Tag Archives: EU

J&J vaccine and thrombosis: EU begins check

The EMA will check reports that those vaccinated against the coronavirus with the J&J drug in the United States have experienced side effects.

The European Medicines Agency (EMA) will check information about possible severe side effects of the Johnson & Johnson vaccine before the drug is actually used in the European Union. This was reported by the EMA on Friday, April 9.

As specified in the agency’s message, we are talking about the occurrence of thrombosis after vaccination. The vaccine of the American pharmaceutical company Johnson & Johnson was approved by the European Commission for use in the EU in March this year.

Reports of side effects from J&J in the US

Earlier, on April 8, it was reported that in the US state of North Carolina, the vaccination center against COVID-19 was temporarily closed after several people showed side effects after being vaccinated with the J&J vaccine. A day earlier, the same measures were followed in the state of Denver, where patients after vaccination with this drug complained of dizziness and nausea.

J&J Vaccine Benefits

Unlike most other vaccines, the J&J vaccine only needs to be given once, so more people can get access to the vaccine. In addition, the J&J vaccine does not require ultra-low temperatures to be stored and transported. Like the AstraZeneca and Sputnik V vaccines, J&J is a vector vaccine.

The U.S. Food and Drug Administration (FDA) registered the J&J vaccine in February 2021. The results of phase 3 clinical trials indicate that this drug reduces the risk of moderate to severe coronavirus by 66% after four weeks of vaccination.

EU wants to buy additional 1.8 billion doses of Pfizer vaccines/Biotech

The European Commission is seeking approval from EU governments to begin negotiations with Pfizer/BioNTech to purchase up to 1.8 billion doses of their COVID-19 vaccines, which could be delivered in 2022 and 2023.

This was reported to Reuters by an EU official on the condition of anonymity.

Earlier on Friday, the German daily Die Welt reported that the European Commission will soon sign a contract for the purchase of up to 1.8 billion doses, but did not say with which company.

An EU official, who asked not to be named, said the EU leadership had decided to approach Pfizer/BioNTech, and EU governments supported the plan, although a final “yes” had not yet been given.

Separately, a representative of the European Commission confirmed that the EU leadership has already identified one supplier, the manufacturer of mRNA vaccines, but declined to comment on which company will be contacted for the contract.

“If the opportunity presents itself, Pfizer and BioNTech are ready to deliver hundreds of millions of doses of COVID vaccines to Europe in 2022 and 2023, produced at our facilities in Europe,” a Pfizer spokesperson commented.

According to him, both companies can produce more than 3 billion doses of the vaccine in 2022.

Pfizer/BioNTech and Moderna are already supplying mRNA vaccines to the EU, while German biotech company CureVac is seeking EU approval for its mRNA vaccine.

The Austrian Chancellor spoke about the possibility of registering Sputnik V

Austrian Chancellor Sebastian Kurz said that the Russian vaccine against the coronavirus infection COVID-19 “Sputnik V” can be registered in Vienna at the national level if the approval process at the EU level takes too long.

He announced this during a live broadcast on Instagram.

“Of course, there is an opportunity to do this at the national level, if it takes too long at the European level,” Kurz said.

Kurz noted that all procedures at the European Medicines Agency take a very long time. In his opinion, including in this regard, Europe lags behind in the issue of vaccination from the United States and Great Britain.

Earlier, the Austrian Chancellor said that the government of the country in the coming days will discuss with doctors the possibility of self-registration of the Russian vaccine against the coronavirus “Sputnik V”.

EU Regulator Confirms AstraZeneca Side Effect

The European Medicines Agency’s Safety Committee has concluded that the formation of unusual blood clots in combination with a low platelet count should be included in the list of very rare side effects of the AstraZeneca vaccine.

This is stated in the press release of the EU regulator, published on Wednesday.

At the same time, according to the regulator, the benefits of using the AstraZeneca vaccine continue to outweigh the risks.

In reaching this conclusion, the committee took into account all the evidence currently available, including the recommendations of the ad hoc expert group.

“The EMA reminds health professionals and people who receive the vaccine of the possibility of very rare cases of blood clots in combination with low platelet levels within two weeks of vaccination,” the EU regulator said in a statement.

The regulator noted that at the moment, the majority of reported cases of thrombosis occurred in women under the age of 60 years within two weeks after vaccination. However, based on the currently available data, specific risk factors have not been confirmed.

People who have received the vaccine are advised by the regulator to seek immediate medical attention if they develop symptoms of this combination of blood clots and low platelet levels.

The EMA Committee noted that blood clots in vaccinated patients formed in the veins of the brain (cerebral venous sinus thrombosis) and the abdominal cavity (internal vein thrombosis), and in the arteries, along with low platelet levels, sometimes with bleeding.

At the same time, the EMA notes that the combination of blood clots and low platelet counts is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.

A likely explanation for the combination of blood clots and low platelet levels is an immune response, leading to a condition similar to that sometimes seen in patients treated with heparin, the regulator notes.

The EMA Committee has requested new studies and amendments to the current ones to provide more information and promises to take any further action necessary.

So far, the EMA has recommended the AstraZeneca vaccine as safe and pointed to the lack of evidence of a link between the vaccine and blood clots. However, several EU countries, including Germany, have restricted the use of the vaccine.

In early March, dozens of European countries suspended the use of the vaccine due to such reports, but after the conclusion of the EU regulator, they mostly resumed vaccinations.

The EU has been subjected to a serious cyberattack

A number of European Union bodies, including the European Commission, were subjected to a massive cyberattack last week. This is reported by Bloomberg.

According to the EC representative, the EU institutions faced “an incident in the field of IT security in their IT infrastructure.” Currently, experts are investigating the circumstances of the incident, so there is no final assessment of the nature of the attack yet.

“We work closely with the computer emergency response team for all EU institutions, bodies, and agencies, as well as with the supplier of the affected IT product. So far, no serious information leaks have been found, “ the EC said.

According to an agency source familiar with the situation, the incident turned out to be more serious than normal attacks, so senior EC officials were informed about the incident. This information was confirmed by another representative of the European Union.

According to the agency, at least two serious cyberattacks on Western organizations have been revealed recently.

Earlier, experts named the main cyber threats of 2021. So, attackers can break into home systems, since many companies are still on the remote site.