Category: Covid-19 Vaccine

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AstraZeneca announced on Tuesday that it is globally withdrawing its COVID-19 vaccine, as reported by UK-based media outlet The Telegraph.The company cited an abundance of newer vaccine options available since the pandemic began.

Additionally, AstraZeneca plans to revoke marketing authorizations for its vaccine, Vaxzevria, within Europe due to reduced demand and discontinuation of production and supply.

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"As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines," the company said.

The withdrawal announcement comes at the heels of media reports suggesting that AstraZeneca has acknowledged in court documents that the vaccine can lead to side effects such as blood clots and low blood platelet counts.

The withdrawal process, initiated on March 5, officially took effect on May 7, according to The Telegraph. AstraZeneca, based in London, has diversified its focus into respiratory syncytial virus vaccines and obesity drugs following a slowdown in COVID-19 medicine sales.

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AstraZeneca announces global withdrawal of COVID-19 vaccine amid demand crunch - Moneycontrol

In the wake of pharmaceutical giant AstraZeneca admitting in a UK court that its Covid vaccine can cause blood clots in rare cases, a group of doctors on Thursday expressed deep concern over the safety of the Covishield vaccine manufactured by the Serum Institute of India. (Also read | Covishield rolled back; should those jabbed with it need to worry? Experts answer)

At a press conference, the doctors, under the banner of the Awaken India Movement (AIM), urged the government to review the science behind all Covid vaccines and audit their commercialisation as well as implementation of active surveillance and monitoring mechanism to ensure vaccine adverse events are identified as early as possible.

"The government has wholly ignored the rising number of cases of tragic deaths post-Covid vaccination all the while and continues to promote Covid vaccines as 'safe and effective', without scientific investigation and invoking epidemiology," Dr Tarun Kothari, a radiologist and an activist, said at the press conference.

The world is learning about a side effect of the Covid vaccine called Thrombosis with Thrombocytopenia Syndrome (TTS), he said.

When the COVID-19 vaccines were being administered, not many people were aware that it was being done without the completion of phase-3 trials. Administration of COVID-19 vaccines was started without the manufacturers having complete information and data on the possible short-term or long-term side effects, or fatalities, said Dr Sujata Mittal, a gynaecologist and oncologist.

There is an already low awareness around vaccine injuries, especially in India, she said.

Thousands of women reported abnormalities in their menstrual cycles, which was confirmed much later as a side effect of the vaccine in a study published in September 2022, she added.

"The Awaken India Movement (AIM) has been collecting details of Covid Vaccine deaths covered by media/social media in India and sharing them with various high authorities of the country since 2021, when the vaccination began. The government has failed to respond to our repeated requests to investigate deaths and debilitation from adverse effects of vaccination," Dr Kothari said.

The AIM urged the government of India to compensate all the victims of Covid vaccines, including their family members, through a mechanism that involves vaccine manufacturers as well.

"We also demand establishing fast track courts and vaccine courts to provide swift justice to the vaccine injured and their families," Dr Mittal said.

Besides, active surveillance and monitoring mechanisms should be implemented to ensure vaccine adverse events are identified as early as possible and early treatment protocols must be created and widely publicised so that lives can be saved, she stated.

"Review science behind all Covid vaccines and audit their commercialisation," Dr Kothari said.

The United Kingdom-based AstraZeneca has started global withdrawal of its COVID-19 vaccine, which was provided in India as 'Covishield' in partnership with the Serum Institute of India, days after it admitted to rare side effects of blood clotting and lowering of platelet counts.

The withdrawal has been initiated due to a surplus of available updated vaccines since the pandemic, the company said in a statement.

In India, the company's partner Serum Institute of India said it has stopped the manufacturing and supply of additional doses of Covishield since December 2021 while reiterating that it had disclosed all rare to very rare side effects, including TTS, in the packaging insert in 2021.

AstraZeneca had partnered with Oxford University to develop the COVID-19 vaccine, which was sold as Vaxzevria in Europe.

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Covishield side effects: Doctors' group urges govt to review all Covid vaccines - Hindustan Times

Key Takeaways

Novavax (NVAX) shares more than doubled in intraday trading Friday after announcing a $1.2 billion deal to license its vaccine technology to French drugmaker Sanofi (SNY).

Novavax agreed to license its vaccine technology for COVID-19 and other possible future vaccines to Sanofi, as well as co-develop a combination vaccine designed to prevent both COVID-19 and the flu. Sanofi agreed to pay Novavax $500 million upfront, with another $700 million in possible payments depending on developmental and regulatory milestones.

