Tag: AstraZeneca

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EU medicines regulator finds doable hyperlink between AstraZeneca Covid vaccine and blood clots

EU medicines regulator finds possible link between AstraZeneca Covid vaccine and blood clots

Syringes are filled with Astrazeneca’s vaccine in the pharmacy.

Christopher Neundorf | Image Alliance | Getty Images

LONDON – Europe’s Medicines Agency announced on Wednesday a possible link between the coronavirus vaccine developed by AstraZeneca and Oxford University and rare blood clotting problems in adults who received the shot.

It comes after a review of all currently available evidence in extremely rare cases of unusual blood clots in some vaccinated individuals.

Emer Cooke, executive director of the European Medicines Agency, said in a televised press conference that the regulator’s safety committee “has confirmed that the overall benefits of the AstraZeneca vaccine in preventing Covid-19 outweigh the risks of side effects.”

“A plausible explanation for these rare side events is an immune response to the vaccine that is similar to that seen in heparin-treated patients,” said Cooke, noting that it was heparin-induced thrombocytopenia.

The EMA has commissioned further research to investigate the link between the vaccine and blood clots, and said its safety committee had concluded that unusual blood clots with low platelets should be listed as “very rare” side effects of the shot. It also drew the public’s attention to other possible side effects that are flagged as adverse drug reactions on the product information of the vaccine.

The European Medicines Agency said it was “of great importance” that health professionals and those receiving the Oxford-AstraZeneca vaccine are aware of these risks and look out for possible symptoms, typically in the first two weeks after vaccination occur.

“These include, for example, shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, neurological symptoms such as severe or persistent headaches or blurred vision and skin bruises beyond the injection site,” said Dr. Sabine Straus, chair of EMA’s security committee, said at the same press conference.

AstraZeneca’s shares fell nearly 1% during afternoon trading in London.

The Oxford-AstraZeneca shot has been followed by safety concerns in recent weeks, and several European countries temporarily stopped using the vaccine last month.

The EMA said on March 31 that it had found the shot to be safe and effective, but added that it could not rule out the possibility of a causal link between the vaccine and coagulation events, so the investigation will continue.

The World Health Organization, the UK Medicines Agency and the International Society on Thrombosis and Hemostasis have all stated that the benefits of administering the Oxford-AstraZeneca shot far outweigh the risks.

AstraZeneca previously said that its studies didn’t find a higher risk of blood clots as a result of its vaccine.

Most countries have since resumed the use of the shot, but many have suspended vaccinations for certain age groups.

A senior European Medicines Agency official said Tuesday that there was a clear “link” between the Oxford-AstraZeneca vaccine and very rare blood clots in the brain, although the direct cause was not yet known.

In an interview with the Italian newspaper Il Messaggero published on Tuesday, Marco Cavaleri, chairman of the EMA’s vaccine evaluation team, said: “In my opinion, we can now say that there is a link to the vaccine, but we are still me don’t know what is causing this reaction. “

The EMA then denied in a statement to Agence France-Presse that it had made a connection between the Oxford-AstraZeneca shot and rare blood clots.

UK vaccine study in children paused

The drug and health products regulator, which approved the Oxford-AstraZeneca vaccine for use in the UK, examined the data after a handful of reports – in both the UK and continental Europe – of serious but rare blood clots, some of which were fatal .

A UK study of the Oxford AstraZeneca vaccine in children has already been paused while the drug agency investigated a possible link between the shot and the bleeding disorders, particularly cases of blood clots in veins in the brain known as cerebral venous sinus thrombosis (CVST) as well Thrombocytopenia (low levels of platelets in the blood that help blood to clot).

The UK government noted that as of March 24th inclusive, there were 22 reports of CVST and 8 reports of other low platelet thrombosis events totaling 18.1 million doses of the AstraZeneca vaccine (one shot with two doses). given up to this date.

People are waiting in a vaccination center in Cologne on April 5, 2021.

