AstraZeneca exploring options for COVID-19 vaccine

Discussion in 'Health and Fitness' started by themickey, Jul 29, 2021.

  1. themickey

    themickey

    https://www.reuters.com/business/he...vid-19-vaccine-business-exec-says-2021-07-29/

    July 29, 2021
    Healthcare & Pharmaceuticals
    EXCLUSIVE AstraZeneca exploring options for COVID-19 vaccine business, exec says
    Reuters

    [​IMG]
    Vials labelled "Astra Zeneca COVID-19 Coronavirus Vaccine" and a syringe are seen in front of a displayed AstraZeneca logo, in this illustration photo taken March 14, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

    LONDON, July 29 (Reuters) - AstraZeneca (AZN.L) is exploring options for the future of its COVID-19 vaccine business and expects greater clarity on the matter by the end of 2021, a senior executive told Reuters on Thursday.

    The comments are the first time the drugmaker has publicly confirmed that it is reviewing the future of the business after a series of setbacks in its race to develop a shot for the world.

    AstraZeneca agreed to work with the University of Oxford on its COVID-19 shot last year despite having no prior vaccine experience, taking on the project with a pledge not to make a profit during the coronavirus pandemic.

    "We are exploring different options," AstraZeneca Executive Vice President and President of the BioPharmaceuticals Business Unit Ruud Dobber said, referring to the vaccines business.

    "Before year-end, we will have more clarity... if you ask me, is the vaccine business a sustainable business for AstraZeneca for the next five or 10 years, that big strategic question is under discussion."

    Dobber said that AstraZeneca was committed to delivering a massive rollout of hundreds of millions of doses that were covered by current contracts.

    But he added that a "small group of people reporting into Mene (Pangalos, research chief) and myself are thinking about (whether this is) a sustainable business."

    "We need to have that discussion with our senior executive team, and then with the board of AstraZeneca," he said.

    "We are exploring different options, but it is far too early at this stage to conclude that (process)."
     
  2. themickey

    themickey

    Although AstraZeneca has been approved for use in other countries, it has not yet been approved by the US Food and Drug Administration (FDA).
    The AstraZeneca COVID-19 vaccine is not approved for use in the United States.

    The vaccine uses a chimpanzee adenovirus to carry spike proteins from the coronavirus into your body to create an immune response. It can be produced on a large scale and inexpensively, which is crucial during a pandemic. It can also be kept in a regular refrigerator, unlike the vaccines from Pfizer and Moderna.
    While Moderna and Pfizer are based on mRNA, the AstraZeneca vaccine is a viral vector vaccine. This means it uses a different mechanism to induce an immune response. The second dose is also given at a longer interval, instead of the 3- to 4-week suggested interval with the others.

    In March 2021, several European countries paused the use of the AstraZeneca COVID-19 vaccine after several reports of blood clots. The clots that are linked to this vaccine have very specific characteristics:
    • They occur in unusual areas of the body, like the abdomen or brain.
    • People affected also have low platelet levels.
    Other side effects of the AstraZeneca vaccine, which were also rare, included cases of:
    • inflammation around the spinal cord
    • hemolytic anemia
    • high fevers
    All of these symptoms resolved without additional problems. More common side effects included:
    • injection site pain
    • mild tenderness
    • fatigue
    • headache
    • muscle ache
    • chills
    • fever
    Most of these reactions were mild, according to trial data, and resolved within a day or so after vaccination.
     
  3. themickey

    themickey

    In Australia, Who can get the AstraZeneca vaccine?
    AstraZeneca is the preferred vaccine for people over the age of 60.

    That is the health advice from the Australian Technical Advisory Group on Immunisation (ATAGI).

    However Prime Minister Scott Morrison clarified that did not "preclude" people under 60 from getting AstraZeneca.

    "If you wish to get the AstraZeneca vaccine, then we would encourage you to go and have that discussion with your GP," Mr Morrison said.

    So, anyone over age 18 who has been eligible to get a COVID-19 vaccine as part of the Commonwealth rollout has always been able to ask for AstraZeneca.

