Tag Archives: pharmaceutical industry

AstraZeneca Vaccine: Australian drug regulators reject questions raised in the US about outdated data | Australian News | Instant News

Australia’s drug regulator, the Therapeutic Goods Administration, has rejected the questions raised “Outdated information” in AstraZeneca vaccine data by the US Data and Security Monitoring Agency.

On Monday AstraZeneca released preliminary results from a Phase 3 Covid-19 vaccine clinical trial showing 100% efficacy against severe or critical illness and hospitalizations. It shows 80% efficacy in those aged 65 years and over and, overall, had a 79% efficacy in preventing Covid-19 symptoms. These results were based on 32,449 participants.

But the independent Data and Security Monitoring Agency issued a statement saying it was concerned AstraZeneca might include outdated information from the trial. US National Institute Health has urged AstraZeneca to work with the board to review the data and make the most accurate and up-to-date information public as quickly as possible.

Australia relies on locally produced doses of AstraZeneca for most of its vaccine launches. The head of TGA, Prof. John Skerritt, said the regulator was confident that the complete data would be provided next month in line with the contract arrangement.

“We’ll get the warts and all,” Skerritt told the ABC on Wednesday. “I think what’s released is very encouraging.”

Hassan Vally, a professor of epidemiology at La Trobe University in Melbourne, said such questions were not uncommon, but that global attention to Covid-19 was changing things.

“It seems to me like a technical problem,” said Vally, adding: “These small problems usually occur privately, and any kind of clarification usually takes place outside the public arena.”

While transparency is welcome, he said, it is also “a little unfortunate”.

“This has the potential to undermine confidence in the AstraZeneca vaccine,” he said. “We want to try and avoid this situation when it occurs, but at the same time admit that this is another manifestation of how transparent the process is, and how rigorous it is.

“The real world evidence of how vaccines work is absolutely fantastic and this is definitely a safe and effective vaccine and everyone should have full confidence in it.”

AstraZenecasaid’s figures are based on a pre-determined preliminary analysis with a data limit on 17 February. It has reviewed subsequent data and found that they are consistent.

Director of infectious diseases at Mater Health Services, Assoc Prof Paul Griffin, said: “To me this does not signal a concern about vaccines or the science that supports their use.

“However, there may be opportunities to improve the communication of some of this information and resolve issues like these head-on rather than letting them play in the press.

“What is clear is that regulatory approval is not based on press releases and that the data available so far has been, and future data will continue to be available, fully available to regulators for review. Therefore, problems like this should not diminish our confidence in this vaccine or its use in our country or any other country. “

Answering a question on the Senate forecast on Wednesday, Skerritt said it was unclear whether the questions raised about vaccines had led to increasing vaccine doubts in Australia.


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What does the breakthrough Pfizer Covid vaccine mean for Australia? | Australian News | Instant News

News that pharmaceutical giant Pfizer and its partner company BioNTech have developed a vaccine proven to be 90% effective in protecting people from Covid-19 in global trials has been heralded as a “breakthrough”. Pfizer’s chief executive, Dr Albert Bourla, describe the results as “What a day for science and humanity”.

But what do these findings mean for Australia, and for the other Covid-19 vaccines being studied?

There are few details about the results

Victoria’s acting chief health officer, Prof Allan Cheng, said although the Pfizer vaccine was good news, there was “very little detail about what the real results were,” because it had not been published in a peer-reviewed medical journal. Most of the findings have been delivered in a Pfizer press release.

“Pfizer says they have analyzed 94 cases of Covid as part of this trial, but they haven’t even told us about the characteristics of those cases, or the study group they are in. There is always a lot of criticism of science through media releases, because we need to know. more about the findings than a press release can provide. “

Prof Lyn Gilbert, chair of the Australian Infection Control Advisory Group, agrees.

“It sounds promising because it is 90% effective, but these results have not been peer reviewed, and were very disturbing, in fact, when companies reported this in the media before journals,” he said. “Pfizer is a good company and maybe a good one, but we really don’t have a lot of details.”

We need to know more about vaccine safety

Cheng said the key unknown was vaccine safety, including whether there were side effects and how serious they were.

There are more than 170 different vaccines being developed around the world, and they work differently.

The Australian government’s strategy is to enter into agreements with various developers to diversify the types of vaccines it has access to. Now has separate agreements with four vaccine developers: AstraZeneca / University of Oxford, University of Queensland, Pfizer, and Novavax.

The agreement, if all vaccines pass clinical trials, will give Australia access to more than 134 million doses of vaccine. The University of Queensland and Novavax are working on a protein-type vaccine, and the AstraZeneca Oxford vaccine is an adenovirus vector vaccine.

The Pfizer vaccine is an mRNA-based vaccine candidate. In order to infect someone, Covid-19 hijacks cell processes to multiply and infect other cells.

