Category: Covid-19 Vaccine

Sign up for our free Health Check email to receive exclusive analysis on the week in health Get our free Health Check email

AstraZeneca has announced it initiated a worldwide withdrawal of its Covid-19 vaccine, months after the pharma giant admitted the drug could causerare but life-threatening injuries.

The vaccine, initially known as Covishield, was developed by the pharmaceutical giant in collaboration with Oxford University, and produced by theSerum Institute of India.

The Anglo-Swedish company also said it would proceed to withdraw the vaccine Vaxzevrias marketing authorisations within Europe.

On Tuesday, the European Medicines Agency issued a notice that the vaccine is no longer authorised for use.

The Covid jab was widely administered in over 150 countries, including Britain and throughout the EU.

The withdrawal of the vaccine has been attributed to a "surplus of available updated vaccines" since the pandemic, the company said.

Some studies conducted during the pandemic found the vaccine was60 to 80 per centeffective in protecting against Covid.

What are the side effects of the vaccine?

Recent research has found that Covishield can cause some people to develop blood clots, which may prove fatal.

AstraZeneca admitted in court documents lodged with the High Court in February that the vaccine can, in very rare cases, cause TTS (Thrombosis with Thrombocytopenia Syndrome) though the cause is unknown, according to The Telegraph.

Further, TTS can also occur in the absence of the AZ vaccine (or any vaccine). Causation in any individual case will be a matter for expert evidence, it added.

TTS is characterised by blood clots and a low blood platelet count in humans.

The complaint claimed the vaccine led to deaths and severe injuries and sought damages up to 100m for about 50 victims.

One of the complainants also alleged that the vaccine caused him a permanent brain injury after he developed a blood clot, preventing him from working.

The rare syndrome occurred in about two to three people per 100,000 who were vaccinated with the Vaxzevria vaccine.

The World Health Organization also confirmed that the vaccine could have fatal side effects.

A very rare adverse event called Thrombosis with Thrombocytopenia Syndrome, involving unusual and severe blood clotting events associated with low platelet counts, has been reported after vaccination with this vaccine, WHO said.

According to the Council for International Organizations of Medical Sciences, very rare side effects are those reported in less than 1 in 10,000 cases.

In countries with ongoing SARS-CoV-2 transmission, the benefit of vaccination in protecting againstCovid-19far outweighs the risks, the WHO added.

How widespread was use of the vaccine in the UK?

Around 50 million doses of the the Oxford-AstraZeneca were administered in the UK by autumn 2021.

However, the government largely stopped using the jab and it was replaced in the UK with Pfizer and Moderna jabs in time for the winter booster campaign at the end of 2021.

The pharmaceutical company said the decision to withdraw the vaccine is not linked to the court case.

In a statement, AstraZeneca said: We are incredibly proud of the role Vaxzevria played in ending the global pandemic. According to independent estimates,over 6.5 million lives were saved in the first year of use alone and over three billion doses were supplied globally.

Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic.

As multiple, variant Covid-19 vaccines have since been developed there is a surplus of available updated vaccines. This has led to a decline in demand for Vaxzervria, which is no longer being manufactured or supplied.AstraZeneca has therefore taken the decision to initiate withdrawal of the Marketing Authorisations for Vaxzevria within Europe.

We will now work with regulators and our partners to align on a clear path forward to conclude this chapter and significant contribution to the Covid-19 pandemic.

Go here to see the original:

AstraZeneca: What are the rare side effects of the Covid jab? - The Independent

The Oxford-AstraZeneca vaccine was a critical part of the COVID-19 pandemic response. However, on May 7 2024, the European Commission announced the vaccine is no longer authorised for use.

This EU announcement was preceded by an application from AstraZeneca on March 27 2024 to withdraw the EU marketing authorisation.

This development has been covered in various media outlets as primarily related to the known "adverse events", namely a very small risk of blood clots. However, other factors are far more likely to be driving this decision.

The first AstraZeneca vaccine dose, outside of clinical trials, was administered on January 4 2021. In that year, about 2.5 billion doses were administered, and an estimated 6.3 million lives saved.

It was a key product at the peak of the pandemic. This includes during the emergence of the delta variant in India, across the first half of 2021 where, amid significant global supply issues, the AstraZeneca vaccine was one of the few tools available during that humanitarian crisis.

This COVID vaccine, like those from Pfizer, Moderna, Novavax and others, went through the appropriate levels of testing. The phase 3 trials (where the vaccine is tested on thousands of people) showed the AstraZeneca product was safe and effective. It was distributed in many countries in Europe in early 2021, including the UK.

