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EMA says J&J shot may be rolled out throughout EU

Pausing use of J&J Covid vaccine will not affect timeline of getting U.S. vaccinated, says doctor

A box of Janssen COVID-19 vaccine doses from Johnson & Johnson is pictured in Grubbs Pharmacy on Capitol Hill on Monday April 12, 2021.

Tom Williams | CQ Appeal, Inc. | Getty Images

LONDON – The European Medicines Agency said Tuesday the Johnson & Johnson Covid-19 vaccine had possible links to rare blood clots but reiterated that its benefits still outweighed the risks.

“The EMA’s Safety Committee (PRAC) concluded that a warning of unusual blood clots with low platelets should be added to the product information for the Janssen COVID-19 vaccine,” the agency said in a press release.

“Health professionals and those receiving the vaccine should be aware of the possibility of very rare cases of blood clots combined with low platelet levels within three weeks of vaccination.”

The EMA examined all available evidence, including eight reports from the United States of serious cases of unusual blood clots, one of which had a fatal outcome. As of April 7, more than 7 million people in the United States had received the vaccine.

The US Food and Drug Administration advised states earlier this month to suspend the use of J & J’s shot “out of caution”. As a result, the pharmaceutical company decided to delay the launch of its vaccine in Europe while regulators assessed all risks. On Tuesday, the company confirmed that it would resume deliveries to the block after being reviewed by the EMA.

The EMA said last week that when they reviewed the latest details, it was still believing that the vaccine’s benefits outweighed the risks.

The J&J shot, which only requires one, was initially lit in green on March 11 in the European Union. It remains to be seen how different countries will interpret the latest guidelines from the EMA. France has already indicated that it will only use the vaccine in people over 55 years of age.

“COVID-19 is associated with a risk of hospitalization and death. The reported combination of blood clots and low platelets is very rare, and the general benefits of the Janssen COVID-19 vaccine in preventing COVID-19 outweigh the risk of side effects. “said the EMA on Tuesday under the name of the Belgian unit of J & J.

This isn’t the first problem with blood clots and a Covid-19 vaccine.

More than a dozen European countries stopped using the AstraZeneca shot in March after some people who received the shot reported unusual incidents of blood clots, 18 of which were fatal.

The EMA reviewed the cases and also said the vaccine was safe and should be used in the fight against the coronavirus.

However, a few days later, the EMA also said there was a “possible association with very rare cases of unusual blood clots with low platelets” and should therefore be listed as a “very rare side effect” for the AstraZeneca vaccine.

Some countries have adjusted the introduction of this vaccine and decided to only give it to people over the age of 60, and Denmark took it a step further by stopping its use entirely.

According to the European Center for Disease Prevention and Control, more than 103 million doses have been administered in the EU to date.

Correction: The U.S. Food and Drug Administration advised states earlier this month to suspend the use of J & J’s shot. An earlier version incorrectly characterized the move.

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EMA says advantages of J&J Covid vaccine outweigh dangers

EMA says benefits of J&J Covid vaccine outweigh risks

Crystal Jones, 52, head of the Athens City Department of Health, loads syringes of the vaccine on the first day of Johnson and Johnson’s vaccine.

SOPA pictures | LightRocket | Getty Images

LONDON – The European Medicines Agency said Wednesday that the benefits of Johnson & Johnson’s Covid-19 vaccine outweigh the risk of side effects following reports of extremely rare blood clotting.

It comes shortly after the US Food and Drug Administration asked states to temporarily suspend J & J’s use of the vaccine “out of caution” after six cases of bleeding disorder were detected with more than 6.8 million doses of the shot were.

All six cases in the United States occurred in women between the ages of 18 and 48, with symptoms developing six to 13 days after receiving the shot. The FDA said one woman died from complications from blood clotting and another was in critical condition.

The European Medicines Agency has currently investigated all reported cases and will decide whether regulatory action is required.

“The EMA is currently accelerating this assessment and is currently expecting to issue a recommendation next week,” the European Medicines Agency said in a statement.

“During the ongoing review, the EMA continues to believe that the vaccine’s benefits in preventing COVID-19 outweigh the risks of side effects.”

South Africa has stopped the launch of the shot while J&J has announced it is “proactively delaying” delivery of its vaccine to Europe, which began last week.

The vaccine was approved in the EU on March 11, but widespread use of the shot has not yet started.

“Right now, these adverse events seem extremely rare,” the FDA said on Tuesday in a joint statement with the Centers for Disease Control and Prevention. “The safety of COVID-19 vaccines is a top priority for the federal government and we take all reports of health problems following COVID-19 vaccination very seriously.”

Last week, the European Medicines Agency said it had identified a possible link between the coronavirus vaccine developed by AstraZeneca and Oxford University and rare blood clotting problems. AstraZeneca has not received approval for use in the United States

Oxford-AstraZeneca and J&J vaccines work in a similar way, and both use an adenovirus, a common type of virus that typically causes mild cold symptoms.

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Extra EU international locations halt AstraZeneca shot as EMA opinions uncomfortable side effects

More EU countries halt AstraZeneca shot as EMA reviews side effects

An Army health worker prepares a dose of Covishield, AstraZeneca / Oxford’s Covid-19 coronavirus vaccine from the Indian Serum Institute at an Army hospital in Colombo on January 29, 2021.

Sign S. Kodikara | AFP | Getty Images

LONDON – Two other countries decided on Tuesday to suspend use of the AstraZeneca vaccine in Europe amid blood clot concerns as regulators conducted a new side effects review.

Sweden and Latvia announced Tuesday morning that they are suspending the rollout of the AstraZeneca vaccine developed with Oxford University. Portugal, Luxembourg and Slovenia decided to stop using the shot on Monday evening. Earlier in the day, Germany, France, Italy and Spain also joined the group of nations that stopped using the vaccine.