“The mRNA-based vaccine only introduces a small amount of virus, not the virus that functions as a whole, and it is introduced into cells,” Cheng said.

“These mRNA-based vaccines are usually quite reactogenic, so there are a lot of side effects that are usually very mild, such as a sore arm than usual, and 15 to 20% of people have a fever, which is unusual. for the vaccine. If that was the only side effect, most people would be quite happy with it, but we still need to know. “

Another big question is around vaccine failure. Of the 10% of people who develop the virus even though they have received the vaccine, how serious is their case? How long after receiving the vaccine do they become unwell, and how long does protection last in those who use the vaccine? We have no answers.

“The vaccine may be 90% effective from the start, but what about six months?” Cheng said.

“The other big question is storage temperature, considering that this vaccine needs to be stored around minus 70C. This will make transportation and storage much more difficult. “

Will Australia produce this vaccine?

Cheng said this is very unlikely in the short term. Australia does not have the facilities to produce this volatile type of cold chain vaccine, so a new manufacturing facility with all the existing quality safeguards will need to be built.

Infectious diseases Australian National University doctor and professor Peter Collignon agrees that Australia will be in huge demand to produce the Pfizer vaccine locally. “When you need a freezer at minus 70C and to maintain that temperature until delivery, that’s a huge logistical hurdle,” he said.

Can only be stored at 4C for a maximum of 24 hours. This will be a challenge for a mass vaccination campaign.

“That’s why it shouldn’t be seen as the only vaccine,” Collignon said.

“If there are nine billion people in the world and assuming we need two doses for the vaccine to be effective, it will take several different vaccines and the type of vaccine available somewhere may depend on the manufacturing and distribution options available.”

Has Australia secured sufficient doses?

There is some concern about the volume of Pfizer vaccine Australia has secured. The 10m dose sequence, at two doses per person, will only be sufficient for five million Australians, and Pfizer has reached an agreement to deliver hundreds of millions of doses to the United States, Japan and the European Union.

The deal with US company Novavax will provide Australia with a 40m dose, and CSL has agreed to supply 51m doses of University of Queensland vaccine and 30m doses of AstraZeneca / Oxford vaccine.

“This shows the importance of having multiple vaccines available, to ensure that everyone around the world will be protected,” said Associate Prof. Linda Selvey, an infectious disease epidemiologist at the University of Queensland.

“The 90% efficacy is encouraging, however, in situations where there are no restrictions on encounters or movements, this means that about 65% of the population will have to be vaccinated to stop the spread of the virus. [assuming an R0 (reproduction number) of 2.5]. “


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BioNTech Covid Vaccine: a shot for the Turkish community in Germany | World News | Instant News

When the German biotech company BioNTech chose the street named An der Goldgrube or At the Gold Mine in the western city of Mainz as its headquarters, the pair behind it could not predict how prophetic that address would be.

The company’s shares jumped 23.4% on Monday morning after the Covid-19 vaccine it developed with US pharmaceutical giant Pfizer becoming the first candidate worldwide to get it. showed positive results in the phase 3 trial, the final, critical stage of testing.

The total value of BioNTech’s shares is currently $ 21.9 billion (£ 16.6 billion), more than four times that of German national airline Lufthansa and a win for the company that only debuted on the US stock market a year ago.

Founded in 2008 by married scientists Özlem Türeci and Ugur Sahin and Austrian oncologist Christoph Huber, the company initially developed a new type of immunotherapy to fight cancer, modifying patients’ T cells to target cancer-specific antigens.

When news of the coronavirus first broke out earlier in the year, BioNTech, which employs 1,300 people, quickly relocated its resources. Sahin, its CEO, told German Manager Magazin that when he read about the Covid-19 outbreak in Wuhan in January, he told his wife that “in April they will have to close schools here”.

German entered its first lockdown in March, earlier than Sahin had expected, but by then his company had developed 20 candidates for the vaccine, which would test five for immune reactions in a research program accompanied by 500 scientists called Lightspeed.

Sahin said in a Interview by the end of October the company could develop its own vaccine, but had to struggle with distribution challenges.

Pfizer, which has worked with BioNTech on the flu vaccine since 2018, paid $ 185 million up front for the development of a coronavirus vaccine. It will release another $ 563 million when development is complete.

Monday’s provisional results showing 90% efficacy is a win for the scientific method of Pfizer and BioNTech. Their vaccine pioneers an entirely new technology that involves injecting part of the virus’s genetic code to train the immune system.

In a country where debate over the willingness of Germans with Turkish roots to integrate into public life has never been far from the headlines over the past decade, the story of the BioNTech founder also stands out.

Türeci and Sahin were Turkish children Guest worker or “guest workers” who came to Germany in the late 1960s. Sahin was born in southern Turkey but moved to Cologne when he was four years old. Türeci, the company’s chief medical officer, was born in Lower Saxony.

