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Another Rotavirus Vaccine Bites the Dust

Serum instituteAnother Rotavirus Vaccine Bites the Dust: Rotavirus vaccine that increases diarrhea instead of reducing it

By Jacob Puliyel MD

Clinical trial of the new rotavirus vaccine from the Serum Institute of India shows that the vaccine increases the incidence of diarrhea instead of decreasing it.

The vaccine was field tested in Niger in Western Africa. The results were published in the prestigious New England Journal of Medicine (NEJM). The authors report that vaccine efficacy was 66.7% against severe rotavirus diarrhea. What was not highlighted was that diarrhea caused by other agents increased significantly and the vaccinated children had more diarrhea than those not vaccinated.

The New England Journal of Medicine has this week published a letter in response to the original article which shows that there was a significantly higher rate of gastroenteritis and diarrhea in the vaccinated group compared to those given the placebo - an inert dummy vaccine. The NEJM letter points out that this vaccine could aggravate the problem it is meant to solve in resource-poor countries. An anti-diarrhea vaccine that increases the incidence of diarrhea is unlikely to find a market.

This is not the first rotavirus vaccine that is under a cloud for not being upfront with trial data.   

Adverse Effects with Rotavac (Bharat Biotech India)

Another vaccine Rotavac, manufactured by Bharat Biotech was recently in the news for not disclosing adverse events in a vaccine trial. This vaccine was tested in 3 centers in India. It appears there was a significant increase in the incidence of intussusceptions – a potentially life threatening complication where the intestine telescopes into itself and can become gangrenous - at the Vellore center. This data from Vellore has not been published in spite of repeated requests for it from various quarters including from the Indian Prime Minister’s office.  

In response to a public interest litigation (PIL) filed  in the Delhi High Court, lawyers for the opposite side  argued that “… site specific data on safety is inappropriate for release as per protocol and its inappropriate interpretation or publication which would lead to disinformation about the product (that has been) developed by government with great effort and expense, and will give unfair advantage to multinational products which were never tested in India, (and) yet (were) licensed.”

This vaccine Rotavac has now been licensed in India and the vaccine is being administered in a Phase IV trial without informing parents of the risks observed in the randomized control trial in Vellore – a clear violation of basic ethical values.

This phenomenon of incomplete and inaccurate reporting of crucial clinical trial data is not limited to Indian manufacturers of vaccines. The GSK recently tested its vaccine in Bangladesh and the outcome was similar.

 Rotarix (GSK) in Bangladesh

PLoS Medicine recently published the results of the Rotarix trial in Bangladesh.  The PLoS Comments by Jain and Mittal point out that the purpose of the vaccine is to reduce the overall burden of disease from diarrhea and diarrhea deaths. However there were more cases of children reporting diarrhea among those vaccinated with Rotarix in Bangladesh, although this increase in diarrhea was not statistically significant. The fact remains that this vaccine did not reduce diarrhea among the vaccinated – in spite of its exorbitant cost.  The authors have not responded to the comments till now.

It all boils down to making a profit. Misrepresenting research findings, cherry picking data, and concealment of adverse events in clinical trials are now seemingly acceptable practices.    (END)

 Jacob Puliyel MD

puliyel@gmail.com

09868035091

Puliyel is a member of the

National Technical Advisory Group on Immunization

Government of India.

The views expressed are his own.

Below is the prepublication galley proof of the NEJM letter

Correspondence

Heat-Stable Oral Rotavirus Vaccine

Jaspreet Kaur, M.B., B.S. Jacob Puliyel, M.D. St. Stephens Hospital Delhi, India puliyel@gmail.com To the Editor: Isanaka and colleagues (March 23 issue)1 tested a heat-stable rotavirus vaccine in Niger and report an efficacy of 66.7% against severe rotavirus gastroenteritis in the per-protocol population. The purpose of rotavirus vaccination is ultimately to reduce the incidence of diarrhea and diarrhea-related death. However, the rate of severe gastroenteritis due to any cause was not significantly lower among the vaccinated infants than among those who received placebo (difference in rate, 1.97 cases per 100 person-years; 95% confidence interval [CI], −1.28 to 5.22). The lack of efficacy against severe gastroenteritis has not been highlighted in the discussion although this information is crucial for decision makers. The intention-to-treat analysis more closely reflects efficacy in real-world conditions. Everyone who received the first dose of vaccine was given was included in the intention-to-treat analysis; 86% of them went on to receive all three doses per the protocol and were included in the per-protocol analysis. In the intention-to-treat analysis, there was a significantly higher rate of gastroenteritis due to any cause in the vaccine group than in the placebo group (difference in rate, −6.59 cases per 100 person-years; 95% CI, −11.89 to −1.29 [negative difference values favor the placebo group]). Again, there was no benefit of the vaccine against severe gastroenteritis. This vaccine could aggravate the problem it is meant to solve in resource-poor countries. Conflict No potential conflict of interest relevant to this letter was reported.

