The government has issued new advice after more evidence emerged regarding the Oxford/AstraZeneca coronavirus vaccine and its connection to blood clots, leading in some cases to fatal results.
According to the MHRA (Medicine and Healthcare Products Regulatory Agency), the benefits of the Oxford-AstraZeneca vaccine continue to outweigh the risks for the “vast majority of people”, and the risk of rare blood clots remains “extremely small” according to MHRA chief Dr June Raine. She said “the evidence is firming up” but the MHRA’s review has concluded that “while it’s a strong possibility, more work is needed to establish beyond all doubt that the vaccine has caused these side effects.”
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Nonetheless the JCVI (Joint Committee on Vaccination and Immunisation) has advised that under-30s with no underlying health conditions should be offered an alternative to the AstraZeneca vaccine where available. Those who have received their first dose of the AZ vaccination should continue to be offered a second dose of the same treatment. England’s deputy chief medical officer Professor Jonathan Van-Tam said the impact of the change on the timing of the UK’s vaccine programme “should be zero or negligible.”
Professor Van-Tam describes the change in advice for the under-30s as “a course correction, but nevertheless the UK vaccination programme is full speed ahead”. He says it remains vitally important that people called back for their second dose come back for it and all adults come for their vaccination when offered it.
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Some European countries and Canada have decided not to give the Oxford/AstraZeneca vaccine to under-55s, but in the UK this approach is regarded as being over-cautious.
Professor Jonathan Van-Tam said that the idea of withholding a vaccine from the 40-49 age group would be “pretty absurd” in a high-exposure scenario, given the potential benefits.
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Updated
Prime Minister Boris Johnson responded to the recommendation that under-30s in the UK should be offered an alternative to the Oxford-AstraZeneca vaccination. He said: “We will follow today’s updated advice, which should allow people of all ages to continue to have full confidence in vaccines, helping us save lives and cautiously return towards normality.”
The announcement followed a briefing by the European Medicines Agency in which Dr Sabine Straus, chair of the EMA’s Safety Committee, was asked if there was a “causal link” between the AstraZeneca vaccine and adverse results. “Sometimes our regulatory way of talking might be a little bit more complicated than it should be,” she said. “What we have learned from the very detailed review of the cases is that there is a strong association with the AZ vaccine and the adverse events… that is a sign that we feel that there is a probable causal association between the occurrence of the events and the administration of the vaccine.”
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The EMA has carried out a detailed review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis in the EU drug safety database as of 22nd March. Eighteen of these events have been fatal.
Sabine Straus stressed that though most of the blood clotting cases had occurred in people under 60 years and in women, “due to different ways the vaccine in being use in different countries” her committee “did not conclude that age and gender were clear risk factors for these very rare side effects”.
In Britain, tests of the Oxford/AstraZeneca vaccination on children and teenagers are being suspended while investigations into instances of blood clotting continue.
“Whilst there are no safety concerns in the paediatric clinical trial, we await additional information from the MHRA on its review of rare cases of thrombosis/thrombocytopaenia that have been reported in adults, before giving any further vaccinations in the trial,” the University said in a statement.
“Parents and children should continue to attend all scheduled visits and can contact the trial sites if they have any questions.”
Advice
Current advice remains that the risk of a blood clotting incident from taking the Oxford/AstraZeneca vaccine is far smaller than the risks involved in contracting COVID-19, so it should continue to be used.
A further 45 deaths in the UK have been recorded within 28 days of a positive COVID-19 test, taking the total by this measure to 126,927. A further 2,763 new coronavirus cases have been reported.
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Roll-out of vaccinations continues, with another 85,227 having had the first dose of a vaccine and 186,793 a second vaccination.
This brings the total of people in the UK who have had a first vaccination to 31,707,594, with 5,683,509 having had both doses.
The EMA’s Emer Cooke said that clots were seen in “all ages, and in men and women”, and there was no available evidence of “specific risk factors such as age, gender, or previous medical history of clotting disorders”.
“Our safety committee… has confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risks of side effects,” she said.
“Covid-19 is a very serious disease with high hospitalisation and death rates and every day Covid is still causing thousands of deaths across the EU.”
“This vaccine has proven to be highly effective – it prevents severe disease and hospitalisation, and it is saving lives.”
Incidence
Researchers are trying to establish whether there’s any significance in the fact that of the 79 blood clot cases recorded, 51 were women and 28 were men. The small numbers recorded may reflect who is getting the vaccine, because many healthcare workers for example are women. Looking at the incidence rate according to the number of vaccines administered, there is no difference between men and women.
The current theory is that an immune response occurring after an event such as the vaccine or a previous Covid infection may be causing the blood clotting incidents, and understanding this might help with modifying a vaccine in the future which could prevent the side effect. Several other COVID-19 vaccines use a similar method to the AstraZeneca vaccine, but it is not clear if this is what is causing the issue.
Other vaccines such as Pfizer are available, and from April 7th the Moderna vaccine, which is said to be 100 percent effective against severe cases, is also available. Less sensitive to transport conditions that other vaccines, the Moderna formulation is expected to be used in isolated communities. The Janssen vaccine will also be available shortly, offering the advantage of being effective in a single dose.
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