June 20, 2024: In light of a recent media report , that raised unfounded concerns about the safety of the Bharat Biotech Rotavirus vaccine, Dr. Cyriac Abby Philips, Senior Consultant in Clinical & Translational Hepatology at St. Johns Medical College, has debunked these claims. In his x handle @theliverdr ‘PUBLIC HEALTH ANNOUNCEMENT: IMPORTANT” Dr. Philips strongly criticized the misleading report, describing it as “untrue and devoid of factual scientific interpretation.”
He begins by highlighting “As always trust the Indian “health reporter” to fearmonger the public and demoralize the vaccine industry and vaccination policies to increase vaccine hesitancy and anti-vaccine sentiments within the community. Just like “Make in India” initiative, it seems that India’s “top” health reporters are hell-bent on “Make in India” anti-science sentiments.”
Dr. Philips gave his explanation on his X handle and he goes on to state: Time to get the facts straight. When it comes to health reporting (I should not be teaching this to journalists) please make headlines – black and white and lose that uncertainty/ ambiguity. Such a headline means that even the reporter could not figure out what was happening – science illiteracy.
“As always, trust the Indian ‘health reporter’ to fearmonger the public and demoralize the vaccine industry and vaccination policies, thereby increasing vaccine hesitancy and anti-vaccine sentiments within the community,” Dr. Cyriac Abby Philips stated
He voiced, this study was done specifically to fearmonger anti-vaccine sentiments in India and to destroy India’s image of vaccine power to the world from an author who is associated with The Children’s Health Defense. These people are trying to penetrate Indian population with their American anti-vaccine methods. And unfortunately, an Indian doctor is whoring for them.
Bharat Biotech‘s (BB) Rotavirus vaccine, Rotavac has been in the market for decades. The immunogenicity and safety profiles have been studied across multiple groups, across multiple countries since decades. And It is not only used in India, but many other countries have switched to this Indian made vaccine due to low cost, good efficacy and safety profile. In fact, African countries like Ghana switched from Rotarix made by GSK to Rotavac made by BB because it reduced costs and freed cold chain capacity at comparable efficacy.
See here: https://path.org/our-impact/resources/switch-rotarix-rotavac-ghana-answers-four-key-questions/
Rotavac has an upgraded oral form called Rotavac 5D which has undergone multiple clinical trials to assess safety and efficacy and was pre-qualified by the World Health Organization for use in multiple countries. BB has been doing excellent work in the Rotavirus prevention and they must be congratulated, instead of pulling into conspiracies. See the WHO clearance and full data here: https://extranet.who.int/prequal/sites/default/files/vwa_vaccine/pq_367_368_Rotavac5D_BBIL_VPSAR-WHOPAR-2023.pdf
The peer review on Bharat Biotech Rotavac Vaccine published world is replete with multiple high quality data on various forms of Rotavac. See here:
Now this news report which appeared in recently claims that Rotavac was associated with increased risk of intussusception in infants – this happens when one part of the bowel slides into the next, much like the pieces of a telescope leading to a medical emergency involving obstruction of the intestine. This is based on a NEW STUDY conducted by just two authors.
Self-controlled risk interval study of rotavirus vaccine safety: Findings and implications
Jacob Puliyel, Brian S Hooker
https://pubmed.ncbi.nlm.nih.gov/38875047/
Who is Jacob Puliyel?
Jacob Puliyel is a pediatrician who is now misled and deep into anti-vaccine and science conspiracies, spending time feeding other anti-vaccine groups. And a known vaccine misinformation fearmonger – he started off with the Covid-19 mandates and is now looking to destroy and destabilize life saving National vaccine protocols – https://livelaw.in/top-stories/supreme-court-covid-vaccine-adverse-effects-clinical-trial-vaccine-mandate-194267
who is Brian Hooker?
Brian Hooker is the venom in this story. He is a chemical engineer and has no experience in anything related to healthcare, especially pediatrics. And has been a biology and chemistry teacher for long. Now, he is part of Children’s Health Defense, a cringe-conspiracy platform looking to destabilize vaccination programs.
