The European Medicines Agency (EMA) has started a rolling review of one of the Chinese Covid-19 vaccines.
The Beijing-based company Sinovac is developing the inactivated vaccine, and the review is based on preliminary results from laboratory and clinical studies.
The EMA said studies indicate that the vaccine leads to the production of antibodies that may help protect against Covid-19.
“The EMA will evaluate the data as soon as it becomes available, to decide whether the benefits outweigh the risks,” a statement added.
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“The periodic review will continue until there is sufficient evidence to apply for the official marketing license”
The EMA said that a timeline cannot be predicted, but that the review is expected to take less time than usual, due to the work done during the periodic review.
According to the EMA, the inactivated vaccine is expected to prepare the body to defend itself against a Covid infection.
The vaccine also contains SARS-CoV-2 that has been inactivated or killed, and cannot cause the virus.
It also “contains an” adjuvant “, which is a substance that helps to strengthen the immune response to the vaccine.
The EMA said: “When a person is given the vaccine, their immune system recognizes the inactivated virus as foreign and makes antibodies against it.”
And she added, “If the vaccinated person later comes into contact with SARS-CoV-2, the immune system will recognize the virus and be ready to defend the body against it.”
Sinovac’s CoronaVac Strike is just one being developed by China, and the state-owned company Sinopharm is developing two vaccines.
In Ireland, people aged 59 or over can register for the Covid-19 vaccine starting today.
Previously, only those 60 years of age or over were allowed to apply.
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People between the ages of 50 and 54 will be invited to register starting Sunday, May 9.
Currently, the AstraZeneca vaccine is approved for everyone over the age of 50 in Ireland, as is the Johnson & Johnson vaccine.
Separately, EMA has begun evaluating an app to expand the use of the Comorinaty – Pfizer vaccine, to youth between the ages of 12 and 15.
It is currently authorized for more than 16 years
The EMA’s Human Medicines Committee (CHMP) will conduct a rapid evaluation of the data for Comirnaty.
Including the results of a large ongoing clinical study involving adolescents from the age of 12 years in order to decide whether an extension of the indication should be recommended.
The CHMP’s opinion will then be sent to the European Commission, which will issue a final, legally binding decision that applies in all EU member states.
The EMA will also report the outcome of the assessment, which is expected in June, unless supplementary information is required.