    The key change announced on Monday night was the introduction of a new no-fault indemnity scheme for GPs.

    What is indemnity?
    Indemnity is a form of protection.

    In practical terms, the new no-fault scheme means GPs cannot be sued if a patient under 60 has an adverse reaction to AstraZeneca.

    It also means a person who has an adverse reaction is entitled to compensation from the federal government without having to establish anyone was at fault.

    The Royal Australian College of General Practitioners (RACGP) has been calling for no-fault indemnity for some time, chair of Queensland branch Dr Bruce Willett said.

    However, Dr Willett said the details of the indemnity scheme were not yet known.

    He said until the scheme was enacted, patients under 60 could be turned away by their GP because there was no protection for either of them.
     
  4. themickey

    themickey

    The real bs in Australia, those over 60 yo have no choice, it's AstraZeneca or nothing!
     
  5. themickey

    themickey

    AstraZeneca vaccine shipped to Canada, Mexico before adequate plant inspections

    [​IMG]
    Vial labelled "AstraZeneca coronavirus disease (COVID-19) vaccine" placed on displayed AstraZeneca logo is seen in this illustration picture taken March 24, 2021. REUTERS/Dado Ruvic/Illustration

    July 29 (Reuters) - Canada and Mexico imported millions of doses of AstraZeneca's COVID-19 vaccine and offered them to the public without health officials properly inspecting the operations of the U.S. manufacturer, according to inspection records and the regulators involved.

    The Baltimore plant belonging to Emergent BioSolutions Inc (EBS.N) was producing vaccines for both AstraZeneca Plc (AZN.L) and Johnson & Johnson (JNJ.N) under a $628 million U.S. government contract.

    In late March, under pressure to help other nations access COVID-19 vaccines, the Biden administration released 1.5 million AstraZeneca doses to Canada, and 2.5 million to Mexico.

    European regulators had certified Emergent's factory as complying with "good manufacturing practices," and on that basis both Canada and Mexico began using the vaccine, regulators in both countries told Reuters.

    But the European Medicines Agency (EMA) told Reuters that the certification was based on a remote inspection that focused on a part of the facility that was not actually producing the AstraZeneca shots - a fact that has not been previously reported.

    The U.S. Food and Drug Administration halted production at the factory three weeks later, after J&J's vaccine was found to be contaminated with material used in the AstraZeneca shots.

    FDA inspectors later documented unsanitary conditions and poorly-trained staff at the plant, which had been rapidly overhauled to make vaccines during the pandemic. read more Production remains halted, with tens of millions of doses of both vaccines in regulatory limbo.

    No reports of illness have been linked to vaccines manufactured by Emergent, and regulators have not alleged that contaminated vaccines were given to anyone. Emergent said there has been no evidence of contamination in the AstraZeneca shots produced at its site.

    But details of the flawed approval process show blind spots that can develop when national regulators share responsibility for overseeing a complex global pharmaceutical industry. Those were only exacerbated given the urgency of the pandemic.

    "It's a risk, because who knows what the standards are that are being applied?" said Joel Lexchin, a Canadian professor and expert in drug regulation. Health Canada typically relies heavily on foreign regulators, he said. "It's a gap that exists outside of crisis times."

    Emergent said in a statement that it "has worked with health officials around the world to ensure any vaccine drug substance we manufactured meets strict safety and quality requirements before being released."

    AstraZeneca said vaccines manufactured by Emergent were subject to more than 40 tests to meet its requirements for safety, purity and quality, and that its manufacturing standards "are rigorously assessed and independently verified by regulators."

    Health Canada told Reuters it is confident the vaccines it received were safe, pointing in part to AstraZeneca's quality control systems. Mexico health regulator COFEPRIS said it remains "confident that the approval process was carried out with all the necessary rigor."

    Canada signed deals to formally recognize some other regulators' certifications as early as 2003, and the United States and Europe reached similar deals in 2019.

    A EUROPEAN INSPECTION
    Early in the vaccine rollout, the European Union was due to receive doses of the J&J vaccine made by Emergent. In early February, Italian officials conducted a remote inspection of the plant that only focused on areas where J&J production was taking place "and not the AstraZeneca vaccine, which was not manufactured at Emergent for the EU market," EMA said in a statement.

