Covid-19: More European countries hit pause on AstraZeneca vaccine rollouts after reports of blood clotting, Medsafe still assessing for NZ

Medsafe is still assessing the AstraZeneca vaccine, which has had its roll-out temporarily suspended in multiple countries around the world following reports of clotting in a small number of patients.
Data for the vaccine is being evaluated, with more yet to be provided.

No vaccine will be made available for public use in New Zealand until Medsafe complete their assessment, and it has been approved or provisionally approved, Medsafe New Zealand group manager Chris James said.

There are no guarantees that all the vaccines will successfully complete clinical trials or be approved for use.

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The Oxford/AstraZeneca vaccine is just one of four vaccines New Zealand secured in pre-purchase agreements. The Pfizer/BioNTech vaccine is the only one that has been approved and rolled out so far.

Germany and Spain recently suspended the roll-out of the AstraZeneca vaccine as a precautionary measure. Ireland, Norway, Denmark, Iceland and The Netherlands, have also hit pause on the distributionof the vaccine.

Italy, Austria, Estonia, Latvia, Luxembourg and Lithuania have stopped inoculations from a particular batch of it.

Germany decided to suspend its use of the vaccine following advice from its vaccine regulator. Health Minister Jens Spahn said the decision was a purely precautionary measure while investigations are underway.

Spain made the decision to suspend use of the vaccine after its first case of blood clots was detected at the weekend. Almost 940,000 people in Spain have received a dose of the vaccine. AP reported Spanish Medicines Agency head Maria Jesus Lamas said this was the most prudent approach

The World Health Organisations (WHO) Director General Tedros Adhanom Ghebreyesus said most reports of blood clots emerged after people received two batches of the vaccine produced in Europe.

This does not necessarily mean these events are linked to vaccination, but its routine practice to investigate them, and it shows that the surveillance system works and that effective controls are in place.

The WHOs advisory committee on vaccine safety is reviewing the available data and in close contact with the European Medicines Agency.

Experts around the globe have said these countries have taken a very cautious approach, while the vaccine manufacturer has said a review shows no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia.

Paul Kane/Getty Images
A vial of AstraZeneca Covid-19 vaccine pictured in Perth, Australia.

The company's chief medical officer Ann Taylor said in a statement that of the 17 million people vaccinated, the number of cases of blood clots reported was lower than the hundreds of cases that would be expected among the general population.

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.

New Zealand has secured a further 8.5 million additional vaccines of the Pfizer/BioNTech vaccine which is currently being rolled out here. The Government also has prepurchase agreements for three other vaccines: AstraZeneca, Janssen and Novavax.

Clinical microbiologist professor David Murdoch, who is dean of the University of Otagos Christchurch campus, said some countries overseas were taking a very cautionary approach while awaiting further information particularly from the European Medicines Agency (EMA) which was investigating.

This sort of pause is not unusual with the introduction of new vaccines, and is a sign that the adverse reaction monitoring system is working, he said.

Luke Dray/Getty Images
A nurse draws a vaccine dose in Kampala, Uganda.

Murdoch, who is also a anggota of the Covid-19 vaccine strategy taskforce and a anggota of the vaccine strategy scientific and technical advisory group, said a key task overseas would be to investigate whether the clotting events might be related to the vaccine or whether they have occurred by chance.

Very large numbers of people are being vaccinated for Covid-19 at the moment, many of whom have pre-existing health conditions. In this situation, we expect a number of illnesses are going to happen following vaccination by chance alone, he said.

At present, there is no evidence that clot-related illnesses are happening more frequently than usual among populations receiving Covid-19 vaccines. This is reassuring. However, safety is of critical importance, and it is essential that we continue to rigorously monitor the safety of vaccines.

AstraZeneca is the main vaccine currently being rolled out across Australia, and the country has no plans to halt it there.

Rick Rycroft/AP
Australia's Prime Minister Scott Morrison pictured speaking to the media in Sydney.

Last week, Prime Minister Scott Morrison reassured Australians that the vaccine was safe, and told media that all vaccine batches were tested in Australia with a robust process in place.

Home Affairs Minister Peter Dutton also insisted the vaccine was safe for use in Australia, 9 News reported.

Vaccination programmes are continuing in France and the UK, with British officials encouraging people to be inoculated, The Guardian reported.

Professor Stephen Evans, from the London School of Hygiene and Tropical Medicine, said coagulation disorders were very common in patients diagnosed with Covid-19.

Unless we are sure that those who suffered these unfortunate events very definitely did not have Covid-19 then it would seem to be premature to suggest it was the vaccine that caused these events.

Alessandra Tarantino/AP
A health worker shows the media how she prepares a dose of the AstraZeneca vaccine to be administered to a patient at a vaccination centre set up in front of Rome's Termini central station.

Covid definitely causes coagulation disorders and each of the vaccines prevents Covid disease, including more severe cases. Therefore, it is extremely likely that the benefit of the vaccine notably outweighs any risk for coagulation disorders and the vaccine prevents other consequences of Covid including deaths from other causes, he said.

It is entirely reasonable that detailed studies are done on the vaccines in regard to coagulation disorders, but it seems a step too far in taking precautions that would stop people getting vaccines that would prevent disease.


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