EMA begins rolling review of Chinese Covid-19 vaccine
The EMA said that studies suggest that the vaccine triggers the production of antibodies which may help protect against Covid-19. File picture
The European Medicines Agency (EMA) has started a rolling review of one of China’s Covid-19 vaccine.
The Beijing based company Sinovac is developing the inactivated jab and the review is based on preliminary results from lab and clinical studies.
The EMA said that the studies suggest that the vaccine triggers the production of antibodies which may help protect against Covid-19.
“EMA will evaluate data as they become available to decide if the benefits outweigh the risks,” a statement added.
“The rolling review will continue until enough evidence is available for a formal marketing authorisation application.”
The EMA said that a timeline can’t be predicted but it is expected that the review will take less time than normal because of the work done during the rolling review.
According to the EMA, the inactivated jab “is expected to prepare the body to defend itself against” a Covid infection.
The jab contains SARS-CoV-2 that has been inactivated or killed and cannot cause the virus.
It also "contains an ‘adjuvant’, a substance that helps strengthen the immune response to the vaccine.”
The EMA said: “When a person is given the vaccine, their immune system identifies the inactivated virus as foreign and makes antibodies against it.
"If, later, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the virus and be ready to defend the body against it.”
Sinovac’s CoronaVac jab is just one that is being developed by China. Sinopharm, a state-owned company, is developing two vaccines.
The announcement from the Amsterdam-based agency came a day after a senior World Health Organisation official said the group is set to decide this week whether to approve two Chinese Covid-19 vaccines for emergency use.
Such approval would mark the first time that a Chinese vaccine had been granted a so-called emergency use listing by the UN health agency, and would trigger a broader rollout of Chinese vaccines that are already being used in some countries outside China.
In Ireland, people aged 59 or over can register for their Covid-19 vaccine from today. Previously, only those aged 60 and over had been allowed to apply.
People aged 50 to 54 will be invited to register from Sunday, May 9.
Currently, the AstraZeneca vaccine is approved for all over-50s in Ireland, as is the Johnson & Johnson shot.
Separately, the EMA has started evaluating an application to extend the use of Comorinaty - the Pfizer vaccine - to potentially include young people aged 12 to 15.
It is currently authorised for over 16s.
EMA’s human medicines committee (CHMP) will carry out an accelerated assessment of data on Comirnaty, including results from a large ongoing clinical study involving adolescents from 12 years of age, in order to decide whether to recommend the extension of indication.
The CHMP’s opinion will then be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
EMA will communicate on the outcome of its evaluation, which is expected in June unless supplementary information is needed.
