Abbott launches new four-strain flu vaccine for wide protection against influenza

• Globally approved, this 3^rd generation quadrivalent vaccine, offers wide coverage protection against four flu virus strains for children and adults vs. three strains in previous generation

• Sub-unit vaccines offer similar immunization benefits with better tolerability compared to other flu vaccine types, with lesser side effects

• New vaccine is also the first and only quadrivalent flu vaccine (0.5 ml) in India approved for use in children under 3 years of age

• Influenza reported cases have increased 23% per annum in Maharashtra from 643 in 2013 to 2,287 reported cases in 2019¹. Vaccination is the best defense against influenza

MUMBAI, India; February 24, 2020 — Abbott, the global healthcare company, recently launched a new inactivated quadrivalent vaccine for influenza, the first of its kind sub-unit vaccine offering protection against four virus strains, in India. It is the only 0.5 ml quadrivalent flu vaccine in India that has been approved for use in children below 3 years. In fact, it can be given to children from 6 months onwards, and to adults. A 0.5 ml vaccine could improve the immune response in children below 3 years².

A globally approved product, Abbott’s vaccine offers wide protection by immunizing against four different flu virus strains simultaneously. Hence, it is called a quadrivalent or tetravalent vaccine. It includes a second B-strain of influenza virus, compared to one B-strain included in trivalent vaccines. Recommending a vaccine can be complex for the health authorities. This is because there may be a mismatch in the vaccine strain and the circulating viral strain. Therefore, the inclusion of an additional B-strain in quadrivalent vaccines can help broaden protection.

As per a recently published study on this vaccine globally, in children, quadrivalent vaccines demonstrated superior immunogenicity or immune response compared with the alternate- lineage B-strains in trivalent vaccines, with comparable safety³.

This is the first 3^rd generation, quadrivalent sub-unit flu vaccine in India. A sub-unit vaccine is the most advanced flu vaccine⁴. The benefit of a sub-unit vaccine is that it undergoes a further step of purification as compared to split vaccines, and thus is more refined. This may lead to lesser side-effects ⁵. In clinical studies conducted globally across high-risk groups including children, the elderly, pregnant women, asthmatics and diabetics, sub-unit vaccines have shown better tolerability and a favourable safety profile compared to other flu vaccine types.⁶”

An inactivated influenza vaccine is beneficial in high risk populations, since it can be given to a larger set of people, such as pregnant women, children below 2 years, older adults and immunocompromised patients⁷.

Dr. Srirupa Das, Medical Director, Abbott India said, “We are excited with the launch of the quadrivalent version of our flu vaccine, which can be offered to both children above 6 months and adults. This particular type of vaccine provides good immune response with less side-effects. This is yet another significant step in Abbott’s endeavor to protect as many people as possible against the flu. As part of its “Mothers Against Influenza” (MAI) campaign, which recognizes the potentially serious consequences that influenza can have, Abbott is raising awareness among people on the importance of protecting families against influenza so that they may live healthier, fuller lives.”

A respiratory infection that affects all ages, influenza is distinct from the common cold. An influenza infection typically results in high fever lasting for 3 to 4 days, including symptoms such as headache, myalgia or muscle pain, exhaustion and severe chest discomfort and cough. Moreover, influenza can cause serious complications in certain groups such as those with respiratory ailments, cardiac disease and diabetes, as well as young children and the elderly. Influenza A and B, the two viruses that cause human disease, are currently circulating globally and in India causing seasonal outbreaks. The disease burden of influenza is substantial, and B viruses have been estimated to be associated with 25% of all influenza related mortality.⁸

Dr. Agam Vora, a leading Pulmonologist from Mumbai and President, Geriatric Society of India said, “The National Center of Disease Control estimates show that influenza reported cases have increased 5-fold in India from 5,044 in 2012 to 28798 in 2019⁹. And in Maharashtra, influenza reported cases have increased 23% per annum from 643 in 2013 to 2,287 reported cases in 2019¹⁰. Vaccination is the best defense against influenza, and there is compelling evidence to show that quadrivalent vaccines offer wide-coverage protection. Studies show that these vaccines offer increased protection against alternate B-strains across different age-groups.¹¹ Quadrivalent vaccines most benefit infants and children, not yet exposed to influenza B ¹².”

Children are particularly vulnerable to influenza. One India study estimates over 16 million influenza cases occurred in 2016 in under-5-year-old patients, accounting for 10.9 million outpatient visits and 109,000 hospitalizations.¹³ Despite the proven benefits of influenza vaccination in children as well as adults and the elderly, immunization rates across all vaccine preventable diseases remain low.

About Influenza

Influenza is a highly infectious respiratory disease caused by viruses. The virus causing influenza undergoes mutation (into new strains) and causes periodic epidemics and pandemics. Thus, influenza is a global public health problem, causing considerable mortality and morbidity.

In India, seasonal influenza epidemics can occur during winter and rainy season months. One study found that influenza accounted for 20-42% of monthly acute illness hospitalizations during the rainy season.¹⁴ People with underlying (chronic) conditions such as respiratory, cardiac disease and diabetes, as well as young children and the elderly, are at increased risk for complications / hospitalizations associated with influenza.

About quadrivalent influenza vaccines (QIV)

Trivalent influenza vaccines (TIV) include two influenza A strains (H1N1 and H3N2) and only one influenza B virus (of either Victoria or Yamagata lineage). A mismatch can occur between the B-strain included in the vaccine and the circulating B strain. When such a mismatch occurs, conventional trivalent vaccines have shown limited ability to protect against the circulating strain.¹⁵

In February 2013, the World Health Organization issued guidelines recommending both expected B-strains be included in the vaccine composition. Quadrivalent influenza vaccines (QIVs), which include another type B-strain in line with this recommendation, can offer enhanced protection. The disease burden of both A and B viruses is substantial, and B viruses have been estimated to be associated with 25% of all influenza related mortality.¹⁶

As influenza B is associated with substantial mortality¹⁷, the use of QIVs over TIVs may further reduce the burden of influenza¹⁸. According to one study, QIV administration could prevent 11.2% of all influenza B infections which still occur with TIV¹⁹. The belief that influenza B illness is less severe than influenza A leads to underestimation of its impact. There is evidence of circulation of both lineages of influenza B virus in India,²⁰ making a case for additional protection.

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries. In India, Abbott was established in 1910, and is one of the country’s oldest and most admired healthcare companies. With over 12,000 employees in the country, Abbott in India is helping to meet the healthcare needs of consumers, patients and doctors throughout urban and rural India.

Connect with us at www.abbott.com and www.abbott.in, on Facebook at www.facebook.com/Abbott and www.facebook.com/AbbottIndia, and on Twitter @AbbottNews and @AbbottGlobal.