Marius Becker | Image Alliance | Getty Images

“We need to know more about those affected and understand exactly how the diseases came about while many other questions remain open,” said Adam Finn, professor of pediatrics at Bristol University, UK, ahead of the announcement on Wednesday.

“There are some things that are very clear, however. The first is that these cases are indeed very rare. The second is that the vaccines available and used in the UK are very effective in preventing COVID,” said Finn.

“In short, if you are currently offered a dose of Oxford AstraZeneca vaccine, your chances of staying alive and staying healthy will go up if you take the vaccine and go down if you don’t.”

– CNBC’s Holly Ellyatt contributed to this report.

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AstraZeneca Covid vaccine will likely be Thailand’s ‘principal’ shot: Well being minister

AstraZeneca Covid vaccine will be Thailand's 'principal' shot: Health minister

A health worker holds a box of the AstraZeneneca vaccine at the Bamrasnaradura Institute for Infectious Diseases in Nonthaburi Province on the outskirts of Bangkok.

Chaiwat subprasome | SOPA pictures | LightRocket via Getty Images

The coronavirus shot developed by AstraZeneca and Oxford University will be Thailand’s “main vaccine” as the country seeks to revitalize its crucial tourism sector, the Thai health minister told CNBC on Monday.

Renewed safety concerns over the AstraZeneca-Oxford shot led countries such as Germany and the Netherlands to stop using the vaccine for those under the age of 60.

Before these final steps, several countries – including Thailand – suspended the use of the AstraZeneca vaccine after blood clots were reported in some people who received the shot. However, many lifted their suspension after the World Health Organization announced that a review of the available data found that the vaccine’s benefits outweigh the risks.

In Thailand, more than 150,000 people have been vaccinated with the AstraZeneca vaccine and the percentage of people who experienced side effects is considered “very low,” said Anutin Charnvirakul, the country’s deputy prime minister and health minister.

Anutin told CNBC’s Street Signs Asia that Thailand is waiting for further deliveries of the vaccine from AstraZeneca, which are expected to take place in June. In addition to the AstraZeneca vaccine, Thailand is also using one developed by China’s Sinovac Biotech, the minister said.

Almost 250,000 people have received Covid vaccines in Thailand since late February, Anutin said.

Attracting foreign visitors

Compared to many countries around the world, Thailand has reported relatively few Covid cases and deaths. Official data showed the country had confirmed more than 29,000 infections and 95 deaths as of Sunday.

However, the tourism-dependent economy was hit hard, shrinking 6.1% year over year in 2020 as countries restricted travel to avoid the spread of Covid-19, according to the Office of the National Council for Economic and Social Development to slow down.

Thailand is stepping up efforts to restart its tourism industry, including introducing vaccines in “significant” numbers in popular destinations like Phuket and Koh Samui, Anutin said.

“We want to make sure that our people are safe, that is our top priority. Once our people are safe, we believe that our guests, namely tourists or business people, would definitely come to visit our country,” he said Minister.

To attract visitors, Thailand has cut the quarantine period for foreigners entering the country from this month. The country is also striving to waive quarantine requirements for vaccinated foreign visitors to its largest holiday island, Phuket.

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EU steps up vaccine exports guidelines and pressures AstraZeneca over deliveries

EU steps up vaccine exports rules and pressures AstraZeneca over deliveries

President of the European Commission Ursula von der Leyen.

Thierry Monasse | Getty Images News | Getty Images

LONDON – The European Union has tightened strict rules on the export of Covid vaccines while putting pressure on AstraZeneca to deliver more shots to the area.

It is because the sluggish introduction of vaccines in the region is under scrutiny, even as the EU continues to export millions of coronavirus shots abroad.

In order to gain a stronger negotiating position with pharmaceutical companies that fail to meet delivery targets, the bloc has expanded its strict rules on vaccine exports.

Before approving the delivery of Covid-19 shots, the EU will check whether the recipient country has any restrictions on vaccines or raw materials and whether it is in a better epidemiological situation.

