European Medicines Agency

The European Medicines Agency announced Friday that it is reviewing a possible connection between the Johnson & Johnson Covid-19 vaccine and blood clots, Reuters reports.

"Four serious cases of rare blood clots with low platelets, one of which was fatal, have been reported after inoculation with J&J’s vaccine from its Janssen unit, the European Medicines Agency’s (EMA) said," Reuters wrote.

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.

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.

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"

There is no indication that the Covid-19 vaccine is linked to an increased risk of blood clots, the European Medicines Agency (EMA) says. It said the number of cases in vaccinated people was no higher than in the general population.

Some countries, including Denmark and Norway, suspended the jab's use after reports that a small number of people had developed clots after receiving the jab.

The European Medicines Agency has announced, that their human medicines committee (CHMP) concluded by consensus that the data on the Covid-19 vaccine Janssen were robust and met the criteria for efficacy, safety and quality.

"With this latest positive opinion, authorities across the European Union will have another option to combat the pandemic and protect the lives and health of their citizens," said Emer Cooke, EMA's Executive Director, adding, "this is the first vaccine which can be used as a single dose". These measures will allow regulators to swiftly assess data emerging from a range of different sources and take any necessary regulatory action to protect public health.

An official of the European Medicines Agency (EMA) is cautioning the European Union to hold back on granting emergency authorization for Sputnik V, Russia's Covid-19 vaccine until its effectiveness has been reviewed.

“We need documents that we can review. We also don’t at the moment have data...about vaccinated people. It is unknown. That’s why I would urgently advise against giving a national emergency authorization,” EMA managing board head Christa Wirthumer-Hoche said. “We can have Sputnik V on the market here in future when the appropriate data have been reviewed. The rolling review has begun now at EMA.”

The European Medicines Agency (EMA) has stated it has received an application for approval of the Johnson & Johnson Covid-19 vaccine and a decision is expected by mid-March.

The state-owned Direct Investment Fund, which co-finances the vaccine and markets it abroad, announced in Moscow on Friday that Russia wants to help out the European Union with its vaccine. In the second quarter, 100 million doses of the vaccine Sputnik V could be delivered, which would allow 50 million people to be vaccinated. The prerequisite is that the European Medicines Agency (EMA) approves the active ingredient.

Independent studies testing the efficiency of the vaccine are outstanding.

The EMA has recommended conditional market approval for the Oxford-AstraZeneca vaccine claiming the vaccine "was safe and effective at preventing COVID-19 in people from 18 years of age."

Germany's vaccine commission had said on Thursday that it could not recommend the use of the jabs on people aged 65 years and older because efficacy data for the group were lacking.

The European Medicines Agency (EMA) has announced that AstraZeneca has applied for approval of their Covid-19 which has been developed by AstraZeneca and Oxford University.

According to the EMA "the assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline" and added that "an opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human medicines (CHMP), provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required to complete the assessment is promptly submitted."

From now on, more people can be vaccinated with the Covid-19 vaccine from one ampoule of the manufacturers BioNtech and Pfizer.

The European Medicines Agency (EMA) has approved that six instead of five doses may be drawn from an ampoule, said a spokesman for the Federal Ministry of Health in Berlin on Friday.

This approval of six instead of five vaccinations per ampoule applies only to the EU. In the remaining countries outside the EU, the national authorities decide whether to change the vaccine approval.

On Wednesday, the European Parliament Committee on Environment, Public Health and Food Safety announced on Twitter that they are "expected to follow the European Medicines Agency (EMA) recommendation and grant the authorization shortly after which the roll-out of the vaccine in the EU can begin."

Emer Cooke, EMA executive director, said on Wednesday that "this vaccine provides us with another tool to overcome the current emergency." and "It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO," she said.

One ampoule of Biontech vaccine can often be used to produce six rations instead of five. The Mainz-based manufacturer Biontech has now submitted an application to the European Medicines Agency Ema for a change in the conditions of approval. The Ema had told the German newspaper SPIEGEL on Tuesday that if Biontech submitted an application to change the terms of its marketing authorisation, it would be "rapidly" reviewed by its human medicines committee.

Biontech is lobbying for doctors to be allowed to draw six full vaccine doses of 0.3 ml each from the provided vials containing a total of 2.25 ml of finished vaccine in the future - provided they can draw up six full doses.

The president of the European Commission Ursula von der Leyen has announced via Twitter that the European Medicines Agency has "just issued a positive scientific opinion on the #BioNTech / @pfizer vaccine". She now expects that the European Commission will decide "by this evening" if the vaccine will be permitted.

After the European Medicines Agency (EMA) announced it would issue its decision on the Pfizer-BioNTech vaccine on December 21, German Health Minister Jens Spahn, speaking at a joint press conference with the Robert Koch Institute, the government agency responsible for disease control and prevention, said the report was "good news."

A fortnight ago, BioNTech and Pfizer submitted an application to the EMA for conditional marketing authorization for their COVID-19 vaccine. President of the EU Commission, Ursula von der Leyen tweeted that she welcomed the EMA's decision to bring the meeting forward.

According to Moderna, the pharmaceutical company will submit its application for conditional market authorization for its new Covid-19 to the European Medicines Agency Ema on Monday.

The EU Commission has already secured up to 160 million doses of the vaccination according to EU Commission President Ursula von der Leyen.