EMA begins review of China’s Sinovac COVID vaccine

Europe’s medicines regulator, the European Medicines Agency (EMA), has begun a rolling review of China’s Sinovac COVID vaccine, it announced on Tuesday.

The decision to start the review is based on preliminary results from laboratory studies (non-clinical data) and clinical studies which, the EMA said, suggest that the vaccine produces an immune response.

The EMA will evaluate data to decide if the benefits of the vaccine outweigh its risks. Its review will continue until enough evidence is available for a formal marketing authorisation application, the Agency explained. 

The advantage of a rolling review, it commented, is that while normally all data on a medicine or vaccine is required to be ready at the start of the evaluation process, in the case of a rolling review, the regulator will be able to assess data as it comes in.

“EMA will assess the compliance of [Sinovac] with the usual EU standards for effectiveness, safety and quality”, it wrote. 

As things stand, the EMA has granted market authorisation for four COVID vaccines, produced by Pfizer, Moderna, AstraZeneca, and Johnson & Johnson. 

It is also currently carrying out a rolling review of three other vaccines, including Sputnik’s, CureVac’s and Novavax’s. 

Sinovac has posted differing efficacy rates in various real-world studies that range between 51 and 82 per cent. It has been approved by Chinese regulators, along with three other homegrown offerings.

The World Health Organisation (WHO) is expected to provide a decision on the vaccine at the end of this week.

The consideration of the vaccine comes as the European Commission has launched a lawsuit against AstraZeneca over delivery shortfalls which have left the bloc’s vaccine rollout programme lagging behind.

Malta’s, on the other hand, continues to race ahead, with those aged over 30 now eligible to receive the vaccine.

At the end of April, it was also revealed that 42 per cent of those aged 40 to 50 have been vaccinated with their first dose of the vaccine, official figures show that, as of Tuesday, 346,951 vaccine doses had been administered in Malta.