"Together, we can broaden access to both our COVID-19 vaccine and our adjuvant to ensure more individuals can benefit from the protection vaccines can provide," Novavax Chief Executive Officer (CEO) John C. Jacobs said in a statement. "Novavax is now in a stronger position to refocus our efforts on leveraging our technology platform and novel adjuvant in R&D and pipeline expansion to help advance our mission of developing life-saving vaccines to fight infectious diseases."

The deal will allow Novavax to lift its "going concern" warning, Jacobs told CNBC. The company first issued the warning in early 2023 over concerns that it may not be able to financially survive as demand for COVID-19 vaccines waned.

As part of the deal, Sanofi is also taking a less than 5% equity stake in Novavax, and Novavax will receive royalty payments for future sales of its COVID-19 vaccine and the future combination COVID-19 and flu vaccine.

Alongside the Sanofi deal, Novavax also reported first-quarter results Friday morning that missed analyst estimates.

Novavax reported revenue for the first quarter of $93.9 million, shy of the $101.3 million analysts expected, according to estimates compiled by Visible Alpha. Novavax posted a loss of $147.6 million, or $1.05 per share, wider than the loss of $127.4 million, or 90 cents per share, that analysts projected.

Revenue increased by about $13 million from last year's first quarter, while it effectively cut its net loss in half from last year's mark of $293.9 million.

For the full fiscal year, Novavax lowered its projected revenue to $400 million to $600 million, down from the previous range of $800 million to $1 billion. However, the estimated $570 million the company expects to receive from Sanofi this year pushed its combined revenue and payments projections higher, to $970 million to $1.17 billion.

The company also said it is prepared to introduce a cost-cutting program over the next year, with goals of reducing its combined costs of research and development (R&D) and selling, general, and administrative expenses (SG&A) to below $500 million by the end of fiscal 2025. For fiscal 2024, Novavax projects that those expenses will be within a range of $700 million to $750 million.

Novavax shares were up over 120% by 10:30 a.m. ET Friday to $9.90.

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Novavax Stock Doubles on $1.2B Sanofi Deal for COVID-19, Flu Vaccines - Investopedia

NEW DELHI: In the wake of pharmaceutical giant AstraZeneca admitting in a UK court that its Covid vaccine can cause blood clots in rare cases, a group of doctors on Thursday expressed deep concern over the safety of the Covishield vaccine manufactured by the Serum Institute of India. At a press conference, the doctors, under the banner of the Awaken India Movement (AIM), urged the government to review the science behind all Covid vaccines and audit their commercialisation as well as implementation of active surveillance and monitoring mechanism to ensure vaccine adverse events are identified as early as possible. "The government has wholly ignored the rising number of cases of tragic deaths post-Covid vaccination all the while and continues to promote Covid vaccines as 'safe and effective', without scientific investigation and invoking epidemiology," Dr Tarun Kothari, a radiologist and an activist, said at the press conference. The world is learning about a side effect of the Covid vaccine called Thrombosis with Thrombocytopenia Syndrome (TTS), he said. When the COVID-19 vaccines were being administered, not many people were aware that it was being done without the completion of phase-3 trials. Administration of COVID-19 vaccines was started without the manufacturers having complete information and data on the possible short-term or long-term side effects, or fatalities, said Dr Sujata Mittal, a gynaecologist and oncologist. There is an already low awareness around vaccine injuries, especially in India, she said. Thousands of women reported abnormalities in their menstrual cycles, which was confirmed much later as a side effect of the vaccine in a study published in September 2022, she added. "The Awaken India Movement (AIM) has been collecting details of Covid Vaccine deaths covered by media/social media in India and sharing them with various high authorities of the country since 2021, when the vaccination began. The government has failed to respond to our repeated requests to investigate deaths and debilitation from adverse effects of vaccination," Dr Kothari said. The AIM urged the government of India to compensate all the victims of Covid vaccines, including their family members, through a mechanism that involves vaccine manufacturers as well. "We also demand establishing fast track courts and vaccine courts to provide swift justice to the vaccine injured and their families," Dr Mittal said. Besides, active surveillance and monitoring mechanisms should be implemented to ensure vaccine adverse events are identified as early as possible and early treatment protocols must be created and widely publicised so that lives can be saved, she stated. "Review science behind all Covid vaccines and audit their commercialisation," Dr Kothari said. The United Kingdom-based AstraZeneca has started global withdrawal of its COVID-19 vaccine, which was provided in India as 'Covishield' in partnership with the Serum Institute of India, days after it admitted to rare side effects of blood clotting and lowering of platelet counts. The withdrawal has been initiated due to a surplus of available updated vaccines since the pandemic, the company said in a statement. In India, the company's partner Serum Institute of India said it has stopped the manufacturing and supply of additional doses of Covishield since December 2021 while reiterating that it had disclosed all rare to very rare side effects, including TTS, in the packaging insert in 2021. AstraZeneca had partnered with Oxford University to develop the COVID-19 vaccine, which was sold as Vaxzevria in Europe.

