WHY ISN’T IRELAND, or the EU, using the Chinese vaccines yet? Will they ever be used here? It’s possible but unlikely anytime soon.

While China has developed and approved a number of Covid-19 vaccines, none are yet licensed in Europe.

A number of African, Latin American and Asian countries have chosen to approve and use the Vero Cell vaccine by the Beijing-based pharmaceutical company Sinovac and the Sinopharm vaccine, produced by Beijing Bio-Institute of Biological Products Co Ltd, subsidiary of China National Biotec Group (CNBG)

About half of China’s population have also received at least one dose of a home-grown Covid-19 vaccine.

There has been some criticism about the initial lack of published clinical trial data and then inconsistent real world results for the Chinese Covid-19 vaccines to date, compared to the vaccines already licensed in Europe.

However, on 4 May, the European Union medicines regulator, the European Medicines Agency (EMA), announced that it had started a rolling review of the Sinovac Vero Cell vaccine to assess its effectiveness and safety.

This review is the first step towards the Covid-19 vaccine’s possible approval for use in the EU, with a decision on such expected soon.

No application has yet been submitted by the company for marketing authorisation for the vaccine to supply it in Europe, though.

Meanwhile, on 7 May, the World Health Organization (WHO) listed a Sinopharm Covid-19 vaccine for emergency use, for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks, giving the green light for this vaccine to be rolled out globally.

Vaccine efficacy for symptomatic and hospitalised disease was estimated to be 79%, all age groups combined, according to the WHO.

Few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. 

WHO’s Emergency Use Listing (EUL) is a prerequisite for COVAX Facility vaccine supply, which is helping supply Covid-19 to lower- and middle-income countries and international procurement.

It also allows countries to expedite their own regulatory approval to import and administer Covid-19 vaccines. 

WHO has already listed the Pfizer/BioNTech, AstraZeneca-SK Bio, Serum Institute of India, Astra Zeneca EU, Janssen, and Moderna Covid-19 vaccines for emergency use.

On 1 June, the WHO also validated the Sinovac (CoronaVac) Covid-19 vaccine for emergency use. The WHO said vaccine efficacy results showed that the vaccine prevented symptomatic disease in 51% of those vaccinated and prevented severe Covid-19 and hospitalisation in 100% of the studied population.

Again, few older adults (over 60 years) were enrolled in clinical trials, so efficacy could not be estimated in this age group. 

Nevertheless, the WHO is not recommending an upper age limit for the vaccine because data collected during subsequent use in multiple countries and supportive immunogenicity data suggest the vaccine is likely to have a protective effect in older persons. 

Both of these Covid-19 vaccines are inactivated vaccines and can be stored in standard refrigerators at 2-8 degrees Celsius, thus their easy storage requirements make them very manageable and particularly suitable for low-resource settings, noted the WHO.

Speaking to The Journal, one Irish doctor with strong connections to China, said he didn’t see why the EU or Ireland wouldn’t licence the aforementioned two Chinese vaccines, pointing out that they have been good enough for WHO approval despite the naysayers. He suggested geopolitical reasons might be at play.

He said that, at the very least, any Chinese vaccines approved for use in China itself should be recognised in the EU through the EU Digital Passport certificate, granting people vaccinated with them the same recognition as vaccines licensed in the EU.

Separately a HSE public health medicine expert, speaking to The Journal on the condition of anonymity, said that there may be no need for the Chinese vaccines in Ireland, particularly if they lead to greater vaccine hesitancy in the population. 

They said that given Covid-19 vaccine supply has dramatically improved in Europe, maintaining optimum levels of vaccine uptake and avoiding vaccine hesitancy would be best served by sticking with the vaccines already licensed to date.

They said as supply increases the preferred vaccines should be the ones with the lowest reported side-effects, highest efficacy and best supply guarantees, like the Pfizer vaccine, as opposed to new vaccines from China or Russia where there might be some public scepticism.

That scepticism about the rising superpower, common internationally, could mirror similar thoughts worldwide about China’s initial handling of the virus, and criticism over a perceived lack of transparency about Covid’s origins, case numbers and impact on the country. 

