COVID-19: Alert in Singapore; ICMR junks BHU’s “study” of vaccine side effects

Virendra Pandit

New Delhi: When COVID-19 is rearing its head again in Singapore, the Indian Council of Medical Research (ICMR) has junked a purported “study” carried out by some Benares Hindu University (BHU) researchers who claimed the COVAXIN vaccine used in India created ‘side effects.’

According to the media reports, Singapore’s government is sounding the alarm over a potential new COVID-19 wave. On Saturday last week, Health Minister Ong Ye Kung warned that the estimated weekly case count almost doubled in the week ending May 11.

“We are at the beginning part of the wave where it is steadily rising,” Kung was quoted as saying by the Straits Times. “The wave should peak in the next two to four weeks, which means between mid and end-June,” he added.

The Ministry of Health (MOH) said the estimated number of COVID-19 cases in the week of May 5 5 to 11 surged to 25,900 cases compared to 13,700 cases in the previous week. This has led health authorities to advise masking up again.

Now, as the new set of ‘FLiRT’ variants now account for over two-thirds of the country’s cases, we look deeper into the matter.
As the new subvariant spread, the average hospitalization cases in the island country also witnessed an uptick to 250, vis-a-vis 181 the week before.

Kung said that if the number of COVID-19 cases doubles once, Singapore will have 500 patients in its healthcare system – which is manageable. However, if the cases double again, there will be 1,000 patients, which would place “a considerable burden on the hospital system.”

“One thousand beds is equivalent to one regional hospital,” Kung said. “So I think the healthcare system has to brace itself for what is to come.”

The ministry pointed out that one of the reasons behind the surge in cases is that 80 per cent of Singapore’s population received an initial or additional vaccine dose. However, they have not received a dose within the last year against emerging strains.

“This indicates that immunity in the population is likely to have waned,” said MOH. “Even as we live with COVID-19 as an endemic disease, we cannot afford to lower our guard.”

The minister also encouraged those at highest risk of disease—including individuals aged 60 and above, medically vulnerable individuals, and residents of aged care facilities to get the updated COVID-19 jab. To send people to get vaccinated, the government is also sending SMS to the public, and extending the working hours of the five Joint Testing and Vaccination Centres from May 21 to June 29, Channel NewsAsia (CNA) reported.

The minister said that Singapore, being a transport and communications hub, would be one of the cities affected by a COVID-19 wave earlier than others.

The new set of COVID-19 variants collectively known as “FLiRT” are responsible for two-thirds of cases in Singapore. First detected in India, the two strains, KP.1 and KP.2 belong to a group of COVID-19 variants scientists have dubbed ‘FLiRT’, after the technical names of their mutations.

They are all descendants of the JN.1 variant, which spread rapidly around the world several months ago. The WHO classified KP.2 as a ‘variant under monitoring’ in May, meaning it is a signal to public health authorities that a COVID-19 variant may require prioritized attention and monitoring.

It is also the dominant strain in the US and has been detected in China, Thailand, India, Australia, and the United Kingdom.

However, the Singapore MOH pointed out that, “There are currently no indications, globally or locally, that KP.1 and KP.2 are more transmissible or cause more severe disease than other circulating variants.”
KP.2, which has now become a predominant variant in the US, currently makes up 28.2 percent of the cases. Experts are pointing to a rise in KP.2 variant cases this summer.

In India, around 91 cases of FLiRT have so far been detected in several regions of Maharashtra.

Meanwhile, the ICMR on Monday slammed a group of researchers from BHU for “erroneously” associating the medical body (ICMR) with a recent study on the effects of Covaxin, saying that it was a “poorly designed” study.

ICMR also directed the researchers to remove the acknowledgment of ICMR from the study and publish an apology, or face legal and administrative action.

“ICMR is not associated with this study and has not provided any financial or technical support for the research. Further, you have acknowledged ICMR for research support without any prior approval of or intimation to the body, which is inappropriate and unacceptable,” a letter, addressed to the authors of the research paper and editor of the science journal in which it was carried out, said.

ICMR Director-General Dr, Rajiv Bahl said: “We request you to retract this paper which implicitly makes conclusions about vaccine safety that are not supported by evidence.

Earlier this month, a team of researchers at BHU conducted a one-year follow-up study on Covaxin, manufactured by Hyderabad-based vaccines maker Bharat Biotech. It involved 635 adolescents and 291 adults, who received Covaxin. The participants were interviewed over the phone about long-term adverse events of special interest (AESI) after one year of vaccination.

According to the study, nearly one-third of the individuals who received Covaxin were reported to have faced AESI, such as viral upper respiratory tract infections, menstrual abnormalities, and Guillain-Barre Syndrome.

Published in a peer-reviewed journal “Drug Safety of Springer Nature,” the study comes in the wake of the British pharmaceutical giant AstraZeneca admitting in a UK court its COVID vaccine can cause rare side effects of blood clotting and lowering of platelets.

However, ICMR flagged poor methodology and critical flaws in the design of the study.

Highlighting that the method of data collection in the study had a high risk of bias, Dr. Bahl pointed out that study participants were contacted telephonically one year after vaccination and their responses were recorded without any confirmation with clinical records or physical examination.

The study has no control arm of unvaccinated individuals for comparing the rate of events between the vaccinated and the unvaccinated groups. “Hence, the reported events in the study cannot be linked or attributed to COVID-19 vaccinations,” the letter stated.
He also said that the study did not provide a rate of observed events in the population, making it impossible to assess the change in the incidence of observed events in the post-vaccination period.

On its part, Bharat Biotech said that its indigenously developed COVID-19 vaccine Covaxin has shown an “excellent safety track record” in various studies.

The vaccine maker said that several studies have been carried out on the safety of Covaxin, and published in peer-reviewed journals, demonstrating an excellent safety track record.