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Dean of Aarhus University to join the Danish Medicines Agency as new Director General
| 26 May 2021 |
The Ministry of Health has appointed Lars Bo Nielsen, Dean at Aarhus University, as Director General of the Danish Medicines Agency. Lars Bo Nielsen is a qualified doctor and has extensive leadership experience within both the health and science areas.
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Danes know how vaccines work, but they underestimate how common mild side effects are
| 25 May 2021 |
A new population survey shows that Danes are generally well-informed when it comes to how COVID-19 vaccines prevent the disease. But almost half of Danes underestimate how many get mild, transient side effects, such as fever, after their COVID-19 vaccination.
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More than one in two young people say the COVID-19 vaccine debate is characterised by misinformation
| 25 May 2021 |
In a new survey, more than half of the 16 to 34-year-olds find that the vaccine debate is characterised by misinformation, and that the tone is negative. The Danish Medicines Agency is now stepping up its ‘think before you share campaign’ (#TænkFørDuDeler) – a campaign encouraging people to check facts and to respect other people on social media.
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New survey: Four in ten Danes would contact their doctor if they develop fever after COVID-19 vaccination
| 25 May 2021 |
Almost four in ten Danes say in a population survey that they would contact their doctor if they develop fever as a side effect after the COVID-19 vaccine jab. Theoretically, this corresponds to up to half a million Danes when everyone has been fully vaccinated.
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Guidance on the implementation of decentralised elements in clinical trials with medicinal products is now available
| 04 May 2021 |
Decentralised clinical trials with medicinal products meet the patients, wherever they are, in a faster and more efficient process benefitting both patient, healthcare professionals and industry. It is therefore gratifying to be able to announce that another important milestone has been reached in the Danish Medicines Agency's project to ensure an up-to-date and robust regulatory framework for decentralisation of clinical trials.
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Annual report of the Danish Medicines Agency: The COVID-19 pandemic had a considerable impact on our work in 2020.
| 26 April 2021 |
The year 2020 was a year like no other at the Danish Medicines Agency. Both internally and externally, the handling of COVID-19 had a decisive impact on much of our work. However, we managed to retain our European position and to carry through an important reinforcement of our IT landscape, so concludes the Danish Medicines Agency’s annual report for 2020.
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EMA: Possible link between the Johnson & Johnson vaccine and unusual symptoms
| 21 April 2021 |
There is a possible link between the Johnson & Johnson vaccine and unusual symptoms with a combination of blood clots in unusual sites, low levels of blood platelets and several cases of bleeding. A few cases have been observed in the USA. The frequency of these unusual symptoms is still being investigated.
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EMA to undertake a review of data as to the AstraZeneca vaccine’s efficacy in preventing COVID-19 disease
| 15 April 2021 |
The European Medicines Agency (EMA) is undertaking a review of vaccination data of the COVID-19 vaccine from AstraZeneca. The review will include infection rates, hospitalisations, morbidity and mortality. The EMA will also prepare a recommendation for those who have received the first dose of the vaccine.
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EMA: The AstraZeneca vaccine possibly causes rare, serious symptoms – but remains authorised for use
| 08 April 2021 |
An expert committee formed by the EMA has now concluded that it is possible that the rare cases of blood clots combined with low levels of platelets and bleeding are caused by the AstraZeneca COVID-19 vaccine. It is maintained, however, that the benefits of using the vaccine still outweigh any possible risks.
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COVID-19 Vaccine AstraZeneca: Investigations of blood clots with low numbers of platelets and bleeding continue in Denmark and in the EU
| 26 March 2021 |
The EMA is convening an expert group on 29 March to provide input to the continued investigation of blood clot cases, including the very rare cases of blood clots accompanied by low numbers of platelets in people vaccinated with COVID-19 Vaccine AstraZeneca.
