A pharmacist will administer a dose of the Pfizer-BioNTech Covid-19 vaccine to a resident of a nursing home in the Bronx neighborhood of New York on Dec. 21.
Photographer: Eric Lee / Bloomberg
Photographer: Eric Lee / Bloomberg
Pfizer Inc. said the second dose of its Covid-19 vaccine should be delivered to individuals within the recommended 21-day period, questioning a decision by the UK to delay the dosing regimen.
The UK’s decision not to withhold anything from its vaccine offerings aims to reach as many high-risk people as possible as soon as possible. Under the government plan, second doses could be administered up to 12 weeks later, longer than the three-week timing determined as optimal by late-stage Pfizer studies and the four weeks suggested for the shot developed by From Moderna Inc.
People should get their photos on the recommended schedule, Pfizer said Thursday, warning “there is no data to show that protection lasts after the first dose after 21 days.”
Information about the efficacy of a single dose has been misinterpreted, said Peter Marks, director of the United States Food and Drug Administration’s office that oversees vaccines. Relying on one shot, he said, “is concerning.”
“If people don’t really know how protective a vaccine is,” Marks said in an email, “there is a potential for harm because they assume they are fully protected when they are not, and adjust their behavior to avoid unnecessary risks. take. “
Marks’ comments come as the The British Medical Association said Thursday that the UK decision requires doctors to reschedule appointments for tens of thousands of elderly and vulnerable patients to get their second vaccination dose. The group called the move “Grossly dishonest.”
Anthony Fauci, America’s top infectious disease expert, also weighed in on the UK’s decision on Thursday in an interview on NBC’s Today Show. Spreading the two doses is “Under consideration,” he said, although he did not specify by whom.
“I still think that if done right, you can do a single dose, reserve doses for the second dose and still get the job done,” Fauci said. But he added, “You can argue, and some people are, about stretching out the doses and giving a single dose across the board and hoping you get the second dose in time to get to individuals. to give.”
In its statement, Pfizer said that all alternative vaccination schedules need to be monitored, and that authorities must work to ensure that each recipient receives the maximum possible protection.
Data from the phase 3 study showed that although partial protection against the vaccine appears to begin as early as 12 days after the first dose, two doses of the vaccine are required to provide maximum protection against the disease, an efficacy of the vaccine of 95%, ”Pfizer said in his statement.
An FDA document with frequently asked questions about Pfizer and partner BioNTech SE’s vaccine notes that the agency’s assessment of the vaccine’s safety and effectiveness was based on data from patients who received two injections three weeks apart.
(Adds statement from FDA’s Peter Marks in fourth and fifth paragraphs.)