However, Ireland has had positive experiences with the country since February 2020 in relation to the novel coronavirus. 

When news about the first reported cases of Covid-19 in China emerged at the start of 2020, it didn’t seem like something that was ever really going to affect us here in Ireland.

Like previous serious coronaviruses -SARS and MERS – many assumed this new virus would either be contained or die off before it could reach our shores and even if it did, it would not cause too much bother.

Clearly what happened couldn’t be further from that scenario as the resulting Covid-19 pandemic has caused widespread global human and economic devastation in the last 18 months, with over 264,000 confirmed cases and approximately 4,950 deaths in Ireland alone.

From the early days of the pandemic there was “close co-operation” between the Irish and Chinese governments on Covid-19, according to China’s ambassador to Ireland, He Xiangdong.

The first reported cases of coronavirus occurred in China’s Wuhan region in late December 2019 before spreading to Japan, South Korea and Thailand, and then into Europe with the first known case in Ireland confirmed on 29 February.

In an interview with the Irish Times in March 2020, reposted by the Chinese Embassy in Ireland, Xiangdong said that in early February he initiated a meeting between himself, the HSE, the Department of Health and the Irish Department of Foreign Affairs to exchange information. He also had calls with then Minister for Health Simon Harris and Minister of Foreign Affairs Simon Coveney.

Medical knowledge share

The medical community in Ireland was also on high alert in the early days of the pandemic, as they scrambled to prepare for the unknown, which included reaching out to contacts in China for help – primarily in relation to clinical advice and the sourcing of medical equipment and for personal protective equipment (PPE).

On 13 March, facilitated by the Second Affiliated Hospital, Zhejiang University School of Medicine (SAHZU), over 60 medical experts from China and Ireland participated in a special video conference to share information and guidance on the prevention and treatment of COVID-19.

The video conference was a response to a ‘letter for help’ from the Irish medical community, spearheaded by Dr Oisín O’Connell, respiratory medicine consultant in the Bon Secours Hospital Cork, asking how the Zhejiang Province organised manpower and resources within a short time period for the training, prevention, control and treatment of Covid-19.

Dr O’Connell, who also had extensive immunology and ICU experience was very aware of the potential devastating implications of Covid-19 for Ireland with its bottom-of-Europe ICU bed capacity, given the shocking early reports of absolutely overwhelmed health services from China and then Italy.

Before reaching out to China, he sought advice from Cork-based Dr Paul O’Brien, a qualified doctor who had worked in China for a number of years in both the medical and business arenas. His expertise on how things worked in China, its regulatory and hierarchical systems, and his business contacts through his work for a Chinese employer proved invaluable in the early months of the Irish medical response to the pandemic.

Dr O’Brien advised on the drafting of a formal appeal for assistance type letter with high ranking input from various medical bodies and politicians in Ireland, which both he and Dr O’Connell told The Journal was taken quite seriously by China – there was widespread coverage on local media – with the Covid-19 expert medical China-Ireland online conference quickly put together.

During the conference, SAHZU President Dr Wang Jianan and colleagues shared their experiences in prevention of community transmission and imported cases of Covid-19, home quarantine policies, control and interruption of transmission routes, early detection and intervention, medical resources management, ‘big data’ assistance, etc, and answered questions on the scheduling of protective equipment, ICU support programmes, and coping solutions for surges of patient numbers.

This was at a time when very little was known in Ireland about this new virus and how transmissible it could be, and a distinct lack of experience in dealing with serious coronaviruses in general.

Dr Wang Weilin, executive vice president of SAHZU and leader of its medical team to Wuhan, commented: “As a hospital, when we have difficulties, many foreign friends have helped us. And now they have difficulties, we should help them. Medical exchanges know no borders.”

“The conference was incredibly helpful,” Dr O’Connell told The Journal.

“They gave about a two-hour presentation on the different aspects [of Covid-19]…. and slides were sent on from the three main experts who spoke in English and an 180-page translated handbook on everything they knew on managing Covid-19, and I mean on everything, including how to manage it in a lung transplant patient.