Reference 1. Isanaka S, Guindo O, Langendorf C, et al. Efficacy of a low-cost, heat-stable oral rotavirus vaccine in Niger. N Engl J Med 2017;376:1121-30. [PMID: 28328346]

Comments

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Hans Hitten

Posted by: Someone | July 20, 2017 at 06:30 PM

I also heard yesterday the meningitis vaccine has been shown to be contaminated with E coli.
It wasn't made clear if this was Bexsero or some other permutation\concoction.

Someone

Now, now, everyone, don't despair-- Pharma will find a brand new application for the Rotavirus vaccine. Perhaps it will reduce the incidence of - perhaps-- maybe-- say--- Syphilis -- in one's later years!!! Yeah, that's the ticket-- I mean-- injection! Why let it go to waste? Surely it can have some positive effect. Just like the Meningitis vaccine is now said to protect against Gonorrhea, too!

Jeannette Bishop

The placebo may not be inert:

"The trial vaccine, the calcium carbonate buffer, and the placebo were developed and manufactured by Serum Institute of India, which donated the vaccine, buffer, and placebo. BRV-PV is a bovine–human reassortant vaccine containing rotavirus serotypes G1, G2, G3, G4, and G9 (>5.6 log10 fluorescent focus units per serotype per dose) and is stable for 2 years at a temperature of 37°C and for 6 months at 40°C.21 The placebo was the same formulation but without the viral antigens. The vaccine and placebo were administered orally in liquid form and were identical in appearance and packaging."

Paul Thomas

My own data from the rotavirus vaccine use here in the USA showed significant increased diarrhea and gastroenteritis in the vaccinated compared to those who did not get this vaccine.
Of 2012 children who did NOT get the rotavirus vaccine 17% had diarrhea, and 21% gastroenteritis
Of 218 children who got the rotavirus vaccine 72% had diarrhea, and 87% gastroenteritis
during the 7 year period of the study.

Obviously I need to get this data published!

Hans Litten

The French Situation\Fight (latest news)

http://www.blogtalkradio.com/themaryandsallieshow/2017/07/06/france-threatened-with-8-mandated-vaccines-sophie-guillot-sallie-o-elkordy

Hans Litten

There are some good men in India - I have to say (Jacob Puliyel)

Question for AoA , can we have a Flu vaccine corner ? As well as the Gardasil corner - lol !

http://realfarmacy.com/johns-hopkins-scientist-reveals-shocking-report-flu-vaccines/

A Johns Hopkins scientist has issued a blistering report on influenza vaccines in the British Medical Journal (BMJ). Peter Doshi, Ph.D., charges that although the vaccines are being pushed on the public in unprecedented numbers, they are less effective and cause more side effects than alleged by the Centers for Disease Control and Prevention (CDC). Further, says Doshi, the studies that underlie the CDC’s policy of encouraging most people to get a yearly flu shot are often low quality studies that do not substantiate the official claims.
Promoting influenza vaccines is one of the most visible and aggressive public health policies in the United States, says Doshi of the Johns Hopkins School of Medicine. Drug companies and public officials press for widespread vaccination each fall, offering vaccinations in drugstores and supermarkets. The results have been phenomenal. Only 20 years ago, 32 million doses of influenza vaccine were available in the United States on an annual basis. Today, the total has skyrocketed to 135 million doses.

Doshi’s article “is a breath of fresh air,” says Dr. Blaylock. “This article exposes in well-defined and articulate terms what has been known for a long time — the flu vaccine promotion is a fraud.


“Here’s the bottom line,” says Dr. Blaylock. “The vast number of people who get the flu vaccine aren’t going to get any benefit, but they get all of the risks and complications.”

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