Yahoo Finance GSK's (GSK) Boostrix Gets FDA Nod for Pertussis in Newborns
GSK plc GSK announced that the FDA expanded Boostrix’s label for immunization during pregnancy to help prevent pertussis (whooping cough) in infants not older than two months.
Following the label expansion, Boostrix is the first vaccine in the United States specifically approved for use in pregnancy to prevent disease in young infants by vaccinating pregnant women.
Pertussis is a highly contagious respiratory illness which affects all people of all ages. Out of all age groups, infants have the highest risk since they cannot be administered a vaccine directly at an early stage. Per CDC estimates, 4.2% of pertussis cases in 2021 were reported in infants not older than six months.
To protect newborns against pertussis, the FDA approved the dosing of Boostrix in pregnant mothers in their third trimester of pregnancy. Per the regulatory agency, a dose of Boostrix will generate antibodies against pertussis in the mother, which will be transferred to the developing baby.
Boostrix, or tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap), is already approved by the FDA since 2005 for use in individuals aged 10 years and older for immunization against tetanus, diphtheria and pertussis.
While Boostrix was already approved by the FDA for use during pregnancy to protect the mother against tetanus, diphtheria and pertussis, the new approval will allow the vaccine’s use during pregnancy to prevent pertussis in the infant as well.
Shares of GSK have plunged 45.4% in the year so far compared with the industry’s 27.7% decline.
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The FDA’s decision is based on real-world data gathered from a re-analysis of the effectiveness of the Tdap vaccine. This data showed that infants born to mothers who received Boostrix in their third trimester during pregnancy achieved a preliminary estimate of 78% efficacy in preventing pertussis.
Apart from the United States, Boostrix is also approved in more than 80 countries, including European countries, Australia and Canada, as a Tdap vaccine.
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Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold). Some better-ranked stock in the overall healthcare sector includes Aerie Pharmaceuticals AERI, Codiak BioSciences CDAK and Novartis NVS. While Aerie Pharmaceuticals sports a Zacks Rank #1 (Strong Buy), while Codiak BioSciences and Novartis carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Aerie Pharmaceuticals’ 2022 loss per share have narrowed from $1.83 to $1.82. During the same period, the loss estimates per share for 2023 have narrowed from $1.01 to $0.96. Shares of Aerie Pharmaceuticals have gained 116.5% in the year-to-date period.
Earnings of Aerie Pharmaceuticals beat estimates in two of the last four quarters and missed the mark twice, witnessing a surprise of 70.27% on average. In the last reported quarter, AERI delivered an earnings surprise of 38.46%.
In the past 60 days, estimates for Codiak BioSciences’ 2022 loss per share have narrowed from $1.94 to $1.81. During the same period, the loss estimates per share for 2023 have narrowed from $2.14 to $1.53. Shares of Codiak BioSciences have lost 93.7% in the year-to-date period.
Earnings of Codiak BioSciences beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 35.40% on average. In the last reported quarter, CDAK delivered an earnings surprise of 61.54%.
In the past 60 days, estimates for Codiak BioSciences’ 2022 loss per share have narrowed from $1.94 to $1.81. During the same period, the loss estimates per share for 2023 have narrowed from $2.14 to $1.53. Shares of Codiak BioSciences have lost 93.3% in the year-to-date period.
Earnings of Codiak BioSciences beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 35.40% on average. In the last reported quarter, CDAK delivered an earnings surprise of 61.54%.
In the past 60 days, estimates for Novartis’ 2022 earnings per share have increased from $6.06 to $6.09. During the same period, earnings per share for 2023 have increased from $6.68 to $6.69. Shares of Novartis have lost 13.5% in the year-to-date period.
Earnings of Novartis beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 1.39% on average. In the last reported quarter, NVS delivered an earnings surprise of 3.31%.
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