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Covishield side effects: Doctors' group urges govt to review all Covid vaccines - The Times of India

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COVID-19 mRNA Vaccination-Induced Myopericarditis in an Otherwise Healthy Young Male: An Evidence-Based ... - Cureus

There is no association between the SARS-CoV-2 vaccine and the risk for new-onset seizure, data from a new meta-analysis of six randomized, placebo-controlled clinical trials (RCTs) showed.

Results of the pooled analysis that included 63,500 individuals vaccinated with SARS-CoV-2 and 55,000 who received a placebo vaccine showed there was no significant difference between the two groups with respect to new-onset seizures at 28- or 43-day follow-up.

Regarding new-onset seizures in the general population, there was no statistically significant difference in risk for seizure incidence among vaccinated individuals vs placebo recipients, according to our meta-analysis, the investigators, led by Ali Rafati, MD, MPH, Iran University of Medical Sciences in Tehran, Iran, wrote.

The findings were published online on April 29 in JAMA Neurology.

Results from previous research have been mixed regarding the link between the SARS-CoV-2 vaccination and new-onset seizures, with some showing an association.

To learn more about the possible association between the vaccines and new-onset seizures, the researchers conducted a literature review and identified six RCTs that measured adverse events following SARS-CoV-2 vaccinations (including messenger RNA, viral vector, and inactivated virus) vs placebo or other vaccines.

While five of the studies defined new-onset seizures according to the Medical Dictionary for Regulatory Activities, trial investigators in the sixth RCT assessed and determined new-onset seizures in participants.

Participants received two vaccinations 28 days apart in five RCTs and only one vaccine in the sixth trial.

The research team searched the data for new-onset seizure in the 28 days following one or both COVID vaccinations.

After comparing the incidence of new-onset seizure between the 63,500 vaccine (nine new-onset seizures, 0.014%) and 55,000 placebo recipients (one new-onset seizure, 0.002%), investigators found no significant difference between the two groups (odds ratio [OR], 2.70; 95% CI, 0.76-9.57; P = .12)

Investigators also sliced the data several ways to see if it would yield different results. When they analyzed data by vaccine platform (viral vector) and age group (children), they didn't observe significant differences in new-onset data.

The researchers also searched for data beyond the month following the injection to encompass the entire blinded phase, so they analyzed the results of three RCTs that reported adverse events up to 162 days after the vaccine.

After pooling the results from the three studies, investigators found no statistical difference between the vaccine and placebo groups in terms of the new-onset seizure (OR, 2.31; 95% CI, 0.86%-3.23; P > .99)

Study limitations included the missing information on vaccine doses or risk factors for the development of seizures. Also, the RCTs included in the meta-analysis were conducted at different times, so the SARS-CoV-2 vaccines may have differed in their composition and efficacy.

"The global vaccination drive against SARS-CoV-2 has been a monumental effort in combating the pandemic. SARS-CoV-2 vaccinations that are now available appear safe and appropriate," the authors wrote.

There were no study funding sources or disclosures reported.

Read more here:

COVID Vaccines and New-Onset Seizures: New Data - Medscape

Pharmaceutical company AstraZeneca has announced its removing its Covid-19 vaccine worldwide.

But why is this coronavirus jab being discontinued?

FactCheck takes a look.

AstraZeneca said on 7 May that it has started to withdraw its Covid vaccine worldwide.

This comes after applying to withdraw its European Union marketing authorisation which is the approval to market a medicine in member states on 5 March.

On 7 May, the European Medicines Agency issued a notice that the vaccine is no longer authorised for use.

The pharmaceutical company said: As multiple, variant Covid-19 vaccines have since been developed there is a surplus of available updated vaccines. Basically, other vaccines are more effective against the versions of Covid that are most common now and demand for Covid jabs overall has fallen.

The statement also said: According to independent estimates, over 6.5 million lives were saved in the first year of use alone and over 3bn doses were supplied globally.

Some countries have already stopped supplying the vaccine, including Australia, where it has not been available for use since March 2023.

The AstraZeneca vaccine which was renamed as Vaxzevria in 2021 had, like all vaccines, side effects.

As well as common side effects such as nausea and joint pain, it was linked to a rare but serious side effect called thrombosis with thrombocytopenia, or TTS.

TTS is a very rare syndrome which occurs when a person has blood clots (thrombosis) together with a low platelet count (thrombocytopenia).

Blood clots can reduce normal blood flow in an affected blood vessel, and thrombocytopenia is a condition where there arent enough platelets in the blood.

