Exclusive: Indian Covid-19 vaccine trials did not monitor menstrual changes

However, the developers of the Indian vaccines — Covishield and Covaxin — apparently did not consider this aspect as part of their trial.

Both the vaccines reportedly also did not consider this as a part of post-vaccine side effects data.

Shockingly, the one who confirmed this to South First is Dr Jayaprakash P Muliyil, a member of the working group of the National Technical Advisory Group on Immunisation (NTAGI), who was the chairperson of the Data and Safety Monitoring Board (DSMB) of Serum Institue of India (SII) trial.

The DSMB’s role was to review cumulative study data to evaluate the safety, and study the conduct and scientific validity and integrity of the trial.

Muliyil told South First, “I have studied the trial data of both vaccines — Covishield and Covaxin — and the aspect of its effect on menstrual cycles was not studied during or even after licensing.”

What did the studies abroad find?

At least two studies done in other countries identified significantly heavier-than-normal menstrual bleeding among women after their Covid-19 vaccines.

One study was conducted by the Norwegian Institute of Public Health, while another one was in the United States. A follow-up study in Canada and Europe reached a similar conclusion.

Dr Gagandeep Kang, Professor of Microbiology at the Christian Medical College in Vellore. (Twitter/GKangInd)

“After several reports claimed that women aged 18-30 years with regular menstrual cycles bled more heavily than usual after vaccination, the researchers went back and collected some data on this and studied the pattern and did find the association,” explained Dr Gagandeep Kang, virologist and also a professor in the Department of Gastrointestinal Sciences at the Christian Medical College in Vellore in Tamil Nadu.

However, the menstrual cycles in most of these women who reported heavy bleeding returned to normal after a few months, she added.

In an editorial published recently in the Journal Science, Dr Victoria Male, a senior lecturer in reproductive immunology at the Imperial College in London called on vaccine-makers in future trials to ask people about period changes and also take the respondents seriously when they report any such side effect.

Also Read: Manufacturer rushed development of Covaxin under political pressure?

Indian women underwent menstrual changes

While Muliyil claimed ignorance of the reports from Indian women complaining about any menstrual changes, he told South First that this was not measured for two possible reasons.

“Biologically, it is difficult to construe a relationship between the vaccine and menstrual cycles. We should be probably focusing on this. But the mechanism in terms of evolutionary biology in terms of women is much more hardy, so these things won’t affect them. Also, I have been studying vaccines for a very long time, and I have never heard of such things,” he explained.

He added that the fact that people working in the field collecting data were majorly men, and several women shy away from giving out information regarding menstruation to them until it’s asked for.

However, he does agree that it is important for the committee to look into the menstrual changes that happened in Indian women after they were administered Covid-19 vaccines.

Representational picture of taking the vaccine. Changes in menstural changes were not part of Covid 19 vaccine trial in India. Though several women reported on this side effect, it was not listed as one of the side effects or mentioned in the fact sheet.

Malini Aisola is the co-convenor of the All India Drugs Action Network and a civil-society activist who has closely investigated the approval process of the Covid-19 vaccines in India and has individually spoken to and monitored people who have been part of the Covid-19 vaccine trials in India.

Angered by Muliyil’s statement, she told South First, “There were multiple female participants at the trial sites reporting period disruptions of multiple nature. While some stated about periods getting delayed, some spoke on high bleeding and few on period pain. They have even reported it during the trial and even were counselled.”

Aisola recalled: “At least in two cases that I know of from the SII trial — one from a trial site in South India and another from a site in the North — on such period disruptions, they were counselled and were told to take gynaecological advice, contraceptive pills to get their periods, and also get ultrasound scans.”

She added: “So, if you tell me that the company or the DSMB was not aware of such complaints, it makes no sense. They should have reported it as an adverse effect and it should have been put into the fact sheet.”

Aisola also said: “This was in fact even discussed widely on social media after people reported this after the mRNA vaccines abroad. It was even reported in newspapers. At this time, Indian vaccines were still on trial. Why didn’t they take note of it? This is nothing but a failure to ensure the safety of the people by vaccine-makers and approving committees.”

Many vaccines ignore women’s health

Meanwhile, experts agree that vaccine-makers and even approving committees normally ignore women’s health.

Kang said, “No vaccine actually looks at the menstrual changes with vaccination. There has been some discussion now with Covid-19 vaccines as several women reported period changes. Now that it is proven, we must record such associations in the future.

She added: “Also, many vaccine-makers do not talk about women’s health and that’s something that needs to be changed.”

Interestingly, Dr Rajeev Jayadevan, former president of the Indian Medical Association for Kochi, who conducted an extensive survey on post-vaccination symptoms in India reported by healthcare workers, said menstrual irregularities were reported by people in Western nations who took mRNA vaccines.

“Our study from February 2021 was the first to look at immediate post-vaccination symptoms after the Covid-19 vaccines were administered in India, and we did not find any. However, menstrual disturbances would become apparent only with longer follow-up, our study was not designed for that,” he added.

He argued that retrospective studies were prone to recall bias and sampling bias, and therefore might not be accurate.

“In other words, it would be difficult to reliably compare symptoms among the groups of people who took the vaccine and those who did not take the vaccine at this time,” explained Jayadevan.

However, Aisola said they had even demanded that the companies acknowledge such disruptions.

“The distress women went through during the trial period and even after vaccinations due to the period changes was quite bad. Though this was a temporary issue, it could have been avoided. The vaccine-makers should have told this to the public and women should have known what to expect. There should be a system for women to report it as part of the AEFI (Adverse Event Following Immunisation) mechanism. Women’s problems are always ignored,” she said.

South First is awaiting a reply from both Bharat Biotech and the Serum Institute of India to know whether any menstrual changes in women after vaccination and during the trials were noted. The article will be updated accordingly.