability to take key steps in vaccine production. The step, known as a fill-finish, involves filling the vial with the vaccine, closing the vial, and preparing the product for shipment.

Health authorities around the world are looking forward to it J&J shot, in part because it can be stored in a refrigerator instead of a freezer, making shipping and handling easier than other Covid-19 shoots.

J & J is also only one injection, unlike the vaccine from

Modern Inc.,

Pfizer Inc.

and partners

BioNTech SE

which requires two doses weeks apart.

Catalent is also completing refills for the J&J vaccine at its Bloomington, Ind., Plant. The Italian line will work at the same speed as Indiana, filling 400 bottles per minute, the people said. Each bottle contains 5 doses.

STAY INFORMATION

Get coronavirus briefings six days a week, and a weekly Health bulletin after the crisis has died down: Register here.

Write to Jared S. Hopkins at [email protected]

Copyright © 2020 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

Appears in the print issue of March 17, 2021 as ‘A Catalent for Expanding J&J Dose Production.’

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Germany, France, Italy Suspend Use of the AstraZeneca Covid-19 Vaccine | Instant News


BERLIN – Germany, France and Italy join this group of smaller European countries has stopped managing for a while The Covid-19 vaccine is made by

AstraZeneca

AZN -0.17%

PLC, said the move was a precautionary measure amid the small number of cases of blood clots being reported on the continent.

Denmark last week said it had stopped shooting AstraZeneca for two weeks after reports of blood clots, and several other European countries were quick to follow suit, saying they were doing it out of extreme caution. Norway, Ireland and the Netherlands are among the countries that have stopped vaccination with AstraZeneca injections.

Health regulators in the UK and Europe, together with AstraZeneca and its vaccine development partners at the University of Oxford, say there is no known link between severe clotting and injections. AstraZeneca said the number of cases of blood clots among about 17 million people in the European Union and the UK who received injections was lower than the general population.

The European drug regulator said last week it was investigating some 30 reported cases of severe freezing, out of the roughly five million people who had received injections in the block. Last week, the regulator, the European Medicines Agency, said “the current benefits of the vaccine still outweigh the risks” and continued to recommend its use. The agency said most side effects were mild or moderate. Clinical trials do not show a risk of blood clots.

French President Emmanuel Macron, in announcing his country’s hiatus, said the EMA was expected to issue recommendations regarding a vaccine on Tuesday. The agency did not immediately respond to a request for comment.

A series of lulls across Europe threatens the credibility of the AstraZeneca vaccine just three months after its launch. English is the first country to adopt the shot for mass use, in late December.

The shot had previously faced doubts over the results of clinical trials showing that the vaccine was not as effective as other vaccines on the market. Some of that perception has faded as the UK injects millions of people with injections, yielding real-world data showing that these injections are highly effective in preventing serious illness and death.

The UK’s relatively fast vaccination program – with around 11 million AstraZeneca injections playing a key role – does not cause blood clotting problems. British drug regulators say they maintain confidence in the vaccine and its safety.

Last week, reports emerged of a potential clotting problem, with one death and one case of severe disease, in Austria. The country suspended a batch of the vaccine but said it had no evidence of a link between health incidents and injections and kept using it the other way around.

On Thursday, Denmark, Norway and Iceland completely halted vaccine use. The Danish authorities said they would wait at least two weeks before managing it again. The EMA, which acts like the Food and Drug Administration in regulating treatment across the European Union, has said that serious blood clots are no more common among vaccinated people than among the general population. It said it was investigating reported cases of multiple thrombosis, or the formation of blood clots inside a vein, and similar conditions.

Last week, AstraZeneca warned him will fail the projected vaccine delivery to Europe in the coming months, with 100 million doses – nearly two-thirds less than the continent expected based on previous company pledges.

AstraZeneca Chief Executive Pascal Soriot has repeatedly dismissed doubts about the effectiveness of the shot and criticism of its launch. Last month, AstraZeneca said it would roughly double global vaccine production to 200 million doses a month by April.

Write to Bojan Pancevski at [email protected] and Jenny Strasburg at [email protected]

Copyright © 2020 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

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