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We all need to know this about the vaccine received from WHO

Why has EMA recommended the authorisation of COVID-19 Vaccine AstraZeneca?

COVID-19 Vaccine AstraZeneca offers a good level of protection against COVID-19 which is a critical need in the current pandemic. The main trials showed that the vaccine has around 60% efficacy. Most side effects are mild to moderate in severity and are gone within a few days.

The European Medicines Agency therefore decided that COVID-19 Vaccine AstraZeneca’s benefits are greater than its risks and it can be recommended for authorisation in the EU.

COVID-19 Vaccine AstraZeneca has been recommended for ‘conditional marketing of COVID-19 Vaccine AstraZeneca was recommended by EMA’s human medicines committee (CHMP) on 29 January 2021 for a conditional marketing authorisation valid throughout the EU. The European Commission will issue a decision shortly.

Detailed recommendations for the use of this product are described in the product information, which will be available in all official European Union languages after a decision on the marketing authorisation has been issued by the European Commission.authorisation’. This means that there is more evidence to come about the vaccine (see below), which the company is required to provide. The Agency will review any new information that becomes available and this overview will be updated as necessary.

What information is still awaited for COVID-19 Vaccine AstraZeneca?

Since COVID-19 Vaccine AstraZeneca has been recommended for conditional marketing authorisation, the company that markets COVID-19 Vaccine AstraZeneca will continue to provide results from the clinical trials, which are ongoing. These trials and additional studies will provide information on how long protection lasts, including against new variants of the virus, how well the vaccine prevents severe COVID-19, how well it protects older people, immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases.

In addition, independent studies of COVID-19 vaccines coordinated by EU authorities will also give more information on the vaccine’s long-term safety and benefit in the general population.

The company will also carry out studies to provide additional assurance on the pharmaceutical quality and testing of the vaccine as the manufacturing continues to be scaled up.

What measures are being taken to ensure the safe and effective use of COVID-19 Vaccine AstraZeneca?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of COVID-19 Vaccine AstraZeneca have been included in the summary of product characteristics and the package leaflet.

A risk management plan for COVID-19 Vaccine AstraZeneca is also in place and contains important information about the vaccine’s safety, how to collect further information and how to minimise any potential risks. A summary of the RMP is available.

Safety measures will be implemented for COVID-19 Vaccine AstraZeneca in line with the EU safety monitoring plan for COVID-19 vaccines to ensure that new safety information is rapidly collected and analysed. The company that markets COVID-19 Vaccine AstraZeneca will provide monthly safety reports.

As for all medicines, data on the use of COVID-19 Vaccine AstraZeneca are continuously monitored. Suspected side effects reported with COVID-19 Vaccine AstraZeneca are carefully evaluated and any necessary action taken to protect patients.COVID-19 Vaccine AstraZeneca was recommended by EMA’s human medicines committee (CHMP) on 29 January 2021 for a conditional marketing authorisation valid throughout the EU. The European Commission will issue a decision shortly.

Detailed recommendations for the use of this product are described in the product information, which will be available in all official European Union languages after a decision on the marketing authorisation has been issued by the European Commission.

Content created and supplied by: RichGeorge (via Opera News )

EMA European Medicines Agency European Union Vaccine WHO

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