A pharmacist is administering a dose of Pfizer-BioNTech Covid-19 vaccine to a resident of a nursing home in the Bronx neighborhood of New York on December 21st.
Photographer: Eric Lee / Bloomberg
Photographer: Eric Lee / Bloomberg
Pfizer Inc. stated that the second dose of its Covid-19 vaccine should be given to individuals within the recommended 21-day period, calling into question a UK decision to exceed the dosing regimen.
The UK’s decision not to retain any vaccines aims to reach as many people at high risk as possible. According to the government’s plan, the second dose could be given up to 12 weeks later, more than the three-week schedule determined as optimal by Pfizer’s late-stage studies and the four weeks suggested for the vaccine developed by Pfizer. Moderna Inc.
People should take photos according to the recommended schedule, Pfizer said on Thursday, warning that “there is no evidence that protection after the first dose is sustained after 21 days.”
Information on the effectiveness of a single dose has been misinterpreted, said Peter Marks, director of the U.S. Food and Drug Administration’s office that oversees vaccines. Based on a single shot, he said, “it’s worrying.”
“If people don’t really know how protective a vaccine is,” Marks said in an email, “there’s the potential for harm, because it could mean they’re fully protected when they’re not and can change.” behavior to take unnecessary risks. “
Marks’ comments come as The British Medical Association said on Thursday that the UK’s decision would require doctors to reschedule appointments for tens of thousands of elderly and vulnerable patients to receive a second dose of vaccine. The group called the move “Extremely unfair.”
Anthony Fauci, America’s leading infectious disease expert, also weighed Britain’s decision in an interview on NBC Today Show on Thursday. The spread of the two doses is “In the analysis,” he said, though he did not specify who.
“I still think that if done correctly, you can make a single dose, you can reserve doses for the second dose and you can continue the work,” Fauci said. But he added that “you can argue, and some people are thinking of spreading the doses and offering a single dose everywhere and hoping that you will receive the second dose in time to give to individuals.”
In its statement, Pfizer said that there is a need to monitor any alternative vaccination program and that the authorities should work to ensure that each beneficiary is given the maximum possible protection.
“Data from the Phase 3 study showed that although partial protection against the vaccine appears to start as early as 12 days after the first dose, two doses of vaccine are needed to provide maximum protection against the disease, a 95% effectiveness of the vaccine.” , Pfizer said in a statement.
An FDA document with frequently asked questions about Pfizer and its partner The BioNTech SE vaccine found that the agency’s assessment of the safety and efficacy of the vaccine was based on data from patients who received two photographs three weeks apart.
(Add the statement of Peter Marks from the FDA in the fourth and fifth paragraphs.)