“We want to make sure that Europe gets its fair share of vaccines. Because we have to explain to our citizens that companies that export their vaccines around the world are fully committed to their commitments and are not taking any risks.” Security of supply in the European Union, “said the President of the European Commission, Ursula von der Leyen, on Thursday.

We all know we could have been a lot faster if all the pharmaceutical companies had fulfilled their contracts.

Ursula von der Leyen

President of the European Commission

The data released on Thursday showed that the EU has exported 77 million cans of Covid shots to 33 countries around the world since December. At the same time, 88 million were delivered to EU countries, of which 62 million were managed. As such, the EU has exported more shots than it has previously given its citizens.

However, some EU countries have raised concerns about stricter export regulations, with countries like Belgium and the Netherlands wanting supply chains to remain open. There is a risk that stopping vaccine exports will trigger a trade war and other parts of the world – which produce the raw materials needed to make vaccines – stop shipping to Europe.

Pressure on AstraZeneca

The EU has also quarreled with the Swedish-UK drug maker over not firing as many Covid shots as the bloc expected.

The 27 nations waited for 90 million doses of this vaccine in the first quarter and 180 million in the second quarter of 2021. However, AstraZeneca said that due to manufacturing issues, only 30 million doses can be dispensed by the end of March and 70 million between April and June.

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The reduced delivery targets are a problem for EU countries, some of which wanted more of this vaccine as it is cheaper and easier to store than others. Further delivery delays to Europe could affect the broader rollout plans.

“We all know we could have been much faster if all pharmaceutical companies had fulfilled their contracts,” said von der Leyen on Thursday.

During a press conference, she added that AstraZeneca “needs to catch up, respect the treaty with European member states, before it can export vaccines again”.

The introduction of vaccines in the EU has posed a number of challenges from the start and the Commission, which has negotiated with drug manufacturers, has been criticized for taking too long to sign vaccination contracts.

Italy’s former Prime Minister Mario Monti told CNBC on Friday: “We shouldn’t be surprised that Europe has reacted quite well in terms of the monetary and financial response to the pandemic and so far not quite (so) in terms of procurement and in terms of the pandemic industrial response. “

He argued that while the EU countries have integrated their monetary policy and part of their fiscal responses, “there has never been a health union”.

Individual governments remain responsible for their own health policies, while areas such as international trade remain the primary responsibility of the European Commission.

A deal with the UK

The EU’s stricter export regulations could become a problem especially for the UK, which has received vaccines from the EU. The vaccination rate is higher than that of the block based on the number of first doses given.

European Commission figures show the UK has received 21 million doses of vaccine block-made – the highest share of EU exports yet. The UK has so far given its population 31 million doses of Covid-19 syringes, suggesting that around two-thirds of the vaccines used in the UK come from the EU.

“We discussed what else we can do to ensure a mutually beneficial relationship between the UK and the EU on Covid-19,” the two sides said in a joint statement on Wednesday.

“Given our interdependencies, we are working on specific steps that we can take in the short, medium and long term to create a win-win situation and expand the supply of vaccines to all of our citizens.”

Dutch Prime Minister Mark Rutte said at a press conference on Thursday that a vaccine deal between the EU and Great Britain could be announced on Saturday.

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Fauci says AstraZeneca will seemingly concern modified assertion

Fauci says AstraZeneca will likely issue modified statement

Anthony Fauci, director of the National Institute for Allergies and Infectious Diseases at the NIH, speaks about the daily press conference at the White House in Washington on January 21, 2021.

Jonathan Ernst | Reuters

AstraZeneca is likely to release a modified statement on its Covid-19 vaccine after questioning the accuracy of the company’s clinical trial results earlier this week, said Dr. Anthony Fauci, Chief Medical Advisor of the White House, on Wednesday.

The company announced on Monday the long-awaited results of its Phase 3 clinical trial of the Covid-19 vaccine it was developing at Oxford University. It is 79% effective in preventing symptomatic diseases and 100% effective against serious illness and hospitalization.