The potential adverse events related to blood clots were publicly reported in February 2021, with, for example, the UK government and the drugs regulator (the MHRA) then publishing a statement about its continued use on March 18 2021.

Amid speculation and investigation, the European Medicines Agency and the World Health Organization both highlighted how the benefits of the vaccine greatly outweighed any possible risks.

This was a time when COVID levels were extremely high, and getting higher, with around 4 million confirmed new cases globally per week.

It is well established that COVID itself caused a significantly increased risk of these related blood clots (thrombocytopenia). An August 2021, analysis of 30 million vaccinated people in the UK showed that the risks of thrombocytopenic events were much higher following a COVID infection, compared with any COVID-related vaccine.

From that study, the British Heart Foundation describes how for every 10 million people who are vaccinated with AstraZeneca, there are 66 extra cases of blood clots in the veins and seven extra cases of a rare type of blood clot in the brain. By comparison, infection with COVID is estimated to cause 12,614 extra cases of blood clots in the veins and 20 cases of rare blood clots in the brain.

To put this into some perspective, these vaccine-associated blood clot rates are much lower than many widely prescribed medicines. For example, the combined contraception pill, prescribed widely to women, has blood clot-related risks of around one in 1,000. With women taking postmenopausal hormone therapy, around one in 300 per year are likely to develop a blood clot.

The AstraZeneca vaccine did suffer from a poor public profile, arguably much of it undeserved. There was some poor quality reporting in Germany in January 2021, with claims that the vaccine was only "8% effective in the elderly". This claim was widely repeated, but it turns out that 8% figure referred to the percentage of people aged over 65 years in the study and not the efficacy measure.

The anti-vaccine lobby had a field day with fuelling the "infodemic", including other false claims such as fabricated links between the vaccine and female infertility. As with the blood clots, COVID infection is known to increase the risks of infertility, but there is no link between infertility and the vaccine.

For individuals and families likely to have been injured by any medicine, including any of the COVID vaccines, compensation schemes are available. Many claimants report difficulties and frustrations with accessing the compensation.

This is an area where the government-led schemes should be more transparent, and also where the misinformation from the anti-vaccine lobby hinders those groups they are claiming to support.

So, why would AstraZeneca withdraw this high-profile product? One reason for the withdrawal is likely to be that other COVID vaccines, such as Pfizer and Moderna, are essentially better products.

AstraZeneca is very good, but the mRNA versions have better effectiveness and safety levels.

The initial concerns around the difficulties of the specialist refrigeration needed to transport and store the Pfizer and Moderna vaccines have been overcome, including in low-income countries. The mRNA vaccines are also easier to update when new variants emerge.

With those factors, orders for the AstraZeneca vaccine are probably much lower now than they were in previous years. It is being overlooked in favour of better-performing vaccines.

For the Oxford AstraZeneca vaccine, perhaps its time has indeed passed. But it has been a safe and effective vaccine and a key part of the pandemic response for most countries around the world.

Michael Head, Senior Research Fellow in Global Health, University of Southampton

This article is republished from The Conversation under a Creative Commons license. Read the original article.

View original post here:

AstraZeneca's COVID Vaccine Withdrawn But Let's Untangle The Facts From The Fiction - ScienceAlert

NEW DELHI: AstraZeneca on Tuesday announced that it has started the global withdrawal of its Covid-19 vaccine, days after the UK pharmaceutical company admitted that its vaccine has the potential to cause a rare side effect called Thrombosis with Thrombocytopenia Syndrome (TTS). The company said the withdrawal was due to a "surplus of available updated vaccines" since the pandemic. According to media reports, the Anglo-Swedish drugmaker had previously admitted in court documents that the vaccine causes side effects such as blood clots and low blood platelet counts. The company also said its decision to remove the vaccine Vaxzevria's marketing authorizations within Europe, noting that this oversupply has resulted in a decrease in demand for Vaxzevria, which is no longer being produced or distributed. "As multiple, variant Covid-19 vaccines have since been developed there is a surplus of available updated vaccines," the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied. AstraZeneca which collaborated with the University of Oxford to create the vaccine is currently dealing with a lawsuit that claims their vaccine has caused deaths and severe harm to those who received it. The UK-based pharma company also collaborated with the Serum Institute of India (SII), the largest vaccine producer globally, to provide the vaccine (Covishield) to the Indian government. The Telegraph, which initially reported the news, said that AstraZeneca's application to withdraw the vaccine was submitted on March 5 and became effective on May 7. Previous year, Jamie Scott, a father of two, took legal action after suffering from a blood clot that left him unable to work. Scott said that he developed a blood clot and a bleed on his brain, leaving him with a lasting brain injury following his vaccination in April 2021. According to The Telegraph, Scotts wife Kate said, "The medical world has acknowledged for a long time that vaccine-induced immune thrombocytopenia and thrombosis (VITT) was caused by the vaccine." However, in May 2023, the company informed Scott's lawyers that they do not acknowledge that TTS is induced by the vaccine on a general level. Later in the legal document submitted to the high court, the multinational pharmaceutical company said, "It is admitted that the AZ vaccine can, in very rare cases, cause TTS. The causal mechanism is not known." Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines, AstraZeneca said in a statement.

