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United States Pfizer Steps Ahead of Glaxo in Race for Maternal RSV Vaccine
The race to offer pregnant women a vaccine for respiratory syncytial virus is being reshuffled this week: Pfizer announced a step forward as GlaxoSmithKline acknowledged a setback.
Pfizer (ticker: PFE) said Wednesday that the Food and Drug Administration had designated its experimental RSV vaccine as a breakthrough therapy, a status that speeds up the review of new drugs or vaccines thought to be promising.
The respiratory syncytial virus, which is common, causes mild, cold-like symptoms in healthy adults, but can lead to life-threatening disease in infants. The maternal RSV vaccines are in large part designed to prevent the disease in the babies born to the vaccinated mothers.
There is currently no RSV vaccine approved in the U.S.
The announcement came two days after Glaxo (GSK) said it had stopped enrollment and administration of its experimental RSV vaccine in three trials of the inoculation in pregnant women. Ten days earlier, Glaxo said it had paused enrollment in the trials “based on an observation from a routine safety assessment.” The company hasn’t described the safety issues, or offered any other details.
In a note on Feb. 22, after the announcement of Glaxo’s pause but before the announcement of the stop, Bernstein analyst Ronny Gal called the pause a “win for Pfizer.”
“Even if GSK resolves the issue, PFE will now have a ~6month commercial head start (less relevant for vaccines, but still material),” Gal wrote. “If the issue proves fatal for the program, PFE will be alone.”
A Phase 3 trial of Pfizer’s RSV vaccine is under way. Data is expected in the coming months.
RSV vaccines are a hot area of development, so other firms are working on similar projects: Sanofi (SNY) is testing an RSV vaccine in toddlers, while Moderna (MRNA) is testing an RSV vaccine in adults and children.
Pfizer shares were up 2.9% Wednesday morning, while Glaxo’s American depositary receipt was 0.3% higher.
“Today’s decision is a pivotal next step in our path towards potential regulatory approval for our maternal RSV vaccine candidate,” said Pfizer’s head of vaccine research and development, Kathrin Jansen, in a statement. “If approved by the FDA, this maternal immunization has the potential to be the first vaccine candidate to help protect infants in their vulnerable first months of life from disease caused by this highly-contagious virus.”
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
