Limited, Not Full-scale Booster Shots Mulled
FDA has alerted Biden Administration officials that it may only be able to give the green light for those vaccinated with the Pfizer/BioNTech Covid-19 vaccine to begin receiving booster shots later this month. So far, only Pfizer has submitted full data to FDA on booster shots, and an advisory committee is scheduled to review its data 9/17 (see earlier story). Moderna just began submitting data earlier this week, and it is very unlikely that submission will be completed and approved before October, and details are vague as to when the Johnson & Johnson booster vaccine submission would be finalized.
FDA acting commissioner Janet Woodcock and CDC director Rochelle Walensky reportedly met with White House coronavirus officials 9/2 to advise them about a potential delay in authorizing full-scale booster shots by the planned rollout date of 9/20. It appears the best case scenario is that the Pfizer booster would be the first to get FDA backing. White House officials are now signaling that they will rely on FDA and CDC’s full review and approval before moving ahead to encourage such boosters.
Meanwhile, Woodcock 9/2 appeared in an online WebMD interview and addressed criticism about senior FDA officials and the White House getting ahead of agency reviewers by announcing the booster plan and its anticipated 9/20 rollout. She said everyone needs to calm down and look at the facts. “The facts are: it looks as if there is immunity from the current regimen of vaccines that we have in the United States, but immunity is waning over time and we are seeing breakthrough infections,” she said. “There are a few people who are needing hospitalization who’ve been fully vaccinated.”
Woodcock defended the Biden Administration’s announcement of its plan on booster shots. “Well, we need to have a plan and the plan would involve the vaccination of very large numbers of people in the United States, with a booster dose,” she said in the WebMD interview. “And we have to make a plan somewhat before we have all the data. And I think that is what’s confusing people.
“With the trends that we’re seeing in resistance to the virus in fully immunized people lead us to believe that at some point we’re going to cross that threshold,” Woodcock continued, “and we’re going to see more hospitalizations and more serious disease. And when that happens, we want to be ready. If it doesn’t happen, fine, but when it happens, we don’t want to have a couple more months where we have to get ready and make a plan, and then execute against that plan... You could talk to me in two months and if a plan hadn’t been made, you would be saying, ‘well, why was there no contingency plan’ if, in fact, vaccine efficacy waned to the point where we were seeing a lot of hospitalizations, and yet we were not ready.”
Asked what the pandemic will look like in six months, Woodcock said: “Our best case that we hope is that we will get more of our population vaccinated, we will reduce the spread of this virus, and we can move back to an ordinary way of managing it, which would be contact tracing and isolation of infected people and so forth... But it’s also possible we may see additional resistant variants that have other characteristics. We hope we won’t see any that really elude protection from the vaccines, but we have to think that could happen and plan for it. And, you know, there are other possibilities in between those scenarios. So, I think with a pandemic you have to think about scenario planning, not ‘this is what's going to happen in six months,’ because we don’t know.”