Reasons for myelitis to halt COVID-19 vaccine testing?

Volunteer transverse myelitis caused testing of one of the most promising COVID-19 vaccines to be suspended? Such information was found by the newspaper “The New York Times”, although AstraZeneca did not confirm it. What is this disease? And what is the future of the British vaccine that the world had high hopes for?

1. On September 9, the world learned that the company decided to suspend testing of the vaccine against COVID-19. The reason is a symptom observed in one of the volunteers
2. According to the NYT daily, citing an anonymous informant, it is transverse myelitis. AstraZeneca did not confirm this diagnosis
3. Transverse myelitis is a neurological disease caused by inflammation. The disease may appear, among others after viral or bacterial infection or in the course of autoimmune diseases
4. It is not yet known whether the complication reported by the New York Times is related to the use of the SARS-CoV-2 coronavirus vaccine.
5. Dr. Dzieiątkowski: until a cause-and-effect relationship is found or ruled out, the tests cannot be continued

Testing of one of the most promising vaccines suspended

Back in June, the World Health Organization recognized the vaccine developed by the pharmaceutical company AstraZeneca and the University of Oxford as the world’s leading project and the most advanced in terms of development. The results of the study were indeed promising, and the tests showed that the vaccine (AZD1222) was safe to use and appeared to elicit an immune response.

In early September we wrote about the commencement of the third phase of research on the British vaccine. Tens of thousands of volunteers in the USA, Great Britain, Brazil and South Africa were involved.

1. COVID-19 vaccine ready soon? Production started and thousands of people received doses

Despite the fact that tests on the effectiveness of AZD1222 were carried out, mass production of the preparation began. Everything so that it is ready to be released as soon as possible. (Of course, it was realized that without completing the rigorous testing, there was no certainty that it would be used).

Meanwhile, on September 9, the world learned that the company decided to suspend testing. The reason is a serious symptom in one of the volunteers. It is known that it comes from Great Britain. However, AstraZeneca did not reveal what the ailment was or when it was observed.

Transverse myelitis causes tests to be stopped? What is this disease?

The New York Times has a certain theory about the observed symptom. The American newspaper reached a person “familiar with the situation” who made his statement on condition of anonymity. According to this informant, a volunteer who participated in the COVID-19 vaccine trial was diagnosed with transverse myelitis. AstraZeneca did not confirm this diagnosis.

1. Which country will win the race for the COVID-19 vaccine? Here’s what we know today

Transverse myelitis is a neurological disease caused by inflammation. It destroys the myelin, the sheath of nerve fibers, which disrupts communication between the nerve cells in the spine and the rest of the body.

The disease may appear after a viral or bacterial infection, in the course of autoimmune diseases (e.g. systemic lupus erythematosus), or it may not have a clear cause.

The symptoms of transverse myelitis depend on the level of damage to the spinal cord, including the section that is affected. They most often affect both sides of the body, although this is not always the case.

Common symptoms of transverse myelitis include:

1. Pain, e.g. in the lower back, in the chest or abdomen. This symptom varies according to the affected section of the spinal cord.
2. Some patients may experience numbness, tingling, coldness or burning sensations. Some people may be especially sensitive to touch, heat, or cold (known as hyperaesthesia).
3. Some patients complain of a feeling of heaviness in the legs, stumble or pull on one foot. Some may experience weakness, loss of sensation, even partial or complete paralysis of the legs and lower torso. This can be accompanied by a general feeling of being unwell, headaches, fever, and a decrease in appetite.
4. Bladder and bowel problems. This may include the need to urinate more often, urinary incontinence, difficulty urinating and constipation.

Treatment of transverse myelitis includes pharmacotherapy, rehabilitation therapy, and psychotherapy. “Most people with transverse myelitis recover at least partially,” says mayoclinic.org. Although there is also a risk of long-term or permanent motor disability.

Let us emphasize at this point that it is not yet certain whether the complication described in The New York Times is related to the use of the vaccine protecting against the SARS-CoV-2 coronavirus. The disease may have occurred in the test person by chance during this period and not related to clinical trials.

What does it mean to halt vaccine testing?

Announcing the halt to the tests, a spokesman for AstraZeneca described the move as routine, stating that “the standard review process has prompted a break in vaccination to investigate the safeguards”.

And actually. As virologist Dr. Tomasz Dziecistkowski said in an interview for MedTvoiLokony, “if unexpected symptoms appeared in one tested person, it is necessary to find out whether they were really related to the vaccine – because this is not necessarily the case. Until a causal relationship has been found or ruled out, the tests cannot continue ».

At the moment, it is not known whether the research will resume or whether the work on the vaccine will be completed. «If it turns out that this was the case, clinical trials will continue. However, if they do find a link between an adverse symptom and the vaccine, they will need to follow up on the rest of the test participants. In a situation where the link with the vaccine is proven in this one person – this case will be described and the research will be continued »- the expert explains.

What if it also shows up in other volunteers? – If in the group of 5 thousand one or more people develop these problems, it is necessary to consider whether the benefits of using the vaccine are greater / less than the risk of the observed side effects. If this symptom appears too often, the vaccine will be withdrawn from clinical trials and will never be available on the market, explains Dr. Dzieścitkowski.

“Vaccine clinical trials are often interrupted,” said Wellcome Trust director Jeremi Farrar, an infectious disease specialist, in a statement to BBC News. – The most important thing is that the detected complication has not been underestimated, and the whole matter will be examined by an independent body (after PAP).

You may be interested in:

1. If US citizens remove their masks, the number of coronavirus victims could increase by 4 in 410 months
2. Six ways to protect yourself from coronavirus infection that are not worthwhile. Scientists debunk myths
3. COVID-19 has a “long tail”. What are the long-term effects of coronavirus infection?

The content of the medTvoiLokony website is intended to improve, not replace, the contact between the Website User and their doctor. The website is intended for informational and educational purposes only. Before following the specialist knowledge, in particular medical advice, contained on our Website, you must consult a doctor. The Administrator does not bear any consequences resulting from the use of information contained on the Website. Do you need a medical consultation or an e-prescription? Go to halodoctor.pl, where you will get online help – quickly, safely and without leaving your home.