The couple, who have German citizenship and have a teenage daughter, met at Saarland University in Homburg and have been married since 2002. In an interview with Süddeutsche Zeitung, Türeci said she and her husband started their wedding day in lab coats and continued their research. after a brief run to the registry office.

The Berlin newspaper Tagesspiegel wrote that their success was a “balm for the soul” of Germans with Turkish roots after decades of stereotyping as poorly educated vegetable traders.

2020 also marks the 10th anniversary of the publication of Germany Does Away With Itself, a book in which a former government official argued that Turkish migrants were fooling the country’s education standards.


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Prescription Drug Cost Management | Regulatory Review | Instant News

Experts are considering how regulators can make drugs affordable without getting in the way of research and development.

Prescription drug prices in the United States is notoriously higher than in other high-income countries. Unlike in other countries, the US government is not direct set or negotiating drug prices. In contrast, US drug companies set their own prices, but insurance companies and pharmacies determine how much patients actually pay themselves.

Critic of US pharmaceutical company drug price inflation claim that the pharmaceutical industry benefits from vulnerable patients. Pharmaceutical companies, however, against drug price reforms and argue that lowering the cost of prescription drugs will stifle innovation, ultimately leading to fewer options for patients.

Reducing costs can slow new drug development, but research recommend that slow innovation may not have a significant negative effect on patient health. Recently article researchers found that of 46 new drugs approved in the United States in 2017, 17 provided no or little additional benefit when compared to drugs on the market. Reducing costs may not be necessary get in the way innovation, because the UK and Canada enjoy low drug prices and innovative and profitable pharmaceutical companies.

Society owns researched prescription drug costs over the years, but trying Graduated Drug charge laws have largely failed. Only the COVID-19 pandemic made worse situations like those of the law stopped, the use of prescription drugs has rise up, and the price of prescription drugs increased. In June, the pharmaceutical company Gilead Science set price Remdesivir–The first drug approved to treat COVID-19 – is priced at $ 3,120 per treatment for privately insured patients, although health insurance can lower self-incurred costs for patients. Fee once again triggered criticism of US pricing methods, though Institute for Clinical and Economic Review counted that Remdesivir can be cost-effective for insurance companies even if it costs $ 5,080 per treatment.

This Saturday week seminar focuses on managing drug costs in the United States.

  • The United States is ineffective in dealing with rising drug prices, William Padula from University of Southern California argue in a article To Journal of Health Care Law and Policy. He confirms that the absence of a unified national approach to tackling drug prices has created a patchwork of state legislation. Padula argue that the state regulatory approach makes it easier for the pharmaceutical industry to do so file a case against anti-price gouging laws. Padula note that while bipartisan support exists for drug price regulation, any unified change will “ultimately continue to depend on federal action.”
  • The biopharmaceutical industry has former claims void-for-obscurity – which challenge laws intended to regulate drug prices by arguing that terms such as “exaggerated” or “unreasonable” are ambiguous – to attack drug price regulation and anti-grafting laws. In a article To Northwestern University Law Review, Michelle Mello from Stanford Law School and Rebecca Wolitz, a researcher at Harvard Medical School, Discuss how state and federal drug pricing laws can survive this vacuum-for-obscurity by looking to other areas of the law. Mello and Wolitz conclude that borrowing the standard of what is meant by “unreasonable” or “exaggerated” rates in consumer loan laws, which have withstood industry challenges, may be the most appropriate model for guiding future state and federal regulation.
  • In a learn published on Journal of the American Medical Association, University of Southern California Martha S. Ryan and Neeraj Sood analyze how legislators can improve price transparency throughout the drug supply chain. Even though the state recently passed many new transparency laws, Ryan and Sood conclude that most existing laws are “insufficient to reveal the true transaction price”. They Find it that there is no state law that creates price transparency throughout the supply chain. In order for drug pricing legislation to be effective, they are recommend laws that require all supply chain participants to report true prices, including discounts and rebates.
  • Current regulatory policies fail to foster transparency and price negotiations, which allow pharmaceutical manufacturers to “charge whatever they like”, University of California San Francisco Nisarg A. Patel argue. In a article published on Journal of Law and Bioscience, he urged Congress to create an “independent drug review board” that would use clinical trial results to recommend base drug prices. Patel recommend that review boards can analyze drug efficacy data to determine the value of drugs relative to their competitors’ products. Based on that data, the board can adjust recommended drug prices over time.
  • In a article published on Minnesota Legal Review, Rachel E. Sachs from Washington University at St’s Law School. Louis check the relationship between insurance reimbursement and US Food and Drug Administration (FDA), and how these two systems are “tightly linked by law” and ultimately impact the cost of prescription drugs. Sachs consider three potential effects of delinking insurance reimbursement systems and FDA approval. First, if the two are separated, Sachs argue, access to certain drugs is likely to decrease as insurance companies no longer have to cover all or most of the FDA-approved drugs. Second, Sachs claim that removing links would encourage more thorough research and more transparent drug costs as drug companies have to prove to insurance companies that their product is justified. Finally, Sachs confirms that delinking will ultimately reduce drug costs because insurers will have more information and negotiating power.
  • In a article to Health Affairs, Sean Dickson and Timothy A. Lash from Western Health proposes a “domestic reference price approach” for setting new drug prices. Using the drug Remdesivir as a case in point, they are rate historical price data for similar drugs released in the United States and adjusting prices for inflation to determine the most reasonable price of remdesivir. Dickson and Lash then model benefits of Remdesivir at different price points based on estimates of revenue, production costs, and research costs. Acknowledging that their model may not fully value innovative drugs, they are argue that the manufacturer can still prove that their product is worth more than the domestic reference indicates. Dickson and Lash conclude that the domestic reference pricing approach would lead to savings by hindering the ability of pharmaceutical companies to set their own prices.


