This week, the FDA made some adjustments to the U.S.’s COVID-19 vaccine guidance in order to standardize all new mRNA shots to bivalent (or Omicron-specific) vaccines, and to allow adults at higher risk to receive additional boosters. The CDC’s vaccine advisory committee and Director Rochelle Walensky both endorsed these changes.
This week, the White House announced that it’s setting up a $5 billion program, called Project Next Gen, to support next-generation COVID-19 vaccines and treatments. Project Next Gen is a big step toward actually ending the pandemic, not just pretending it’s over. The federal government can support large-scale clinical trials and speed up regulatory approval in a way that no research group or company could. Still, the U.S.’s prior vaccine campaigns don’t inspire confidence that this project will lead to widespread adoption of new shots when they become available.
When the public health emergency ends this spring, COVID-19 testing is going to move further in two separate directions: rapid, at-home tests at the individual level, and wastewater testing at the community level. That was my main takeaway from an online event last Tuesday, hosted by Arizona State University and the State and Territory Alliance for Testing.
On Thursday, the FDA’s Vaccines and Related Biological Products Advisory Committee (or VRBPAC) met to discuss the future of COVID-19 vaccines. While the committee readily agreed that our current, Omicron-specific shots are working well and should be used more broadly, it had a hard time answering other questions about future vaccine regimens—largely due to a lack of good data.
This week, the FDA and CDC authorized new booster shots from both Pfizer and Moderna that are tweaked to specifically target Omicron BA.4 and BA.5. Here are some data considerations for the new boosters.
Last fall, I wrote that the U.S. did not have the data we needed to make informed decisions about booster shots. Several months later, we still don’t have the data we need, as questions about a potential BA.2 wave and other future variants abound. Discussions at a recent FDA advisory committee meeting made these data gaps clear.
This week, the FDA’s vaccine advisory committee had a two-day meeting to discuss booster shots for Moderna’s and Johnson & Johnson’s COVID-19 vaccines. From the outside, these meetings may have appeared fairly straightforward: the committee voted unanimously to recommend booster shots for both vaccines. But in fact, the discussions on both days were wide-reaching and full of questions, touching on the many continued gaps in our knowledge about the need for additional vaccine doses.
Why has the booster shot decision-making process been so confusing? Why don’t the experts agree on whether booster shots are necessary, or on who should get these extra shots? From my (data journalist’s) perspective, the booster shot confusion largely stems from a lack of data on breakthrough cases.