The next day, the National Institute of Allergy and Infectious Diseases released an unusual statement informing it from the Data and Safety Monitoring Board (DSMB) overseeing the study that the UK-based company may have included information in its US results which provided an “incomplete view of the efficacy data”.

Fauci, director of NIAID, said the DSMB has raised concerns with the U.S. agency because it believes the results in AstraZeneca’s press release are more favorable than more recent data from the vaccine study showed, according to STAT News.

The company is now working with the DSMB and “is likely to make a modified statement,” Fauci told reporters Wednesday during a White House press conference on the pandemic.

Public health and vaccines experts told CNBC that AstraZeneca’s data problem is just the latest example of a series of mistakes by the company that could affect people’s willingness to take the vaccine, which may be approved in the US as early as next month becomes.

President Joe Biden’s senior advisor on the pandemic, Andy Slavitt, attempted to reassure Americans about the vaccines on Tuesday, telling CNN: “The public should be confident that nothing will be approved if the FDA gets this data not thoroughly analyzed. “

When the AstraZeneca vaccine is reviewed by the FDA, the agency will “judge what the data says or what it says and whether or not it is approved. Until then, this is all just stuff that will do it.” happen in the background, “said Slavitt.” We believe this transparency and scientific independence are critical to public trust.

AstraZeneca’s vaccine is already approved for use in other countries. The company said in a statement Tuesday that it intends to release results of its primary analysis of the Covid-19 vaccine “within 48 hours”.

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AstraZeneca points up to date part three trial knowledge

AstraZeneca issues updated phase three trial data

A healthcare worker prepares to inject a vaccine against AstraZeneca coronavirus disease (COVID-19).

Eloisa Lopez

AstraZeneca released updated Phase 3 trial data for its Covid-19 vaccine on Wednesday after asking accuracy questions related to a preliminary report from its US study earlier this week.

The company now says its vaccine is 76% effective against symptomatic virus cases. A press release published on Monday reported a symptomatic efficacy rate of 79%. The updated report claims the shot is 100% effective against serious illness and hospital stays.

A group of US health officials criticized the company over the past few days for claiming that they are collecting data to make the results seem more favorable.

The National Institute of Allergy and Infectious Diseases announced Tuesday that the UK-based company may have included information from its US findings that provided an “incomplete view of efficacy data”.

AstraZeneca said at the time that the numbers were based on a “pre-determined interim analysis” and promised to share the updated analysis in the coming days.

Dr. Anthony Fauci, Chief Medical Officer and White House Director at NIAID, described the situation as “unfortunate” and said it was likely that AstraZeneca would issue a modified statement.

“This is really what you call an easy mistake as it is most likely a very good vaccine,” Fauci told ABC’s Robin Roberts on Good Morning America Tuesday. “Something like that … really creates doubts about the vaccines and maybe adds to hesitation. It wasn’t necessary.”

The updated results include data from 190 symptomatic cases in more than 32,000 participants – an increase of around 50 symptomatic cases studied compared to the dataset published Monday.

The results suggest that the vaccine is more effective than previously thought in patients aged 65 and over, with a newly reported efficacy rate of 85% for this population versus 80% previously reported.

AstraZeneca reiterated Wednesday that the vaccine was “well tolerated” among participants and that no safety concerns were identified.

AstraZeneca has faced a separate backlash over the past few weeks due to reports of blood clotting related to its vaccine, which is already approved and used by dozen of countries around the world. Several European nations have suspended and then resumed use of the vaccine after independent safety reviews.

– CNBC’s Berkeley Lovelace Jr., Sam Meredith, and Steve Kopack contributed to this report.

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AstraZeneca missteps threaten to additional erode belief as firm seeks U.S. approval

AstraZeneca missteps threaten to further erode trust as company seeks U.S. approval

A medical syringe and vial in front of the logo of UK biopharmaceutical company AstraZeneca in this illustrative photo taken on November 18, 2020.