What is the rare side effect of AstraZeneca?

See more here:

AstraZeneca says it will withdraw Covid-19 vaccine globally - The Times of India

By Thomas Moore, Science correspondent @SkyNewsThomas

Wednesday 8 May 2024 13:28, UK

AstraZeneca has begun the worldwide withdrawal of its COVID vaccine - ending an era in which it saved millions of lives while being dogged by controversy.

The jab, developed at Oxford University, was once hailed as "the vaccine for the world" because it could be stored in fridges rather than the ultra-cold freezer temperatures originally required for alternative mRNA shots, making it more suitable for developing countries.

But AstraZeneca (AZ) said demand for the jab had tailed off as more up-to-date vaccines target newer variants of the virus. It no longer manufactures nor supplies the vaccine.

The voluntary withdrawal has started in the EU, with the European Medicines Agency announcing that the vaccine is no longer authorised for use.

In a statement, AZ said: "According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over three billion doses were supplied globally.

"Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic.

"We will now work with regulators and our partners to align on a clear path forward to conclude this chapter and significant contribution to the COVID-19 pandemic."

The vaccine had only been in use for a few months before reports emerged of unusual blood clots.

Read more: Dad who suffered brain injury days after COVID vaccine sues AstraZeneca 'Next pandemic is around the corner,' expert warns

Advertisement

Thrombosis with thrombocytopenia, or TTS, occurred in around one in 50,000 patients and was sometimes fatal.

Several European countries and some Canadian provinces suspended use of the vaccine as a result.

This is a limited version of the story so unfortunately this content is not available. Open the full version

Keep up with all the latest news from the UK and around the world by following Sky News

In the UK, medicines regulators responded by first recommending the vaccine only for people over 30, before raising the age cut-off to 40.

The vaccine hasn't been used in the UK since the start of the booster programme, though the government says this was because mRNA vaccines were more effective, not because of concern over side effects.

However, more than 50 people who developed clots after vaccination are taking legal action against AZ in the High Court, claiming that the company failed to adequately inform them of a potential risk.

The company says the clinical trials and real-world evidence have shown the vaccine has "an adequate safety profile".

See the rest here:

AstraZeneca starts worldwide withdrawal of COVID vaccine - Sky News

SII disclosed Covishield's rare side-effects in 2021, AstraZeneca withdrew global vaccine due to surplus, TTS. India halted manufa... Read More SII disclosed Covishield's rare side-effects in 2021, AstraZeneca withdrew global vaccine due to surplus, TTS. India halted manufacturing, faced mutant strains. Health experts note TTS involves blood clots, low platelet counts in major vessels. Read Less PUNE: City-based Serum Institute of India (SII) on Wednesday said it had disclosed all rare to very rare side-effects of Covid-19 vaccine, supplied under the name Covishield, in the packaging insert in 2021 itself. Serum Institute's statement follows UK-based drug major AstraZeneca's move to withdraw its Covid-19 vaccine globally because of a "surplus of available updated vaccines" since the Covid-19 pandemic. The drug major had earlier admitted to a UK court that its vaccine, in very rare cases, could cause a side-effect called thrombosis with thrombocytopenia syndrome (TTS). AstraZeneca's Covid-19 vaccine formula was used by SII to manufacture Covishield. "With India achieving high vaccination rates in 2021 and 2022, coupled with the emergence of new mutant variant strains, the demand for previous vaccines diminished significantly. Consequently, since Dec 2021, we have stopped the manufacturing and supply of additional doses of Covishield," a statement issued by SII stated. On the potential side-effects of the vaccine, the Serum Institute of India statement stated that the firm fully understood the concerns. "From the outset, we have disclosed all rare to very rare side effects, including thrombosis with thrombocytopenia syndrome [TTS], in the packaging insert in 2021," the statement read. TTS refers to the formation of blood clots with low platelet counts. The condition is rare, but usually serious, particularly when the blood clot happens in major vessels, health experts said. Steffy Thevar is a Pune-based senior correspondent working for th... Read More Steffy Thevar is a Pune-based senior correspondent working for the Times of India. She writes on health, urban infrastructure and gender parity issues. She has worked in Mumbai for three years and shifted to Pune and covered the Covid19 pandemic. She had completed her masters in Journalism and Mass Communication from Savitribai Phule Pune University's department of Mass Communication and Journalism. She also writes on a range of issues including housing, human rights and environment.Read Less

