What WHO prequalification means for Bharat Biotech’s Rotavac 5D

Bharat Biotech on Monday announced in a press release that the World Health Organisation (WHO) has awarded prequalification to its rotavirus vaccine, Rotavac 5D, to prevent rotavirus diarrhea.

What is Rotavirus?

According to WebMD, Rotavirus causes diarrhea and other intestinal symptoms. It is very contagious and is the most common cause of diarrhea in infants and young children worldwide. It has a round shape. The Latin word for wheel is “rota,” which explains how the virus got its name.

Rotavirus causes inflammation in the stomach and intestines. It can cause severe diarrhea, vomiting, fever, belly pain, and dehydration in infants, young children, and some adults.

Medication can help alleviate the symptoms, but there’s no cure for rotavirus.

Even children who have been vaccinated against it may get it more than once.

The Rotavirus symptoms include fever, vomiting, and stomach pain. Rotavirus usually starts with these symptoms, which then fade away. Diarrhea begins after the first three symptoms have stopped. As the virus works its way through the system, diarrhea can remain for 5 to 7 days.

What is ROTAVAC 5D?

A new variant of rotavirus vaccine (ROTAVAC) ROTAVAC 5D, is the world’s first and only liquid formulation with lowest dosage form and can be stored at 2-8°C.

As per Bharat Biotech, ROTAVAC 5D is a monovalent vaccine containing suspension of live, naturally attenuated rotavirus neonatal 116E strain prepared in Vero cells for the prevention of rotavirus gastroenteritis. Each dose of 0.5 mL ROTAVAC 5D contains not less than 105.0 FFU [Focus forming unit] of live rotavirus 116E. It is administered in five drops as a three-dose regimen, four weeks apart, beginning at six weeks of age.

ROTAVAC 5D is a unique rotavirus vaccine formulation that can be administered without buffer. Low dose facilitates easy vaccine logistics and cold chain management, and low biomedical waste disposal post-vaccination.

It can be stored at 2 to 8°C for up to 24 months. ROTAVAC 5D confers similar clinical safety and immunogenicity profiles when compared to the WHO Prequalified ROTAVAC. It is available in three different presentations: single-dose vial/pre-filled syringe and multi-dose vial. The available presentations and lowest dosage form make it convenient and easy to adapt under Universal Immunization Programs (UIP) by countries.

How serious is the Rotavirus mortality in India?

In the study Rotavirus mortality in India: estimates based on a nationally representative survey of diarrhoeal deaths conducted to estimate the number of rotavirus-associated deaths among Indian children younger than five, researchers found that the “burden of rotavirus-associated mortality is high among Indian children, highlighting the potential benefits of rotavirus vaccination.”

It said: “Rotavirus caused an estimated 113 000 deaths (99 percent confidence interval, CI: 86 000-155 000); 50 percent (54 700) and 75 percent  (85 400) occurred before one and two years of age, respectively. One child in 242 died from rotavirus infection before five years of age. Rotavirus-associated mortality rates overall, among girls and among boys were 4.14 (99 percent  CI: 3.14-5.68), 4.89 (99 percent  CI: 3.75-6.79) and 3.45 (99 percent  CI: 2.58-4.66) deaths per 1,000 live births, respectively. Rates were highest in Bihar, Uttar Pradesh and Madhya Pradesh, which together accounted for > 50 percent of deaths (64 400) nationally. Rotavirus vaccine could prevent 41 000-48 000 deaths among children aged 3 to 59 months.”

In India, every year 37 out of every 1,000 children born are unable to celebrate their 5th birthday, and one of the major reasons for this is diarrheal deaths. Of all the causes of diarrhoea, rotavirus is a leading cause of diarrhoea in children less than 5 years. It is estimated that rotavirus cause 8,72,000 hospitalisations; 32,70,000 outpatient visits and estimated 78,000 deaths annually in India. Rotavirus diarrhoea presents in similar manner like any other diarrhoea but can mainly be prevented through rotavirus vaccination.

Rotavirus vaccine was introduced in 2016 in a phased manner, beginning with four states initially and later expanded to seven more states making it a total of 11 states by end of 2018, where Rotavirus vaccine was available in the country. Rotavirus vaccine is now available in 28 States/UTs: Andhra Pradesh, Haryana, Himachal Pradesh, Jharkhand, Odisha, Assam, Tripura, Rajasthan, Tamil Nadu, Madhya Pradesh, Uttar Pradesh, Manipur, Daman & Diu, Gujarat, Bihar, Sikkim, Arunachal Pradesh, Chhattisgarh, Maharashtra, Dadra & Nagar Haveli, Goa, Chandigarh, Nagaland, Delhi, Mizoram, Punjab, Uttarakhand, and Andaman and Nicobar Islands.

What is WHO prequalification?

Prequalification is a systematic process to determine the capacity of a manufacturer to produce a product of consistent quality in accordance with international standards and WHO/UNFPA specifications. The purpose of prequalification is to protect the buyer and the end-user by ensuring good quality products are procured and distributed.

What WHO prequalification means for Bharat Biotech’s Rotavac 5D

In an official statement, the company explained that its low dose volume (0.5 mL) facilitates easy vaccine logistics, cold chain management and low biomedical waste disposal post-vaccination. Moreover, it is used for the prevention of rotavirus infection, which is prevalent in infants and young children.

“The WHO prequalification enables the procurement of Rotavac 5D by UN agencies namely UNICEF and PAHO. It is a validation of the global quality and safety standards required for paediatric vaccines. The WHO prequalification of Rotavac 5D will fast-track global access to this life saving vaccine,” as per the statement.

Bharat Biotech’s Joint Managing Director Suchitra Ella said, “Rotavac and Rotavac 5D are projects conceived, innovated, and executed in India; in collaboration with Indian and Global partners. This is the culmination of a 30-year effort to develop a novel rotavirus vaccine, resulting in a major advancement in Rotavirus disease prevention and reasserts India’s leadership in developing and introducing rotavirus vaccines for the world. Today’s announcement is an important step to further strengthen and fulfill Bharat Biotech’s vision to address neglected diseases and prevent infections that continue to affect millions in the developing world.”

When was ROTAVAC 5D launched?

On 3 December, 2019, Vice- President M Venkaiah Naidu had launched the new rotavirus vaccine – ROTAVAC5D designed and developed by Bharat Biotech in New Delhi. Naidu had said that the vaccine would be a great help in tackling the spread of Rotavirus. The vice president also pointed out that the disease could push many Indian families, especially those below the poverty line into considerable financial distress and also impose a significant economic burden on the country.