Updated COVID-19 vaccines are coming this fall

This past Thursday, the FDA’s advisory committee on vaccines and similar biological products met to discuss COVID-19 boosters for this fall. They voted in favor of updating the vaccines based on Omicron XBB, a variant lineage that has dominated both in the U.S. and globally this year.

Read More

FDA and CDC simplify COVID-19 vaccine guidance

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.

Read More

Next-generation COVID-19 vaccines: what you should know

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.

Read More

At-home tests, wastewater: COVID-19 testing after the public health emergency ends

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.

Read More

The future of COVID-19 vaccines needs more data

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.

Read More

The US still doesn’t have the data we need to make informed decisions on booster shots

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.

Read More

Booster shots: What we’ve learned—and what we still don’t know

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.

Read More