Popular from City

'Am I inside Delhi Metro?': Video of couple getting intimate in Bengaluru Metro goes viral

Bengaluru: When ice apple vendors make a killing

Kolkata cafe murder: Husband stabs estranged wife inside cafe, chases & kills her on road outside

Bengaluru horror: Residents risked their lives to get patients out of hospital on fire

19-year-old dies after eating 'chicken shawarma'; two arrested

end of article

Excerpt from:

Disclosed all rare to very rare side-effects of Covid vaccine 'Covishield' since '21: SII - The Times of India

NEW DELHI: UK-based drug major AstraZeneca's decision to withdraw its Covid-19 vaccine globally, days after admitting to side effects, prompted Serum Institute of India to disclose that it had stopped manufacturing Covishield in Dec 2021 due to a fall in demand as well as the emergence of new variants. "With India achieving high vaccination rates in 2021 and 2022, coupled with the emergence of new mutant variant strains, the demand for previous vaccines diminished significantly. Consequently, since Dec 2021, we have stopped the manufacture and supply of additional doses of Covishield," said a SII spokesperson. The global drug giant had recently admitted to Vaxzervria causing Thrombosis with Thrombocytopenia (TTS) in very rare cases. Covishield accounted for nearly 80% of Covid-19 vaccine doses administered in India. AstraZeneca said its decision to withdraw marketing authorisation of Vaxzevria was due to a "surplus of available updated vaccines" since the pandemic. The SII spokesperson said the company fully understood the ongoing concerns. " We have disclosed all rare to very rare side effects, including Thrombosis with TTS, in the packaging insert in 2021," the spokesperson said. TTS refers to the formation of blood clots with low platelet counts. The condition is rare but is usually serious, particularly when the blood clot happens in major vessels, say doctors. The epidemiologic data on TTS among Indians is not known but in the UK, researchers have found 2.4 cases of TTS per lakh vaccines. "As the number of cases are small, studies face challenges in establishing risk factors. However, the UK study found that male gender and age above 65 years put people at higher risk of TTS . Moreover, chronic diseases of heart, kidney, liver, neurological diseases and cancer were found to place such affected persons at higher risk of developing TTS," Dr Kameshwar Prasad, former head of neurology at AIIMS told TOI.

Go here to read the rest:

Stopped producing Covishield in Dec 2021: SII after AstraZeneca recall - The Times of India

AstraZeneca was one of the first pharma laboratories to launch a COVID vaccine on the market at the end of 2020, a year after the virus appeared.

Pharmaceutical giant AstraZeneca has requested that the European authorisation for its COVID-19 vaccine be pulled, according to the EU medicines regulator.

In an update on the European Medicines Agencys (EMA) website Wednesday, the regulator said that the approval for AstraZenecas Vaxzevria had been withdrawn "at the request of the marketing authorisation holder".

AstraZenecas COVID-19 vaccine was first given the nod by the EMA in January 2021.

Within weeks, however, concerns grew about the vaccines safety, when dozens of countries suspended the vaccines use after unusual but rare blood clots were detected in a small number of immunized people.

The EU regulator concluded AstraZenecas shot didnt raise the overall risk of clots, but doubts remained.

Partial results from its first major trial - which Britain used to authorise the vaccine - were clouded by a manufacturing mistake that researchers didnt immediately acknowledge.

Insufficient data about how well the vaccine protected older people led some countries to initially restrict its use to younger populations before reversing course.

Billions of doses of the AstraZeneca vaccine were distributed to poorer countries through a UN-coordinated programme, as it was cheaper and easier to produce and distribute.

But studies later suggested that the pricier mRNA vaccines made by Pfizer-BioNTech and Moderna provided better protection against COVID-19 and its many variants, and most countries switched to those shots.

For more on this story, watch the report in the media player above.

Visit link:

AstraZeneca asks for European approval of COVID jab to be pulled - Euronews

Descrease article font size

Increase article font size

AstraZenecas COVID-19 vaccine Vaxzevria is no longer being manufactured or supplied due to declining demand, the company said Wednesday.