So far, 13 countries in the European Union have made this decision, while a few others have stopped using individual lots of the AstraZeneca vaccine. Austria first decided last week after the death of a 49-year-old woman who received this vaccine to stop using a certain batch of AstraZeneca shots.

“The benefits still outweigh the risks.”

The European health authority has insisted that “the benefits of the AstraZeneca vaccine in preventing Covid-19, with the associated risk of hospitalization and death, outweigh the risks of side effects”.

In a statement on Monday, the European Medicines Agency said it would “look further into the information” and called an extraordinary meeting on Thursday on the subject. The institution then reiterated its position during a press conference on Tuesday.

“There is currently no evidence that vaccination caused these conditions,” said Emer Cooke, director of the European Medicines Agency. “The benefits still outweigh the risks, but this is a serious problem and requires serious and detailed scientific assessment. We are currently involved in that.”

She added, “We are concerned that this could affect vaccine confidence … but our job is to make sure the products we approve are safe.”

Of course, we need speed, not just for the economy, but above all for the health of our citizens, but at the same time we need security.

Paolo Gentiloni

EU commissioner for the economy

The World Health Organization has urged nations to continue their vaccination campaigns with the AstraZeneca vaccine and Oxford University.

A number of EU countries have spoken out in favor of the shot. In Belgium, Health Minister Frank Vandenbroucke said on Monday that interrupting use was “irresponsible”. While the authorities in the Czech Republic have also announced that they will continue to administer the vaccine.

Outside the EU, Canada, Australia and the UK have also joined forces to support AstraZeneca.

According to the European Center for Disease Prevention and Control, more than 6 million doses of the AstraZeneca shot have been administered in the EU to date.

AstraZeneca announced on Sunday that of the 17 million people vaccinated in the EU and the UK, 15 had deep vein thrombosis events and 22 cases of pulmonary embolism. This is based on data received as of March 8th.

“This is much less than expected to occur naturally in a general population of this size and it is similar to other approved Covid-19 vaccines,” the company said in a statement.

Concerns about the vaccine could jeopardize the EU’s goal of vaccinating 70% of the adult population by the end of the summer. The AstraZeneca vaccine has proven popular in Europe so far because it is cheaper than its competitors and easier to store. This could then possibly delay the economic recovery in the region.

“Of course we need speed, not only for the economy, but above all for the health of our citizens, but at the same time we need security,” said Paolo Gentiloni of the European Commission at a press conference on Monday.

He added that the precautionary measures were “justified” and that the EMA review should “keep our EU citizens safe”.

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EMA begins evaluation of Russia Sputnik V jab

EMA starts review of Russia Sputnik V jab

A woman receives the second component of the Gam-COVID-Vac (Sputnik V) COVID-19 vaccine.

Valentin Sprinchak | TASS | Getty Images

LONDON – The European Medicines Agency has announced it will begin assessing the Russian coronavirus sting Sputnik V as the block seeks to speed up its vaccination program.

“The EMA will assess compliance with the usual EU standards for effectiveness, safety and quality by Sputnik V. While the EMA cannot predict the overall deadlines, the evaluation of a possible application should take less time than normal,” said the regulator in a statement on Thursday.

If the review is successful, the Russian vaccine would still need a regulatory filing before it is lit green for administration in the 27 Member States.

The news comes after some European countries indicated they could start giving Sputnik V by bypassing the regulator.

This is a breaking news item that will be updated.

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Pfizer-BioNTech vaccine paperwork ‘unlawfully accessed’ in EMA hack

Pfizer-BioNTech vaccine documents ‘unlawfully accessed’ in EMA hack

A man will receive the first of two Pfizer / BioNTech Covid-19 stitches on December 8, 2020 at Guy’s Hospital in London.

Victoria Jones | AFP | Getty Images

LONDON – Documents related to the development of the Pfizer-BioNTech Covid-19 vaccine were “illegally accessed” in a cyberattack on the European Medicines Agency.

The EMA said in a brief statement on its website on Wednesday that it was “the subject of a cyberattack” and has opened an investigation “with law enforcement and other relevant authorities”.

The regulator did not disclose details of the nature of the attack, but BioNTech announced on its website that documents contained in the regulator’s filing and stored on an EMA server were accessed. It is unclear exactly which documents were accessed and by whom.

“It is important to note that no BioNTech or Pfizer systems were breached in connection with this incident, and we do not know that study participants were identified through access to the data,” BioNTech said.

The German biotech company said it had decided to release details of the hack “given the critical public health considerations and the importance of transparency”.

The EMA, which approves the use of medicines across the European Union, is currently reviewing two Covid-19 shocks. One is from Pfizer and BioNTech, the other from Moderna. It is not known whether Moderna documents were also accessed.

The regulator is expected to announce a decision in the coming weeks on whether the vaccines are safe across Europe.

“EMA has assured us that the cyberattack will not affect the schedule for its review,” said BioNTech.

Hackers target vaccine

Last week, IBM researchers announced that hackers had also attempted to attack the cold store supply chain that transports vaccines at low temperatures. The researchers warned that a nation-state would likely be behind the effort.

Security officials said in July that hackers linked to Russian intelligence services were attempting to steal information about coronavirus vaccine research in the US, Canada and the UK. Kremlin spokesman Dmitry Peskov denied the allegations, according to the state news agency TASS.

The UK’s National Cyber ​​Security Center said: “The NCSC supports the research and manufacture of essential vaccines to defend against cyber threats.”

“We are working with international partners to understand the impact of this incident on the EU Medicines Agency. However, there is currently no evidence that the UK Medicines Agency is affected.”