“They actually graded the level of PPE for what service/procedure you were doing; it was that level of granularity, which was incredibly helpful and did improve clinical outcomes.”

This information was shared widely in the Irish medical community, with Dr O’Connell and others who attended the online conference giving summaries of what had been learned through medical webinars in the following weeks.

Additionally, a China-Europe video conference on combating Covid-19 was held on 19 March, jointly hosted by the Department of European Affairs of the Ministry of Foreign Affairs and the International division of National Health Commission of the People’s Republic of China.

The conference was attended by government officials and health experts from 18 European countries, including Dr Cillian De Gascun, director of the National Virus Reference Laboratory (NVRL).

“China were exceptionally helpful,” reiterated Dr O’Connell. “They shared information on how to structure hospitals, on how to improve ventilation in our hospitals, on early mask use, which took much longer to be adopted in Europe, on the use of steroids and immunosuppression in Covid-19…

“This was well ahead of the big study four months later from the UK saying that steroids were beneficial in Covid-19, so it was quite controversial at the time [March] in Europe about whether steroids would help, as they didn’t in previous coronaviruses but China and Italy both suggested to us that they would.

“Ireland had incredibly good survival data, higher that the European average in terms of those [with Covid-19] who made it through ICU – we had about 80% survival which was significantly higher than the EU average,” Dr O’Connell noted.

“I honestly think people under appreciated the level of knowledge that they had achieved at that stage and their ability to share it,” he commented, adding that the Chinese approach of swift strict lockdowns and closing its borders was very effective at stopping transmission of Covid-19.

Ireland and many other Western countries dithered and baulked at such an approach and missed the opportunity to stop the rapid and devastating spread of the virus in their regions, he believes.

“I mean China are phenomenally technologically advanced. Their track-and-trace ability was phenomenal. Their whole infrastructure societally for dealing with a pandemic was incredibly well-structured… their ability to track people’s movements and study their interactions through mobile phone data is phenomenally effective in supressing community transmission.

“There is a fine margin between elimination and exponential growth. The countries, including China, that recognised that are the ones that did exceptionally well,” Dr O’Connell continued, though he acknowledged that the level of Government data control and stringent lockdown measures employed by China would be considered unacceptable in Europe.

Covid-19 testing and PPE help

Another key issue faced by Ireland- and the world – in the early days of the pandemic was the rapid scaling up of PCR testing for Covid-19.

Laboratories were quickly overwhelmed in Ireland by April 2020 and testing had to be limited to those with the most obvious symptoms and patients faced long delays for results as cases increased, while some of the vital re-agent supplies needed for the PCR testing process were also in short supply globally.

In late March and early April 2020, Dr Paddy Mallon, consultant in infectious diseases at St Vincent’s Hospital in Dublin, worked with Dr O’Brien, the HSE, the NVRL, and others to source new testing platforms from a trusted supplier in China which would significantly upscale Ireland’s testing capacity.

In about 10 days, 19 new PCR testing machines along with large supplies of reagent arrived in Ireland from China, Dr O’Brien told The Journal, which were distributed nationally and allowed for the roll-out of a rapid 24-hour testing large-scale service for the virus.

Global demand for PPE soared in early 2020 as the pandemic took hold.

Like many countries, Ireland very quickly faced major shortages of PPE as it became clear how transmissible Covid-19 was, and we entered into a global battle to secure increased supplies of PPE against a volatile backdrop of steep price hikes, ‘gazumping’ of agreed orders, and issues over supply reliability and quality control; a situation described by HSE CEO Paul Reid as “modern day piracy”.

China was Ireland’s, and much of the world’s, biggest supplier of PPE. Dr O’Brien used his contacts early on in 2020, against the rise of counterfeit and shady operators, to get access to reliable PPE supply chains for some companies and healthcare providers in Ireland.

