FDA OKs GSK’s Boostrix vaccine to safeguard newborns against whooping cough

USA – The US Food and Drug Administration (FDA) has approved Boostrix (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed; Tdap) for immunization during the third trimester of pregnancy to help prevent pertussis (whooping cough) in newborns.

Boostrix has been approved to prevent whooping cough in infants as young as two months old. When administered during pregnancy, the vaccine boosts antibodies in women, which are then passed on to the developing baby.

This is the first vaccine approved specifically for use during pregnancy to prevent disease in young infants whose mothers are vaccinated during pregnancy.

People of all ages can contract the highly contagious respiratory condition, but infants are especially vulnerable to serious health consequences, including hospitalization and death, because their immune systems are still developing.

According to the Centers for Disease Control and Prevention (CDC), 4.2% of total pertussis cases reported in the United States last year were in infants under the age of six months, with nearly 31% requiring hospitalization.

While the FDA’s approval of Boostrix has always included its use during pregnancy to protect the vaccinated individual, the latest decision expands its use to help prevent pertussis, commonly known as whooping cough, in infants younger than two months.

In 2005, Boostrix was approved by the FDA as a single dose to boost immunization against pertussis, tetanus, and diphtheria in individuals aged 10 years to 18 years.

Later, the vaccine was also approved for use in individuals aged 19 years and above, as well as for use as an additional dose for individuals aged nine years or above following the first Tdap vaccine dose.

The CDC has also recommended the Tdap vaccines’ use during the third trimester of each pregnancy since 2012.

Boostrix’s effectiveness was determined based on its re-analysis from an observational case-control study of Tdap vaccine effectiveness.

Re-analysis of data from an observational case-control study showed that the Dtap vaccine was 78% effective in preventing whooping cough.

GSK earned £521 million (US$576 million) from Boostrix last year, a 14% increase over 2020 at constant exchange rates. Higher demand and market share in the United States contributed to the increase.

Boostrix is currently approved in over 80 countries worldwide, including the US, most European Union countries, Canada, Australia, and New Zealand for immunization against tetanus, diphtheria, and pertussis.

GSK’s respiratory virus jab shows positive results

In another milestone development, GSK trial results appeared to show that its potential blockbuster vaccine for respiratory syncytial virus is more effective than Pfizer’s, pitting the two rivals against each other in new markets for protecting older adults against the common lung infection.

In clinical trials data released by the company, it said its vaccines showed overall efficacy of 82.6 percent, which is above Pfizer’s previously announced 66.7 percent, although trials are not always directly comparable.

GSK’s vaccine candidate, which it plans to submit for approval this year, reduced severe RSV disease by 94.1 percent above Pfizer’s 85.7 percent for preventing severe disease.

In the meantime, GSK is investigating treatments for COVID-19 patients, collaborating with Vir Biotechnology to evaluate monoclonal antibodies that could be used as COVID-19 therapeutic or preventive options.

GSK and Vir Biotechnology announced a U.S. government agreement in January 2022 to purchase additional supplies of sotrovimab, which is approved for the early treatment of COVID-19.

Further to that, the World Health Organization (WHO) granted prequalification to GSK’s groundbreaking malaria vaccine Mosquirix (also known as RTS,S/AS01) in September 2022.

According to the company, this is the first prequalification for a malaria vaccine and is an important step toward distributing the vaccine in countries with moderate-to-high malaria transmission.

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