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UK Minister praises coronavirus ‘immune test that changes the game’ | Science | Instant News

A health minister praised Britain’s approval for a corona virus immunity test as a game changer that could allow more people to work with confidence, even though the government has not yet managed to buy one of the tests.

Edward Argar said the test developed by Roche “appeared to be very reliable and received the green light from the public Health English testers “.

Initially only patients in the hospital can undergo tests in the UK. Then the testing was extended to NHS staff and home care staff. Now up to 10 million important workers and their families who show symptoms of coronavirus can apply for a test through a government website.

The list of important workers is the same as that used to permit key worker children to continue going to school during lockdown. In addition to health and social care staff, the list includes teachers, judges, several lawyers, religious staff, and journalists who provide public service broadcasts.

Also included are local civil servants, police, armed service officers, fire and rescue service staff, immigration officers and prison staff and probation. Some private sector staff also qualify including veterinarians, those in food production, important financial services and information technology, as well as those working in the oil, gas, electricity and water sectors.

Matthew Weaver

He said the government wanted to get the test on stream quickly because it could make a significant difference.

However, he acknowledged that no test was purchased by the British because the government was still in discussions with Roche about obtaining it.

Speaking at BBC Breakfast, Argar said: “We want to get as much as we can and bring it out especially to the front lines directly and broader, because as the prime minister said it has the potential to be a game changer.”

He could not give a date when they would be available for the NHS and then be used more widely by the public.

But he said they would make a big difference, as scientific evidence shows it could provide an immunity level.

He said this could “really change the way you could work” because people could be sure that they all could no longer get coronavirus or send it to other people.

Antibody testing can be very useful because this state arises from locking because the presence of antibodies to the virus in the blood proves who has it. However, whether a person is immune, and if so how long the immunity lasts, is still uncertain.

Coronavirus test: how it works and what is displayed

This test is likely to be used to find out if certain regions of the country, or people in certain professions, have Covid-19, but it will not give individuals an immune passport to let them restart their social life.

This Roche antibody test is not a finger prick test at home that creates a wave of excitement when Prof. Sharon Peacock of Public Health England told a parliamentary committee on March 25 that it would be available for purchase within a few days.

Oxford University is testing several versions of the home antibody test, which looks like a pregnancy test, at the time. However, all failed to reach the standard.

The best is said to be 70% accurate and at least more than 50%. The health secretary, Matt Hancock, who has bought 3m from them, is said to be looking for government money back.

The Roche test was approved in early May by the EU and by the Food and Drug Administration in the US as 99.8% specific to Covid-19 – so it is not confused by antibodies to other corona viruses that cause colds – and 100% sensitive, so it will take away any antibodies that are present.

This will work on blood samples taken by health professionals at least 14 days after someone develops Covid-19.

That Elecsys Anti-Sars-CoV-2 serological test processed in the laboratory using Roche analyzers that are already owned by the hospital. Roche said his fully automated system could give results in about 18 minutes for one single test, with the ability to do 300 tests per hour, depending on the analyzer.

Prof. John Newton, national coordinator of the UK coronavirus testing program, told Telegraph experts at the Porton Down PHE laboratory that had evaluated the tests and confirmed 100% accuracy.

“This is a very positive development, because very specific antibody tests are very reliable markers of past infection,” he said.

“This in turn could indicate some future immunity to infection, although the extent of the presence of antibodies indicates immunity is still unclear.”

Scientists hope to get valuable data about the spread of pandemics through mass antibody tests, which can reveal how many people have the virus but without experiencing any symptoms. Looking at certain groups will help in finding a vaccine and treatment.

Coronavirus UK: should I wear a mask? – video explorer


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