STR | NurPhoto | Getty Images

U.S. health officials released a bizarre statement early Tuesday that AstraZeneca may have based the results of its Covid-19 vaccine study on outdated information.

The company’s fumbling was just the latest “self-inflicted wound” in a series of missteps that threaten to undermine public confidence in his shot, public health and vaccine experts told CNBC.

On Monday, AstraZeneca announced the long-awaited results of its Phase 3 clinical trial of the Covid-19 vaccine it was developing at Oxford University. It is 79% effective in preventing symptomatic diseases and 100% effective against serious illness and hospitalization. According to the company, the analysis was based on 32,449 participants in 88 test centers in the USA, Peru and Chile.

Results questioned

The National Institute of Allergy and Infectious Diseases questioned the accuracy of these results early Tuesday when it was informed by the data and safety oversight body overseeing the study that the UK-based company may have information in the results of its U.S. Vaccine studies included that have provided an “incomplete view of efficacy data”.

“We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is released as soon as possible,” said a NIAID statement.

NIAID director Dr. Anthony Fauci said the DSMB, an independent group of experts overseeing clinical trials in the United States, has raised concerns with the agency that the results in AstraZeneca’s press release are more favorable than more recent data from the vaccine study showed, according to STAT News. “I was kind of stunned,” Fauci told STAT, The agency could not be silent.

Unusual statement

The statement by NIAID, which is part of the National Institutes of Health, is highly unusual, health experts said. The last time a US agency statement caused a stir was in September when one of its panels said there was “insufficient data” to show convalescent plasma work against the coronavirus, in line with claims made at the time FDA Commissioner Dr. Stephen Hahn disagreed.

AstraZeneca’s data hiccup is just the latest example in a series of mistakes the company has made that could affect people’s willingness to take the vaccine, which may be approved as early as next month in the U.S., said Isaac Bogoch, an infectious disease expert sat on numerous data and security oversight bodies.

The problems first started in September after the company failed to promptly inform Food and Drug Administration officials that it called off its trial worldwide after a study participant fell ill, according to the New York Times. The company would face other issues later, including criticism, after volunteers were given incorrect vaccine doses in its studies and countries asked if its vaccine was suitable for use in people over 65. Most recently, countries suspended the use of the shot after reports of temporary blood clots in some vaccinated people.

Avoidable defects

“This has been an endless roller coaster ride of what I might call preventable communications mistakes,” Bogoch told CNBC. “You have to be open, you have to be honest, you have to be transparent. That includes both the good and the bad news.”

Bogoch said the missteps were not good for public confidence in the vaccine, adding: “We are already dealing with issues of public confidence in the launch of the vaccine [overall] and one must have public trust to have a successful public health initiative. “

Dr. Leana Wen, professor of public health at George Washington University and former Baltimore health commissioner, said AstraZeneca’s recent hiccups could damage not only public confidence in the company’s vaccine, but confidence in all of its Covid-19 vaccines .

“At this point it is really important that there is full transparency. We need to know what happened. Why does there seem to be this discrepancy in the data?” Said Wen. “I don’t remember seeing public disagreements like this one. And that is again throwing red flags at a time when we can least afford it.”

‘Be assured’

During an interview on CNN Tuesday, Andy Slavitt, President Joe Biden’s senior advisor on the pandemic, tried to reassure Americans about the vaccines. He said, “The public should be confident that nothing will be approved unless the FDA thoroughly analyzes it.” Data.”

When the AstraZeneca vaccine is reviewed by the FDA, the agency will “judge what the data says or what it says and whether or not it is approved. Until then, this is all just stuff that will do it.” happen in the background, “said Slavitt.” We believe this transparency and scientific independence are critical to public trust.

While Americans may not trust the vaccine, the data debacle is unlikely to affect the FDA’s review of the shot once the company submits it for emergency approval, said Lawrence Gostin, a law professor and director of the Collaborating Center on National and International the World Health Organization Global Health Act.