It is also withdrawing the vaccines authorization to be marketed or sold in countries that are part of the European Union, AstraZeneca said.

As multiple variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines. This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied, the company told Global News in an email Wednesday.

AstraZeneca has therefore taken the decision to initiate withdrawal of the Marketing Authorizations for Vaxzevria within Europe.

Alongside Pfizer-BioNTech and Moderna, AstraZenecas Vaxzevria was one of three primary vaccines administered worldwide against COVID-19 beginning in 2021.

2:19 NACIs latest AstraZeneca vaccine advice leaves Canadians confused

However, safety concerns arose in March 2021 when Canadas National Advisory Committee on Immunization (NACI) recommended the vaccine not be administered to people under age 55 following reports of blood clots.

Story continues below advertisement

The committee said majority of the cases of the adverse effect known as vaccine-induced prothrombotic immune thrombocytopenia (VIPIT) were identified in women under the age of 55.

Trending Now

Ontario and Alberta both paused the use of Vaxzevria a few months later out of caution.

Dr. David Williams, Ontarios chief medical officer of health at the time, said the decision was also made, in part, because of an increased and reliable supply of the Pfizer-BioNTech and Moderna vaccines and a continued downward trend in COVID-19 cases.

Canadas authorization for use of Vaxzevria was officially cancelled in December of 2023.

AstraZeneca said in its email to Global News that its working with regulators and partners to align on a clear path forward to conclude its chapter on the COVID-19 pandemic.

We are incredibly proud of the role Vaxzevria played in ending the global pandemic, the company said.

with files from Global News Nick Westoll, Nicole Gibillini, Amanda Connolly and Hannah Jackson

2024 Global News, a division of Corus Entertainment Inc.

Follow this link:

AstraZeneca says it's withdrawing COVID vaccine amid low demand - National | Globalnews.ca - Global News

By BRUCE SHIPKOWSKI (Associated Press)

An Ohio doctor who drew national attention when she told state legislators that COVID-19 vaccines made people magnetic has had her medical license reinstated after it was suspended for failing to cooperate with an investigation.

The Ohio State Medical Board recently voted to restore Sherri Tenpennys license after she agreed to pay a $3,000 fine and cooperate with investigators.

Tenpenny, an osteopathic doctor, has been licensed in Ohio since 1984. She drew national attention in 2021 when she testified before a state legislative panel in support of a measure that would block vaccine requirements and mask mandates.

During her remarks, Tenpenny claimed that COVID-19 vaccines made their recipients magnetic, interface with cell towers and interfered with womens menstrual cycles.

Roughly 350 complaints were soon filed about Tenpenny with the medical board, which regulates physicians and can discipline them for making false or deceptive medical statements. A probe was launched but Tenpenny refused to meet with investigators, answer written questions or comply with a subpoena ordering her to sit for a deposition.

Tenpennys license was suspended in August 2023 on procedural grounds for failing to cooperate with the investigation. Her attorney had told the board she wouldnt participate in an illegal fishing expedition.

The board voted 7-2 last month to restore her license, with proponents saying she had met the requirements for reinstatement.

Tenpenny announced the reinstatement in a post made on the X social platform.

Standing strong and steadfast! she wrote. Thank you all for your unwavering love and support but most importantly for your prayers during these challenging times.

Read the rest here:

Ohio doctor whose views on COVID-19 vaccinations drew complaints has her medical license reinstated - The Morning Journal

AstraZeneca said on Tuesday it had initiated the worldwide withdrawal of its COVID-19 vaccine due to a "surplus of available updated vaccines" since the pandemic.

The company also said it would proceed to withdraw the vaccine Vaxzevria's marketing authorizations within Europe.

"As multiple, variant Covid-19 vaccines have since been developed there is a surplus of available updated vaccines," the company said, adding that this had led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.

According to media reports, the Anglo-Swedish drugmaker has previously admitted in court documents that the vaccine causes side-effects such as blood clots and low blood platelet counts.

The firm's application to withdraw the vaccine was made on March 5 and came into effect on May 7, according to the Telegraph, which first reported the development.

London-listed AstraZeneca began moving into respiratory syncytial virus vaccines and obesity drugs through several deals last year after a slowdown in growth as COVID-19 medicine sales declined.

Published 08 May 2024, 01:19 IST

See original here:

AstraZeneca says it will withdraw Covid-19 vaccine globally after admitting to 'rare' side effects - Deccan Herald