PATH TO APPROVAL
Early data released by FDA shows Pfizer’s vaccine is highly effective after first dose
Atwo-shot coronavirus vaccine developed by Pfizer and German firm BioNTech appears to be on the cusp of regulatory clearance after a 53-page review published Tuesday confirmed that the vaccine meets the standard for emergency use authorization.
The Food and Drug Administration’s review, the first hint of how its career scientists are approaching one of the most momentous decisions in the agency’s history, arrived during a week that could mark a turning point in the pandemic. In Britain, elderly people and nursing home caregivers began receiving shots of Pfizer’s vaccine, even as hospitals in the United States prepared to receive shipments if the Pfizer vaccine gets the green light. The first peer-reviewed publication of results from the University of Oxford and AstraZeneca vaccine candidate fueled that company’s push toward approval in some countries.
But dueling events by the incoming Biden administration and the outgoing Trump administration highlighted the dissonance between historic success in vaccine
development and the growing crisis around the country as the United States surpassed 15 million confirmed cases, just five days after reaching 14 million.
At Joe Biden’s event in Wilmington, Del., the president-elect unveiled a 100-day plan to rein in the coronavirus and acknowledged the difficult struggle ahead. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, appeared by video and endorsed a goal of near-universal mask-wearing this winter and spring. In contrast, the mood at the White House was jubilant, the event opening with a video seeming to mock scientists who had doubted the ambitious timeline for vaccine development, including Fauci.
“Very few people thought that this was possible,” President Donald Trump said when he took the stage.
A weekly White House coronavirus task force report to governors struck a grim tone, noting that the current surge is the “most rapid increase in cases; the widest spread of intense transmission, with more than 2,000 counties in COVID-19 red zones; and the longest duration of rapid increase.” It stresses that vaccines under review “will not substantially reduce viral spread, hospitalizations, or fatalities” until 100 million high-risk Americans are fully immunized, which will take until late spring.
Although distributing a vaccine promises to be a logistically complex and time-consuming proposition, the FDA briefing document is the surest sign so far that the Pfizer vaccine is on track to be cleared for use in the United States. The independent review provides the greatest transparency yet about data so far announced only by news release.
FDA scientists found the vaccine was 95 percent effective at preventing illness after two shots spaced three weeks apart. They identified a promising signal that the vaccine appeared to provide a level of protection even after a single shot, meaning vaccinations could begin to have an impact sooner after immunization than many had expected.
An advisory committee to the FDA is scheduled to hold an all-day virtual meeting to recommend to the agency whether the vaccine should be authorized for use in people ages 16 and up. A decision, informed but not dictated by that debate, is expected to come within days of the meeting. The first doses are expected to be shipped within hours of a decision, with a target of 6.4 million doses distributed in the first week.
Biden said a “herculean task” lies ahead to distribute vaccines but pledged to pursue “the most efficient mass vaccination plan in U.S. history,” resulting in 100 million people receiving shots in 100 days. He said it would be essential for Congress to provide money for the effort.
The document illustrates that the vaccine has clearly surpassed the minimum threshold of being at least 50 percent effective. Reviewers found that the two months of follow-up on 38,000 participants in the trial provide evidence of “a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an [emergency authorization].” The side effects included sore arms, fatigue, headaches, muscle pain and chills that resolved within a few days.
The finding most likely to provoke debate shows that the first shot protected against COVID-19, the disease caused by the virus, and was estimated to be 52 percent effective in the three weeks between the two shots. But the FDA noted there wasn’t enough data to draw firm conclusions.