Yesterday’s FDA VRBPAC meeting was a big success, we got everything that we were hoping for within the scope of the meeting agenda:
1. Novavax is permitted to continue using a monovalent JN.1 target (1⬇️), which they showed is still inducing robust neutralizing antibody titers across JN.1 lineage strains, such as predominant LP.8.1 (2⬇️). The mRNA manufacturers are also permitted to target LP.8.1, if they wish.
2. There was lengthy and productive discussion about the idea of needing to move away from a seasonal approach to updating COVID vaccines, since COVID doesn’t fit into a seasonal box like viruses such as Influenza or RSV. Most of the committee was supportive of this shift and expressed their desire for future meetings to accomplish that goal. This would be important for getting vaccines available late in the summer, when children are returning back to school.
Next, it’s onto the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting, which is likely going to be the tallest task of the season. They will be considering the implementation of Vinay Prasad and Marty Makary’s new framework for COVID-19 vaccination that seeks to limit access to people under the age of 65, so we need to push back hard against that and (3⬇️):
1. Pressure them to maintain universal recommendations for all ages without the consideration of underlying conditions.
We also want to maintain these 2 things:
2. The allowance to self-attest to immunocompromised status without documentation (cdc.gov/covid/vaccines…)
3. This broad list of underlying conditions that covers upwards of 70% of Americans (cdc.gov/covid/hcp/clin…)
ACIP is meeting on June 25-27th, and the public comment period will run from June 9th to June 20th.
For the next 17 days until public comment opens, take the opportunity to email the 17 ACIP voting members directly (4⬇️) and get them familiar with how much support there is for Novavax and for maintaining broad vaccine recommendations. As always, please remember to be respectful when reaching out.
1. Novavax is permitted to continue using a monovalent JN.1 target (1⬇️), which they showed is still inducing robust neutralizing antibody titers across JN.1 lineage strains, such as predominant LP.8.1 (2⬇️). The mRNA manufacturers are also permitted to target LP.8.1, if they wish.
2. There was lengthy and productive discussion about the idea of needing to move away from a seasonal approach to updating COVID vaccines, since COVID doesn’t fit into a seasonal box like viruses such as Influenza or RSV. Most of the committee was supportive of this shift and expressed their desire for future meetings to accomplish that goal. This would be important for getting vaccines available late in the summer, when children are returning back to school.
Next, it’s onto the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting, which is likely going to be the tallest task of the season. They will be considering the implementation of Vinay Prasad and Marty Makary’s new framework for COVID-19 vaccination that seeks to limit access to people under the age of 65, so we need to push back hard against that and (3⬇️):
1. Pressure them to maintain universal recommendations for all ages without the consideration of underlying conditions.
We also want to maintain these 2 things:
2. The allowance to self-attest to immunocompromised status without documentation (cdc.gov/covid/vaccines…)
3. This broad list of underlying conditions that covers upwards of 70% of Americans (cdc.gov/covid/hcp/clin…)
ACIP is meeting on June 25-27th, and the public comment period will run from June 9th to June 20th.
For the next 17 days until public comment opens, take the opportunity to email the 17 ACIP voting members directly (4⬇️) and get them familiar with how much support there is for Novavax and for maintaining broad vaccine recommendations. As always, please remember to be respectful when reaching out.
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