    Health Canada said it assumed both products would be made to the same standard. "The quality systems assessed by the EMA for this product would be applicable to all similar products made at this site," it said in a statement.

    This is the wrong approach, according to University of Ottawa professor Amir Attaran, who studies drug policy, including Health Canada's reliance on foreign regulators.

    "It's precisely because they were similar (products) that cross contamination is a risk," he said. Canada was "out on a limb" approving AstraZeneca doses from the facility before the FDA, he said.

    Health Canada said it reviewed test results and quality control steps for every vaccine lot sent to Canada.

    Initially, Mexico's COFEPRIS told Reuters the FDA was responsible for certifying U.S. operations, but later confirmed that the factory had been certified by European regulators.

    When Reuters shared the European regulators' statement that it had not assessed AstraZeneca production specifically, COFEPRIS said it would review the file, but remained confident in the approval process.

    The Mexican regulator said vaccines went through quality control systems at Emergent, and twice more during the vial filling process handled by another contract manufacturer.

    "When evaluating vaccines, the product and its entire production process are considered and examined," it said in a statement.

    Emergent's contract with the U.S. government is the focus of a Congressional investigation, which unearthed documents that highlight early concerns about the Baltimore plant.

    Soon after the Trump administration announced Emergent's contract last summer, its own vaccine officials visited the plant and wrote a report flagging inadequate staffing and training. The report warned of the need to strengthen quality oversight, a process that would "require significant resources and commitment."

    The FDA, following a February 2021 visit to the plant, noted in a June memo that Emergent staff turnover was high and record-keeping inadequate. While European regulators said they were aware of that visit, Health Canada said it did not learn about it until last month.

    An FDA spokesperson said the agency works closely with international partners, and that it notified various health authorities of its findings after its April 2021 inspection of the Emergent facility.

    Emergent said it is still working with the FDA to release more of the already produced COVID-19 vaccine batches.

    "We have manufactured tens of millions of doses that could be used to help vaccinate people around the world as the pandemic shows no signs of slowing down," the company said.

    Reporting by Allison Martell in Toronto, Emilio Parodi in Milan, Francesco Guarascio in Brussels, Carl O'Donnell in New York and Cassandra Garrison in Mexico City; Editing by Michele Gershberg and Bill Berkrot
     
  6. Europe and AZ have a "rocky relationship" (to put it mildly) due to multiple delivery problems and angry messages hurled at each other in the press. AZ didn't deliver promised quantities or delayed deliveries by months. Threats of lawsuits and damage claims ensued. In the end Europe bought more vaccines from other suppliers and stopped buying from AZ altogether. Europe doesn't need AZ anymore and their reputation is in tatters. Several Asian countries have the same experience with AZ: promised deliveries being postponed by months, causing major logistical nightmares in national inoculation programs.
     
  7. wrbtrader

    wrbtrader

    Canada has recently been giving away their supply of AstraZeneca to other countries in need of vaccines. :sneaky:
    Yet, they did have a massive earlier rollout of the vaccine. I wasn't qualified to take the vaccine after my Doctor determine I was allergic to an ingredient in the AstraZeneca and J&J vaccines.

    Instead, I was fully vaccinated with Moderna.

    wrbtrader
     
    themickey likes this.
  8. themickey

    themickey

    AstraZeneca stockpile grows to millions as Pfizer stock set to arrive
    By Farrah Tomazin, Clay Lucas and Melissa Cunningham
    August 21, 2021 https://www.smh.com.au/politics/vic...izer-stock-set-to-arrive-20210820-p58kl7.html

    Australia has a stockpile of more than 6 million unused AstraZeneca vaccine doses, and doctors and state leaders fear many will go to waste as people increasingly turn to the new supply of Pfizer jabs promised by the federal government.