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Status on reviewed reports of suspected side effects of the COVID-19 Vaccine AstraZeneca after vaccination of more than 140,000 Danes
| 25 March 2021 |
More than 140,000 Danes have been vaccinated with the COVID-19 Vaccine AstraZeneca. As of 23 March 2021, a total of 499 reports of suspected side effects of the COVID-19 Vaccine AstraZeneca have been reviewed. Most of these side effects are known and transient in nature. Eight cases of anaphylaxis have been treated. The drug regulatory authorities are presently investigating reports of the very rare and unusual symptoms of a low level of platelets, blood clots in small and large vessels and bleeding.
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Status on reviewed reports of suspected side effects of the COVID-19 Vaccine AstraZeneca after vaccination of more than 140,000 Danes
| 25 March 2021 |
More than 140,000 Danes have been vaccinated with the COVID-19 Vaccine AstraZeneca. As of 23 March 2021, a total of 499 reports of suspected side effects of the COVID-19 Vaccine AstraZeneca have been reviewed. Most of these side effects are known and transient in nature. Eight cases of anaphylaxis have been treated. The drug regulatory authorities are presently investigating reports of the very rare and unusual symptoms of a low level of platelets, blood clots in small and large vessels and bleeding.
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Status on the drug regulatory authorities’ investigation of blood clots after vaccination with the AstraZeneca vaccine
| 18 March 2021 |
The European Medicines Agency, EMA, and the drug regulatory authorities in Europe have reviewed reports of the rare and unusual symptoms of low levels of blood platelets, blood clots and bleeding after vaccination with the AstraZeneca’s COVID-19 vaccine. The conclusion is that the AstraZeneca vaccine is generally a safe and efficient vaccine, but that it cannot be ruled out that these symptoms may be caused by the AstraZeneca vaccine.
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European Commission authorises COVID-19 vaccine from Johnson & Johnson
| 16 March 2021 |
On 11 March, the European Commission granted a conditional marketing authorisation for the COVID-19 vaccine from Johnson & Johnson. The authorisation is valid in Denmark and the rest of the EU.
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Danish Medicines Agency sends out updated letter to people who have received the AstraZeneca vaccine within the last 14 days
| 15 March 2021 |
Today, the Danish Medicines Agency has sent out an updated letter to people who have received the AstraZeneca vaccine within the last 14 days. The purpose is to increase awareness on the symptoms that people should react to.
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Danish Medicines Agency clarifies information on the death reported in Denmark after vaccination with the AstraZeneca vaccine
| 14 March 2021 |
The Danish Medicines Agency would like to clarify information on the death reported in Denmark after vaccination with the AstraZeneca vaccine. It was unusual symptoms in the reported death that made
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EMA starts rolling review of new medicines for treatment of COVID-19
| 12 March 2021 |
The European Medicines Agency, EMA, has started a rolling review of a number of medicines for the treatment of COVID-19. No conclusions about the medicines have been drawn yet.
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Drug regulatory authorities are investigating reports of blood clots after AstraZeneca vaccinations
| 11 March 2021 |
The Danish Medicines Agency together with the EMA and the other drug regulatory authorities in Europe have launched an investigation of the AstraZeneca vaccine after reports of blood clots in people given the vaccine. One report concerns the death of a person in Denmark. At present, there is no evidence to conclude that there is an association between the vaccine and the blood clots.
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First COVID-19 vaccine authorised in the European Union
| 01 March 2021 |
The European Commission has granted a conditional marketing authorisation for the Comirnaty vaccine for COVID-19 from BioNTech/Pfizer. The authorisation is valid throughout the European Union including Denmark.
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Data requirements in place in the EU for second-generation COVID-19 vaccines
| 26 February 2021 |
With continued mutations of SARS-CoV-2, the current COVID-19 vaccines may need to be adapted to ensure their efficacy. To ensure that second-generation vaccines can be made available as fast as possible, the European Medicines Agency has just issued guidance for manufacturers.