Pivot

“It certainly doesn’t help if the NIH rebukes you shortly before the application for approval,” Gostin said, adding that the number of “self-inflicted wounds” the company had “was astounding.” “AstraZeneca has a good and safe vaccine that I think will help vaccinate America and the world.”

Dr. William Schaffner, an epidemiologist who previously sat on two data security supervisory boards for staphylococcal vaccines, said the eventual FDA approval will be critical not only for the US but for other countries as well, as AstraZeneca’s vaccine is cheaper and easier to sell than its competitors.

“That would resonate around the world and give other health ministries confidence in this vaccine,” said Schaffner.

Correction: This story has been updated to correct the AstraZeneca vaccine dosing regimen. It requires two doses.

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U.S. Well being Officers Query AstraZeneca Vaccine Trial Outcomes

U.S. Health Officials Question AstraZeneca Vaccine Trial Results

This US trial, which was attended by more than 32,000 participants, was the largest test of its kind for the shot. The results, AstraZeneca released on Monday, came from an interim look at the data after 141 Covid-19 cases occurred in volunteers.

The company had only announced on Tuesday how up-to-date this data was. This information is important because sometimes a more up-to-date look at clinical trial results may reveal different efficacy and safety.

If the analysis was done on data from a month or two ago, it is possible that a more recent look may give a different picture of the vaccine’s effectiveness and safety. The company has announced that it will provide the FDA with a more comprehensive and up-to-date dataset than it released on Monday. Although no clinical study is large enough to rule out extremely rare side effects, AstraZeneca reported that its study did not identify any serious safety issues.

The new data may have arrived too late to make a big difference in the United States, where the vaccine has not yet been approved and is not expected to be available until May. By then, federal officials say, there will be enough vaccine doses for all adults in the country from the three already approved vaccines: Pfizer-BioNTech, Moderna, and Johnson & Johnson.

Even so, the better-than-expected results have been seen as an encouraging turn for AstraZeneca’s shot, whose low cost and simple storage requirements have made it an important part of the quest to vaccinate the world.

The results were also believed to allay concerns about the AstraZeneca vaccine in Europe. Regulators there said the shot was “safe and effective” last week after conducting a review after a small number of people who had recently been vaccinated developed blood clots and abnormal bleeding. The US study found no evidence of such problems, although some real-world safety issues can only be identified when a drug or vaccine is widely used.

Millions of people have received the AstraZeneca shot worldwide, including more than 17 million in the UK and the European Union, almost all without serious side effects. To increase public confidence, many European political leaders have received the injections in the past few days. The AstraZeneca vaccine was also given to executives in South Korea, Taiwan and Thailand last week.

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U.S. well being company casts doubt over AstraZeneca vaccine knowledge

U.S. health agency casts doubt over AstraZeneca vaccine data

A nurse makes syringes with the preparation of Astrazeneca in Axel Stelzner’s family doctor’s practice.

Hendrik Schmidt | Image alliance via Getty Images

LONDON – A US health agency on Tuesday expressed concern that AstraZeneca may have included out of date information from a clinical trial of its Covid-19 vaccine, which may cast doubt on the published efficacy results.

The Data Safety Monitoring Board “was concerned that AstraZeneca may have included out of date information from this study that may provide an incomplete view of the efficacy data,” the US National Institute of Allergy and Infectious Diseases said in a statement.

“We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is released as soon as possible.”

The NIAID is led by the White House Chief Medical Officer, Dr. Anthony Fauci, directs and is part of the National Institutes of Health.

AstraZeneca did not immediately respond to a CNBC request for comment.

The statement comes just a day after the results of a large U.S. study showed that the coronavirus vaccine developed by AstraZeneca and Oxford University is 79% effective against symptomatic illness and 100% effective against serious illness and hospitalization.

Data from the late-stage human study was based on more than 32,000 volunteers at 88 trial centers in the United States, Peru, and Chile.

The results were welcomed as “surprisingly positive” and “good news for the global community”.