    After Prime Minister Scott Morrison announced on Thursday that anyone over 16 would be eligible for a Pfizer jab by the end of this month, The Age and Sydney Morning Herald can reveal that of the 16 million doses of the AstraZeneca vaccine that have been released to the government by manufacturer CSL, only about 8 million have gone into the arms of Australians.

    A further 1.6 million doses have been sent offshore to help regional neighbours such as Papua New Guinea, Fiji and East Timor tackle COVID-19.

    But about 6 million doses are yet to be used, even as more than half the nation is in lockdown due to outbreaks of the highly infectious Delta variant.

    With only 29 per cent of Australian adults fully vaccinated, doctors and health authorities have urged patients not to scrap their appointments for the AstraZeneca vaccine following the Prime Minister’s announcement. The vaccine has a 92 per cent effectiveness against hospitalisation, severe disease and death........
     
  9. themickey

    themickey

    Hundreds of protesters arrested as Australia reports record COVID-19 cases
    After months of strict lockdown, authorities still struggle to contain surge of infections
    [​IMG]
    Police use pepper spray on protesters during an anti-lockdown protest in Melbourne on Aug. 21. Protesters have been rallying against restrictions aimed at controlling the latest COVID-19 outbreak. © Reuters
    August 21, 2021 https://asia.nikkei.com/Spotlight/C...ed-as-Australia-reports-record-COVID-19-cases

    MELBOURNE (Reuters) -- Australian police arrested hundreds of anti-lockdown protesters in Melbourne and Sydney on Saturday and seven officers were hospitalized as a result of clashes, as the country saw its highest ever single-day rise in COVID-19 cases.

    Mounted police used pepper spray in Melbourne to break up crowds of more than 4,000 surging toward police lines, while smaller groups of protesters were prevented from congregating in Sydney by a large contingent of riot police.

    Victoria state police said that they arrested 218 people in the state capital Melbourne. They issued 236 fines and kept three people in custody for assaulting police. The arrested people face fines of A$5,452 ($3,900) each for breaching public health orders.

    Police in New South Wales, where Sydney is the capital, said they charged 47 people with breaching public health orders or resisting arrest, among other offences, and issued more than 260 fines ranging from A$50 ($35) to $3,000. The police said about 250 people made it to the city for the protest.

    Sydney, Australia's biggest city with more than 5 million people, has been in a strict lockdown for more than two months, failing to contain an outbreak that has spread across internal borders and as far as neighboring New Zealand.

    The vast majority of the 894 cases reported across Australia on Saturday were found in Sydney, the epicenter of the Delta variant-fueled outbreak.

    "We are in a very serious situation here in New South Wales," said state Health Minister Brad Hazzard. "There is no time now to be selfish, it's time to think of the broader community and your families."

    Police patrolled Sydney's streets and blocked private and public transport into the city center to reduce the number of people gathering at an unauthorized protest.

    In Melbourne, the country's second-most populous city, a large crowd managed to march and some clashed with police, after state Premier Daniel Andrews expanded a city lockdown to the entire state.

    Victoria Police Chief Commissioner Shane Patton had earlier warned people to stay away from the protest, adding it was "just ridiculous to think that people would be so selfish and come and do this."

    Several hundred people also protested peacefully in Brisbane, which is not in lockdown.

    Just 7% of Australians support the often-violent protests, according to a late-July poll by market research firm Utting Research.

    Compliance with public health rules has been one of the key cited reasons behind Australia's success, relative to other rich countries, in managing the pandemic. But the country has been struggling to rein in the third wave of infections that began in Sydney in mid-June.

    Australia has had about 43,000 COVID-19 cases and 978 deaths. But while those numbers are low, only about a third of Australians aged 16 and above have been fully vaccinated, according to federal health ministry data released on Saturday.

    New South Wales officials reported three deaths and 516 people in hospital on Saturday. Of the 85 people in intensive care, 76 were unvaccinated, officials said.

    At least 96 people were active in the community during their infectious period, and there were a number of breaches of public health orders, all slowing the efforts to curtail the outbreak. In Victoria, at least 39 people were active in the community while infectious. Eighteen people were in hospital, eight in intensive care and six on ventilators.
     
  10. themickey

    themickey