AstraZeneca

Denmark has removed the AstraZeneca Covid-19 vaccine from its vaccination program, saying it is not needed because the country has already reached "such an advanced point" in its vaccine rollout.

The Danish Health Authority said studies had shown a higher than expected frequency of blood clots following doses, affecting about one in 40,000 people.

There's a clear link between the AstraZeneca vaccine and blood clots, EMA's Head of Anti-infectives and Vaccines Marco Cavaleri told the Italian daily newspaper Il Messagero on Thursday.

“In my opinion, we can now say it, it is clear that there is an association with the vaccine. However, we still do not know what causes this reaction,” so Cavaleri.

The European Medicines Agency issued a statement hours later, denying that a connection has been already established, saying it had “not yet reached a conclusion and the review is currently ongoing”, but expects to announce findings later this week.

Frank-Walter Steinmeier, the president of Germany, has been vaccinated with AstraZeneca's Covid-19 vaccine at the Bundeswehr Hospital in Berlin on Thursday, his office reported.

"I trust the vaccines approved in Germany," Steinmeier said in a statement. "Today I received my first vaccination with AstraZeneca. Vaccination is the crucial step on the way out of the pandemic. Take advantage of the opportunities. Get involved!"

German Health Minister Jens Spahn and the 16 state health ministers on Tuesday decided to suspend the routine use of the AstraZeneca vaccine for people under age 60 at an emergency meeting. The decision came amid fresh concern over unusual blood clots reported in a tiny number of younger people who received the vaccine.

Several European countries briefly suspended the use of the vaccine earlier this month, albeit in that instance for more elderly people rather than the young, but resumed jabs after EU regulators said the shot was safe for use.

Canada announced Monday that the National Advisory Committee on Immunization is recommending that the AstraZeneca Covid-19 vaccine should not be administered to people under the age of 55 due to safety reasons.

“There is substantial uncertainty about the benefit of providing AstraZeneca Covid-19 vaccines to adults under 55 given the potential risks,” said Dr Shelley Deeks, vice-chair of the National Advisory Committee on Immunization.

"Following population-based analyses of VIPIT assessing risk of COVID-19 disease by age, and considering that alternate products are available (i.e., mRNA vaccines), from what is known at this time, there is substantial uncertainty about the benefit of providing AstraZeneca COVID-19 vaccine to adults under 55 years of age given that the potential risks associated with VIPIT, particularly at the lower estimated rates," committee officials said.

As 29 million apparently hoarded AstraZeneca vaccine doses have been traced in Italy, Britain's health minister Matt Hancock has conceded preferential treatment for his country by the British-Swedish pharmaceutical company.

"I believe that free trading nations follow contract law," Hancock told the Financial Times. "Our treaty trumps theirs. It's called contract law and it's clear," he said, referring to the dispute between the EU and AstraZeneca over cut supply volumes.

New regulations announced Wednesday will make it easier to halt shipments of Covid-19 vaccines outside of the EU. The new rules were announced as a report emerged about 29 million AstraZeneca doses that were found during an inspection of a bottling plant in Italy.

The European Commission had negotiated vaccine supply contracts on behalf of the 27 EU member states, and Brussels has been frustrated by the slow pace of deliveries. British Prime Minister Boris Johnson took note of the new EU rules without mentioning vaccines but saying they could influence companies' decisions on where to invest.

Italian inspectors found a secret stock of 29 million doses of the AstraZeneca Coronavirus vaccine in a filling plant of the company near Rome. AstraZeneca delivered around 30 million doses to the EU so far, but promised three times as much. The EU Commission is now demanding accountability.

The National Institute of Allergy and Infectious Diseases (NIAID) has released a statement, saying that the Data and Safety Monitoring Board (DSMB), an independent group of experts that advises US National Institute of Dental and Craniofacial Research, was concerned "that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data."

"Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial,” the statement says. “The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”

Alain Fischer, France's vaccination chief, said Monday that he excepts a return to some kind of "normal" life by either Summer or Autumn. France has just resumed use of the AstraZeneca Coronavirus vaccine last week and Prime Minister Jean Castex received the first dose of the vaccine on Thursday.

A US trial with over 32,000 participants has shown that the Oxford-AstraZeneca Covid-19 vaccine is both safe and effective, preventing symptomatic infections with a 79% efficacy and severe infections and hospitalizations with a 100% efficacy. The trial has also shown no safety concerns associated with blood clots.

Several European countries, inclduing France, Italy, Cyprus, Latvia, Portugal, Germany, the Netherlands and Lithuania will resume administering AstraZeneca's Covid-19 vaccine in the following days after European Medicines Agency (EMA) announced the vaccine was "safe and effective".

Emer Cooke, head of the EMA, said that while "a small number of cases of rare and unusual but very serious clotting disorders" were uncovered, the agency did not find that the vaccine caused an increase in the risk of blood clots.

Spain's Health Minister Carolina Darias announced Thursday that the country will resume administering the AstraZeneca vaccine next Wednesday after the European Medicines Agency (EMA) deemed it "safe and effective."

"The decision was taken unanimously as the benefits outweighed the risks, in line with the findings from the European Medicines Agency," so Darias.

The World Health Organization (WHO) said on Wednesday it was still reviewing safety concerns over the AstraZeneca vaccine. Still, it recommended the continuation of its use based on the current benefit-risk assessment.

The jab suspension and an already sluggish inoculation campaign across the EU pose a threat to plans announced by the European Commission on Wednesday to launch a "green digital certificate" to collate vaccine information.

Jutta Paulus, a licensed pharmacist and a member of the European Parliament for the Green Party, said the "benefits of taking the AstraZeneca vaccine do outweigh the risks."

The World Health Organization's vaccine safety experts were due to meet Tuesday to discuss the AstraZeneca Covid-19 vaccine, as more countries stopped vaccinations over blood clot concerns. WHO on Monday appealed to countries to keep vaccination campaigns going, saying there was no evidence the vaccine caused clotting issues.

But much of Europe has gone against that advice in recent days, temporarily halting AstraZeneca shots even as the continent confronts a third wave of the pandemic, spurred by variants of the virus, and faces criticism over sluggish vaccination campaigns.

In a statement on Sunday, the pharmaceutical giant said that of the 17 million people vaccinated in the European Union and the United Kingdom so far, blood clot incidents were "much lower than would be expected to occur naturally in a general population."

A total of 13 European countries have suspended the use of the AstraZeneca Covid-19 vaccine as of Tuesday due to blood clot concerns. Germany, France, Italy, Span, Portugal, Luxembourg and Slovenia suspended the vaccine on Monday, Sweden and Latvia followed on Tuesday.

Germany on Monday halted the use of the AstraZeneca coronavirus vaccine, the Health Ministry announced in a statement. Italy, France and Spain follow suit later in the day.

"After new reports of thrombroses of the cerebral veins in connection with the vaccination in Germany and Europe, the PEI considers further investigations to be necessary," the Health Ministry announced.

The European Medicines Agency will decide "whether and how the new information will affect the authorization of the vaccine"

AstraZeneca has released a statement, saying its Covid-19 vaccine has shown no evidence of an increased risk of blood clots.

"Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine," the report said. "A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country."

Ireland temporarily suspended the use of the AstraZeneca Covid-19 vaccine. The move follows a report from Norway of patients developing blood clots post-inoculation.

The Norwegian Medicines Agency said there were four new cases of serious blood clotting in adults.

The Irish National Immunization Advisory Committee (NIAC) made the directive as a precaution.

The Swedish-British vaccine manufacturer AstraZeneca has again revised the announced delivery quantity downwards. According to this, the member states of the European Union will probably only receive 30 million doses of Corona vaccine by the end of the month - ten million less than last announced. This was already a reduced quantity: originally, AstraZeneca had contractually promised to deliver 90 million doses.