AstraZeneca said it plans to prepare the primary analysis, which will be submitted to the U.S. Food and Drug Administration for emergency approval before mid-April.

The Oxford AstraZeneca vaccine had been temporarily suspended in several countries after blood clots were reported in some people who had been vaccinated. However, AstraZeneca said Monday that the independent DSMB had not found an increased risk of blood clots.

Ruud Dobber, executive vice president of AstraZeneca’s biopharmaceuticals business, told CNBC’s “Squawk Box” Monday that it was “very gratifying to see that the Data Safety Monitoring Board, even with a magnifying glass, is not an imbalance between the vaccinated group and the vaccinated group the placebo group. “

“That gives us a lot of confidence,” he added.

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European nations resume utilizing AstraZeneca Covid vaccine after regulator OK

European nations resume using AstraZeneca Covid vaccine after regulator OK

A dose of the Oxford / AstraZeneca coronavirus vaccine is being made by a member of the Hampshire Fire and Rescue Service of the Basingstoke Fire Station, which has been set up as a vaccination center and where crews are still answering 999 calls on February 4, 2021 in Basingstoke, England.

WPA pool | Getty Images

LONDON – The European Medicines Agency has decided that the AstraZeneca coronavirus vaccine is safe and effective, despite some concerns about possible side effects.

Thursday’s announcement comes after more than a dozen EU countries stopped using the AstraZeneca shot developed with Oxford University after around 30 cases of blood clots. Some other countries have stopped using individual batches of the vaccine.

France, Germany, Italy, the Netherlands, Portugal, Spain and several other European nations are now planning to resume the use of the shot after the regulatory authority’s OK.

The EMA said Thursday that the vaccine’s benefits outweighed the risks. No batch or quality problems with the vaccine were found, although an association with the blood clot incidents could not be definitively ruled out.

“This is a safe and effective vaccine,” said Emer Cooke, EMA Executive Director, at a news conference Thursday.

“The benefits of protecting people from Covid-19, with the associated risks of death and hospitalization, outweigh the potential risks. The committee also concluded that the vaccine was not associated with an increase in the overall risk of thromboembolic events or blood clots. … We still cannot rule out a definitive link between these cases and the vaccine. “

The regulator said it will continue to investigate possible links between rare blood clots and the vaccine. It will also update its guidelines for the vaccine to clarify the potential risks.

Suspensions

The suspensions were not uniform across the 27 member states of the European Union and a number of nations continued to use the AstraZeneca shot in their vaccination campaigns.

Austria became the first country to stop using a certain batch of AstraZeneca shots last week after a 49-year-old woman who received the vaccine died.

Reports of blood clots elsewhere followed, albeit in a very small number of people, causing other leaders to suspend use and await a reassessment by the region’s health authority.

The EMA said in its review that the vaccine may be associated with very rare cases of thrombocytopenia-related blood clots, which are low platelet levels, including rare cases of blood clots in the vessels that drain blood from the brain known as CVST.

“These are rare cases – around 20 million people in the UK and EEA (European Economic Area) had received the vaccine by March 16, and the EMA had only looked at 7 cases of multiple blood clots and 18 cases of CVST. One cause A link to the vaccine has not been established but it is possible and deserves further analysis, “added the EMA in a statement.

AstraZeneca’s vaccine is widely used in the UK but has not yet been approved by the US authorities.

The benefits outweigh the risks.

The World Health Organization said Wednesday that “vaccination against Covid-19 will not reduce disease or death for other reasons. Thromboembolic events are known to be common.”

In addition, WHO said the response from some EU countries had shown that “the surveillance system is working and that there are effective controls in place”. Nonetheless, the institution reiterated its belief that “the benefits of the AstraZeneca vaccine outweigh the risks and recommends that vaccinations be continued”.

The UK Medicines Agency also said Thursday that people should continue to receive the AstraZeneca shot.