In 2014 Hooker published a paper titled “Measles-mumps-rubella vaccination timing and autism among young African American boys: a reanalysis of CDC data” in the journal Translational Neurodegeneration. The paper claimed that the 2004 study showed a statistically significant correlation between autism and the MMR vaccine among African-American boys if it was administered at a certain age. Later, the journal retracted the paper for scientific misconduct, saying that Hooker had not disclosed important conflicts of interest and that there were “concerns about the validity of the methods and statistical analysis”. Hooker was a board member of an anti-vaccine group who had provided funding for the study.
Read more on the pseudoscientific anti-vaccine group Children’s Health Defense here: https://en.wikipedia.org/wiki/Children%27s_Health_Defense and more on its cult member Brian Hooker here: https://en.wikipedia.org/wiki/Brian_Hooker_(bioengineer)
Hooker is funded by anti-vaccine groups and Children’s Health Defense and it is possible that Dr. Jacob Puliyel has also received funds for this study. Someone ought to investigate this.
Now the study on Bharat Biotech Rotavirus Vaccine by Jacob Puliyel and Brian Hooker – What we all should know
It is cherry picked garbage. The authors claimed that their new statistical method of identifying vaccine safety – called self-controlled risk interval (SCRI) was superior to the traditional self-controlled case series (SCCS) method in identifying intussusception complication within Rotavac-exposed infants. This is not true.
The self-controlled case series (SCCS) and self-controlled risk interval (SCRI) designs have recently become widely used in the field of post-licensure vaccine safety monitoring to detect potential elevated risks of adverse events following vaccinations. The SCRI design can be viewed as a subset of the SCCS method in that a reduced comparison time window is used for the analysis. Compared to the SCCS method, the SCRI design has less statistical power due to fewer events occurring in the shorter control interval. The relative efficiency declines as the ratio of control-period length between SCRI and SCCS methods decreases, or with an increase in the relative risk – meaning, without the selection of an appropriate length for control interval (and ideally two time frames), SCRI results are of poor quality. The study by Puliyel and Hooker suffers from methodical quality. https://ncbi.nlm.nih.gov/pmc/articles/PMC10878473/
The SCCS and SCRI designs are self controlled, comparing the TaR (the time shortly following the vaccination) to some other time in the same patient’s record. The SCCS design uses all available patient time in the vaccine study period when not at risk as the control time. To account for the fact that people are less likely to be vaccinated directly after a serious health outcome, the 30 days prior to vaccination are removed from the analysis.
The SCRI design uses a pre-specified control interval relative to the vaccination date as the control time. This unexposed time can be either before or after the TaR (meaning SCRI can be modulated as per researcher’s need) – this means that BOTH methods must be used and two time frames included in SCRI to capture events with respect to type 1 and type 2 errors in statistical analysis: https://frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.893484/full
The SCCS design may be advantageous when identification of a vaccinated group is challenging and the outcome is rare. For Rotavirus vaccine, intussusception is considered to be 1 in 100,000 among US infants.
Such a well-designed study, published in the NEJM in 2020 on 970 cases of children by Prof. Gagandeep Kang, DID NOT SHOW any additional risk of intussusception with Rotavac use.
https://ncbi.nlm.nih.gov/pmc/articles/PMC7492078/
When making a medical report for a news media, the reporter must focus on all aspects for people to understand. Here, the reporter seems to have missed the conspiracy group who performed the study, failed to interview real doctors and a vaccine specialist who has already published on this topic in the world’s best journal and has failed to identify mistakes and methodical errors in the study. Indian health reporting is still inside the womb or delivered prematurely. Waiting for a normal delivery. Hopefully in my lifetime. Dr. Cyriac Noted
Disclaimer : This information was derived from the X post by Dr. Cyriac Abby Philips. Senior Consultant – Clinical & Translational Hepatology. MBBS St. Johns Medical College, Bangalore MD (Internal Medicine)
