CAUTION’S RIGHT. BUT THESE JABS SAVE LIVES

Our drug regulators have made the right call. The Oxford-AstraZeneca vaccine represents a tremendous scientific achievement. It has saved thousands of lives and continues to protect millions of people in this country and beyond.

But I agree that it should not be given to the under-30s while there are doubts about its safety in younger adults, especially women.

More time is needed to evaluate the evidence being gathered, interpret it and then scrutinise the conclusions. What we know so far is that, out of 20 million people vaccinated with the Oxford-AZ jab in the uK, 79 (the majority female) have suffered a rare type of blood clot, known as cerebral venous sinus thrombosis (CVST), following administration of a first dose.

Tragically, 19 have died – that is almost three times greater than the number of fatalities being reported before yesterday’s Press conference – and three were under-30.

We also know that similar effects have not been seen with either of the other leading vaccines, Pfizer-BioNTech and Moderna.

So it makes sense that young people should be given alternative vaccines until we have determined the cause of the clots – be it a random event, a causal link to the vaccine or some other factor related to the health of the patients themselves.

While some countries in Europe have discontinued Oxford-AZ use in all but the oldest age groups (for example, in France under-55s and in Germany under-60s), with others (like Denmark, Holland and Norway) banning it entirely, I think the Medicines and Healthcare products regulatory Agency (MHrA) reached the right conclusion in difficult circumstances.

I am also encouraged by the response of the European Medicines Agency. Following a review of 62 cases in Europe (involving CVST plus 24 cases of blood clots in abdominal veins), 18 of which were fatal, it concluded that it had found a ‘possible link’ between the OxfordAstraZeneca jab and ‘very rare cases’ of blood clots, but the benefits of the vaccine continued to outweigh the risks of side effects.

SO where do we go from here? To the Government, I would say – do not be draconian when it comes to who gets which vaccine. The cut-off point of 30 should not be a hard and fast line. Allow GPs and healthcare workers to exercise their discretion when listening to patients’ concerns about the Oxford-AstraZeneca vaccine and be able to offer alternatives to the over-30s when appropriate and subject to availability.

If I had a daughter or granddaughter in her 30s, my advice to her would be – talk to your GP if you are worried. Ask why you should not be offered an alternative.

At the same time, of course, it is essential that we do not fuel vaccine hesitancy in the population or give vaccine sceptics and the vociferous anti-vaxxer movement any opportunity to twist the facts. Transparency is crucial and both the manufacturer and the regulatory authorities have so far played by the rules.

Of the 79 people who developed clots in the uK post-jab, 51 were female. Similar preliminary research from Germany also showed a marked majority of women.

Norwegian researchers, who raised the alarm about clots last month, have presented findings that suggest they could be caused by an autoimmune response to the jab. We know that some auto-immune diseases, including thyroid disorders and lupus (a chronic hyperactivity of the immune system), are considerably more common among women. So might a rare auto-immune response – to which women are more susceptible biologically – trigger CVST following the Oxford-AstraZeneca jab?

We must also take into account the fact that CVST – rare as it is – is a recognised complication of the contraceptive pill. We have not been told exactly how many of the 19 fatalities were female or whether any of them were on the Pill, but this could be a very significant factor. It might be – and this is just a theory – that the vaccine reacts or synergises with the hormones and chemicals in the Pill, triggering the clots. As a former Government adviser, I know just how rigorous the MHrA is. Its members will stick with data and the science and resist all pressure to be swayed by political considerations. There is urgent impetus at the moment for the swiftest possible action to stem the pandemic, to come out of lockdown and kick-start the economy, but that does not mean we should ignore new evidence as it emerges.

DESPITE exhaustive clinical trials necessary for the approval of a new drug or vaccine, it is only when they start to be used in large populations that complications/side-effects, many of them very rare, start to emerge.

That is the point of follow-up, gathering and analysing pharmaceutical data so that problems are identified and patients safeguarded.

It’s important to emphasise again that the incidence of blood clots following the Oxford-AstraZeneca vaccine is extremely rare – and CVST is potentially very treatable, if caught early. Certainly, anyone (of any age) who suffers bad headaches or numbness for a prolonged period, perhaps 48 hours, following vaccination should contact their surgery or A & E.

Overall, my advice to individuals has not changed – vaccines are a lifesaver. We have to proceed with caution, but we can’t turn our backs on one of the best defences we have against Covid.