Showing posts with label AstraZeneca. Show all posts
Showing posts with label AstraZeneca. Show all posts

Oxford pauses pediatric trial of its vaccine with AstraZeneca, pending review by UK regulator

A pediatric trial of the Oxford-AstraZeneca vaccine has been paused pending a review by the UK's medicines regulator of rare blood clot cases in adults, a University of Oxford spokesperson told CNN Tuesday.

The spokesperson said the trial in children had not raised any safety concerns, but it would be paused while Britain's Medicines and Healthcare products Regulatory Agency, or MHRA, reviews rare cases of people who suffer blood clots while at the same time having low levels of blood platelets.

"Parents and children should continue to attend all scheduled visits and can contact the trial sites if they have any questions," the spokesperson said.

When contacted by CNN, AstraZeneca referred queries to Oxford University.
Last week, the medicines regulator said at least 30 people in the country had experienced rare types of blood clots after receiving the vaccine, but warned it was too early to know whether the shot itself triggered the clots.

The head of MHRA, Dr. June Raine, told CNN on Tuesday that the MHRA was "aware of the decision taken by the University of Oxford to pause dosing in the trial...whilst the MHRA safety review is ongoing."

"Participant safety in any clinical trial is our top priority, and no safety concerns have been reported with this trial," she added.

MHRA said in a statement it received 22 reports of cerebral venous sinus thrombosis (CVST), where clotting forms in the sinuses that drain blood from the brain, and eight other reports of thrombosis among a total of 15.8 million people who had been given at least one dose of the vaccine by March 21.

They did not say how many blood clots might otherwise have been expected among 15.8 million people

The agency has advised the UK to continue administering the vaccine in all groups, arguing that such clotting incidents are very rare and that the benefits still greatly outweigh the risks, echoing similar assessments by the European Medicines Agency (EMA) and the World Health Organization (WHO).

Regulators in other countries have also reported blood clots among people who have received the vaccine, particularly in Europe, where the AstraZeneca vaccine is widely used. Some countries are choosing to suspend the vaccine altogether, while others have limited its use to certain age groups.

Blood clots in general are so common that it is expected that a certain number of people will get them for various reasons at any given day of any given week. If someone has had a vaccine and then develops a blood clot, it doesn't necessarily mean the shot caused the clot.

After initial reports of clotting last month, AstraZeneca was quick to point out that the incidence of clots overall is lower in people who have received the shot that in the general population.

An AstraZeneca spokesperson said in a statement to CNN last week: "Patient safety remains the Company's highest priority," and pointed to authorities in the UK, EU and the WHO's recommendations to continue its use.

"The benefit risk profile of the vaccine was reaffirmed in the EMA's monthly safety update," the spokesperson said. CNN

Covid: Germany limits use of AstraZeneca Covid jab for under-60s

Germany is suspending routine use of the Oxford-AstraZeneca Covid-19 vaccine for people aged below 60 because of a risk of rare blood clots.

The German medicines regulator found 31 cases of a type of rare blood clot among the nearly 2.7 million people who had received the vaccine in Germany.

Canada earlier suspended use of the AstraZeneca jab in people under 55.
AstraZeneca said international regulators had found the benefits of its jab outweighed risks significantly.

It said it was continuing to analyse its database to understand "whether these very rare cases of blood clots associated with thrombocytopenia occur any more commonly than would be expected naturally in a population of millions of people".

"We will continue to work with German authorities to address any questions they may have," it added.

The EU and UK medicine regulators both backed the vaccine after previous cautionary suspensions in Europe this month.

The European Medicines Agency (EMA) and the UK Medicines & Healthcare products Regulatory Agency stressed that the benefits of the AstraZeneca vaccine continued to outweigh the risk of side effects.

In the UK, a government spokesperson said: "The Oxford/AstraZeneca vaccine is safe, effective and has already saved thousands of lives in this country. As the UK's independent regulator has said, when people are called forward, they should get the jab.

"Over 30 million people have already received their first dose of a vaccine, and we are on track to offer jabs to all over-50s by 15 April and all adults by the end of July." (BBC)

Suspend AstraZeneca use for people under 55, vaccine committee recommends

Canada's National Advisory Committee on Immunization (NACI) is recommending provinces pause the use of the AstraZeneca-Oxford COVID-19 vaccine on those under the age of 55 because of safety concerns — guidance most provinces said today that they would follow.

The change comes following reports out of Europe of very rare instances of blood clots in some immunized patients — notably among younger women.

But 300,000 of these shots have been administered in Canada already, with no reports of blood clots here, officials said. The blood clotting problem also has not been reported in people who have received mRNA vaccines like the Pfizer and Moderna products.

