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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.
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Announcement of altered dispensing status for gadolinium-containing contrast agents (ATC code: V08CA)
| 22 February 2021 |
The Danish Medicines Agency hereby informs you that the dispensing status for all gadolinium-containing contrast agents, regardless of strength, pack size and indication is changed to ‘BEGR’ (only to be dispensed to hospitals) as of 5 October 2020.
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Danish Medicines Agency expands capacity for safety monitoring of COVID-19 vaccines
| 10 February 2021 |
The Danish Medicines Agency and drug regulatory authorities around the world find themselves in a massive historic task of monitoring the safety of COVID-19 vaccines. Thousands of people have already been vaccinated in Denmark, and within a short period of time, the rest of the Danish population is expected to be offered vaccination against COVID-19. To ensure intensive and close monitoring of the COVID-19 vaccines, the Danish Medicines Agency is stepping up its capacity by recruiting more employees to process reports of suspected side effects.
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Clinical trials of the future place the patient at the centre
| 20 January 2021 |
In many cases, participating in a clinical trial is a considerable burden for the trial subjects. Clinical trials often involve many hospital appointments with a lot of travel and waiting time. The people who are affected the most live far away from the hospital departments concerned, with resulting unequal access to clinical research in Denmark.
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Home-based clinical trials will be possible in the future
| 20 January 2021 |
Participate in a clinical trial from the comfort of your own home. It may sound a little crazy, but it is actually possible in many respects. The Danish Medicines Agency has started a project to enable researchers and pharmaceutical companies to conduct so-called decentralised clinical trials which by means of new technologies make it easier for people to participate in clinical trials. It makes it more convenient for the participants and increases efficiency, while ultimately getting medicines to market faster for the benefit of patients.
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EMA’s expert committee meets 6 January to decide on Moderna’s COVID-19 vaccine
| 22 December 2020 |
The expert committee of the European Medicines Agency, EMA, which is presently assessing Moderna’s application for conditional marketing authorisation of their COVID-19 vaccine in the EU has scheduled a meeting on 6 January at which it may recommend authorisation to the European Commission. If so, the European Commission may formally authorise the vaccine within a few days.
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EMA starts rolling review of corona vaccine from Janssen
| 02 December 2020 |
The European Medicines Agency, EMA, has started a rolling review of data from the clinical trials of a potential COVID-19 vaccine from the manufacturer Janssen. The EMA has previously started the same process for other potential vaccines from AstraZeneca, BioNTech/Pfizer and Moderna.
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EMA receives the first applications for conditional marketing authorisation of COVID-19 vaccines
| 02 December 2020 |
The EMA has received the first two applications from companies for conditional marketing authorisation of COVID-19 vaccines. The authorisations could be granted in only a few weeks’ time if the agency’s independent pharmaceutical experts assess the documentation on efficacy and safety to be sufficient.