Some health professionals have raised major concerns about discontinuing use of this vaccine. Earlier this week, Cooke, of the EMA, said the institution was concerned the suspensions could affect people’s confidence in vaccines.

Recent concerns about the side effects stem from the uncertainty of some EU countries about an alleged lack of data on the effectiveness of the AstraZeneca vaccine in the elderly. However, these countries later decided to use the shot for vaccination.

Situation in Europe “worsening”

The distribution of vaccines is vital in Europe from both a health and an economic perspective.

The President of the European Commission, Ursula von der Leyen, said on Wednesday: “The epidemiological situation is deteriorating.”

“We are seeing a third wave forming in Member States and we know we need to speed up vaccination rates,” she added.

The EU aims to vaccinate 70% of its adult population by the end of summer.

The data presented on Wednesday suggests that the bloc is on track to achieve this goal, provided that drug companies honor their supply contracts over the next three months and member states use them successfully.

– CNBC’s Sara Salinas contributed to this report.

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AstraZeneca Vaccine Beneath Extra Scrutiny After Denmark Demise

AstraZeneca Vaccine Under More Scrutiny After Denmark Death

Denmark reported on Saturday that after receiving the AstraZeneca Covid-19 vaccine, two people suffered cerebral haemorrhage, one of whom died. The Danish Medicines Agency said it was looking to see if the disease was a possible side effect.

A spokesman for the capital region of Denmark confirmed the death, and the Danish news agency Ritzau reported that the other person, a civil servant in her thirties, was seriously ill.

Millions of people in dozens of countries have received the AstraZeneca Covid-19 vaccine with few reports of side effects. However, the European Medicines Agency, the continent’s top medicines agency, carried out a review after several countries stopped using the vaccine. On Thursday, the agency said it thought the vaccine was safe, although it would continue to look out for links to blood disorders. It was determined that any threat would be very minor and that the gunfire would prevent far more deaths than they could cause.

Recent blood clots and abnormal bleeding in a small number of vaccine recipients in European countries raised safety issues and resulted in suspensions. This resulted in a disruptive pause in vaccination campaigns this week, although some European countries entered a third wave of infections.

“At the moment we are investigating whether this is exactly the same clinical picture with multiple blood clots, low platelet counts and bleeding,” said Tanja Erichsen, director of the Danish Medicines Agency, in a radio interview with the Danish national broadcaster DR.

“We prioritize reports of suspected serious side effects like these and investigate them thoroughly to determine whether there is a possible link to the vaccine,” Ms. Erichsen said on Twitter on Saturday. “We are in the process of dealing with the two specific cases.”

This is the second death in Denmark after a person received the AstraZeneca vaccine. Norway is investigating the deaths of two people who received the vaccine.

Denmark has suspended the use of AstraZeneca until Thursday, despite assurances from the European Medicines Agency. Other Scandinavian countries and Finland have made similar decisions. However, some European countries, including France and Germany, have resumed recording.

Part of the continued caution is due to preliminary results from medical experts in Norway and Germany, which suggest a possible link between the vaccine and the extremely rare blood disorders. The German experts said the sinus or cerebral vein thrombosis, which Germans suffered 13 days after receiving the vaccine, was caused by an immune system reaction they believe may be related to the shot. They did not publish detailed data, but planned to present their results to The Lancet.

AstraZeneca didn’t immediately comment on the claims on Friday.

Dr. James Bussel, an expert in platelet disorders and professor emeritus at Weill Cornell Medicine, said the occurrence of abnormal clotting and low platelets in people under the age of 50 was unusual. He found that researchers in Europe had identified antibodies produced by the immune system – possibly in a highly unusual response to the vaccine – that may have activated platelets and triggered a cascade of abnormal clotting and bleeding.

Researchers in Germany and Norway will continue their research. In Germany, where the vaccine is being re-administered, doctors are now warning anyone who receives an AstraZeneca shot to see a doctor immediately if they have a headache, dizziness, or blurred vision more than three days later. They said the problems could very likely be addressed if identified in time.