Speaking to reporters Monday, Dr. Shelley Deeks, the vice-chair of NACI, said that with "substantial uncertainty" around cases of vaccine-induced thrombocytopenia (VIPIT) in people with low platelets, the committee is recommending the suspension of shots in all people under 55 as a "precautionary measure."

Based on early research out of Europe, VIPIT seems to be rare, occurring in anywhere from 1 in every 125,000 to 1 in 1 million people.

The European Union's drug watchdog, the European Medicines Agency, has said it could not definitively rule out a link between the vaccine and rare types of blood clots associated with thrombocytopenia.
Specifically, it pointed to 18 cases of an extremely rare type of blood clot called cerebral venous sinus thrombosis (CVST), a condition that is much more common in women than men. Most of the cases occurred within 14 days of receiving the AstraZeneca shot, and the majority were in women under the age of 55.

Dr. Howard Njoo, Canada's deputy chief public health officer, said people who develop stroke-like medical symptoms after receiving the AstraZeneca vaccine — shortness of breath, chest pain, leg swelling, abdominal pain, sudden onset of headaches or blurred vision — should immediately seek medical attention. There is no risk for people who have not developed such symptoms 20 days post-vaccination.

Asked why the shot is still recommended for people over the age of 55 given the many unknowns, Dr. Caroline Quach-Thanh, the chair of NACI, said the early data indicate that the rare blood clots are most common in younger people.

She said older Canadians should take whatever vaccine they can get because contracting COVID-19 poses a much greater health risk to them than the outside chance of developing this sort of blood clot.

"If you look at this overall, it's a vaccine that prevents complications and deaths. We're trying to contrast the risks and benefits," she said. (CBC)

SA Halts Use of AstraZeneca’s Covid-19 Vaccine after Proving Infective against New Variant

South Africa halted use of the AstraZeneca-Oxford coronavirus vaccine on Sunday after evidence emerged that the vaccine did not protect clinical-trial participants from mild or moderate illness caused by the more contagious virus variant that was first seen there.

The findings were a devastating blow to the country’s efforts to combat the pandemic.

Scientists in South Africa said on Sunday that a similar problem held among people who had been infected by earlier versions of the coronavirus: the immunity they acquired naturally did not appear to protect them from mild or moderate cases when reinfected by the variant, known as B.1.351.

The developments, coming nearly a week after a million doses of the AstraZeneca-Oxford vaccine arrived in South Africa, were an enormous setback for the country, where more than 46,000 people are known to have died from the virus. And they were another sign of the dangers posed by new mutations in the coronavirus. The B.1.351 variant has already spread to at least 32 countries, including the United States.

It was not clear from the studies outlined by South African scientists on Sunday whether the AstraZeneca-Oxford vaccine protected against severe disease from the B.1.351 variant

The clinical trial participants who were evaluated were relatively young and unlikely to become severely ill, making it impossible for the scientists to determine if the variant interfered with the AstraZeneca-Oxford vaccine’s ability to protect against severe Covid-19, hospitalizations, or deaths

However, based on the immune responses detected in blood samples from people who were given the vaccine, the scientists said they believed that the vaccine could yet protect against more severe cases.

If further studies show that it does, South African health officials said on Sunday that they would consider resuming use of the AstraZeneca-Oxford vaccine.

Even so, the fact that it showed minimal efficacy in preventing mild and moderate cases of the new variant added to the mounting evidence that B.1.351 makes current vaccines less effective. These research findings have not been published in a scientific journal.

Pfizer and Moderna have both said that preliminary laboratory studies indicate that their vaccines, while still protective, are less effective against B.1.351. Novavax and Johnson & Johnson have also sequenced test samples from their clinical trial participants in South Africa, where B.1.351 caused the vast majority of cases — and both reported lower efficacy there than in the United States.

“These results are very much a reality check,” Shabir Madhi, a virologist at University of the Witwatersrand who ran the AstraZeneca-Oxford vaccine trial in South Africa, said of the findings released on Sunday.

The pause in the country’s rollout of the AstraZeneca-Oxford vaccine means that the first shipments will now be put in warehouses. Instead, South African health officials said they would inoculate health workers in the coming weeks with the Johnson & Johnson vaccine, which has strong efficacy in preventing severe cases and hospitalizations caused by the new variant.

Johnson & Johnson has applied for an emergency use authorization in South Africa. But health officials there indicated that even before it is authorized, some health workers could be given the vaccine as part of an ongoing trial.

In the AstraZeneca-Oxford trial in South Africa, roughly 2,000 participants were given either two doses of the vaccine or placebo shots.

There was virtually no difference in the numbers of people in the vaccine and placebo groups who were infected with B.1.351, suggesting that the vaccine did little to protect against the new variant. Nineteen of the 748 people in the group that was given the vaccine were infected with the new variant, compared to 20 out of 714 people in the group that was given a placebo.

New York Times


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