EMA Could Approve Sinovac Vaccine

Published on 8 May 2021 at 12:25

There is an increasing likelihood that the EMA could approve the Sinovac vaccine that was made in China imminently. According to The Irish Times, this comes after ‘the European Medicines Agency has begun a rolling review of evidence of the safety and efficacy of China’s Sinovac Covid-19 vaccine, after studies suggests it provides an immune response.


It means that evidence will be scrutinised in real time as it emerges from animal and human trials, a process designed to ensure that the vaccine can be approved as quick as possible if it proves to be effective. EMA will evaluate data as they become available to decide if the benefits outweigh the risks’, according to the EMA in a statement. 



According to Politico, the EMA, said in a statement, that ‘preliminary data from lab studies show that the jab produces an immune response’.


This vaccine that is awaiting approval is part of the other vaccines such as CureVac, Novavax and Russia’s Sputnik V vaccine – while the EMA has already approved the Pfizer, Moderna, AstraZeneca and Johnson & Johnson jabs. The rolling review continue until enough evidence is available for the vaccine manufacturers to make a formal application for conditional marketing authorisation.


The Sinovac vaccine contains inactivated Covid-19 virus that cannot cause the disease, along with an ‘adjuvant’, a substance that helps strengthen the body’s immune response. The vaccine is intended to work by provoking an immune response, as the body identifies the inactivated virus and creates antibodies to contain it.


The immune system is then ready to recognise Covid-19 and defend the body against it if it later encounters the virus. Different studies have shown efficacy rates of between 50 per cent and 90 per cent for the Sinovac vaccine, which is currently authorised for use in China, Brazil, Egypt, Indonesia and Turkey. According to the EMA, whilst it ‘didn’t provide a time frame for its final decision', but it said the process should ‘take less time than normal to evaluate because of work done during the rolling review'.


The EMA will assess the compliance of [the vaccine] with the usual EU standards for effectiveness, safety and quality’. According to Politico, ‘the World Health Organization is expected to make a decision about the vaccine at the end of the week’. As of Friday evening, it made a decision to approve the other Chinese vaccine, the Sinopharm vaccine. 


In summary, the prospect of the approval of the Sinovac vaccine is welcome news, alongside the awaiting approval of other vaccines such as Curevac, Novavax and Sputnik V. This means that the more, vaccines become available, the more, countries have in their armour to fight against Covid-19 and increasing Covid-19 cases in many countries. However, whilst the news that Sinovac will be assessed for approval by the EMA, can be welcomed by many people, we must not forget that the news that Sputnik V would be awaiting approval for use in Europe, came on the 4th of March 2021.


However, ever since, little to no progress has been made on approving Russia’s vaccine. Therefore, one must take the news of the Sinovac vaccine awaiting approval with a pinch of salt. It remains to be seen whether Sinovac gets approved, faster than other vaccines such as Sputnik V, but we shall hope that it does not take the length of time that Sputnik V and other vaccines such as Novavax are taking to be approved by the EMA.


Whilst they have relatively positive efficacy rates in countries such as Turkey and Indonesia, with reported efficacy rates of between 50 and 90 per cent, it may take a while for this vaccine to be approved by the EMA as they take time to assess whether this vaccine meets EU standards, etc. It also remains to be seen whether the WHO approve the Sinovac vaccine. 


In the meantime, countries which have excess vaccines in Europe and other richer parts of the world, should give these vaccines to poorer parts of the world in Africa and Asia, for example. Figures have shown that to date, the richer parts of the world are vaccinating in high numbers, whilst the poorer parts of the world, which do not have access to enough vaccines, are not able to vaccinate enough people.


We have viewed the scenes of India and the increased Covid-19 cases and deaths in the past couple of weeks with extreme sadness and we, as a continent, have a responsibility to help these underprivileged nations and people to get out of this pandemic.


We cannot get out of this pandemic without vaccinating all of the people of the poorer countries, alongside the people of the richer countries. Therefore, it is time for all Western countries, including Britain, as well as the European Union, to support the TRIPS waiver which is backed by countries such as South Africa and India and the US, in the last few days and lift intellectual property protections on Covid-19 vaccines. 

Add comment


There are no comments yet.