During a fraught time last March when the Irish healthcare community was desperately short of surgical masks, gowns and face shields – and the HSE scrambled to secure large reliable orders of PPE for its workforce, as well as for private nursing homes, GP surgeries and private hospitals – a number of Irish private companies worked together to raise funds to privately buy tonnes of PPE equipment from China. This included a donation of €10 million from U2, with contracted charter flights bringing in millions of items of PPE and medical equipment to the country in April and May.

Web Summit entrepreneur Paddy Cosgrave also mobilised his influence to facilitate medical equipment and PPE deliveries to Ireland from Chinese companies and benefactors.

There was a number of donations of PPE and medical equipment to Ireland from Chinese individuals and businesses, including a shipment of 300,000 masks, 30,000 testing kits, and 3,000 protective PPE gowns in late March from Chinese entrepreneur Jack Ma of the Alibaba Group. Tech company Huawei made a similarly sized donation, while 40 ventilators and a large consignment of PPE were sent from a group of six Chinese business people in Ireland, according to tweets from the Chinese Embassy in Ireland.

Prior to the emergence of Covid-19, the HSE spent approximately €12 to 15 million on PPE annually but Reid said in May 2020 that the HSE was preparing to spend up to €1 billion in 2020, with €210 million allocated in April in a large-scale deal with international suppliers, mostly in China, for PPE to be flown over through specially chartered Aer Lingus flights.

At a HSE Covid-19 briefing in April, Reid praised the Chinese ambassador to China, He Xiangdong, for his interventions in helping Ireland secure PPE and said without his help “we wouldn’t have secured what we have secured”.

By the end of June 2020, Aer Lingus’s fleet of Airbus 330s flew 259 round trips between Dublin and Beijing, and transported 4,000 tonnes or over 86 million pieces of PPE. It was the largest air cargo operation in the history of Ireland.

However, while much of what arrived from China was useful and very welcome, there were quality issues with some supplies.

For example, one fifth of the first batch of the HSE’s specially chartered Covid-19 PPE – costing roughly €4 million – delivered from China in April 2020 didn’t meet the specified requirements, while a further 15% was only acceptable “if the preferred product isn’t available”.

Issues included masks not being the required medical grade needed, PPE being the wrong size to fit Irish healthcare staff, and some medical equipment, including ventilators, not meeting European quality and safety standards or simply not being compatible with our systems.

As time went on, most of the quality control issues were ironed out, though the HSE acknowledged that securing more local PPE supply within Ireland and the EU was going to be a key priority going forward.

The Journal put a series of questions to the HSE about how much PPE, ventilators and other medical equipment it bought from China last year, the costs of such, value for money, quality issues and what channels were used.

However, it did not provide any of the information requested, saying: “Unfortunately due to the recent cyber attack we are unable to access the information you have requested regarding procurement of PPE at this time.”

A different strategy

All those spoken to for this article agreed that China had been very helpful in many ways in relation to Ireland’s battle against Covid-19, but both countries have taken very different approaches to dealing with this virus.

China succeeded in early elimination of local transmission of Covid-19, with low reported case numbers and death, and a now rapidly increasing high level of population vaccination after a sluggish start.

Despite these successes, the country is yet to signal any intention of shifting away from its ‘zero Covid’ style strategy of closed borders, strict quarantine for pre-approved international arrivals, and aggressive lockdowns and mass testing when flare ups return.

On the other hand, Ireland is racing to vaccinate all adults by the end of the summer, against a phased rolling back of physical mixing restrictions and reopening of recreational and hospitality services and ‘non-essential’ foreign travel in line with our EU counterparts.

While our Covid-19 vaccination programme is already showing very encouraging results, the ongoing emergence of more transmissible variants of concern internationally and case spikes in unvaccinated populations is casting a cloud over our much longed for emergence from this pandemic, with some division in the medical community over whether we are being cautious enough.

Priscilla Lynch is the Clinical Editor of the Medical Independent, Editor of Update medical journal and Nursing in General Practice Journal, and is a regular contributor on national radio and print media on medical and health-related news. 

 This work is co-funded by Journal Media and a grant programme from the European Parliament. Any opinions or conclusions expressed in this work is the author’s own. The European Parliament has no involvement in nor responsibility for the editorial content published by the project. For more information, see here.