Blood clots ‘very rare side effect’ to Astra vaccine: EU drug regulator


Blood clots have been concluded by European medicine regulators to be a “very rare side effect” of the AstraZeneca covid-19 vaccine. However, they urge vaccination to continue.

AstraZeneca is the only WHO-approved vaccine available for Solomon Islands, with a current 24-000 dose roll-out being piloted. Ministry of Health has not responded to Island Sun’s enquiry for comments.

The European Medicine Agency (EMA), a medical arm of the EU, published in its website on Thursday last week that “unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca)”.

Having said this, EMA echoes the usual advice that vaccinations must continue since the “overall benefits of the vaccine in preventing covid-19 outweigh the risks of side effects”.

“EMA is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.”

EMA notes that “the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.

“[EMA] carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal. The cases came mainly from spontaneous reporting systems of the EEA and the UK, where around 25 million people had received the vaccine.

“COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.

“EMA’s scientific assessment underpins the safe and effective use of COVID-19 vaccines. Use of the vaccine during vaccination campaigns at national level will also take into account the pandemic situation and vaccine availability in the individual Member State.

“One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin (heparin induced thrombocytopenia, HIT).” Said EMA in its website on April 7.

While governments around the world are responding to this EMA finding by altering their AstraZeneca vaccination programmes, Solomon Islands government has chosen to continue with its above-18 years old AstraZeneca jab programme. [See separate article]

In the UK under-30s are being offered alternative jabs to AstraZeneca, Australia is applying alternative jabs for under-50s, similarly France and Belgium are offering alternative jabs for under-55s even those who have taken their first AstraZeneca shot, Italy and Spain have restricted AstraZeneca dosage to over-60s.

However, a spin to these varying policies as experts have cautioned is that “the confusing messages about the vaccine could still dampen enthusiasm for it at a time when Europe and many other parts of the world are facing surging cases”.

According to the Paris-based AFP news agency, AstraZeneca is administered in more countries than its other WHO-approved counterparts (Pfizer-BioNTech and Moderna); 111 countries. BBC reports that AstraZeneca makes for 90 percent of the vaccines dished out by COVAX, the WHO-led scheme designed to ensure poor countries, including Solomon Islands, access covid-19 vaccines in time.

AstraZeneca company has come out welcoming the EMA finding that the blood clot cases “have a possible link to the vaccine … as an extremely rare potential side effect”.

The company adds that it is working on improving its product:

“Overall, both of these reviews reaffirmed the vaccine offers a high-level of protection against all severities of COVID-19 and that these benefits continue to far outweigh the risks.

“AstraZeneca has been actively collaborating with the regulators to implement these changes to the product information and is already working to understand the individual cases, epidemiology and possible mechanisms that could explain these extremely rare events.

“In addition, the World Health Organisation (WHO) today [April 7] said that, based on current information, a causal relationship is considered plausible but is not confirmed, adding that further specialised studies are needed to fully understand the potential relationship between vaccination and possible risk factors.” [AstraZeneca website, April 7]

Meanwhile, WHO is not budging from its support of the vaccine, reiterating the need for vaccination to continue in spite.

Responding to the EMA finding on April 7, WHO in its website announced:

“Based on current information, a causal relationship between the vaccine and the occurrence of blood clots with low platelets is considered plausible but is not confirmed. Specialised studies are needed to fully understand the potential relationship between vaccination and possible risk factors.

“The GACVS subcommittee will continue to gather and review further data, as it has done since the beginning of the COVID vaccine programme.

“It is important to note that whilst concerning, the events under assessment are very rare, with low numbers reported among the almost 200 million individuals who have received the AstraZeneca COVID-19 vaccine around the world.

“Rare adverse events following immunizations should be assessed against the risk of deaths from COVID-19 disease and the potential of the vaccines to prevent infections and reduce deaths due to diseases. In this context, it should be noted that as of today, at least 2.86 million people have died of COVID-19 disease worldwide.”

For Solomon Islands, the EMA finding may not mean much, now, since AstraZeneca is the only WHO-approved vaccine available. The recently arrived Sinopharm, government says, will not be used but stored until such a time it is given the greenlight by WHO.

However, the EMA finding may not be helpful to a government facing a skeptical population (including its frontliners) with an AstraZeneca vaccination drive plan. High low-turnout to the country’s vaccination programme indicates the populace’s hesitancy towards the vaccine. Today, three weeks from launch and the programme is still to reach halfway in its 7,000-dosage planned for Honiara (first phase of rollout).

Leaders can only bank on public seeing the benefits of taking the jab in relation to the risks of not taking it. More so, understand the very low chances of getting one of the rare side effects.

As one UK covid-19 expert said to the BBC, quoted in an April-9 article, hammering home on the rarity of the blood clot: “I mean it’s the equivalent of the risk of dying in the bath, drowning in the bath, for example, it’s that rare, or a plane landing on your house.”

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