Platelets help the blood to clot which then stops you from bleeding excessively, for example, if you cut yourself.

The side effect was found to have occurred in about two to three people per 100,000 who were vaccinated with the Vaxzevria vaccine.

The UK governments Medicines and Healthcare products Regulatory Agency (MHRA) said in November 2023 that TTS has been observed very rarely following vaccination with Vaxzevria.

Up to 23 November 2022, the MHRA had received Yellow Card reports from doctors of 445 cases of blood clots with low platelet counts in the UK following an AstraZeneca Covid vaccine.

The overall case fatality rate was 18 per cent with 81 deaths, six of which occurred after the second dose.

The Pfizer jab is also associated with a very rare side effect (reported in 1 out of every 10,000 people) of inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis).

Like almost any medical intervention, vaccines carry the risk of side effects. The question for scientists and clinicians is whether the benefits of the treatment outweigh the risks.

At the start of the pandemic, Covid was so widespread and immunity so low that the benefits of vaccination outweighed the risk of rare side effects for almost every age group. As we reported in 2021, the chances of developing severe complications from Covid itself are much higher than that of potential complications from a Covid vaccination.

As Covid rates have fallen and more people have acquired immunity through vaccination and exposure to infection, the calculation has changed.

The Joint Committee on Vaccination and Immunisation (JCVI), which advises the government on vaccine use, now says that a booster Covid jab (made by Pfizer or Moderna) should be offered to adults over 75, residents in a care home for older adults, and anyone aged six months or over who is immunocompromised.

(Image Credit:Mustasinur Rahman Alvi/Shutterstock)

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FactCheck: why is the AstraZeneca Covid vaccine being withdrawn worldwide? - Channel 4 News

Lawyers for claimants in the High Court case argue that the drug caused vaccine-induced immune thrombocytopenia and thrombosis (VITT) a subset of TTS and that it was not as safe as individuals were entitled to expect. AstraZeneca has always insisted that patient safety is our highest priority.

The company has said: From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects.

But Kate Scott, whose husband Jamie was left with a permanent brain injury after having the vaccine and who was the first person in the UK to bring a legal action, said: AstraZenecas Covid vaccine no longer being used in the UK or Europe, and soon the rest of the world, means no one else will suffer from this awful adverse reaction.

They say it is for commercial reasons, but maybe its because it can no longer be seen as being within the acceptable safety parameters, with 445 confirmed cases of VITT, 81 of these fatal in the UK alone.

Mr Scott, 47, a father of two who has had to give up work, said: This is good news, but I will always wish they had, like they did in other countries, paused it in the UK after just one case. More lives could have been saved and I would not be suffering the way I am.

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AstraZeneca withdrawing Covid vaccine worldwide - The Telegraph

8 May 2024

Image source, Getty Images

After more than three billion doses, the Oxford-AstraZeneca Covid vaccine is being withdrawn.

AstraZeneca said it was "incredibly proud" of the vaccine, but it had made a commercial decision.

It said the rise of new coronavirus variants meant demand had shifted to the newer updated vaccines.

Its vaccine was estimated to have saved millions of lives during the pandemic, but also caused rare, and sometimes fatal, blood clots.

In the race to lift the world out of pandemic lockdowns, the Covid vaccine was developed by scientists at the University of Oxford in record time. A process that normally takes 10 years was accelerated down to about 10 months.

Initially, it was the cornerstone of the UK's plans to vaccinate our way out of lockdown.

"The truth is it made an enormous difference, it was what lifted us out of the catastrophe that was unfolding at the time, combined with the other vaccine from Pfizer," said Prof Adam Finn, from the University of Bristol.

However, its reputation was dented as unusual blood clots emerged as a rare side effect of the vaccine, and the UK turned to alternatives.

In a statement, AstraZeneca said: "According to independent estimates, over 6.5 million lives were saved in the first year of use alone.

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

It said the development of new vaccines that more closely match the mutated forms of Covid that are now circulating meant there was a "surplus of available updated vaccines", leading to a "decline in demand" for its vaccine which is "no longer being manufactured or supplied".

Prof Finn added: "I think the withdrawal of the vaccine simply reflects it's no longer useful.

"It's turned out that this virus is very agile and it's evolved away from the original vaccines, so they have in a sense become irrelevant and only the reformulated vaccines are likely to be being used now."

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AstraZeneca to withdraw Covid vaccine - BBC.com

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.

(For top health news of the day,subscribeto our newsletter Health Matters)

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

ALSO READ | AstraZenecas submission in U.K. court nothing new, say doctors over Covishields potential to cause blood clots

"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.

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AstraZeneca to withdraw COVID-19 vaccine globally as demand falls - The Hindu