CHICAGO. — Pfizer Inc’s push for health regulators to authorize a third dose of its COVID-19 shot is not yet backed by evidence, despite the fast-spreading Delta variant, vaccine experts said.
Pfizer and German partner BioNTech SE said last week that they will ask US and European regulators within weeks to authorize a booster dose due to an increased risk of infection after six months.
The companies did not share the data showing that risk, but said it would soon be made public. A meeting with federal health officials to discuss the matter was scheduled for Monday, Pfizer said.
In interviews with Reuters, some leading vaccine experts questioned Pfizer’s rationale and said that more data was needed to justify a booster, especially as many countries struggle to administer the initial vaccine doses needed to protect their citizens.”It’s disappointing that with such a complicated decision they took such a unilateral approach,” said Dr. Larry Corey, a virologist at Seattle’s Fred Hutchinson Cancer Center who is overseeing US-government backed COVID-19 vaccine trials.
The rise of the Delta variant, first detected in India and now the dominant form of new coronavirus infections in many countries, has raised concerns over whether currently available vaccines offer enough protection. Several experts say a booster shot would be warranted if there is a substantial increase in hospitalizations or deaths among vaccinated people.
“That’s the line for boosters,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an advisor on vaccines to the US Food and Drug Administration.
That has not been the case so far in the United States, where the overwhelming majority of severe illness occurs in unvaccinated people, he said.
Shortly after Pfizer’s announcement late on Thursday, U.S. health officials sought to reassure the public that anyone who already received two doses of the drug maker’s vaccine was protected against severe disease and death, even from the Delta variant.
“Americans who have been fully vaccinated do not need a booster shot at this time,” the FDA and Centers for Disease Control and Prevention said in a statement.
A Pfizer spokesperson declined to comment on the criticism. — Reuters
