Major European nations remain divided over the use of Oxford/AstraZeneca’s COVID-19 vaccine, while the pharma company said there was no evidence of increased risk of blood clotting and abnormal bleeding among people who get the vaccine.    

AstraZeneca’s review of all the safety data of more than 17 million people vaccinated in the European Union (EU) and the United Kingdom (UK) has shown no increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia in any particular age group, gender, or country, the company said on Sunday. 

Across the EU and the UK, there have been 15 cases of DVT and 22 cases of pulmonary embolism reported among those given the AstraZeneca vaccine. Five deaths have also been reported – two dying from brain hemorrhages.

The reports have prompted more than a dozen countries to either partially or fully suspend the vaccine’s use while cases are being investigated. Some 17 countries, including Spain and Sweden have joined France, Germany, and Italy in suspending use of the vaccine. 

“The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety,”  AstraZeneca said in its statement on Sunday. Ann Taylor, Chief Medical Officer, added:

 “number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population,” but she said that the company will continue to closely monitor the vaccine rollout.   

UK’s Boris Johnson Issues Strong Defense – Australia, and Thailand Also Remain Confident in AstraZeneca 

Outside of Europe, however, the AstraZeneca vaccine rollout through the WHO co-sponsored COVAX initiative was continuing in most countries – although the Democratic Republic of Congo said they had postponed an immunization launch that had been planned for this week. 

And Australia, India and Thailand were moving ahead with the vaccine as well as the UK. 

UK Prime Minister Boris Johnson issued a series of strong statements in defense of the vaccine – whose R&D the UK also supported. “The vaccine is safe and works extremely well,” Johnson wrote in an article published on Tuesday in The Times.

“People should still go and get their COVID-19 vaccines when asked to do so,” said Dr Phil Bryan, UK Medicines and Healthcare products Regulatory Agency (MHRA) Vaccines Safety Lead, in a statement. 

Bryan added: “We are working closely with international counterparts in understanding the global safety experience of COVID-19 vaccines and on the rapid sharing of safety data and reports.” 

On Monday, Johnson told reporters that Britain’s MHRA is “one of the toughests and most experienced regulators in the world,” saying it’s approval signalled that the vaccine was safe. He went on to praise the UK’s vaccine rollout, one of the largest so far, which is helping to bring down COVID-19 rates. . 

More than 24 million people in the UK have received at least one dose of a coronavirus vaccine, with the UK government aiming to offer a first vaccine dose to about 32 million people in nine priority groups by 15 April.  

But Johnson reiterated, “Successful as the UK vaccination programme may be, there is little point in achieving some isolated national immunity. We need the whole world to be protected.” 

Australia will also not pause their AstraZeneca COVID-19 vaccine rollout with Chief Medical Officer Paul Kelly remaining “confident that [the vaccine] is safe.”  

“The Therapeutic Goods Administration is aware of the issue and also does not’ see any link between the AstraZeneca vaccine and blood clots,” Kelly said in a press conference on Tuesday.  

Kelly also stated that there have been no increased incidence of blood clots among Australians who have already received the AstraZeneca vaccine. 

Thailand’s prime minister, Prayuth Chan-ocha, who received a dose of the AstraZeneca vaccine on Tuesday, urged people to “believe doctors” as other countries suspended the vaccine’s use. 

“There are people who have concerns,” Chan-ocha said after receiving the vaccine. “But we must believe doctors, believe in our medical professionals.”

Most Asian countries have continued to administer the AstraZeneca vaccine, with India the largest user. 

Thailand has ordered enough doses from AstraZeneca and China to cover around half of its population. The country has so far vaccinated around 50,000 people in high-risk groups. 

Suspensions of Vaccine is ‘Political’, Says Italy 

As many national vaccination strategies remain reliant on the vaccine made by AstraZeneca, the decision to suspend its use may slow down rollout even more, as efforts are marred by political infighting, mixed messaging, and supply shortages. 

Despite delays of the vaccine in several countries, Spain remains confident that the Spanish government’s two-week suspension will not alter the country’s vaccination calendar, government spokeswoman Maria Jesus Montero said on Tuesday. 

Spain aims to vaccinate 70% of its 47 million population by the end of the summer. 

Italy’s medicines authority director-general called the decision to delay the vaccines largely “political”.

“We got to the point of a suspension because several European countries, including Germany and France, preferred to interrupt vaccinations… to put them on hold in order to carry out checks. The choice is a political one,” Nicola Magrini told the la Repubblica daily in an interview, Reuters reported. Prior to taking on his new role,  Magrini was a former top WHO official specializing in medicines approvals and access.   

Italy has recently blocked a shipment of AstraZeneca vaccines from leaving the country, arguing that it had failed to meet its contractual obligations to provide the vaccine to the European Union. 

EMA and WHO Urge Continued Use  – WHO Data Review to be Completed on Thursday 

The European Medicines Agency and the World Health Organization have been quick to defend the Oxford/AstraZeneca vaccine – and urge its continued use. 

“I’m not here to give you the outcome of any scientific review”, said EMA director Emer Cooke at the start of a press conference on AstraZeneca vaccine safety on Tuesday. 

“I’m here to explain the steps in the process, what we’re doing, and when you can expect us to come to a conclusion.”

Experts will meet on Thursday “to come to a conclusion on the full information that has been gathered and to advise us as to whether there are further actions that need to be taken,” said Cooke. “We will inform the public of the outcome immediately after this meeting.” 

The EMA currently concludes that while the investigation is still ongoing, “We are firmly convinced that the benefits of the AstraZeneca vaccine in preventing COVID-19 with its associated risk of hospitalization and death outweigh the risk of the side effects.” 

The WHO has also issued similar messages, with the WHO’s Global Advisory Committee on Vaccine Safety saying that at the moment, “benefits of the vaccine outweigh the risks”.  The  EMA is to issue reports about the safety of the vaccine on Thursday, after examining all data. 

WHO Director General Dr Tedros Adhanom Ghebreyesus said the events are not necessarily linked to vaccination, “but it’s routine practice to investigate them, and it shows that the surveillance system works and that effective controls are in place.”

–Updated 18 March, 2021

Image Credits: Flickr, gencat cat/Flickr, The Guardian, Sophie Scott/ABC.